Aripiprazole: Side Effects, Uses & Monitoring
Aripiprazole Oral Tablets, are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1)] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2)] Adju
- Data source
- FDA labeling via NIH DailyMed (label facdb9a9…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Tremor | 5% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Aripiprazole Oral Tablets, are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1)] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see CLINICAL STUDIES (14.2)] Adjunctive Treatment of Major Depressive Disorder [see CLINICAL STUDIES (14.3)] Irritability Associated with Autistic Disorder [see CLINICAL STUDIES (14.4)] Treatment of Tourette’s Disorder [see CLINICAL STUDIES (14.5)]
Conditions associated with Aripiprazole in labeling
Frequently Asked Questions
What is Aripiprazole used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Aripiprazole?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Aripiprazole. Individual risk varies.
Does Aripiprazole require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Aripiprazole.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.