Drug · FAERS side-effect profile with label screen
Aripiprazole side effects: what 121,713 FDA adverse event reports show
Who reports
121,713 reports · 67% serious · 6,758 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Aripiprazole Oral Solution is indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depre.
FDA label, Indications and Usage
What it is
Aripiprazole is an N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4.
PubChem CID 60795 (ChEBI)
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 5Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 23
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,233 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Bankruptcy | 387 | 1,038.0 795.4–1,354.6ROR 1,041.3 · calibrated p 5e-17 ✓ | 145.1 EB05 133.4 · IC025 +6.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 27.0 (23.2–31.4) | Not in label — unassessed | serious n=367 · 100% consumer | not reported in cached trials |
| Gambling disorder | 2,053 | 553.3 506.0–604.9ROR 562.8 · calibrated p 2e-14 ✓ | 130.1 EB05 125.4 · IC025 +6.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 23.1 (21.7–24.6) | Labeled (related wording) related wording | serious n=1,675 | not reported in cached trials |
| Compulsive hoarding | 245 | 552.0 426.2–714.9ROR 553.1 · calibrated p 5e-14 ✓ | 128.8 EB05 115.9 · IC025 +6.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 34.5 (28.1–42.4) | Not in label — unassessed | serious n=236 | not reported in cached trials |
| Compulsive sexual behaviour | 601 | 493.0 420.9–577.4ROR 495.4 · calibrated p 9e-14 ✓ | 126.1 EB05 117.8 · IC025 +6.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 36.0 (31.6–41.1) | Not in label — unassessed | serious n=567 | not reported in cached trials |
| Shoplifting | 184 | 334.3 260.5–429.0ROR 334.8 · calibrated p 7e-12 ✓ | 111.6 EB05 98.7 · IC025 +6.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 37.6 (29.5–48.0) | Not in label — unassessed | serious n=175 | not reported in cached trials |
| Blood prolactin abnormal | 571 | 332.7 288.9–383.2ROR 334.3 · calibrated p 4e-12 ✓ | 112.3 EB05 104.8 · IC025 +6.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.1 (2.9–3.4) | Lab value / disease marker | serious n=562 | not reported in cached trials |
| Divorced | 282 | 301.6 248.2–366.4ROR 302.3 · calibrated p 1e-11 ✓ | 108.2 EB05 98.0 · IC025 +6.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 35.8 (29.5–43.4) | Not in label — unassessed | serious n=268 · 100% consumer | not reported in cached trials |
| Homeless | 274 | 272.3 224.9–329.8ROR 273.0 · calibrated p 3e-11 ✓ | 104.1 EB05 94.2 · IC025 +6.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 32.9 (27.2–39.9) | Not in label — unassessed | serious n=252 · 100% consumer | not reported in cached trials |
| Anosognosia | 468 | 269.0 232.5–311.2ROR 270.0 · calibrated p 3e-11 ✓ | 104.0 EB05 96.3 · IC025 +6.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.8 (2.6–3.1) | Not in label — unassessed | serious n=460 | not reported in cached trials |
| Compulsive shopping | 1,166 | 224.7 205.9–245.2ROR 226.8 · calibrated p 1e-10 ✓ | 96.9 EB05 92.3 · IC025 +6.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 26.2 (24.0–28.5) | Labeled adverse reaction exact term | serious n=1,047 · 72% consumer | not reported in cached trials |
| Rhesus incompatibility | 68 | 216.8 151.4–310.5ROR 216.9 · calibrated p 6e-10 ✓ | 93.1 EB05 76.0 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Not in label — unassessed | serious n=68 | not reported in cached trials |
| Gambling | 528 | 140.3 125.0–157.4ROR 140.9 · calibrated p 8e-9 ✓ | 76.9 EB05 71.5 · IC025 +6.0 3/3 methods agree vs other Atypical Antipsychotics: PRR 46.1 (39.6–53.8) | Labeled — boxed warning exact term | serious n=314 · 83% consumer | not reported in cached trials |
| Stubbornness | 174 | 115.3 95.1–139.8ROR 115.5 · calibrated p 5e-8 ✓ | 68.4 EB05 60.3 · IC025 +5.6 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Not in label — unassessed | serious n=173 · ♀ 100% (drug 59%) | not reported in cached trials |
