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Zoloft sertraline hydrochloride 100 mg Tablet, Film Coated

by Viatris Specialty LLC · 100 BLISTER PACK in 1 CARTON (58151-576-88) / 1 TABLET, FILM COATED in 1 BLISTER PACK (58151-576-32)

NDC 58151-0576-88

🏷️ FDA NDC (as labeled) 58151-576-88 billing pads the product segment with a zero

This package

Contains1 tablet, film coated in 1 blister pack Cost per ea$14.95 NADAC Per package$1,495.04 / 100 tablet Pack sizes2 compare ↓

Also priced by: Part D plans $15.41/unit — full pricing hub ↓

Also comes in: 30 tablets 58151-0576-93

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Sertraline Hydrochloride (different manufacturers) — 2 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Nov 5, 2025 — Defective container - seal not adhering to bottles (Lupin Pharmaceuticals Inc.) · FDA recall D-0227-2026

Class II · Dec 11, 2023 — CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. (Legacy Pharmaceutical Packaging LLC) · FDA recall D-0205-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 58151-576-88

Product NDC 58151-576

11-digit billing NDC 58151057688

NCPDP billing unit EA — each (per item)

RxCUI 208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066

UNII UTI8907Y6X

Application # NDA019839

SPL Set ID fda754f6-d0f3-4dce-a17a-927d64f912f7

Established class (EPC) Serotonin Reuptake Inhibitor

Mechanism of action Cytochrome P450 2D6 Inhibitors; Serotonin Uptake Inhibitors

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-10-30

Route ORAL

Dosage form TABLET, FILM COATED

Substance SERTRALINE HYDROCHLORIDE

GPI-14 58160070100320

GCN Seq No 046229

GCN 16375

HICL code 006324

Ingredient (HICL) Sertraline Hcl

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H2

Therapeutic class — intermediate (HIC2) Psychoactive Drugs

HIC3 code H2S

Therapeutic class — specific (HIC3) Selective Serotonin Reuptake Inhibitor (Ssris)

AHFS code 28:16.04.20

AHFS class Selective-Serotonin Reuptake Inhibitors

FDB label name ZOLOFT 100 MG TABLET

FDB brand name Zoloft

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 58151-576-88 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58151-0576-88. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor

Drug family (ATC) Selective serotonin reuptake inhibitors

How it works Serotonin Uptake Inhibitors, Cytochrome P450 2D6 Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerViatris Specialty LLC

Application holderVIATRIS SPECIALTY LLC

FDA applicationNDA019839 (NDA)

Labeler code58151

First marketedOct 2024

Product typeHuman Prescription Drug

Portfolio120 products on file

🔎 All NDCs from Viatris Specialty LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ZOLOFT 100 MG TABLET Ingredient Sertraline Hcl

📖 What it is MedlinePlus · NLM

Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, (mood swings, irrita...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Most people don't feel the full benefit right away — sertraline typically takes several weeks to build up to steady levels in your body. Some people notice small improvements in sl...
How long does it take for sertraline to start working?
You should be cautious. Sertraline affects the blood's ability to clot, and combining it with aspirin, ibuprofen, naproxen, or other anti-inflammatory pain relievers raises your ri...
Is it okay to take sertraline with ibuprofen or aspirin?

📖 Read our full Sertraline guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Sertraline may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

SODIUM Moderate Depletion

🧪 Full Sertraline nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Green / Blue / Yellow

ShapeOval

ImprintZOLOFT;100;mg

Size13 mm

ScoringScored — splits in 2

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$14.950	$1,495.04 / 100 tablet
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$15.41	$1,540.60 / 100 tablet

NADAC price history (per ea) — tap or hover for the price & month

Flat over the last 5 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sertraline Hydrochloride 100 mg 16729-0217-15	Accord	90 tablets	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 00904-6926-61	Major	1 tablet	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 16714-0613-01	NorthStar	30 tablets	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 31722-0147-05	Camber	500 tablets	$0.050	—	Availability likely	save 100%
Sertraline 100 mg 50268-0770-15	AvPAK	1 tablet	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 50268-0825-15	AvPAK	1 tablet	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 60687-0253-01	American	100 tablets	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 65862-0013-01	Aurobindo	100 tablets	$0.050	—	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 68180-0992-01	Lupin	30 tablets	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 68645-0523-54	Legacy	30 tablets	$0.050	AB	Availability likely	save 100%
Sertraline Hydrochloride 100 mg 69097-0835-02	Cipla	30 tablets	$0.050	AB	Availability likely	save 100%
Sertraline hydrochloride 100 mg 70010-0205-03	Granules	30 tablets	$0.050	AB	Availability likely	save 100%
Sertraline 100 mg 76282-0214-01	Exelan	100 tablets	$0.050	AB	Discontinued	save 100%
Sertraline Hydrochloride 100 mg 82009-0050-05	Quallent	500 tablets	$0.050	AB	Availability likely	save 100%
Zoloft 100 mg 00049-4910-30	ROERIG	30 tablets	$14.947	AB	Discontinued	+0%
Zoloft 100 mgthis 58151-0576-88	Viatris	1 tablet	$14.950	AB	Availability likely	—
Sertraline Hydrochloride 100 mg 00615-8604-05	NCS	15 tablets	—	AB	FDA listed	—
Sertraline 100 mg 23155-0759-03	Heritage	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 43063-0754-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 43353-0447-15	Aphena	15 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 43602-0981-15	Ascent	30 tablets	—	—	FDA listed	—
Sertraline 100 mg 50090-0991-00	A-S	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-2080-00	A-S	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-3203-00	A-S	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-6917-00	A-S	90 tablets	—	AB	FDA listed	—
Sertraline 100 mg 50090-7295-00	A-S	90 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-7693-00	A-S	30 tablets	—	—	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-7694-00	A-S	90 tablets	—	—	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-7700-00	A-S	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 50090-7701-00	A-S	90 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 50228-0469-05	ScieGen	500 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 51655-0173-26	Northwind	90 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 55154-3570-00	Cardinal	1 tablet	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 55154-4692-00	Cardinal	10 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 55700-0362-30	Quality	30 tablets	—	AB	Discontinued	—
Sertraline Hydrochloride 100 mg 60760-0091-90	St.	90 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 60760-0738-90	St.	90 tablets	—	AB	FDA listed	—
Sertraline 100 mg 63187-0212-30	Proficient	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 63187-0795-30	Proficient	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 67046-0554-03	Coupler	30 tablets	—	AB	FDA listed	—
Sertraline hydrochloride 100 mg 67046-1682-03	Coupler	30 tablets	—	AB	FDA listed	—
Sertraline 100 mg 68071-3534-03	NuCare	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 68071-4658-03	NuCare	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 68071-4973-06	NuCare	60 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 68180-0353-01	Lupin	100 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 68788-6835-01	Preferred	100 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 68788-8210-03	Preferred	30 tablets	—	AB	FDA listed	—
Sertraline 100 mg 70518-1040-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 70518-2448-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 70518-4590-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71205-0047-30	Proficient	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71205-0455-30	Proficient	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71335-0210-01	Bryant	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71335-0510-01	Bryant	30 tablets	—	AB	Discontinued	—
Sertraline Hydrochloride 100 mg 71335-0896-01	Bryant	30 tablets	—	AB	Discontinued	—
Sertraline Hydrochloride 100 mg 71335-3110-01	Bryant	30 tablets	—	AB	FDA listed	—
Sertraline 100 mg 71335-3115-01	Bryant	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71610-0433-15	Aphena	15 tablets	—	AB	Discontinued	—
Sertraline Hydrochloride 100 mg 71610-0435-45	Aphena	45 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71610-0651-15	Aphena	15 tablets	—	AB	FDA listed	—
Sertraline 100 mg 71610-0769-15	Aphena	15 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 71610-0886-15	Aphena	15 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 72162-2407-03	Bryant	30 tablets	—	AB	FDA listed	—
Sertraline 100 mg 72162-2411-00	Bryant	1000 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 72189-0122-30	DIRECT	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 72789-0088-60	PD-Rx	60 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 72789-0092-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 72789-0273-01	PD-Rx	100 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 72865-0207-05	XLCare	500 tablets	—	—	FDA listed	—
Sertraline Hydrochloride 100 mg 76420-0786-01	Asclemed	100 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 80425-0310-01	Advanced	30 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 84386-0099-59	Aurobindo	5000 tablets	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 87441-0076-01	Unit	30 tablets	—	AB	FDA listed	—
Sertraline hydrochloride 100 mg 70518-4707-00	REMEDYREPACK	1 tablet	—	AB	FDA listed	—
Sertraline Hydrochloride 100 mg 82804-0311-90	Proficient	90 tablets	—	AB	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2024

On the market since

Oct 2024

📍

2026

Currently FDA-listed

2 years listed

🔓

Generic versions listed

see equivalents

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

30 tablets58151-0576-93 1,568 Rx · $1,334,725

1 tablet this page58151-0576-88 No Medicaid data

Drug total (last 4 qtrs): 1,568 Rx · 94,165 units · $1,334,725 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zoloft — the program that covers self-administered drugs. 2 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zoloft. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$3.24M

Claims incl. refills

3.1K

Beneficiaries

1.8K

Spend / beneficiary

$1,771.28

Spend / claim

$1,034.94

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Zoloft (this brand).

Top reported reactions

Nausea7,492

Fatigue7,045

Headache6,288

Anxiety5,880

Depression5,852

Pain5,184

Diarrhoea5,153

Age at onset

Neonate81

Infant22

Child162

Adolescent451

Adult7,161

Elderly3,805

Reporter sex

Male · 30%

Female · 70%

Unknown · 0%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
58151-0576-88 You're viewing this	100 BLISTER PACK in 1 CARTON (58151-576-88) / 1 TABLET, FILM COATED in 1 BLISTER PACK (58151-576-32)	$14.95 / ea	$1,495.04	2025-07-01	Active
58151-0576-93	30 TABLET, FILM COATED in 1 BOTTLE (58151-576-93)	$14.95 / ea	$448.51	2024-11-26	Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($14.95 NADAC).

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 58151-0576-88?

NDC 58151-0576-88 is listed by the FDA — 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack.

What NDC number is used to bill for this package of Zoloft sertraline hydrochloride 100 mg Tablet, Film Coated?

Bill NDC 58151-0576-88 — the 11-digit billing format is 58151057688. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 94 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 )

🎯 Indications and Usage 91 words ▾

1 INDICATIONS AND USAGE ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14) ] : • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Starting Dosage Maximum Dosage MDD ( 2.1 ) 50 mg per day 200 mg per day OCD ( 2.1 ) 25 mg per day (ages 6-12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD ( 2.1 ) 25 mg per day 200 mg per day PMDD ( 2.2 ) continuous dosing 50 mg per day 150 mg per day PMDD ( 2.2 ) intermittent dosing 50 mg per day during luteal phase only 100 mg per day during luteal phase only • If inadequate response to starting dosage, titrate in 25-50 mg per day increments once weekly in MDD, OCD, PD, PTSD, and SAD ( 2.1 ) • See Full Prescribing Information for titration in PMDD ( 2.2 ) • Hepatic impairment: o Mild: Recommended starting and maximum dosage is half recommended dosage ( 2.4 ) o Moderate or severe: Not recommended ( 2.4 ) • When discontinuing ZOLOFT, reduce dose gradually ( 2.6 , 5.4 ) • Oral solution: Must be diluted before administration ( 2.7 )

2.1Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum ZOLOFT dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage. For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day.

Given the 24-hour elimination half-life of ZOLOFT, the recommended interval between dose changes is one week. Table 1: Recommended Daily Dosage of ZOLOFT in Patients with MDD, OCD, PD, PTSD, and SAD Indication Starting Dose Therapeutic Range Adults MDD 50 mg 50-200 mg OCD 50 mg PD, PTSD, SAD 25 mg Pediatric Patients OCD (ages 6-12 years old) 25 mg 50-200 mg OCD (ages 13-17 years old) 50 mg

2.2Dosage in Patients with PMDD The recommended starting ZOLOFT dosage in adult women with PMDD is 50 mg per day. ZOLOFT may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle. • When dosing continuously , patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day. • When dosing intermittently , patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.

2.3Screen for Bipolar Disorder Prior to Starting ZOLOFT Prior to initiating treatment with ZOLOFT or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions (5.4) ] .

