85/100 · Critical
Manufactured by Accord Healthcare, Inc.
Aripiprazole Oral Adverse Events Show High Seriousness and Diverse Reactions
79,930 FDA adverse event reports analyzed
Last updated: 2026-05-12
ARIPIPRAZOLE ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare, Inc.. Based on analysis of 79,930 FDA adverse event reports, ARIPIPRAZOLE ORAL has a safety score of 85 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 ORAL include DRUG INEFFECTIVE, OFF LABEL USE, PRODUCT USE IN UNAPPROVED INDICATION, DRUG INTERACTION, WEIGHT INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ARIPIPRAZOLE ORAL.
Aripiprazole Oral has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 79,930 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Product Use In Unapproved Indication. Of classified reports, 85.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (85.2%) indicates significant safety concerns.
Diverse reactions include psychiatric, neurological, and metabolic issues, suggesting a broad safety profile. Weight changes (both increase and decrease) are frequently reported, indicating potential impact on body weight.
Patients taking Aripiprazole Oral 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, leading to potential adverse effects. Warnings include drug interactions, particularly with other antipsychotics and antidepressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aripiprazole Oral received a safety concern score of 85/100 (high concern). This is based on a 85.2% serious event ratio across 38,631 classified reports. The score accounts for 79,930 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 18,939, Male: 14,964, Unknown: 191. The most frequently reported age groups are age 23 (617 reports), age 35 (585 reports), age 32 (562 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,631 classified reports for ARIPIPRAZOLE ORAL:
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, leading to potential adverse effects. Warnings include drug interactions, particularly with other antipsychotics and antidepressants.
If you are taking Aripiprazole Oral, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, product use in unapproved indication, drug interaction, weight increased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug interactions and overdose. 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 closely monitors aripiprazole due to its high rate of serious adverse events. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of severe adverse reactions.
The FDA has received approximately 79,930 adverse event reports associated with Aripiprazole Oral. 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 Oral include Drug Ineffective, Off Label Use, Product Use In Unapproved Indication, Drug Interaction, Weight Increased. By volume, the top reported reactions are: Drug Ineffective (4,135 reports), Off Label Use (2,737 reports), Product Use In Unapproved Indication (2,173 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 Oral.
Out of 38,631 classified reports, 32,895 (85.2%) were classified as serious and 5,736 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 Oral break down by patient sex as follows: Female: 18,939, Male: 14,964, Unknown: 191. 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 Oral adverse events are: age 23: 617 reports, age 35: 585 reports, age 32: 562 reports, age 30: 549 reports, age 16: 521 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 Oral adverse event reports is Accord Healthcare, 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 Oral include: Anxiety, Condition Aggravated, Suicide Attempt, Fatigue, Suicidal Ideation. 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 Oral 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 Oral has a safety concern score of 85 out of 100 (high 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. High percentage of serious adverse events (85.2%) indicates significant safety concerns.
Key safety signals identified in Aripiprazole Oral's adverse event data include: High rate of serious adverse events (32,895 out of 38,631, 85.2%). Psychiatric issues like suicide attempts and depression are common. Neurological issues such as akathisia and extrapyramidal disorder are frequently reported. 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, leading to potential adverse effects. Warnings include drug interactions, particularly with other antipsychotics and antidepressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aripiprazole Oral.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug interactions and overdose.
Aripiprazole Oral has 79,930 adverse event reports on file with the FDA. Diverse reactions include psychiatric, neurological, and metabolic issues, suggesting a broad safety profile. The volume of reports for Aripiprazole Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors aripiprazole due to its high rate of serious adverse events. Healthcare providers should be vigilant and consider alternative treatments for patients with a history of severe adverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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