Aripiprazole: uses, dosing, side effects & brands
Aripiprazole is an atypical antipsychotic sold in the U.S. under 7 brand and generic names, for schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Atypical Antipsychotic
- Treats (across its forms)
- Schizophrenia
- Available as
- Solution · Tablet · Tablet, orally disintegrating · Injectable · Kit · Film · Soluble
- Sold as
- 7 products — Aripiprazole, Abilify and Abilify Asimtufii, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 75 hours (mean elimination half-life of the parent drug in typical adults)
- What the pharmacy pays
- about $0.13 per ml — not your price
- Boxed warning
- Boxed warning
How Abilify Asimtufii is dosed
From the FDA label for Abilify Asimtufii (application NDA217006). Other aripiprazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY ASIMTUFII ( 2.1 ) Administer by intramuscular injection in the gluteal muscle by a healthcare professional. Do not administer by any other route ( 2.1 ) Recommended dosage is 960 mg administered once every 2 months as a single injection. Dose can be reduced to 720 mg in patients with adverse reactions ( 2.2 ) For patients currently receiving an oral antipsychotic, there are two ways to initiate treatment with ABILIFY ASIMTUFII 1-day initiation: Administer one injection of ABILIFY ASIMTUFII 960 mg, one injection of Abilify Maintena 400 mg and a single oral dose of aripiprazole 20 mg ( 2.2 ) 14-day initiation: In conjunction with first ABILIFY ASIMTUFII 960 mg dose, take 14 consecutive days of concurrent oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic ( 2.2 ) For patients currently receiving Abilify Maintena Administer ABILIFY ASIMTUFII 960 mg in place of the next scheduled injection of the Abilify Maintena. Missed doses: Dosage adjustment may be required ( 2.3 ) Known CYP2D6 poor metabolizers: Recommended dosage is 720 mg administered once every 2 months as a single injection ( 2.4 ) See Full Prescribing Information for important preparation and administration information ( 2.5 ) 2.1 Important Administration Information For patients who…
Everything below is the FDA label for Abilify Asimtufii (injectable). Aripiprazole is also sold as solution, tablet, tablet, orally disintegrating, kit, film and soluble, and those are different medicines to take — follow the label for the one you were prescribed.
Abilify Asimtufii side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia - Related Psychosis Use [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.3) ] Tardive Dyskinesia [see Warnings and Precautions (5.4) ] Metabolic Changes [see Warnings and Precautions (5.5) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.6) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.7) ] Falls [see Warnings and Precautions (5.8) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.11) ] Body Temperature Regulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Most commonly observed adverse reactions (incidence ≥5% and at least twice the rate of placebo) were increased weight, akathisia, injection site pain, and sedation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or…
Who shouldn’t take Abilify Asimtufii
ABILIFY ASIMTUFII is contraindicated in patients with a known hypersensitivity to aripiprazole, or any of the excipients. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see Adverse Reactions (6.1) ] . Known hypersensitivity to aripiprazole, or to any excipients of ABILIFY ASIMTUFII ( 4 )
Abilify Asimtufii drug interactions
Dosage adjustments for patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers for greater than 14 days ( 2.4 , 7.1 ): Factors Dosage Recommendation CYP2D6 Poor Metabolizers taking concomitant CYP3A4 inhibitors Avoid use Patients taking strong CYP2D6 or CYP3A4 inhibitors 720 mg For the 1-day initiation regimen, administer a single 20 mg oral aripiprazole, 300 mg Abilify Maintena and 720 mg ABILIFY ASIMTUFII on Day 1. Patients taking CYP2D6 and CYP3A4 inhibitors Avoid use Patients taking CYP3A4 inducers Avoid use 7.1 Drugs Having Clinically Important Interactions with ABILIFY ASIMTUFII Table 7 presents clinically significant drug interactions with ABILIFY ASIMTUFII. Table 7: Clinically Important Drug Interactions with ABILIFY ASIMTUFII Strong CYP3A4 Inhibitors AND/OR strong CYP2D6 inhibitors Clinical Rationale Concomitant use of oral aripiprazole with strong CYP3A4 AND/OR CYP2D6 inhibitors increased the exposure of aripiprazole [see Clinical Pharmacology (12.3) ]. Clinical Recommendation Concomitant use of a strong CYP3A4 inhibitor OR a strong CYP2D6 inhibitor Reduce the dosage of ABILIFY ASIMTUFII when administered concomitantly with a strong CYP3A4 inhibitor OR a strong CYP2D6 inhibitor for more than 14 days [see Dosage and Administration (2.4) ]. Concomitant Use of a strong CYP3A4 inhibitor AND a strong CYP2D6 inhibitor Avoid use of ABILIFY ASIMTUFII when administered concomitantly with a strong CYP3A4 inhibitor AND a strong CYP2D6 inhibitor for more than 14 days [see Dosage and Administration (2.4) ]. Strong CYP3A4 Inducers Clinical Rationale Concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole [see Clinical Pharmacology (12.3) ]. Clinical Recommendation Avoid use of ABILIFY ASIMTUFII in combination with a strong CYP3A4 inducer (e.g., carbamazepine) for greater than 14 days [see Dosage and Administration (2.4) ] . Antihypertensive Drugs Clinical Rationale Due to its alpha-adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents. Clinical Recommendation Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions (5.7) ]. Benzodiazepines Clinical Rationale 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 (5.7) ]. Clinical Recommendation Monitor sedation and blood pressure. Adjust dose accordingly. 7.2 Drugs Having No Clinically Important Interactions with ABILIFY ASIMTUFII Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of ABILIFY ASIMTUFII is required when administered concomitantly with famotidine, valproate, lithium, lorazepam [see Clinical Pharmacology (12.3) ] . In addition, no dosage adjustment is necessary for substrates of CYP2D6, CYP2C9, CYP2C19, or CYP3A4 when coadministered with ABILIFY ASIMTUFII. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when coadministered with ABILIFY ASIMTUFII [see Clinical Pharmacology (12.3) ] .