2.4Dosage Modifications in Patients with Hepatic Impairment Both the recommended starting dosage and therapeutic range in patients with mild hepatic impairment (Child Pugh scores 5 or 6) are half the recommended daily dosage [See Dosage and Administration (2.1 , 2.2) ] . The use of ZOLOFT in patients with moderate (Child Pugh scores 7 to 9) or severe hepatic impairment (Child Pugh scores 10-15) is not recommended [See Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .

2.5Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of ZOLOFT. In addition, at least 14 days must elapse after stopping ZOLOFT before starting an MAOI antidepressant [See Contraindications (4) , Warnings and Precautions (5.2) ] .

2.6Discontinuation of Treatment with ZOLOFT Adverse reactions may occur upon discontinuation of ZOLOFT [See Warnings and Precautions (5.5) ]…

💊 Dosage Forms and Strengths 144 words ▾

3 DOSAGE FORMS AND STRENGTHS 25 mg tablets : light green film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “25 mg” 50 mg tablets : light blue film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “50 mg” 100 mg tablets : light yellow film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “100 mg” Oral solution : a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol.

It is supplied as a 60 mL bottle with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. • Tablets: 25 mg, 50 mg and 100 mg ( 3 ) • Oral solution: 20 mg/mL ( 3 )

⛔ Contraindications 163 words ▾

4 CONTRAINDICATIONS ZOLOFT is contraindicated in patients: • Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2) , Drug Interactions (7.1) ] . • Taking pimozide [See Drug Interactions (7.1) ] . • With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1 , 6.2) ] . In addition to the contraindications for all ZOLOFT formulations listed above, ZOLOFT oral solution is contraindicated in patients: • Taking disulfiram.

ZOLOFT oral solution contains alcohol, and concomitant use of ZOLOFT and disulfiram may result in a disulfiram-alcohol reaction. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 , 7.1 ) • Concomitant use of pimozide ( 4 , 7.1 ) • Known hypersensitivity to sertraline or excipients ( 4 , 5.4 ) • ZOLOFT oral solution only: Concomitant use of disulfiram ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue ZOLOFT and serotonergic agents and initiate supportive treatment. ( 5.2 ) • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk.

( 5.3 ) • Activation of Mania/Hypomania: Screen patients for bipolar disorder. ( 5.4 ) • Seizures: Use with caution in patients with seizure disorders. ( 5.6 ) • Angle Closure Glaucoma: Avoid use of antidepressants, including ZOLOFT, in patients with untreated anatomically narrow angles.

( 5.7 ) • QTc Prolongation: ZOLOFT should be used with caution in patients with risk factors for QTc prolongation. ( 5.10 ) • Sexual Dysfunction: ZOLOFT may cause symptoms of sexual dysfunction. ( 5.11 )

5.1Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18-24 5 additional patients Decreases Compared to Placebo 25-64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing ZOLOFT, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), including ZOLOFT, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [See Contraindications (4) , Drug Interactions (7.1) ] .

Serotonin syndrome can also occur when these drugs are used alone . Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastro…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: • Hypersensitivity reactions to sertraline [See Contraindications (4) ] • Disulfiram-alcohol reaction when ZOLOFT oral solution is taken with disulfiram [See Contraindications (4) ] • QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4) , Clinical Pharmacology (12.2) ] • Suicidal thoughts and behaviors [See Warnings and Precautions (5.1) ] • Serotonin syndrome [See Contraindications (4) , Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Increased risk of bleeding [See Warnings and Precautions (5.3) ] • Activation of mania/hypomania [See Warnings and Precautions (5.4) ] • Discontinuation syndrome [See Warnings and Precautions (5.5) ] • Seizures [See Warnings and Precautions (5.6) ] • Angle-closure glaucoma [See Warnings and Precautions (5.7) ] • Hyponatremia [See Warnings and Precautions (5.8) ] • Sexual Dysfunction [See Warnings and Precautions (5.11) ] Most common adverse reactions (≥5% and twice placebo) in pooled placebo-controlled MDD, OCD, PD, PTSD, SAD and PMDD clinical trials were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below are from randomized, double-blind, placebo-controlled trials of ZOLOFT (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to ZOLOFT for 8 to12 weeks represent 568 patient-years of exposure.

The mean age was 40 years; 57% were females and 43% were males. The most common adverse reactions (≥5% and twice placebo) in all pooled placebo-controlled clinical trials of all ZOLOFT-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of ZOLOFT (≥5% and twice placebo) by indication that were not mentioned previously. • MDD: somnolence; • OCD: insomnia, agitation; • PD: constipation, agitation; • PTSD: fatigue; • PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain; • SAD: insomnia, dizziness, fatigue, dry mouth, malaise.

Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD Adverse reactions that occurred greater than 2% in ZOLOFT-treated patients and at least 2% greater in ZOLOFT-treated patients than placebo-treated patients. ZOLOFT (N=3066) Placebo (N=2293) Cardiac disorders Palpitations 4% 2% Eye disorders Visual impairment 4% 2% Gastrointestinal disorders Nausea 26% 12% Diarrhea/Loose stools 20% 10% Dry mouth 14% 9% Dyspepsia 8% 4% Constipation 6% 4% Vomiting 4% 1% General disorders and administration site conditions Fatigue 12% 8% Metabolism and nutrition disorders Decreased appetite 7% 2% Nervous system disorders Dizziness 12% 8% Somnolence 11% 6% Tremor 9% 2% Psychiatric disorders Insomnia 20% 13% Agitation 8% 5% Libido decreased 6% 2% Reproductive system and breast disorders Ejaculation failure Denominator used was for male patients only (n=1316 ZOLOFT; n=973 placebo).

8% 1% Erectile dysfunction 4% 1% Ejaculation disorder 3% 0% Male sexual dysfunctiom 2% 0% Skin and subcutaneous tissue disorders Hyperhidrosis 7% 3% Adverse Reactions Leading to Discontinuation in Placebo-Controlled Clinical Trials In all placebo-controll…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Protein-bound drugs: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted. ( 7.1 , 12.3 ) • CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6. ( 7.1 , 12.3 )

7.1Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with ZOLOFT [See Clinical Pharmacology (12.3) ] . Table 5. Clinically-Significant Drug Interactions with ZOLOFT Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including ZOLOFT and MAOIs increases the risk of serotonin syndrome.

Intervention: ZOLOFT is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See Dosage and Administration (2.5) , Contraindications (4) , Warnings and Precautions (5.2) ]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide Clinical Impact: Increased plasma concentrations of pimozide, a drug with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention: Concomitant use of pimozide and ZOLOFT is contraindicated [See Contraindications (4) ].

Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs with ZOLOFT increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of ZOLOFT and/or concomitant serotonergic drugs [See Warnings and Precautions (5.2) ].

Examples: Other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort. Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact: The concurrent use of an antiplatelet agent or anticoagulant with ZOLOFT may potentiate the risk of bleeding.

Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [See Warnings and Precautions (5.3) ]. Examples: aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact: ZOLOFT is highly bound to plasma protein.

The concomitant use of ZOLOFT with another drug that is highly bound to plasma protein may increase free concentrations of ZOLOFT or other tightly-bound drugs in plasma [See Clinical Pharmacology (12.3) ] . Intervention: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs as warranted. Examples: warfarin Drugs Metabolized by CYP2D6 Clinical Impact: ZOLOFT is a CYP2D6 inhibitor [See Clinical Pharmacology (12.3) ] .

The concomitant use of ZOLOFT with a CYP2D6 substrate may increase the exposure of the CYP2D6 substrate. Intervention: Decrease the dosage of a CYP2D6 substrate if needed with concomitant ZOLOFT use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if ZOLOFT is discontinued.

Examples: propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, venlafaxine Phenytoin Clinical Impact: Phenytoin is a narrow therapeutic index drug. ZOLOFT may increase phenytoin concentrations. Intervention: Monitor phenytoin levels when initiating or titrating ZOLOFT.

Reduce phenytoin dosage if needed. Examples: phenytoin, fosphenytoin Drugs that Prolong the QTc Interval Clinical Impact: The risk of QTc prolongation and/or ventricular arrhythmias (e.g., TdP) is increased with concomitant use of other drugs which prolong the QTc interval [See Warnings and Precautions (5.10) , Clinical Pharmacology (12.2) ] . Intervention: Pimozide is contraindicated for use with sertraline.

Avoid the concomitant use of drugs known to prolong the QTc interval.…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the neonate. ( 8.1 ) • Pediatric use: Safety and effectiveness of ZOLOFT in pediatric patients other than those with OCD have not been established. ( 8.4 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations ] .

Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data ] . There are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including ZOLOFT, during the third trimester of pregnancy [See Clinical Considerations ] .

Although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses 3.1 times the MRHD in rabbits on a mg/m 2 basis in adolescents. When sertraline was administered to female rats during the last third of gestation, there was an increase in the number of stillborn pups and pup deaths during the first four days after birth at the MRHD [See Data ] .

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise a pregnant woman of possible risks to the fetus when prescribing ZOLOFT.

ZOLOFT oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.

Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of ZOLOFT in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3) ] . Fetal/Neonatal Adverse Reactions Exposure to SSRIs and SNRIs, including ZOLOFT in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN).

When treating a pregnant woman with ZOLOFT during the third trimester, carefully consider both the potential risks and benefits of treatment. Monitor neonates who were exposed to ZOLOFT in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [See Data ] . Data Human Data Third Trimester Exposure Neonates exposed to ZOLOFT and other SSRIs or SNRIs late in the third tr…

🤰 Pregnancy ~3 min read ▾

These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis,…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and efficacy of ZOLOFT have been established in the treatment of OCD in pediatric patients aged 6 to 17 [See Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.2) ] . Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD.

Two placebo-controlled trials were conducted in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients. Monitoring Pediatric Patients Treated with ZOLOFT Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [See Boxed Warning , Warnings and Precautions (5.1) ] . Decreased appetite and weight loss have been observed with the use of SSRIs.

Monitor weight and growth in pediatric patients treated with an SSRI such as ZOLOFT. Weight Loss in Studies in Pediatric Patients with MDD In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50-200 mg) outpatient trials for MDD (n=373), there was a difference in weight change between ZOLOFT and placebo of roughly 1 kg, for both children (ages 6-11) and adolescents (ages 12-17), in both age groups representing a slight weight loss for the ZOLOFT group compared to a slight gain for the placebo group.

For children, about 7% of the ZOLOFT-treated patients had a weight loss greater than 7% of body weight compared to 0% of the placebo-treated patients; for adolescents, about 2% of ZOLOFT-treated patients had a weight loss > 7% of body weight compared to about 1% of placebo-treated patients. A subset of patients who completed the randomized controlled trials in patients with MDD (ZOLOFT n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. Those subjects who completed 34 weeks of ZOLOFT treatment (10 weeks in a placebo-controlled trial + 24 weeks open-label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers.

However, there are no studies that directly evaluate the long-term effects of ZOLOFT on the growth, development, and maturation in pediatric patients. Alcohol Content in ZOLOFT Oral Solution ZOLOFT oral solution contains 12% alcohol. Juvenile Animal Data A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females.

In this study in which juvenile rats were treated with oral doses of sertraline at 0, 10, 40 or 80 mg/kg/day from postnatal day 21 to 56, a delay in sexual maturation was observed in males treated with 80 mg/kg/day and females treated with doses ≥10 mg/kg/day. There was no effect on male and female reproductive endpoints or neurobehavioral development up to the highest dose tested (80 mg/kg/day), except a decrease in auditory startle response in females at 40 and 80 mg/kg/day at the end of treatment but not at the end of the drug-free period.

The highest dose of 80 mg/kg/day produced plasma levels (AUC) of sertraline 5 times those seen in pediatric patients (6-17 years of age) receiving the maximum recommended dose of sertraline (200 mg/day).

🧓 Geriatric Use 198 words ▾

8.5Geriatric Use Of the total number of patients in clinical studies of ZOLOFT in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

In 354 geriatric subjects treated with ZOLOFT in MDD placebo-controlled trials, the overall profile of adverse reactions was generally similar to that shown in Table 3 [See Adverse Reactions (6.1) ] , except for tinnitus, arthralgia with an incidence of at least 2% and at a rate greater than placebo in geriatric patients. SNRIs and SSRIs, including ZOLOFT, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [See Warnings and Precautions (5.8) ] .

🆘 Overdosage 101 words ▾

10 OVERDOSAGE The following have been reported with sertraline tablet overdosage: • Seizures, which may be delayed, and altered mental status including coma. • Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. • Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose.

Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

12.2Pharmacodynamics Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors.

The chronic administration of sertraline was found in animals to down regulate brain norepinephrine receptors. Sertraline does not inhibit monoamine oxidase. Alcohol In healthy subjects, the acute cognitive and psychomotor effects of alcohol were not potentiated by ZOLOFT.

