What the label lists and what reports show
Aripiprazole side effects
Aripiprazole's FDA label: “The most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.” FAERS holds 121,736 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is weight increased (7,849 reports).
- Generic listed
- Boxed warning
Check it at the source: the aripiprazole FDA label on DailyMed (effective January 29, 2025, Otsuka America Pharmaceutical, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ABILIFY?ABILIFY may cause serious side effects, including: See " What is the most important information I should know about ABILIFY? " Stroke in elderly people (cerebrovascular problems) that can lead to death Neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms. Uncontrolled body movements (tardive dyskinesia). ABILIFY may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY. Tardive dyskinesia may also start after you stop receiving ABILIFY. […]
Source: FDA drug label, Otsuka America Pharmaceutical, Inc., effective January 29, 2025 (SPL set c040bd1d-45b7-49f2-93ea-aed7220b30ac), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in adult patients in clinical trials (≥10%) were nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.
Table 15: Adverse Reactions in Short-Term, Placebo-Controlled Trials in Adult Patients Treated with ABILIFY
| Reaction | Preferred Term ABILIFY (n=1,843) | Percentage of Patients Reporting Reaction Adverse reactions reported by at least 2% of… Placebo (n=1,166) |
|---|---|---|
| Blurred Vision | 3 | 1 |
| Nausea | 15 | 11 |
| Constipation | 11 | 7 |
| Vomiting | 11 | 6 |
| Dyspepsia | 9 | 7 |
| Dry Mouth | 5 | 4 |
| Toothache | 4 | 3 |
| Abdominal Discomfort | 3 | 2 |
| Stomach Discomfort | 3 | 2 |
| Fatigue | 6 | 4 |
| Pain | 3 | 2 |
| Musculoskeletal Stiffness | 4 | 3 |
| Pain in Extremity | 4 | 2 |
| Myalgia | 2 | 1 |
| Muscle Spasms | 2 | 1 |
| Headache | 27 | 23 |
| Dizziness | 10 | 7 |
| Akathisia | 10 | 4 |
| Sedation | 7 | 4 |
| Extrapyramidal Disorder | 5 | 3 |
| Tremor | 5 | 3 |
| Somnolence | 5 | 3 |
| Agitation | 19 | 17 |
| Insomnia | 18 | 13 |
| Anxiety | 17 | 13 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Orthostatic Hypotension [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10) ] Seizures/Convulsions [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12) ] Body Temperature Regulation [see Warnings and Precautions (5.13) ] Suicide [see Warnings and Precautions (5.14) ] Dysphagia [see Warnings and Precautions (5.15) ] Commonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were ( 6.1 ): Adult patients with schizophrenia: akathisia Pediatric patients (13 to 17 …
Source: FDA drug label, Otsuka America Pharmaceutical, Inc., effective January 29, 2025 (SPL set c040bd1d-45b7-49f2-93ea-aed7220b30ac), via openFDA; the full label on DailyMed
What do FAERS reports show?
121,736 reports list aripiprazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,758 are coded as a death and 35,939 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aripiprazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions