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Aripiprazole 20 mg Tablet, 30-count

by Direct_Rx · 30 TABLET in 1 BOTTLE (72189-455-30)
NDC 72189-0455-30
🏷️ FDA NDC (as labeled) 72189-455-30 billing pads the product segment with a zero
Rx only Generic 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

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

⚠️
Other active recalls for Aripiprazole (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 27, 2026 — Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. (Ajanta Pharma USA Inc) · FDA recall D-0594-2026
Class II · Aug 28, 2025 — Superpotent drug (Ascend Laboratories, LLC) · FDA recall D-0645-2025
Class III · Apr 9, 2024 — Cross Contamination with Other Products (Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.) · FDA recall D-0468-2024
Class III · Apr 9, 2024 — Cross Contamination with Other Products (Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.) · FDA recall D-0466-2024
Class III · Apr 9, 2024 — Cross Contamination with Other Products (Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.) · FDA recall D-0467-2024
Class III · Apr 9, 2024 — Cross Contamination with Other Products (Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.) · FDA recall D-0469-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72189-455-30
Product NDC 72189-455
11-digit billing NDC 72189045530
NCPDP billing unit EA — each (per item)
RxCUI 349553
UNII 82VFR53I78
Application # ANDA201519
SPL Set ID f81d9b82-5879-3c0a-e053-6294a90ac23e
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-30
Route ORAL
Dosage form TABLET
Substance ARIPIPRAZOLE
GCN Seq No 051335
GCN 18539
HICL code 024551
Ingredient (HICL) Aripiprazole
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7X
Therapeutic class — specific (HIC3) Antipsychotics, Atyp, D2 Partial Agonist/5Ht Mixed
AHFS code 28:16.08.04
AHFS class Atypical Antipsychotics
FDB label name ARIPIPRAZOLE 20 MG TABLET
FDB brand name Aripiprazole
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 72189-455-30 — 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 → 72189-0455-30. 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 Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics
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

LabelerDirect_Rx
Application holderTORRENT PHARMACEUTICALS LTD
FDA applicationANDA201519 (ANDA)
Labeler code72189
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio352 products on file
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 ARIPIPRAZOLE 20 MG TABLET Ingredient Aripiprazole
📖 What it is MedlinePlus · NLM

Aripiprazole is used to treat: schizophrenia (a mental illness that affects how a person thinks, feels and behaves) bipolar disorder (a disease that causes depression, mania, and other abnormal moods) major depressive disorder irritability symptoms (aggression, temper tantrums, mood changes) in those with autistic disorder (a developmental problem that affects how individuals communicate, learn and behave) Tourette's disorder (a condition causing involuntary, repetitive movements or sounds) Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing th...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Not at all — aripiprazole actually has several approved uses. It's prescribed for schizophrenia, manic or mixed episodes of Bipolar I Disorder, and as an add-on to antidepressants...
  • What exactly is aripiprazole used for — is it just for schizophrenia?
  • It typically takes up to two weeks for aripiprazole to build up to stable levels in your body, so don't be discouraged if you don't feel a difference right away. For some condition...
  • How long does it take before I notice it working?
📖 Read our full Aripiprazole guide →
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.

🧪 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 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

6 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 $0.3773 $11.32 / 30 tablets
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aripiprazole 20 mg 00904-7370-04 Major 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 16714-0145-01 NorthStar 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 27241-0055-03 Ajanta 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 43547-0306-03 Solco 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 43547-0888-03 Solco 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 50268-0091-12 AvPAK 20 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 60687-0202-21 American 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 65162-0901-03 Amneal 30 tablets $0.174 AB Availability likely —
Aripiprazole 20 mg 16729-0282-01 Accord 100 tablets $0.175 AB Availability likely —
Aripiprazole 20 mg 33342-0126-07 Macleods 30 tablets $0.216 AB FDA listed —
Abilify 20 mg 59148-0010-13 Otsuka 30 tablets $26.250 AB Availability likely —
aripiprazole 20 mg 13668-0220-01 Torrent 100 tablets — AB FDA listed —
Aripiprazole 20 mg 29300-0179-01 Unichem 100 tablets — AB FDA listed —
Aripiprazole 20 mg 31722-0829-01 Camber 100 tablets — AB FDA listed —
Aripiprazole 20 mg 31722-0923-01 Camber 100 tablets — AB FDA listed —
Aripiprazole 20 mg 43598-0558-05 Dr.Reddys 500 tablets — AB FDA listed —
Aripiprazole 20 mg 43598-0969-05 Dr.Reddys 500 tablets — AB FDA listed —
Aripiprazole 20 mg 46708-0258-10 Alembic 100 tablets — AB FDA listed —
Aripiprazole 20 mg 50090-4863-00 A-S 30 tablets — AB FDA listed —
Aripiprazole 20 mg 50090-6063-00 A-S 30 tablets — AB FDA listed —
Aripiprazole 20 mg 50090-6403-00 A-S 30 tablets — AB FDA listed —
Aripiprazole 20 mg 50090-7125-00 A-S 30 tablets — AB FDA listed —
Aripiprazole 20 mg 50228-0328-10 ScieGen 1000 tablets — AB FDA listed —
Aripiprazole 20 mg 50228-0479-10 ScieGen 1000 tablets — AB FDA listed —
aripiprazole 20 mg 60760-0691-30 ST. 30 tablets — AB FDA listed —
Aripiprazole 20 mg 62332-0101-10 Alembic 100 tablets — AB FDA listed —
Aripiprazole 20 mg 65862-0665-01 Aurobindo 100 tablets — AB FDA listed —
Aripiprazole 20 mg 67046-1085-03 Coupler 30 tablets — AB FDA listed —
Aripiprazole 20 mg 67877-0434-01 Ascend 100 tablets — AB FDA listed —
aripiprazole 20 mg 68788-7063-01 Preferred 100 tablets — AB FDA listed —
Aripiprazole 20 mg 70518-2806-00 REMEDYREPACK 30 tablets — AB Discontinued —
aripiprazole 20 mg 71335-0412-01 Bryant 30 tablets — AB FDA listed —
Aripiprazole 20 mg 71335-1364-01 Bryant 30 tablets — AB FDA listed —
Aripiprazole 20 mg 71335-1687-01 Bryant 30 tablets — AB FDA listed —
Aripiprazole 20 mgthis 72189-0455-30 Direct_Rx 30 tablets — AB FDA listed —
Aripiprazole 20 mg 72865-0157-05 XLCare 500 tablets — AB FDA listed —
Aripiprazole 20 mg 72865-0184-05 XLCare 500 tablets — AB FDA listed —
Aripiprazole 20 mg 76282-0048-01 Exelan 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Aripiprazole — the program that covers self-administered drugs. 20 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 Aripiprazole. 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
$46.18M
Claims incl. refills
1M
Beneficiaries
482.8K
Spend / beneficiary
$95.64
Spend / claim
$45.64
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 Aripiprazole — the ingredient across all brands.

Top reported reactions

Weight Increased8,027
Anxiety5,268
Fatigue4,437
Suicidal Ideation4,154
Depression4,147
Nausea4,127
Insomnia4,009

Age at onset

Neonate398
Infant85
Child593
Adolescent868
Adult10,190
Elderly1,432

Reporter sex

125,626 reports
Male · 41%
Female · 59%
Unknown · 1%

Serious outcomes

Hospitalization36,359
Death6,832
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,302 0
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 NDCDescription Marketing startStatus
72189-0455-30 You're viewing this 30 TABLET in 1 BOTTLE (72189-455-30) 2023-03-30 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-455-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0455-30, written without dashes as 72189045530. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0455-30, the first segment (72189) is the labeler code FDA assigned to Direct_Rx; the middle segment (0455) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct_Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct_Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Medication Guide
🚨 Boxed Warning 162 words ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1) ]. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.

These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions ( 5.3) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.3) ].

🎯 Indications and Usage 37 words ▾

Aripiprazole Oral Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder

⏱️ Dosage and Administration ~3 min read ▾

2.1Schizophrenia Adults The recommended starting and target dose for aripiprazole is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state [see Clinical Studies ( 14.1) ] .

Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either aripiprazole 15 mg/day or placebo, and observed for relapse [see Clinical Studies ( 14.1)] . Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Adolescents The recommended target dose of aripiprazole is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days.

Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. Aripiprazole can be administered without regard to meals [see Clinical Studies ( 14.1) ] .

Patients should be periodically reassessed to determine the need for maintenance treatment. Switching from Other Antipsychotics There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to aripiprazole or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others.

In all cases, the period of overlapping antipsychotic administration should be minimized.

2.2Bipolar I Disorder Acute Treatment of Manic and Mixed Episodes Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. Aripiprazole can be given without regard to meals. The recommended target dose of aripiprazole is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate.

The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials. Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days.

Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. Aripiprazole can be given without regard to meals [see Clinical Studies ( 14.2) ] .

2.3Adjunctive Treatment of Major Depressive Disorder Adults The recommended starting dose for aripiprazole as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week [see Clinical Studies ( 14.3) ] .

Patients should be periodically reassessed to determine the continued need for maintenance treatment.

2.4Irritability Associated with Autistic Disorder Pediatric Patients (6 to 17 years) The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 1…

💊 Dosage Forms and Strengths 117 words ▾

Aripiprazole tablets, USP are available as described in Table 3. Table 3: Aripiprazole Tablet, USP Presentations Tablet Strength Tablet Color/Shape Tablet Markings 2 mg yellow round debossed with “2” on one side and “16” on other side 5 mg white to off-white round debossed with “5” on one side and “17” on other side 10 mg white to off-white round debossed with “10” on one side and “18” on other side 15 mg white to off-white round debossed with “15” on one side and “19” on other side 20 mg white to off-white round debossed with “20” on both sides 30 mg white to off-white round debossed with “30” on one side and “21” on other side

⛔ Contraindications 27 words ▾

Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions ( 6.2) ].

⚠️ Warnings and Cautions ~3 min read ▾

5.1Increased Mortality in Elderly Patients with Dementia-Related Psychosis Increased Mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see BOXED WARNING]. Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer's Disease In three, 10 week, placebo-controlled studies of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease (n=938; mean age: 82.4 years; range: 56 to 99 years), the adverse reactions that were reported at an incidence of ≥3% and aripiprazole incidence at least twice that for placebo were lethargy [placebo 2%, aripiprazole 5%], somnolence (including sedation) [placebo 3%, aripiprazole 8%], and incontinence (primarily, urinary incontinence) [placebo 1%, aripiprazole 5%], excessive salivation [placebo 0%, aripiprazole 4%], and lightheadedness [placebo 1%, aripiprazole 4%].

The safety and efficacy of aripiprazole in the treatment of patients with psychosis associated with dementia have not been established. If the prescriber elects to treat such patients with aripiprazole, assess for the emergence of difficulty swallowing or excessive somnolence, which could predispose to accidental injury or aspiration [see BOXED WARNING].

5.2Cerebrovascular Adverse Events, Including Stroke In placebo-controlled clinical studies (two flexible dose and one fixed dose study) of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in aripiprazole-treated patients (mean age: 84 years; range: 78 to 88 years). In the fixed-dose study, there was a statistically significant dose response relationship for cerebrovascular adverse events in patients treated with aripiprazole.

Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see BOXED WARNING].

5.3Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term, placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24 years) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24 years; there was a reduction with antidepressants compared to placebo in adults aged 65 years and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.

There were differences in…

🤒 Adverse Reactions ~3 min read ▾

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 following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1) ] Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions ( 5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see BOXED WARNING and Warnings and Precautions ( 5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4) ] Tardive Dyskinesia [see Warnings and Precautions ( 5.5) ] Metabolic Changes [see Warnings and Precautions ( 5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions ( 5.7)] Orthostatic Hypotension [see Warnings and Precautions ( 5.8) ] Falls [see Warnings and Precautions ( 5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.10) ] Seizures/Convulsions [see Warnings and Precautions ( 5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.12) ] Body Temperature Regulation [see Warnings and Precautions ( 5.13) ] Suicide [see Warnings and Precautions ( 5.14) ] Dysphagia [see Warnings and Precautions ( 5.15) ] The most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

The most common adverse reactions in the pediatric clinical trials (≥10%) were somnolence, headache, vomiting, extrapyramidal disorder, fatigue, increased appetite, insomnia, nausea, nasopharyngitis, and weight increased. Aripiprazole has been evaluated for safety in 13,543 adult patients who participated in multiple-dose, clinical trials in schizophrenia, bipolar disorder, major depressive disorder, Dementia of the Alzheimer's type, Parkinson's disease, and alcoholism, and who had approximately 7,619 patient-years of exposure to oral aripiprazole and 749 patients with exposure to aripiprazole injection.

A total of 3,390 patients were treated with oral aripiprazole for at least 180 days and 1,933 patients treated with oral aripiprazole had at least one year of exposure. Aripiprazole has been evaluated for safety in 1,686 pediatric patients (6 to 18 years) who participated in multiple-dose, clinical trials in schizophrenia, bipolar mania, autistic disorder, or Tourette's disorder and who had approximately 1,342 patient-years of exposure to oral aripiprazole. A total of 959 pediatric patients were treated with oral aripiprazole for at least 180 days and 556 pediatric patients treated with oral aripiprazole had at least one year of exposure.

The conditions and duration of treatment with aripiprazole (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.

6.1Clinical Trials Experience Adult Patients with Schizophrenia The following findings are based on a pool of five placebo-controlled trials (four 4 week and one 6 week) in which oral aripiprazole was administered in doses ranging from 2 to 30 mg/day. Commonly Observed Adverse Reactions The only commonly observed adverse reaction associated with the use of aripiprazole in patients with schizophrenia (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) was akathisia (aripiprazole 8%; placebo 4%).

Adult Patients with Bipolar Mania Monotherapy The following findings are based on a pool of 3-week, placebo-controlled, bipolar mania trials in which oral aripiprazole was administ…

🔄 Drug Interactions ~1 min read ▾

7.1Drugs Having Clinically Important Interactions with Aripiprazole Table 25: Clinically Important Drug Interactions with Aripiprazole: Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) The concomitant use of aripiprazole with strong CYP 3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of aripiprazole alone [see Clinical Pharmacology ( 12.3) ].

With concomitant use of aripiprazole with a strong CYP3A4 inhibitor or CYP2D6 inhibitor, reduce the aripiprazole dosage [see Dosage and Administration( 2.7) ] . Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin) The concomitant use of aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of aripiprazole alone [see Clinical Pharmacology ( 12.3) ] . With concomitant use of aripiprazole with a strong CYP3A4 inducer, consider increasing the aripiprazole dosage [see Dosage and Administration ( 2.7) ] .

Antihypertensive Drugs Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents. Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions ( 5.8) ] . Benzodiazepines (e.g., lorazepam) The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone.

The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepamalone [see Warnings and Precautions ( 5.8)]. Monitor sedation and blood pressure. Adjust dose accordingly.

7.2Drugs Having No Clinically Important Interactions with Aripiprazole Based on pharmacokinetic studies, no dosage adjustment of aripiprazole is required when administered concomitantly with famotidine, valproate, lithium, lorazepam. In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with aripiprazole.

Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with aripiprazole [see Clinical Pharmacology ( 12.3) ] .

👥 Use in Specific Populations ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations).

Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the mother associated with untreated schizophrenia, bipolar I disorder, or major depressive disorder, and with exposure to antipsychotics, including aripiprazole, during pregnancy (see Clinical Considerations). In animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 19 times, respectively, the maximum recommended human dose (MRHD) of 30 mg/day based on mg/m 2 body surface area, produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia.

Oral and intravenous aripiprazole administration during the pre- and post- natal period in rats at doses 10 times the MRHD based on mg/m 2 body surface area, produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk There is a risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth.

It is not known if this is a direct result of the illness or other comorbid factors. A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and 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 risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including aripiprazole) during the third trimester of pregnancy. These symptoms have varied in severity.

Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms.

Data Human Data Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective study from a Medicaid d…

🆘 Overdosage ~2 min read ▾

MedDRA terminology has been used to classify the adverse reactions.

10.1Human Experience In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral aripiprazole have been reported worldwide. These include overdoses with oral aripiprazole alone and in combination with other substances. No fatality was reported with aripiprazole alone.

The largest known dose with a known outcome involved acute ingestion of 1,260 mg of oral aripiprazole (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 years and younger) involving oral aripiprazole ingestions up to 195 mg with no fatalities. Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor.

Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

10.2Management of Overdosage No specific information is available on the treatment of overdose with aripiprazole. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.

Close medical supervision and monitoring should continue until the patient recovers. Charcoal: In the event of an overdose of aripiprazole, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of aripiprazole decreased the mean AUC and C max of aripiprazole by 50%.

Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with aripiprazole, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

12.2Pharmacodynamics Aripiprazole exhibits high affinity for dopamine D 2 and D 3, serotonin 5-HT 1A and 5-HT 2A receptors (K i values of 0.34 nM, 0.8 nM, 1.7 nM, and 3.4 nM, respectively), moderate affinity for dopamine D 4, serotonin 5-HT 2C and 5-HT 7, alpha1-adrenergic and histamine H 1 receptors (K i values of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (K i=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC 50>1,000 nM).

12.3Pharmacokinetics Aripiprazole activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D 2 receptors similar to the parent drug and represents 40% of the parent drug exposure in plasma. The mean elimination half-lives are about 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively. Steady-state concentrations are attained within 14 days of dosing for both active moieties.

Aripiprazole accumulation is predictable from single-dose pharmacokinetics. At steady-state, the pharmacokinetics of aripiprazole is dose-proportional. Elimination of aripiprazole is mainly through hepatic metabolism involving two P450 isozymes, CYP2D6 and CYP3A4.

For CYP2D6 poor metabolizers, the mean elimination half-life for aripiprazole is about 146 hours. Pharmacokinetic studies showed that aripiprazole orally disintegrating tablets are bioequivalent to aripiprazole tablets. ORAL ADMINISTRATION Absorption Tablet: Aripiprazole is well absorbed after administration of the tablet, with peak plasma concentrations occurring within 3 hours to 5 hours; the absolute oral bioavailability of the tablet formulation is 87%.

Aripiprazole can be administered with or without food. Administration of a 15 mg aripiprazole tablet with a standard high-fat meal did not significantly affect the C max or AUC of aripiprazole or its active metabolite, dehydro-aripiprazole, but delayed T max by 3 hours for aripiprazole and 12 hours for dehydro-aripiprazole. Oral Solution: Aripiprazole is well absorbed when administered orally as the solution.

At equivalent doses, the plasma concentrations of aripiprazole from the solution were higher than that from the tablet formulation. In a relative bioavailability study comparing the pharmacokinetics of 30 mg aripiprazole as the oral solution to 30 mg aripiprazole tablets in healthy subjects, the solution to tablet ratios of geometric mean C max and AUC values were 122% and 114%, respectively [see Dosage and Administration ( 2.6) ]. The single-dose pharmacokinetics of aripiprazole were linear and dose-proportional between the doses of 5 mg to 30 mg.

Distribution The steady-state volume of distribution of aripiprazole following intravenous administration is high (404 L or

4.9L/kg), indicating extensive extravascular distribution. At therapeutic concentrations, aripiprazole and its major metabolite are greater than 99% bound to serum proteins, primarily to albumin. In healthy human volunteers administered 0.5 to 30 mg/day aripiprazole for 14 days, there was dose-dependent D 2 receptor occupancy indicating brain penetration of aripiprazole in humans.

Elimination Metabolism Aripiprazole is metabolized primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalyzed by CYP3A4. Aripiprazole is the predominant drug moiety in the systemic circulation.

At steady-state, de…

📦 How Supplied / Storage and Handling ~1 min read ▾

16.1How Supplied Aripiprazole tablets, USP 2 mg are yellow, round, uncoated tablets with scattered specks, debossed with "2" on one side and "16" on other side. Bottles of 30 NDC 13668-216-30 Bottles of 90 NDC 13668-216-90 Bottles of 100 NDC 13668-216-01 Bottles of 500 NDC 13668-216-05 Bottles of 6250 NDC 13668-216-69 Aripiprazole tablets, USP 5 mg are white to off-white, round, uncoated tablets, debossed with "5" on one side and "17" on other side. Bottles of 30 NDC 13668-217-30 Bottles of 90 NDC 13668-217-90 Bottles of 100 NDC 13668-217-01 Bottles of 500 NDC 13668-217-05 Bottles of 6250 NDC 13668-217-69 Aripiprazole tablets, USP 10 mg are white to off-white, round, uncoated tablets, debossed with "10" on one side and "18" on other side.

Bottles of 30 NDC 13668-218-30 Bottles of 90 NDC 13668-218-90 Bottles of 100 NDC 13668-218-01 Bottles of 500 NDC 13668-218-05 Bottles of 7000 NDC 13668-218-52 Aripiprazole tablets, USP 15 mg are white to off-white, round, uncoated tablets, debossed with "15" on one side and "19" on other side. Bottles of 30 NDC 13668-219-30 Bottles of 90 NDC 13668-219-90 Bottles of 100 NDC 13668-219-01 Bottles of 500 NDC 13668-219-05 Bottles of 5000 NDC 13668-219-51 Aripiprazole tablets, USP 20 mg are white to off-white, round, uncoated tablets, debossed with "20" on both sides.

Bottles of 30 NDC 72189-455-30 Bottles of 90 NDC 13668-220-90 Bottles of 100 NDC 13668-220-01 Bottles of 500 NDC 13668-220-05 Bottles of 3400 NDC 13668-220-68 Aripiprazole tablets, USP 30 mg are white to off-white, round, uncoated tablets, debossed with "30" on one side and "21" on other side. Bottles of 30 NDC 13668-221-30 Bottles of 90 NDC 13668-221-90 Bottles of 100 NDC 13668-221-01 Bottles of 500 NDC 13668-221-05 Bottles of 2500 NDC 13668-221-31

📦 Storage and Handling 24 words ▾

16.2Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

📋 Description 84 words ▾

Aripiprazole, USP is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole, USP is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23H 27Cl 2N 3O 2 and its molecular weight is 448.39.

The chemical structure is: [description image] Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, mannitol and microcrystalline cellulose. Additionally, 2 mg tablets contain ferric oxide yellow.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Aripiprazole (AR-i-PIP-ra-zole) Tablets, USP What is the most important information I should know about aripiprazole tablets? (For other side effects, also see "What are the possible side effects of aripiprazole tablets?"). Serious side effects may happen when you take aripiprazole tablets, including: ● Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

Aripiprazole tablets are not approved for the treatment of patients with dementia-related psychosis. ● Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.

These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings. Keep all follow-up visits with the healthcare provider as scheduled.

Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: ● thoughts about suicide or dying ● attempts to commit suicide ● new or worse depression ● new or worse anxiety ● feeling very agitated or restless ● panic attacks ● trouble sleeping (insomnia) ● new or worse irritability ● acting aggressive, being angry, or violent ● acting on dangerous impulses ● an extreme increase in activity and talking (mania) ● other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? ● Never stop an antidepressant medicine without first talking to a healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms. ● Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. ● Antidepressant medicines have other side effects.

Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. ● Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider.

Do not start new medicines without first checking with your healthcare provider. ● Not all antidepressant medicines prescribed for children are FDA approved for use in children . Talk to your child's healthcare provider for more information. What are aripiprazole tablets? ● Aripiprazole Oral tablets, are prescription medicine used to treat: ο Schizophrenia ο manic or mixed episodes that happen with bipolar I disorder ο major depressive disorder (MDD) when aripiprazole tablets are used with antidepressant medicines ο irritability associated with autistic disorder ο Tourette's disorder It is not known if aripiprazole tablets are safe or eff…

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