Cardiac Electrophysiology The effect of sertraline on the QTc interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects. At 2-fold the maximum recommended daily dose (~3-fold the steady-state exposure for sertraline and N-desmethylsertraline), the largest mean ΔΔQTc was 10 ms with upper bound of two-sided 90% confidence interval of 12 ms. The length of the QTc interval was also positively correlated with serum concentrations of sertraline and N- desmethylsertraline concentrations.

These concentration-based analyses, however, indicated a lesser effect on QTc at maximally observed concentration than in the primary analysis [See Warnings and Precautions (5) , Adverse Reactions (6) , Drug Interactions (7) , Overdosage (10) ] .

12.3Pharmacokinetics Absorption Following oral once-daily ZOLOFT dosing over the range of 50 to 200 mg for 14 days, mean peak plasma concentrations (C max ) of sertraline occurred between 4.5 to 8.4 hours post-dosing. The average terminal elimination half-life of plasma sertraline is about 26 hours. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady-state concentrations, which are achieved after one week of once-daily dosing.

Linear dose-proportional pharmacokinetics were demonstrated in a single dose study in which the C max and area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. The single dose bioavailability of ZOLOFT tablets is approximately equal to an equivalent dose of ZOLOFT oral solution. Administration with food causes a small increase in C max and AUC.

Metabolism Sertraline undergoes extensive first pass metabolism. The principal initial pathway of metabolism for sertraline is N‑demethylation. N‑desmethylsertraline has a plasma terminal elimination half‑life of 62 to 104 hours.

Both in vitro biochemical and in vivo pharmacological testing have shown N‑desmethylsertraline to be substantially less active than sertraline. Both sertraline and N‑desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation, and glucuronide conjugation. In a study of radiolabeled sertraline involving two healthy male subjects, sertraline accounted for less than 5% of the plasma radioactivity.

About 40‑45% of the administered radioactivity was recovered in urine in 9 days. Unchanged sertraline was not detectable in the urine. For the same period, about 40‑45% of the administered radioactivity was accounted for in feces, including 12‑14% unchanged sertraline.

Desmethylsertraline exhibits time‑related, dose dependent increases in AUC (0‑24-hour), C max and C min , with about a 5‑ to 9-fold increase in these pharmacokinetic parameters between day 1 and day 14. Protein Binding In vitro protein binding studies performed with radiolabeled 3H-sertraline sh…

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).

📦 How Supplied / Storage and Handling 180 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ZOLOFT 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with “25 mg” NDC 58151-574-93 Bottles of 30 ZOLOFT 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with “50 mg” NDC 58151-575-93 Bottles of 30 NDC 58151-575-88 Unit Dose Packages of 100 ZOLOFT 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with “ZOLOFT” and on the other side scored and engraved with “100 mg” NDC 58151-576-93 Bottles of 30 NDC 58151-576-88 Unit Dose Packages of 100 ZOLOFT oral solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol NDC 58151-601-35 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.

Store ZOLOFT at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S‑cis)‑4‑(3,4‑dichlorophenyl)‑1,2,3,4‑tetrahydro-N‑methyl‑1‑naphthalenamine hydrochloride. The empirical formula C 17 H 17 NCl 2 •HCl is represented by the following structural formula: Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

ZOLOFT tablets for oral administration contain 28.0 mg, 56.0 mg and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

ZOLOFT oral solution is available in a multidose 60 mL bottle. Each mL of solution contains 22.4 mg sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT).

The oral solution must be diluted prior to administration [See Dosage and Administration (2.7) ] . The dispenser contains dry natural rubber. Sertraline Hydrochloride Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [See Boxed Warning and Warnings and Precautions (5.1) ] . Important Administration Instructions for Oral Solution For patients prescribed ZOLOFT oral solution, inform them that: • ZOLOFT oral solution must be diluted before use.

Do not mix in advance. • Use the dropper provided to remove the required amount of ZOLOFT oral solution and mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix ZOLOFT oral solution with anything other than the liquids listed. • Take the dose immediately after mixing. At times, a slight haze may appear after mixing; this is normal. • The dropper dispenser contains dry natural rubber, a consideration for patients with latex sensitivity.

