Abilifyaripiprazole
According to the FDA label: ABILIFY (aripiprazole) 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 ABILIFY is an atypical antipsychotic.
113,915 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Abilify in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 7,965 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Weight Increased 7,387 reports
Off Label Use 7,176 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Anxiety 4,922 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Product Use in Unapproved Indication 4,815 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Fatigue 4,054 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Suicidal Ideation 3,932 reports
Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Depression 3,877 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Nausea 3,867 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Insomnia 3,716 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Tremor 3,527 reports
Involuntary shaking or trembling, often in the hands.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 3,520 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Suicide Attempt 3,490 reports
A report that a person attempted suicide. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Somnolence 3,383 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Dizziness 3,086 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 59,182 |
| Male | 40,125 |
| Unknown | 559 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 11,109 |
| 18-34 | 17,905 |
| 35-49 | 17,107 |
| 50-64 | 15,633 |
| 65-74 | 5,249 |
| 75+ | 2,617 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Abilify. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 54,516 |
| Non-Serious | 36,832 |
| Hospitalization | 34,017 |
| Death | 6,434 |
| Life-Threatening | 5,201 |
| Disability | 4,245 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Abilify. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 4 |
| 2004 | 1,521 |
| 2005 | 1,783 |
| 2006 | 926 |
| 2007 | 1,987 |
| 2008 | 1,062 |
| 2009 | 6,100 |
| 2010 | 2,518 |
| 2011 | 4,122 |
| 2012 | 4,193 |
| 2013 | 3,267 |
| 2014 | 6,448 |
| 2015 | 7,439 |
| 2016 | 7,003 |
| 2017 | 12,293 |
| 2018 | 9,454 |
| 2019 | 6,382 |
| 2020 | 6,052 |
| 2021 | 6,739 |
| 2022 | 5,661 |
| 2023 | 5,983 |
| 2024 | 6,006 |
| 2025 | 5,546 |
| 2026 (partial) | 1,426 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Abilify
In FDA adverse event reports that mention Abilify, these medications appeared most often in the same report.
- Aripiprazole Orally Disintegrating (39,801 reports)
- Quetiapine (13,219 reports)
- Olanzapine (10,753 reports)
- Risperidone (10,171 reports)
- Clonazepam (7,897 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026