Every aripiprazole product we track (7)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 66/100 | Prescription | Solution | Generic | $0 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $0 | View → | |
| 3 | Not yet rated | Prescription | Injectable | Generic | $0 | View → | |
| 4 | Not yet rated | Prescription | Kit | Generic | $0 | View → | |
| 5 | Not yet rated | Prescription | Tablet | Generic | $0 | View → | |
| 6 | Not yet rated | Prescription | Film | Generic | $0 | View → | |
| 7 | Not yet rated | Prescription | Film | Generic | $0 | View → |
What aripiprazole pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Aripiprazole recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Aripiprazole Tablets USP
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Ajanta Pharma USA Inc · May 27, 2026
Aripiprazole Tablets
Superpotent drug
Ascend Laboratories, LLC · Aug 28, 2025
Abilify (aripiprazole)
Cross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Cross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Cross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
How long does aripiprazole take to work?
“It may take 2 weeks or longer before you feel the full benefit of aripiprazole.” — MedlinePlus, U.S. National Library of Medicine.
What the NIH says about how quickly aripiprazole worksHow long aripiprazole keeps
No aripiprazole label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does aripiprazole expire? The in-use limits and storage rules from its labelsAripiprazole and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for aripiprazole: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited information indicates that maternal doses of aripiprazole up to 15 mg daily produce low levels in milk. Aripiprazole can lower serum prolactin in a dose-related manner, and cases of poor milk supply and lactation cessation have been reported. Weight loss and poor weight gain have been reported in breastfed infants whose mothers were taking aripiprazole. Monitor the breastfed infant for dehydration and lack of appropriate weight gain. Cases of gynecomastia and galactorrhea have also been reported. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised April 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about aripiprazole
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 42,796 reports naming aripiprazole, and the FDA flagged 85% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- weight increased2,198 reports
- anxiety1,837 reports
- fatigue1,564 reports
- suicidal ideation1,474 reports
- nausea1,409 reports
- somnolence1,378 reports
- schizophrenia1,337 reports
- sedation1,304 reports
Read these as a signal, not a rate. A report does not mean aripiprazole caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long aripiprazole stays in your system
The elimination half-life of aripiprazole is about 75 hours (mean elimination half-life of the parent drug in typical adults). Aripiprazole has an ACTIVE metabolite, dehydro-aripiprazole, that OUTLASTS the parent: its mean elimination half-life is about 94 hours, and it represents roughly 40% of the parent drug's exposure in plasma with affinity for D2 receptors similar to the parent — so the drug's effective duration is driven by both moieties, not the ~75 h parent alone. The parent's half-life is strongly affected by CYP2D6 metabolizer status, a population the label names: in CYP2D6 poor metabolizers the mean elimination half-life is about 146 hours (roughly double). The label discusses effects of age, renal impairment, and hepatic impairment only in figures rather than as stated half-life values in the text, so no specific altered half-life numbers for those populations are quoted here.
Aripiprazole tablet — FDA label, DailyMed (§12.3 Pharmacokinetics) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Abilify Asimtufii?
Aripiprazole is an atypical antipsychotic which is present in ABILIFY ASIMTUFII as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate.
What kind of drug is aripiprazole?
The FDA classifies aripiprazole as an atypical antipsychotic. Atypical antipsychotics block dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, rebalancing these signaling chemicals to reduce hallucinations, delusions, and mood symptoms in conditions like schizophrenia and bipolar disorder. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does aripiprazole stay in your system?
The elimination half-life of aripiprazole is about 75 hours (mean elimination half-life of the parent drug in typical adults) — that is how long the body takes to clear half of a dose. Aripiprazole has an ACTIVE metabolite, dehydro-aripiprazole, that OUTLASTS the parent: its mean elimination half-life is about 94 hours, and it represents roughly 40% of the parent drug's exposure in plasma with affinity for D2 receptors similar to the parent — so the drug's effective duration is driven by both moieties, not the ~75 h parent alone. The parent's half-life is strongly affected by CYP2D6 metabolizer status, a population the label names: in CYP2D6 poor metabolizers the mean elimination half-life is about 146 hours (roughly double). The label discusses effects of age, renal impairment, and hepatic impairment only in figures rather than as stated half-life values in the text, so no specific altered half-life numbers for those populations are quoted here. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take aripiprazole with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run aripiprazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is aripiprazole sold under?
We track 7 aripiprazole-containing products in the U.S.: Aripiprazole, Abilify, Abilify Asimtufii, Abilify Maintena Kit, Abilify Mycite Kit, Mezofy and Opipza. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does aripiprazole come in?
Across the brands we track, aripiprazole is currently marketed as solution, tablet, tablet, orally disintegrating, injectable, kit, film and soluble, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic aripiprazole?
Yes. Our catalog lists 1 generic aripiprazole product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has aripiprazole been recalled?
The FDA's Enforcement database lists at least 5 recall records whose product description mentions aripiprazole. The most recent: Aripiprazole Tablets USP (May 27, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Does aripiprazole have boxed warnings?
Yes, two. First, elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death — aripiprazole is not approved for that use, and the warning applies to the whole class. Second, antidepressants and drugs used with them increase the risk of suicidal thinking and behavior in children, adolescents and young adults; aripiprazole carries this warning because it's used as an add-on for major depressive disorder. In practice that means close monitoring, especially in the first few months and after any dose change, with family or friends told what to watch for. Neither warning means the drug is wrong for you — it means the risk has to be weighed openly.
What aripiprazole side effect is most worth recognizing early?
Akathisia — an internal restlessness, an inability to sit still, a driven need to pace or shift your legs. In the schizophrenia trials behind the label it occurred in 8% of patients on aripiprazole versus 4% on placebo, and in bipolar mania monotherapy trials in 13% versus 4%. It typically shows up early and is dose-related. The critical point: akathisia is routinely mistaken for worsening anxiety or agitation from the underlying condition, which leads to the dose being raised and the problem getting worse. Describe it as a physical restlessness, not as anxiety, and report it — lowering the dose or slowing the titration usually helps. The label also lists nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia and restlessness among reactions occurring in 10% or more of adults.
Can aripiprazole cause gambling or compulsive behavior?
Yes. FDA added a warning in 2016 about impulse-control problems on aripiprazole: compulsive or pathological gambling, compulsive shopping, binge eating and compulsive sexual urges. These urges can appear in people with no prior history, can start at any dose, and generally stop when the dose is lowered or the drug is discontinued. The reason this warning matters practically is that patients almost never connect the behavior to a medication — they experience it as a personal failing and hide it, sometimes after significant financial or relationship damage. Tell someone close to you to watch for it before it starts, and report any new urge of this kind immediately rather than waiting for the next appointment.
Which aripiprazole side effects are emergencies?
Call 911 for high fever with muscle rigidity, confusion, sweating and unstable blood pressure or heart rate — that pattern is neuroleptic malignant syndrome. Also emergency: severe rash with blistering or peeling, swelling of the face or throat, or signs of very high blood sugar and diabetic ketoacidosis (extreme thirst, frequent urination, weakness, nausea, fruity-smelling breath). Call your doctor promptly for involuntary movements of the lips, tongue, jaw or face, which may be tardive dyskinesia and can become permanent if the drug is continued; for fainting or repeated lightheadedness on standing; and for fever, sore throat or signs of infection, which can reflect a drop in white blood cells.
Will aripiprazole cause weight gain, and what gets monitored?
Aripiprazole tends to cause less weight gain and less metabolic disruption than olanzapine or quetiapine, but less is not none — weight gain, elevated blood sugar and elevated lipids all occur, and children and adolescents are more susceptible than adults. Baseline and periodic checks of weight, fasting glucose or A1c, and a lipid panel are standard. Two other practical items: aripiprazole can interfere with your body's ability to regulate temperature, so be deliberate about hydration and avoiding overheating in hot weather or hard exercise. And blood levels are affected by drugs that inhibit CYP2D6 or CYP3A4 (such as fluoxetine, paroxetine, ketoconazole) or induce them (such as carbamazepine), so dose adjustments are needed when those are started or stopped.
Cite this page
- APA
- pharmaranks. (2026, July 24). Aripiprazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/aripiprazole
- MLA
- “Aripiprazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/aripiprazole.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for aripiprazole on DailyMed (NIH) ↗ — including its boxed warning in full.