Disulfiram Contraindication for ZOLOFT Oral Solution Inform patients not to take disulfiram when taking ZOLOFT oral solution. Concomitant use is contraindicated due the alcohol content of the oral solution [See Contraindication (4) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of ZOLOFT with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St.

John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [See Warnings and Precautions (5.2) , Drug Interactions (7.1) ] . Increased Risk of Bleeding Inform patients about the concomitant use of ZOLOFT with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding.

Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [See Warnings and Precautions (5.3) ] . Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [See Warnings and Precautions (5.4) ] . Discontinuation Syndrome Advise patients not to abruptly discontinue ZOLOFT and to discuss any tapering regimen with their healthcare provider.

Adverse reactions can occur when ZOLOFT is discontinued [See Warnings and Precautions (5.5) ] . Sexual Dysfunction Advise patients that use of ZOLOFT may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11) ] .

Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [See Adverse Reactions (6.2) ] . Pregnancy Inform pregnant women that ZOLOFT may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) [See Use in Specific Populations (8.1) ] . Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes of women exposed to ZOLOFT during pregnancy.

Distributed by: Viatris Specialty LLC Morgantown, WV 26505 U.S.A. © 2023 Viatris Inc. ZOLOFT is a registered trademark of Viatris Specialty LLC a Viatris Company. The brands listed are trademarks of their respective owners.

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💬 Medication Guide ~3 min read ▾

Medication Guide ZOLOFT (ZOH-loft) (sertraline hydrochloride) Tablets and Oral Solution What is the most important information I should know about ZOLOFT? ZOLOFT and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.

1. Suicidal thoughts or actions: • ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. o Pay particular attention to such changes when ZOLOFT is started or when the dose is changed. o Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: o attempts to commit suicide o acting aggressive or violent o new or worse depression o feeling agitated, restless, angry or irritable o an increase in activity or talking more than what is normal for you o acting on dangerous impulses o thoughts about suicide or dying o new or worse anxiety or panic attacks o trouble sleeping o other unusual changes in behavior or mood 2.

Serotonin Syndrome. This condition can be life-threatening and symptoms may include: • agitation, hallucinations, coma, or other changes in mental status • racing heartbeat, high or low blood pressure • coordination problems or muscle twitching (overactive reflexes) • nausea, vomiting, or diarrhea • sweating or fever • muscle rigidity 3. Increased chance of bleeding: ZOLOFT and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

4. Manic episodes. Symptoms may include: • greatly increased energy • racing thoughts • unusually grand ideas • severe trouble sleeping • reckless behavior • excessive happiness or irritability • talking more or faster than usual 5.

Seizures or convulsions. 6. Glaucoma (angle-closure glaucoma).

Many antidepressant medicines including ZOLOFT may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Only some people are at risk for these problems.

You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 7. Changes in appetite or weight.

Children and adolescents should have height and weight monitored during treatment. 8. Low salt (sodium) levels in the blood.

Elderly people may be at greater risk for this. Symptoms may include: • headache • weakness or feeling unsteady • confusion, problems concentrating or thinking, or memory problems 9. Sexual problems (dysfunction).

Taking selective serotonin reuptake inhibitors (SSRIs), including ZOLOFT, may cause sexual problems. Symptoms in males may include: • Delayed ejaculation or inability to have an ejaculation • Decreased sex drive • Problems getting or keeping an erection Symptoms in females may include: • Decreased sex drive • Delayed orgasm or inability to have an orgasm Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with ZOLOFT.

There may be treatments your healthcare provider can suggest. Do not stop ZOLOFT without first talking to your healthcare provider…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arthralgia: Joint pain.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

depression: A lasting low mood with loss of interest that affects everyday life.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erectile dysfunction: Trouble getting or keeping an erection.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

narrow therapeutic index: Describes a medicine where the helpful dose and the harmful dose are very close, so small changes in the amount matter a lot.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pulmonary hypertension: High blood pressure in the arteries that carry blood from the heart to the lungs.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relapse: The return of a cancer after a period of improvement or disappearance.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

suicidality: A general term covering both thoughts about ending one's own life and actions taken toward it.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

therapeutic index: A measure of how much room there is between a helpful dose of a medicine and a dose that could be harmful.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Zoloft sertraline hydrochloride 100 mg Tablet, Film Coated

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