ARIPIPRAZOLE FDA MedWatch Direct Reports Summary

These tables and charts are created from 1,528 voluntary U.S. reports for ARIPIPRAZOLE (ARIPIPRAZOLE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS ARIPIPRAZOLE Report.

Top Adverse Effects Associated with ARIPIPRAZOLE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	TREATMENT FAILURE	168
2	DRUG INEFFECTIVE	124
3	PRODUCT SUBSTITUTION ISSUE	93
4	ANXIETY	61
5	NAUSEA	60
6	FATIGUE	51
7	HEADACHE	49
8	SUICIDAL IDEATION	49
9	DIZZINESS	47
10	VOMITING	46
11	TREMOR	45
12	DEPRESSION	42
13	CONDITION AGGRAVATED	41
14	AGGRESSION	40
15	WEIGHT INCREASED	40
16	THERAPY INTERRUPTED	39
17	AKATHISIA	35
18	INSOMNIA	35
19	ABNORMAL BEHAVIOUR	33
20	THERAPY CESSATION	33
21	DEATH	32
22	HOSPITALIZATION	31
23	AGITATION	30
24	LACK OF STRENGTH AND ENERGY (ASTHENIA)	28
25	SHORTNESS OF BREATH	28

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ARIPIPRAZOLE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
488	756	284	1,528

Medwatch Reporter Type	Count
Consumer	620
Physician	130
Pharmacist	308
Other Health Professional	309

Top Indications

Product used for unknown indication
Schizophrenia
Bipolar disorder
Psychotic disorder
Depression

Type of Outcome Reported
Serious: 954
Not Serious: 574
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 1526
Concomitant Drugs: 905
Note: A single MedWatch report can list more than one drug. This summary includes ARIPIPRAZOLE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

ABILIFY (ARIPIPRAZOLE) Rx Drug:
FDA Safety-related Labeling Changes

ABILIFY MAINTENA KIT (ARIPIPRAZOLE) Rx Drug:
FDA Safety-related Labeling Changes

ABILIFY MYCITE KIT (ARIPIPRAZOLE) Rx Drug:
FDA Safety-related Labeling Changes

ARISTADA (ARIPIPRAZOLE LAUROXIL) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with ARISTADA? Rate ARISTADA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.