FDA-filed SPL labeling · retrieved through openFDA

Sertraline

Sertraline is an SSRI antidepressant used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder — with specific approvals varying by product and formulation.

Brand name Zoloft
Drug class ⓘ Serotonin Reuptake Inhibitor
Rx Forms 3 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 184 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 1, 2022
Clinical labels in scope ⓘ184
AvailabilityRx
Earliest approval/marketing year ⓘ1991
FDA-listed product records ⓘ588
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026 🚨Recall on record · 2
⭐ Sertraline at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Sertraline is a widely used SSRI that treats major depressive disorder, OCD, panic disorder, PTSD, social anxiety disorder, and premenstrual dysphoric disorder — with specific approvals depending on the formulation. It works well for many people but requires close monitoring, especially in younger patients at the start of treatment. Never stop taking it suddenly, and always talk to your pharmacist or doctor before adding new medications.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Sertraline and other antidepressants can increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults under 25. This risk was seen in short-term studies of people being treated for depression and other psychiatric conditions. It is highest in the first few weeks of treatment and around the time of any dose change. Adults older than 24 did not show this increased risk, and in adults 65 and older, antidepressants were associated with a reduced risk of suicidality compared to placebo. Watch closely for warning signs — worsening depression, unusual changes in behavior, agitation, or any talk or actions involving self-harm — and contact the prescriber immediately if these appear. Families and caregivers should be actively involved in watching for these changes. Sertraline tablets are only approved for use in children for OCD, not for depression.

Read the full warning on DailyMed →

📖 Sertraline: Patient Information Guide

A plain-language walkthrough of Sertraline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Sertraline is an SSRI approved to treat several psychiatric conditions — though which conditions are covered depends on the specific product and formulation.

  • All sertraline formulations: Major depressive disorder (MDD) in adults
  • All sertraline formulations: Obsessive-compulsive disorder (OCD) in adults
  • Oral solution (including Zoloft), several tablet formulations, and film-coated tablets: Panic disorder (PD), post-traumatic stress disorder (PTSD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD)
  • Sertraline HCl capsules and sertraline hydrochloride tablets: OCD in pediatric patients aged 6 and older
  • Sertraline HCl capsules: Approved for MDD in adults and OCD in adults and pediatric patients 6 years and older; only available in higher dose strengths — not for starting treatment
  • Sertraline is not approved for MDD in pediatric patients in any formulation
⚙️How it works▾

Sertraline is a selective serotonin reuptake inhibitor (SSRI). It works by blocking the reabsorption of serotonin — a chemical messenger involved in mood, anxiety, and behavior — back into the nerve cells that released it. By keeping more serotonin active between nerve cells, sertraline helps regulate mood and ease symptoms of depression, anxiety, and obsessive thinking over time.

Sertraline is highly selective: it has very little effect on other brain chemicals like norepinephrine or dopamine, and it doesn't significantly interact with receptors linked to sedation, anticholinergic effects (like dry mouth and constipation from older antidepressants), or cardiovascular effects. It does not inhibit monoamine oxidase (MAO), which is important because combining it with MAOI drugs is dangerous.

💊How it's taken▾

Sertraline is taken orally once a day. Tablets and film-coated tablets may be taken with or without food — though food increases absorption slightly. The oral solution must always be diluted in water, ginger ale, lemon or lime soda, lemonade, or orange juice before drinking; never take it undiluted. Capsules must be swallowed whole — do not open, crush, or chew them.

  • Sertraline HCl capsules are only available in higher dose strengths and cannot be used to start treatment — another sertraline product must be used first for initial dosing and dose increases
  • Dose changes should be spaced at least one week apart to allow the body to adjust
  • When stopping, the dose should always be reduced gradually — ask your doctor for a tapering plan
  • Follow your prescriber's exact instructions; the right dose and schedule depend on your condition and individual response
🤒Side effects — in detail▾

The most common side effects with sertraline — seen in at least 5% of patients and more than twice as often as with placebo — include:

  • Nausea
  • Diarrhea or loose stools
  • Insomnia
  • Dizziness
  • Tremor (shaking)
  • Sweating more than usual
  • Decreased appetite
  • Fatigue
  • Dry mouth
  • Sexual side effects (decreased sex drive, ejaculation problems, erectile dysfunction)
  • In children: fever, weight loss, hyperactivity, urinary incontinence, and anxiety have also been reported

More serious reactions — including serotonin syndrome, significant bleeding, mania, seizures, low sodium levels, and angle-closure glaucoma — require immediate medical attention. Stopping sertraline suddenly can cause a discontinuation syndrome (withdrawal-like symptoms), so always taper off gradually under your doctor's guidance.

⚠️Warnings & precautions▾
  • Suicidal thoughts in young people: Sertraline and other antidepressants increase the risk of suicidal thinking and behavior in children, teens, and adults under 25, especially early in treatment or after dose changes. Watch closely and report any warning signs to the prescriber immediately.
  • Serotonin syndrome: Taking sertraline with other serotonin-boosting medications (other SSRIs, SNRIs, triptans, MAOIs) can cause a dangerous buildup of serotonin — symptoms include agitation, rapid heart rate, muscle twitching, high fever, and confusion. Seek emergency care immediately.
  • Increased bleeding risk: Sertraline affects platelet function; bleeding risk goes up further when combined with blood thinners, aspirin, or NSAIDs.
  • Manic episodes: Sertraline can trigger mania or hypomania (abnormally elevated mood, racing thoughts, decreased need for sleep) — especially in people with undiagnosed bipolar disorder. Screen for bipolar disorder before starting.
  • QTc prolongation: Sertraline can slightly lengthen the QT interval (a measure of heart electrical activity); the oral solution should be used with caution in patients at risk for this. Avoid combining with pimozide.
  • Hyponatremia (low blood sodium): Rare but serious — watch for headache, confusion, weakness, or seizures, especially in older adults.
  • Angle-closure glaucoma: Sertraline can dilate the pupil and may trigger acute glaucoma in people with narrow eye angles. Avoid in patients with untreated narrow-angle anatomy.
  • Discontinuation syndrome: Always taper off gradually — stopping suddenly can cause uncomfortable withdrawal-like symptoms.
🔀What it interacts with▾

Sertraline interacts with several medications and substances — some combinations are dangerous and must be avoided:

  • MAOIs (e.g., linezolid, methylene blue IV, phenelzine, selegiline): Combining with sertraline — or using within 14 days of each other — can cause fatal serotonin syndrome. This is an absolute contraindication.
  • Pimozide: Must never be taken with sertraline — serious heart rhythm problems can result.
  • Disulfiram (with the oral solution only): The oral solution contains alcohol; using it with disulfiram can cause a severe reaction.
  • Warfarin and other blood thinners: Sertraline can increase prothrombin time (a measure of clotting); bleeding risk rises. Monitor closely.
  • Aspirin and NSAIDs (e.g., ibuprofen, naproxen): Combined use raises the risk of bleeding.
  • Other serotonergic drugs (SSRIs, SNRIs, triptans): Increases the risk of serotonin syndrome.
  • Highly protein-bound drugs (e.g., digitoxin, propranolol): Sertraline is 98% protein-bound and may compete with or displace other protein-bound drugs, potentially altering their effects.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Do not take sertraline if you have taken an MAOI in the past 14 days — or plan to start one within 14 days of stopping sertraline
  • Do not take sertraline if you are allergic to it (anaphylaxis or angioedema have been reported)
  • Do not take pimozide at the same time as sertraline
  • Do not take the oral solution if you are on disulfiram
  • Tell your doctor if you have bipolar disorder or a family history of it — sertraline can trigger mania
  • Tell your doctor if you have ever had seizures
  • Tell your doctor if you have liver disease — sertraline exposure is significantly higher with liver impairment; moderate to severe liver impairment is not recommended
  • Tell your doctor if you are pregnant: third-trimester use is linked to neonatal complications including persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms in the baby
  • Breastfeeding: sertraline passes into breast milk at low levels; discuss risks and benefits with your doctor
  • Children: sertraline is only established as safe and effective for OCD in patients ages 6 and older — not for depression in children
  • Older adults: the body clears sertraline more slowly with age; closer monitoring is appropriate
  • Tell your doctor about all other medications, supplements, and herbal products you take
🚑If you take too much▾

Taking too much sertraline can cause serious symptoms including extreme drowsiness, vomiting, rapid heart rate, nausea, dizziness, agitation, tremor, and — in severe cases — seizures, heart rhythm abnormalities, serotonin syndrome, and loss of consciousness. If you or someone else may have taken too much, call 911 or your local poison control center immediately.

There is no specific antidote for sertraline overdose. Treatment focuses on supportive care — maintaining breathing, monitoring the heart, and managing symptoms. Activated charcoal may be used if administered soon after ingestion. Dialysis is unlikely to help due to how extensively sertraline binds to proteins in the body.

📡Pharmacodynamics — effects in the body▾

At typical therapeutic doses, sertraline measurably blocks serotonin uptake into human platelets — one way researchers confirm it is working in the body. It has very weak effects on norepinephrine and dopamine reuptake, and does not significantly bind to receptors associated with sedation, anticholinergic effects, or cardiovascular changes seen with older antidepressants. Sertraline also does not inhibit monoamine oxidase.

Sertraline has a small but measurable effect on heart electrical activity: at approximately double the maximum recommended daily dose, it prolonged the QTc interval (a measure of the heart's electrical recovery time) by about 10 milliseconds. The effect is dose- and concentration-related, so keeping within recommended doses is important.

🔬Pharmacokinetics — how your body processes it▾

After a once-daily oral dose, sertraline reaches peak blood levels within roughly 4.5 to 8.4 hours. Its half-life — the time it takes for half the drug to leave the body — is about 26 hours, which is why it is dosed once daily and why steady, stable blood levels are reached after about one week of regular dosing. Taking it with food slightly increases peak concentration and speeds absorption for tablets, but the overall amount absorbed is similar.

Sertraline is extensively broken down by the liver before it reaches the bloodstream (a process called first-pass metabolism), and it is 98% bound to proteins in the blood. The main breakdown product, N-desmethylsertraline, is much less active and has a much longer half-life (62 to 104 hours). Older adults clear sertraline about 40% more slowly than younger adults, and people with even mild liver disease have roughly 3 times greater exposure — both groups need careful monitoring. Kidney disease does not significantly affect sertraline blood levels.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F) .

📄 Written from Sertraline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

188

Supplements & herbs that interact with Sertraline

188 supplements and herbal products have documented interactions with Sertraline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 139
  • Minor · 40
Every supplement checked against Sertraline — ranked by severity The full interaction hub: 9 major · 139 moderate · 40 minor · every one linked to its full report. Check Sertraline against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Sertraline has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Sertraline nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Sertraline — the kind of thing our pharmacy team would talk through with you at the counter.

How long does it take for sertraline to start working? ▾
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 sleep or energy within the first week or two, but the full effect on mood, anxiety, or obsessive thoughts usually takes four to eight weeks or longer. Stick with it and keep your follow-up appointments, even if things feel slow at first.
Is it okay to take sertraline with ibuprofen or aspirin? ▾
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 risk of bleeding — including stomach bleeding. If you need a pain reliever occasionally, talk to your pharmacist or doctor first about the safest option for you.
What should I do if I want to stop taking sertraline? ▾
Don't stop cold turkey — always taper off gradually under your doctor's guidance. Stopping suddenly can cause uncomfortable withdrawal-like symptoms. Your doctor will help you reduce the dose slowly over time. If you're on the capsule form, note that gradual tapering will require switching to another sertraline product, since the capsules only come in higher dose strengths.
Are there any medicines I absolutely cannot take with sertraline? ▾
Yes — a few combinations are off-limits. Never take sertraline within 14 days of an MAOI (a class of older antidepressants), including the antibiotic linezolid and IV methylene blue, because together they can cause a dangerous — potentially fatal — condition called serotonin syndrome. You also cannot take pimozide at the same time as sertraline due to serious heart risks. And if you take the liquid oral solution, avoid disulfiram, since the solution contains alcohol.
I'm pregnant — is sertraline safe to take? ▾
This is a conversation worth having carefully with your doctor. Overall, first-trimester use has not been linked to a clear increase in major birth defects. However, taking sertraline in the third trimester does carry a risk of complications for the newborn, including breathing problems and a rare but serious condition called persistent pulmonary hypertension. That said, untreated depression during pregnancy also carries real risks. Your doctor will help you weigh the benefits and risks for you and your baby.
My child has OCD — can they take sertraline? ▾
Yes, sertraline is approved for OCD in children aged 6 and older. However, it's not approved for depression in children — only adults. If your child is starting sertraline, close monitoring is especially important in the early weeks: watch for any changes in mood, unusual behavior, or any talk of self-harm, and report these to your doctor right away. Growth and weight should also be monitored, as sertraline can cause some weight loss in children.
Is Sertraline available over the counter? ▾
Sertraline is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Sertraline first available? ▾
Sertraline has been available in the United States since at least 1991, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Sertraline? ▾
Sertraline is supplied by 85 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, Remedyrepack Inc., Bryant Ranch Prepack.

💬 Answers drafted from Sertraline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Sertraline comes

Sertraline is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Zoloft
Available strengths 3 strengths
519 FDA-listed product records ⓘ

Capsule

By mouth
Available strengths 2 strengths
24 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Zoloft
Available strengths 1 strength
22 FDA-listed product records ⓘ

📊 Sertraline across the U.S. market

How Sertraline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms ⓘ
85
Manufacturers
4
Brand names
588
FDA-listed product records ⓘ
1991
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (23) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions9%
Remedyrepack Inc.9%
Bryant Ranch Prepack8%
Preferred Pharmaceuticals Inc.5%
NuCare Pharmaceuticals,Inc.5%
PD-Rx Pharmaceuticals, Inc.5%
Other makers60%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Sertraline is used

A general measure of how commonly Sertraline is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Sertraline is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,868,838
Medicaid prescriptions filled (Q1–Q4 2025)
$108.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sertraline prescribed? Of the 1,597 medications we measure, Sertraline ranks #13 by Medicaid prescriptions — more than 99% of them.

Where Sertraline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Sertraline product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg oral tablet is the most-dispensed Sertraline product — about 41% of these Medicaid prescriptions.

sertraline 100 MG Oral Tablet Most dispensed

3,655,456 Medicaid prescriptions (Q1–Q4 2025) 41% of Sertraline prescriptions shown $42.5M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 37 of 398 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312938

sertraline 50 MG Oral Tablet

3,336,698 Medicaid prescriptions (Q1–Q4 2025) 38% of Sertraline prescriptions shown $32.8M gross reimbursement (before rebates) ≈ $9.83 per prescription (gross)

Summed across the 36 of 382 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312941

sertraline 25 MG Oral Tablet

1,749,610 Medicaid prescriptions (Q1–Q4 2025) 20% of Sertraline prescriptions shown $16.2M gross reimbursement (before rebates) ≈ $9.28 per prescription (gross)

Summed across the 29 of 253 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312940

sertraline 20 MG/ML Oral Solution

49,608 Medicaid prescriptions (Q1–Q4 2025) <1% of Sertraline prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $52 per prescription (gross)

Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861064

sertraline 150 MG Oral Capsule

45,944 Medicaid prescriptions (Q1–Q4 2025) <1% of Sertraline prescriptions shown $8.5M gross reimbursement (before rebates) ≈ $184 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 410584

sertraline 200 MG Oral Capsule

31,522 Medicaid prescriptions (Q1–Q4 2025) <1% of Sertraline prescriptions shown $5.9M gross reimbursement (before rebates) ≈ $187 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 251201

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sertraline, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 111 of 1,063 listed Sertraline NDCs with Medicaid activity.

🔍 Compare Sertraline products

A representative set of FDA-listed product records for Sertraline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 588 products — FDA National Drug Code Directory. See every product, package size and price: browse all 588 Sertraline NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Sertraline RxCUI 36437 3 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 373867 In current FDA listings
    Clinical drug / strength (SCD) 150 MG RxCUI 410584 200 MG RxCUI 251201
  2. Dose form (SCDF) Oral Solution RxCUI 374622 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 861064
  3. Dose form (SCDF) Oral Tablet RxCUI 373868 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 312940 50 MG RxCUI 312941 100 MG RxCUI 312938

Look up RxCUI 36437 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Zoloft

🏭 Manufacturers & labelers

A-S Medication Solutions 43 Remedyrepack Inc. 43 Bryant Ranch Prepack 41 Preferred Pharmaceuticals Inc. 26 NuCare Pharmaceuticals,Inc. 25 PD-Rx Pharmaceuticals, Inc. 25 Aurobindo Pharma Limited 23 RPK Pharmaceuticals, Inc. 14 Cipla USA Inc. 14 St. Mary's Medical Park Pharmacy 13 Aphena Pharma Solutions - Tennessee, LLC 12 Lupin Pharmaceuticals, Inc. 12 NorthStar Rx LLC 12 Proficient Rx LP 12 NCS HealthCare of KY, LLC dba Vangard Labs 12 Roerig 11 Cardinal Health 107, LLC 10 Accord Healthcare, Inc. 9 Legacy Pharmaceutical Packaging, LLC 9 American Health Packaging 9 Camber Pharmaceuticals, Inc. 9 Viatris Specialty LLC 8 Denton Pharma, Inc. DBA Northwind Pharmaceuticals 8 Direct Rx 8

…and 16 more on the FDA NDC directory.

RxNorm drug class

Sertraline 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

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 1, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sertraline.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Sertraline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
184
NDC products indexed
588
Distinct labelers/manufacturers represented
85
Linked representative label ⓘ
Proficient Rx LP
Linked label effective
Oct 1, 2022
Composite sections available
26
Linked SPL Set ID
35dea1a2-ec26-4e52-8f09-ee4678e77946
Linked SPL Document ID
820641b5-c569-4a24-b0a4-5d17d3cff8ee
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 184 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.