Aripiprazole: adverse event reports filed with FDA

30,145

reports as suspect product

0.2% of all reports · about 1,340 a year

3,102

reports, 12 months to June 2026

2,997 in the 12 months before

87.8%

marked serious by the reporter

70.7% across the class

8.7%

record death among outcomes, as reported

2,634 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Aripiprazole reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected12.2%3,664
2. Off label useused for a purpose or in a way not on the label7.2%2,180
3. Drug interactionan interaction between medicines6.2%1,860
4. Product use in unapproved indicationused for a purpose not on the label6.1%1,841
5. Weight increasedweight gain5.7%1,721
6. Anxietyanxiety4.1%1,224
7. Suicide attempta suicide attempt3.9%1,189
8. Schizophreniaschizophrenia3.8%1,145
9. Akathisiainner restlessness and an urge to move3.7%1,128
10. Condition aggravatedthe condition being treated got worse3.7%1,125
11. Toxicity to various agentspoisoning or toxic effect of one or more substances3.7%1,116
12. Sedationdrowsiness from a medicine3.7%1,111
13. Somnolencedrowsiness3.5%1,045
14. Extrapyramidal disordermovement problems such as stiffness or tremor3.3%996
15. Suicidal ideationthoughts of suicide3.3%988
16. Insomniadifficulty sleeping3.2%961
17. Psychotic disordera loss of contact with reality3.1%940
18. Tremorshaking3.1%931
19. Dystoniainvoluntary muscle contractions3%909
20. Fatiguetiredness2.9%877
21. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity2.9%866
22. Dyskinesiainvoluntary movements2.8%849
23. Nauseafeeling sick2.7%813
24. Completed suicidedeath by suicide2.7%803
25. Treatment noncompliancethe treatment was not taken as directed2.6%794
26. Depressionlow mood2.5%745
27. Drug abusemisuse of a medicine2.4%725
28. Agitationrestlessness2.3%708
29. Overdosea dose above the recommended amount2.3%708
30. Electrocardiogram QT prolongeda QT prolongation on the ECG2.3%707

Top 30 of 2,341 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 37 drugs in the atypical antipsychotic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 683,680 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 29.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 30,145 reports.

Drugs most often listed in the same reports

Other products listed in reports where Aripiprazole is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the atypical antipsychotic class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Aripiprazole as a suspect or interacting product; reports listing it only as a concomitant medication (11,856) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.