85/100 · Critical
Manufactured by Accord Healthcare, Inc.
Aripiprazole Orally Disintegrating: High Serious Adverse Event Rate
79,930 FDA adverse event reports analyzed
Last updated: 2026-05-12
ARIPIPRAZOLE ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING 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 ORALLY DISINTEGRATING.
Aripiprazole Orally Disintegrating 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 rate of serious adverse events, particularly suicide-related and psychiatric conditions.
Significant number of drug interactions and overdose reports. Common side effects include weight gain, fatigue, and sedation. Serious cardiovascular and neurological events are reported, including QT prolongation and extrapyramidal disorders. Psychiatric disorders and suicidal ideation are frequent.
Patients taking Aripiprazole Orally Disintegrating should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Aripiprazole Orally Disintegrating can interact with other drugs, and patients should be monitored for signs of drug interactions and overdose. Warnings are issued for QT prolongation and other cardiac effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Aripiprazole Orally Disintegrating 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 ORALLY DISINTEGRATING:
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 Orally Disintegrating can interact with other drugs, and patients should be monitored for signs of drug interactions and overdose. Warnings are issued for QT prolongation and other cardiac effects.
If you are taking Aripiprazole Orally Disintegrating, 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 be closely monitored for signs of suicidal ideation and behavior, especially during the first few months of treatment. Inform healthcare providers about any existing medical conditions, particularly cardiovascular and psychiatric issues. 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 Orally Disintegrating for serious adverse events, particularly suicide-related incidents and psychiatric disorders. Regular monitoring and reporting of adverse events are required.
The FDA has received approximately 79,930 adverse event reports associated with Aripiprazole Orally Disintegrating. 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 Orally Disintegrating 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 Orally Disintegrating.
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 Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating 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 rate of serious adverse events, particularly suicide-related and psychiatric conditions.
Key safety signals identified in Aripiprazole Orally Disintegrating's adverse event data include: Suicide-related events (suicide attempt, completed suicide) are a key safety signal.. QT prolongation and other cardiac issues are notable.. Neurological side effects such as akathisia and tardive dyskinesia are frequent.. Weight changes (increase and decrease) are common and may be significant.. Drug interactions and overdose are common, indicating potential misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Aripiprazole Orally Disintegrating can interact with other drugs, and patients should be monitored for signs of drug interactions and overdose. Warnings are issued for QT prolongation and other cardiac effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Aripiprazole Orally Disintegrating.
Patients should be closely monitored for signs of suicidal ideation and behavior, especially during the first few months of treatment. Inform healthcare providers about any existing medical conditions, particularly cardiovascular and psychiatric issues.
Aripiprazole Orally Disintegrating has 79,930 adverse event reports on file with the FDA. Significant number of drug interactions and overdose reports. The volume of reports for Aripiprazole Orally Disintegrating reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Aripiprazole Orally Disintegrating for serious adverse events, particularly suicide-related incidents and psychiatric disorders. Regular monitoring and reporting of adverse events are required. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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