72/100 · Elevated
Manufactured by Otsuka America Pharmaceutical, Inc.
Aripiprazole Adverse Events: High Seriousness and Diverse Reactions
209,896 FDA adverse event reports analyzed
Last updated: 2026-05-12
ARIPIPRAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Otsuka America Pharmaceutical, Inc.. Based on analysis of 209,896 FDA adverse event reports, ARIPIPRAZOLE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ARIPIPRAZOLE include DRUG INEFFECTIVE, WEIGHT INCREASED, OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ARIPIPRAZOLE.
Aripiprazole has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 209,896 adverse event reports for this medication, which is primarily manufactured by Otsuka America Pharmaceutical, Inc..
The most commonly reported adverse events include Drug Ineffective, Weight Increased, Off Label Use. Of classified reports, 66.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Aripiprazole reports show a high percentage of serious adverse events (66.4%).
The most common reactions include weight changes, depression, and suicidal ideation. A diverse range of reactions is reported, indicating potential for multiple side effects.
Patients taking Aripiprazole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Aripiprazole can interact with other drugs, potentially affecting its efficacy and increasing side effects. Consult a healthcare provider for specific interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aripiprazole received a safety concern score of 72/100 (elevated concern). This is based on a 66.4% serious event ratio across 118,342 classified reports. The score accounts for 209,896 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 60,554, Male: 41,805, Unknown: 567. The most frequently reported age groups are age 30 (1,350 reports), age 55 (1,324 reports), age 50 (1,312 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 118,342 classified reports for ARIPIPRAZOLE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Aripiprazole can interact with other drugs, potentially affecting its efficacy and increasing side effects. Consult a healthcare provider for specific interactions.
If you are taking Aripiprazole, here are important things to know. The most commonly reported side effects include drug ineffective, weight increased, off label use, product use in unapproved indication, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of depression, suicidal thoughts, and unusual behavior, especially in the first few months of treatment. Regularly check blood glucose levels, as diabetes is a known side effect. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor aripiprazole safety. Healthcare providers and patients should report any adverse events to the FDA’s MedWatch program.
The FDA has received approximately 209,896 adverse event reports associated with Aripiprazole. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Aripiprazole include Drug Ineffective, Weight Increased, Off Label Use, Product Use In Unapproved Indication, Anxiety. By volume, the top reported reactions are: Drug Ineffective (8,139 reports), Weight Increased (7,698 reports), Off Label Use (7,392 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Aripiprazole.
Out of 118,342 classified reports, 78,533 (66.4%) were classified as serious and 39,809 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Aripiprazole break down by patient sex as follows: Female: 60,554, Male: 41,805, Unknown: 567. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Aripiprazole adverse events are: age 30: 1,350 reports, age 55: 1,324 reports, age 50: 1,312 reports, age 35: 1,294 reports, age 40: 1,290 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Aripiprazole adverse event reports is Otsuka America Pharmaceutical, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Aripiprazole include: Fatigue, Suicidal Ideation, Depression, Nausea, Insomnia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Aripiprazole to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Aripiprazole has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Aripiprazole reports show a high percentage of serious adverse events (66.4%).
Key safety signals identified in Aripiprazole's adverse event data include: Suicidal ideation and suicide attempts are significant safety signals.. Weight changes, both increase and decrease, are frequently reported.. Neurological reactions such as akathisia and tardive dyskinesia are notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Aripiprazole can interact with other drugs, potentially affecting its efficacy and increasing side effects. Consult a healthcare provider for specific interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aripiprazole.
Monitor for signs of depression, suicidal thoughts, and unusual behavior, especially in the first few months of treatment. Regularly check blood glucose levels, as diabetes is a known side effect.
Aripiprazole has 209,896 adverse event reports on file with the FDA. The most common reactions include weight changes, depression, and suicidal ideation. The volume of reports for Aripiprazole reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor aripiprazole safety. Healthcare providers and patients should report any adverse events to the FDA’s MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Otsuka America Pharmaceutical, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with ARIPIPRAZOLE:
Drugs related to ARIPIPRAZOLE based on therapeutic use, drug class, or shared indications: