Aripiprazole 10 mg Tablet, 30-count
Other active recalls for Aripiprazole (different manufacturers) — 6 · tap to view
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Atypical Antipsychotic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Aripiprazole — tap one for details:
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💊 What it looks like
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🧪 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.
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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.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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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.
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UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
5 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 | $0.105 | $3.15 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4549 | $13.65 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.3773 | $11.32 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Aripiprazole 10 mg 16729-0280-01 | Accord | 100 tablets | $0.100 | AB | Availability likely | save 5% |
| Aripiprazole 10 mg 00904-7368-06 | Major | 50 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 16714-0143-01 | NorthStar | 30 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 27241-0053-03 | Ajanta | 30 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 33342-0124-07 | Macleods | 30 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 43547-0304-03 | Solco | 30 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 43547-0886-03 | Solco | 30 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 50268-0089-15 | AvPAK | 50 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 60687-0179-01 | American | 100 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mgthis 65162-0898-03 | Amneal | 30 tablets | $0.105 | AB | Availability likely | — |
| Aripiprazole 10 mg 82009-0090-05 | Quallent | 500 tablets | $0.105 | AB | Availability likely | — |
| Abilify 10 mg 59148-0008-13 | Otsuka | 30 tablets | $18.625 | AB | Availability likely | +17658% |
| Aripiprazole 10 mg 00615-8525-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| aripiprazole 10 mg 13668-0218-01 | Torrent | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 29300-0177-01 | Unichem | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 31722-0827-01 | Camber | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 31722-0921-01 | Camber | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 43598-0556-05 | Dr.Reddys | 500 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 43598-0967-05 | Dr.Reddys | 500 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 46708-0256-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 50090-4936-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 50090-6409-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 50228-0326-10 | ScieGen | 1000 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 50228-0330-30 | ScieGen | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 50228-0477-10 | ScieGen | 1000 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 62332-0099-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| aripiprazole 10 mg 63629-7003-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Aripiprazole 10 mg 65862-0663-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 67877-0432-01 | Ascend | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 68071-3850-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 68071-3906-04 | NuCare | 14 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 68788-7808-01 | Prefferred | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 70518-2281-02 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 70518-2820-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 71335-1515-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Aripiprazole 10 mg 71335-1903-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 72162-2369-05 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 72189-0476-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 72865-0155-05 | XLCare | 500 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 72865-0182-05 | XLCare | 500 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 76282-0046-01 | Exelan | 100 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 82804-0023-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| aripiprazole 10 mg 82804-0236-90 | Proficient | 90 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 67046-0873-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Aripiprazole 10 mg 67046-0492-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 65162-0898-03 You're viewing this | 30 TABLET in 1 BOTTLE (65162-898-03) | $0.1049 / ea | $3.15 | 2016-06-20 | Active |
| 65162-0898-09 | 90 TABLET in 1 BOTTLE (65162-898-09) | $0.1049 / ea | $9.44 | 2016-06-20 | Active |
| 65162-0898-11 | 1000 TABLET in 1 BOTTLE (65162-898-11) | — | — | 2016-06-20 | Active |
| 65162-0898-50 | 500 TABLET in 1 BOTTLE (65162-898-50) | — | — | 2016-06-20 | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1049 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 69% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 65162-0898-03?
What is the difference between NDC 65162-0898-03 and NDC 65162-0898-09?
What NDC number is used to bill for this package of Aripiprazole 10 mg Tablet?
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
🚨 Boxed Warning ▾
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) ] .
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. 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.
( 5.1 ) Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. ( 5.3 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Aripiprazole Tablets are indicated for the treatment of: Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are indicated for: Schizophrenia. ( 14.1 ) Irritability Associated with Autistic Disorder. ( 14.4 ) Treatment of Tourette’s Disorder. ( 14.5 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer once daily without regard to meals ( 2 ) Initial Dose Recommended Dose Maximum Dose Schizophrenia – adults (2.1) 10 to 15 mg/day 10 to 15 mg/day 30 mg/day Schizophrenia – adolescents (2.1) 2 mg/day 10 mg/day 30 mg/day Irritability associated with autistic disorder – pediatric patients (2.4) 2 mg/day 5 to 10 mg/day 15 mg/day Tourette’s Disorder – (2.5) Patients <50 kg 2 mg/day 5 mg/day 10 mg/day Patients ≥50 kg 2 mg/day 10 mg/day 20 mg/day Known CYP2D6 poor metabolizers: Half of the usual dose.
( 2.6 )
2.1Schizophrenia Adults The recommended starting and target dose for aripiprazole tablets is 10 mg/day or 15 mg/day administered on a once-a-day schedule without regard to meals. Aripiprazole tablets have been systematically evaluated and shown to be effective in a dose range of 10 mg/day to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 mg/day or 15 mg/day were not more effective than 10 mg/day 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 tablets 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 tablets is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg 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 tablets 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 tablets 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.
2.4Irritability 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 mg/day to 15 mg/day. Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 mg/day or 15 mg/day if needed.
Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week [see Clinical Studies (14.4) ] . Patients should be periodically reassessed to determine the continued need for maintenance treatment.
2.5Tourette’s Disorder Pediatric Patients (6 to 18 years) The recommended dosage range for Tourette’s Disorder is 5 mg/day to 20 mg/day. For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics.
Dosage adjustments should occur gradually at intervals of no less than one week. For patients weighing 50 kg or more, dos…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Aripiprazole Tablets, USP are available as described in Table 2. Table 2: Aripiprazole Tablet Presentations Tablet Strength TabletColor/Shape TabletMarkings 2 mg green to light green mosaic appearance, modified rectangle shaped “AN896” and “2” 5 mg blue to light blue mosaic appearance, modified rectangle shaped “AN897” and “5” 10 mg pink to light pink mosaic appearance, modified rectangle shaped “AN898” and “10” 15 mg yellow to light yellow mosaic appearance, round shaped “AN899” and “15” 20 mg white to off-white, round shaped “AN901” and “20” 30 mg pink to light pink mosaic appearance, round shaped “AN902” and “30” Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Aripiprazole tablets are 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) ] . Known hypersensitivity to aripiprazole. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities). ( 5.1 , 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate.
( 5.5 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain. ( 5.6 ) Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes. ( 5.6 ) Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics.
( 5.6 ) Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight. ( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation.
( 5.7 ) Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. ( 5.8 ) Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including aripiprazole. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of aripiprazole should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
( 5.10 ) Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. ( 5.11 ) Potential for Cognitive and Motor Impairment: Use caution when operating machinery. ( 5.12 ) Suicide: The possibility of a suicide attempt is inherent in schizophrenia.
Closely supervise high-risk patients. ( 5.14 )
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 ar…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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) ] Commonly observed adverse reactions (incidence ≥ 5% and at least twice that for placebo) were.
( 6.1 ): Adult patients with schizophrenia: akathisia. Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor. Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy.
Pediatric patients (6 to 18 years) with Tourette’s Disorder: sedation, somnolence, nausea, headache, nasopharyngitis, fatigue, increased appetite. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 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 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, other indications, dementia of the Alzheimer’s type, Parkinson’s disease, and alcoholism, and who had approximately 7,619 patient-years of exposure to oral aripiprazole. 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 1 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, autistic disorder, or Tourette’s Disorder or other indications, 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 1 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.
Adu…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Dosage adjustment due to drug interactions ( 7.1 ): Factors Dosage Adjustments for Aripiprazole Known CYP2D6 Poor Metabolizers Administer half of usual dose Known CYP2D6 Poor Metabolizers and strong CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP2D6 or CYP3A4 inhibitors Administer half of usual dose Strong CYP2D6 and CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP3A4 inducers Double usual dose over 1 to 2 weeks
7.1Drugs Having Clinically Important Interactions with Aripiprazole Table 22: 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) Concomitant use of aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of aripiprazole alone [see Clinical Pharmacology (12.3) ] .
Reduce the aripiprazole dosage when administered concomitantly with a strong CYP3A4 inhibitor or a strong CYP2D6 inhibitor [see Dosage and Administration (2.6)] . Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin) Concomitant use of aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of aripiprazole alone [see Clinical Pharmacology (12.3) ] . Increase the aripiprazole dosage when administered concomitantly with a strong CYP3A4 inducer [see Dosage and Administration (2.6)] .
Antihypertensive Drugs Due to its alpha 1 -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 lorazepam alone [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, and 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 ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. ( 8.1 ) Lactation: Monitor the breastfed infant for dehydration and lack of appropriate weight gain ( 8.2 )
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-research-programs/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, and with exposure to antipsychotics, including aripiprazole, during pregnancy (see Clinical Considerations) . Aripiprazole exposure during pregnancy can have variable effects on milk supply in the post-partum period [see Use in Specific Populations (8.2)].
In animal reproduction studies, 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. 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 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 including increased risk of relapse, hospitalization, and suicide. Schizophrenia is 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.
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. 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 database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects.
Animal Data In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. In pregnant rats treated orally wit…
🧒 Pediatric Use ▾
8.4Pediatric Use The pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see Clinical Pharmacology (12.3) ] . Schizophrenia Safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in 202 pediatric patients aged 13 to 17 years [see Dosage and Administration (2.1) , Adverse Reactions (6.1) , and Clinical Studies (14.1) ] .
Although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. Irritability Associated with Autistic Disorder Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two 8-week, placebo-controlled clinical trials in 212 pediatric patients aged 6 to 17 years [see Indications and Usage (1) , Dosage and Administration (2.4) , Adverse Reactions (6.1) , and Clinical Studies (14.4) ] .
A maintenance trial was conducted in pediatric patients (6 to 17 years of age) with irritability associated with autistic disorder. The first phase of this trial was an open-label, flexibly dosed (aripiprazole 2 mg/day to 15 mg/day) phase in which patients were stabilized (defined as > 25% improvement on the ABC-I subscale, and a CGI-I rating of “much improved” or “very much improved”) on aripiprazole for 12 consecutive weeks. Overall, 85 patients were stabilized and entered the second, 16-week, double-blind phase where they were randomized to either continue aripiprazole treatment or switch to placebo.
In this trial, the efficacy of aripiprazole for the maintenance treatment of irritability associated with autistic disorder was not established. Tourette’s Disorder Safety and effectiveness of aripiprazole in pediatric patients with Tourette’s Disorder were established in one 8-week (aged 7 to 17 years) and one 10-week trial (aged 6 to 18 years) in 194 pediatric patients [see Dosage and Administration (2.5) , Adverse Reactions (6.1) , and Clinical Studies (14.5) ] . Maintenance efficacy in pediatric patients has not been systematically evaluated.
Juvenile Animal Studies Aripiprazole in juvenile rats caused mortality, CNS clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). At 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other CNS signs were observed in both genders. In addition, delayed sexual maturation was observed in males.
At all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. A No Observed Adverse Effect Level (NOAEL) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (AUC 0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day.
All drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. Aripiprazole in juvenile dogs (2 months old) caused CNS clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/k…
🧓 Geriatric Use ▾
8.5Geriatric Use No dosage adjustment is recommended for elderly patients [see Boxed Warning , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ] . Of the 13,543 patients treated with aripiprazole in clinical trials, 1,073 (8%) were ≥65 years old and 799 (6%) were ≥75 years old. Placebo-controlled studies of aripiprazole in schizophrenia, or other indications did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Aripiprazole is not approved for the treatment of patients with psychosis associated with Alzheimer’s disease [see Boxed Warning and Warnings and Precautions (5.1) ] .
🆘 Overdosage ▾
10 OVERDOSAGE MedDRA terminology has been used to classify the adverse reactions. Human Experience In clinical trials and in post-marketing experience, adverse reactions of deliberate or accidental overdosage with oral aripiprazole have been reported worldwide. These include overdoses with 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 1260 mg of 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 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.
Management 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 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 ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of aripiprazole in schizophrenia, 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 , alpha 1 -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. Absorption 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. 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 mg/day to 30 mg/day aripiprazole for 14 days, there was dose-dependent D 2 receptor occupancy indicating brain penetration of aripiprazole in humans.
Metabolism and 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, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma. Excretion Following a single oral dose of [ 14 C]-labeled aripiprazole, approximately 25% and 55% of the administered radioactivity was recovered in the urine and feces, respectively. Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% of the dose was recovered unchanged in the feces.
Drug Interaction Studies Effect of other drugs on the exposures of aripiprazole and dehydro-aripiprazole are summarized in Figure 1 and Figure 2, respectively. Based on simulation, a 4.5-fold increase in mean C max and AUC values at steady-state is expected when extensive metabolizers of CYP2D6 are administered with both strong CYP2D6…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of aripiprazole in schizophrenia, 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Aripiprazole tablets USP, 2 mg, are supplied as green to light green colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN896” and “2” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-896-03 Bottles of 90: NDC 65162-896-09 Bottles of 500: NDC 65162-896-50 Bottles of 1000: NDC 65162-896-11 Aripiprazole tablets USP, 5 mg, are supplied as blue to light blue colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN897” and “5” on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-897-03 Bottles of 90: NDC 65162-897-09 Bottles of 500: NDC 65162-897-50 Bottles of 1000: NDC 65162-897-11 Aripiprazole tablets USP, 10 mg, are supplied as pink to light pink colored, mosaic appearance, modified rectangle shaped, uncoated tablet with debossing “AN898” and “10” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-898-03 Bottles of 90: NDC 65162-898-09 Bottles of 500: NDC 65162-898-50 Bottles of 1000: NDC 65162-898-11 Aripiprazole tablets USP, 15 mg, are supplied as yellow to light yellow colored, mosaic appearance, round shaped, uncoated tablet with debossing “AN899” and “15” on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-899-03 Bottles of 90: NDC 65162-899-09 Bottles of 500: NDC 65162-899-50 Bottles of 1000: NDC 65162-899-11 Aripiprazole tablets USP, 20 mg, are supplied as white to off-white, round shaped, uncoated tablet with debossing “AN901” and “20” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-901-03 Bottles of 90: NDC 65162-901-09 Bottles of 500: NDC 65162-901-50 Bottles of 1000: NDC 65162-901-11 Aripiprazole tablets USP, 30 mg, are supplied as pink to light pink colored, mosaic appearance, round shaped, uncoated tablet with debossing “AN902” and “30” on one side and plain on the other side.
They are available as follows: Bottles of 30: NDC 65162-902-03 Bottles of 90: NDC 65162-902-09 Bottles of 500: NDC 65162-902-50 Bottles of 1000: NDC 65162-902-11 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] in tightly closed containers.
📋 Description ▾
11 DESCRIPTION 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 molecular formula is C 23 H 27 Cl 2 N 3 O 2 and its molecular weight is 448.38.
The chemical structure is: Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include croscarmellose sodium, magnesium stearate, microcrystalline cellulose and tartaric acid. The 2 mg and 5 mg tablets contain FD&C Blue No.
2 indigo carmine aluminum lake (30% to 36%). The 2 mg and 15 mg tablets contain ferric oxide yellow. The 10 mg and 30 mg tablets contain FD&C Red No.
40 allura red AC aluminum lake (15% to 17%). 1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Clinical Worsening of Depression and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.3) ] .
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with aripiprazole and should counsel them in its appropriate use. A patient Medication Guide including information about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for aripiprazole. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.
Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that aripiprazole is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder. Pathological Gambling and Other Compulsive Behaviors Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole.
In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions (5.7) ] . Interference with Cognitive and Motor Performance Because aripiprazole may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that aripiprazole therapy does not affect them adversely [see Warnings and Precautions (5.12) ] . Concomitant Medication Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7) ] .
Heat Exposure and Dehydration Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.13) ] . Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with aripiprazole. Advise patients that aripiprazole may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate.
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy [see Use in Specific Populations (8.1) ]. Lactation Aripiprazole use during pregnancy may affect milk supply. Advise the lactating patient to discuss any plans for breastfeeding with their healthcare provider, and to monitor t…
💬 Medication Guide ▾
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 Tablets are a prescription medicine used to treat: Schizophrenia. irritability associated with autistic disorder.
Tourette’s Disorder. It is not known if aripiprazole tablets are safe or effective in children: under 13 years of age with schizophrenia. under 6 years of age with irritability associated with autistic disorder. under 6 years of age with Tourette’s Disorder. Do not take aripiprazo…