| Psychosexual disorder | 111 | 105.4 83.1–133.5ROR 105.5 · calibrated p 1e-7 ✓ | 64.6 EB05 55.1 · IC025 +5.3 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Not in label — unassessed | serious n=103 · ♀ 0% (drug 59%) · 100% consumer | not reported in cached trials |
| Theft | 240 | 96.3 82.2–112.9ROR 96.5 · calibrated p 2e-7 ✓ | 61.4 EB05 55.2 · IC025 +5.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 34.8 (28.3–42.8) | Not in label — unassessed | serious n=219 · 100% consumer | not reported in cached trials |
| Schizoaffective disorder | 575 | 81.3 73.6–89.8ROR 81.7 · calibrated p 5e-7 ✓ | 55.1 EB05 51.4 · IC025 +5.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.3 (3.9–4.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=570 | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 216 | 77.7 66.1–91.2ROR 77.8 · calibrated p 8e-7 ✓ | 53.3 EB05 47.6 · IC025 +5.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.2 (2.8–3.7) | Lab value / disease marker | serious n=213 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Trichotillomania | 172 | 70.9 59.3–84.7ROR 71.0 · calibrated p 2e-6 ✓ | 50.0 EB05 44.0 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 41.9 (32.3–54.3) | Not in label — unassessed | serious n=152 · 100% consumer | not reported in cached trials |
| Sexually transmitted disease | 125 | 69.0 56.1–85.0ROR 69.1 · calibrated p 2e-6 ✓ | 49.0 EB05 42.2 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 39.9 (29.5–53.9) | Not in label — unassessed | serious n=122 | not reported in cached trials |
| Hypersexuality | 456 | 56.9 51.1–63.2ROR 57.1 · calibrated p 6e-6 ✓ | 42.7 EB05 39.5 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.9 (12.3–15.6) | Not in label — unassessed | serious n=367 | not reported in cached trials |
| Dermatillomania | 142 | 55.3 45.7–66.8ROR 55.3 · calibrated p 8e-6 ✓ | 41.7 EB05 36.2 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 31.2 (24.0–40.5) | Not in label — unassessed | serious n=130 | not reported in cached trials |
| Psychotic symptom | 491 | 54.5 49.2–60.3ROR 54.7 · calibrated p 8e-6 ✓ | 41.4 EB05 38.4 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.5 (5.0–6.1) | Labeled (related wording) related wording | serious n=486 | not reported in cached trials |
| Personal relationship issue | 160 | 53.7 45.0–64.2ROR 53.8 · calibrated p 1e-5 ✓ | 40.8 EB05 35.8 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 32.4 (25.3–41.5) | Not in label — unassessed | serious n=136 · 100% consumer | not reported in cached trials |
| Oculogyric crisis | 490 | 52.1 47.1–57.7ROR 52.3 · calibrated p 1e-5 ✓ | 40.0 EB05 37.1 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.6 (5.1–6.2) | Labeled adverse reaction exact term | serious n=456 | not reported in cached trials |
| Delusional disorder, persecutory type | 96 | 50.4 40.1–63.3ROR 50.4 · calibrated p 2e-5 ✓ | 38.8 EB05 32.7 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.1 (5.7–9.0) | Not in label — unassessed | serious n=96 · ♀ 0% (drug 59%) | not reported in cached trials |
| Obsessive-compulsive disorder | 1,814 | 49.8 47.3–52.5ROR 50.6 · calibrated p 1e-5 ✓ | 38.7 EB05 37.2 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 12.0 (11.3–12.7) | Not in label — unassessed | serious n=1,442 | not reported in cached trials |
| Akathisia (inner restlessness) | 3,031 | 49.1 47.1–51.1ROR 50.3 · calibrated p 1e-5 ✓ | 38.2 EB05 37.1 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.9 (6.6–7.2) | Labeled adverse reaction exact term | serious PRR 29.1 | NCT00261443: 6/167 (3.6%) on Aripiprazole; 3/166 (1.8%) control |
| Orthostatic hypertension | 123 | 45.7 37.4–55.7ROR 45.7 · calibrated p 3e-5 ✓ | 36.0 EB05 31.0 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.5 (5.3–8.0) | Labeled (related wording) related wording | serious n=121 · ♀ 100% (drug 59%) | not reported in cached trials |
| Delusion of grandeur | 89 | 42.6 33.8–53.7ROR 42.6 · calibrated p 4e-5 ✓ | 34.0 EB05 28.5 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.4 (2.7–4.3) | Not in label — unassessed | serious n=87 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Drug monitoring procedure incorrectly performed | 130 | 41.5 34.3–50.3ROR 41.6 · calibrated p 5e-5 ✓ | 33.4 EB05 28.8 · IC025 +4.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 20.1 (15.8–25.6) | Reporting / coding artifact | serious n=101 | not reported in cached trials |
| Neuropsychiatric symptoms | 178 | 41.4 35.1–48.7ROR 41.4 · calibrated p 5e-5 ✓ | 33.3 EB05 29.4 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 27.2 (21.7–34.0) | Not in label — unassessed | serious n=142 | not reported in cached trials |
| Disturbance in social behaviour | 454 | 40.7 36.8–45.1ROR 40.9 · calibrated p 5e-5 ✓ | 33.0 EB05 30.5 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.7 (2.5–3.0) | Reporting / coding artifact | serious n=437 | not reported in cached trials |
| Psychiatric decompensation | 364 | 39.4 35.1–44.1ROR 39.5 · calibrated p 6e-5 ✓ | 32.1 EB05 29.4 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.1 (4.5–5.7) | Not in label — unassessed | serious n=324 | not reported in cached trials |
| Disinhibition | 280 | 36.1 31.7–41.1ROR 36.2 · calibrated p 1e-4 ✓ | 29.9 EB05 27.0 · IC025 +4.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.4 (3.9–5.0) | Not in label — unassessed | serious n=275 · ♀ 22% (drug 59%) | not reported in cached trials |
| Impulse-control disorder | 356 | 35.9 32.0–40.2ROR 36.0 · calibrated p 1e-4 ✓ | 29.7 EB05 27.2 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.2 (11.5–15.1) | Labeled (related wording) related wording | serious n=332 | not reported in cached trials |
| Schizophrenia | 2,056 | 34.9 33.3–36.6ROR 35.5 · calibrated p 1e-4 ✓ | 29.1 EB05 28.1 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.1 (3.0–3.2) | Likely indication confounding term in indications; also in warnings | serious PRR 25.4 | not reported in cached trials |
| Loss of employment | 513 | 34.7 31.6–38.2ROR 34.9 · calibrated p 1e-4 ✓ | 29.0 EB05 26.9 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 29.2 (25.5–33.4) | Not in label — unassessed | serious n=483 | not reported in cached trials |
| Cogwheel rigidity | 175 | 34.2 29.1–40.2ROR 34.2 · calibrated p 1e-4 ✓ | 28.5 EB05 25.1 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.9 (4.1–5.8) | Labeled adverse reaction exact term | serious n=145 | not reported in cached trials |
| Binge eating | 171 | 32.5 27.6–38.3ROR 32.5 · calibrated p 2e-4 ✓ | 27.3 EB05 24.1 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 18.4 (15.0–22.6) | Labeled adverse reaction exact term | serious n=141 · 74% consumer | not reported in cached trials |
| Antipsychotic drug level decreased | 81 | 30.8 24.3–39.1ROR 30.8 · calibrated p 3e-4 ✓ | 26.1 EB05 21.7 · IC025 +4.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.0 (2.4–3.8) | Lab value / disease marker | serious n=79 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Extrapyramidal | 11,437 | 20.920.5–21.3 | signal |
| Suicidality | 8,753 | 6.36.2–6.5 | signal |
| Rhabdomyolysis / myopathy | 1,705 | 3.73.5–3.9 | signal |
| Depression | 5,100 | 3.23.1–3.2 | signal |
| Hyperglycaemia / diabetes | 5,372 | 2.72.6–2.8 | signal |
| Pancreatitis | 959 | 2.11.9–2.2 | raised |
| Seizure | 2,248 | 2.01.9–2.1 | raised |
| Arrhythmia / qt | 2,077 | 1.91.8–1.9 | raised |
| Hyponatraemia | 726 | 1.61.4–1.7 | raised |
| Venous thromboembolism | 1,429 | 1.11.1–1.2 | raised |
| Severe cutaneous reaction | 482 | 1.11.0–1.2 | raised |
| Fall / fracture | 2,261 | 1.01.0–1.1 | no difference |
| Liver injury | 1,695 | 1.00.9–1.0 | no difference |
| Dependence / withdrawal | 1,646 | 1.00.9–1.0 | no difference |
| Hypoglycaemia | 520 | 0.90.9–1.0 | no difference |
| Neutropenia / agranulocytosis | 1,342 | 0.90.9–1.0 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Aripiprazole as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT01421342 — VA Augmentation and Switching Treatments for Improving Depression Outcomes (N=1522, PHASE3; 145 AE terms posted; arms: Switching: Bupropion-SR; Augmenting: Antidepressant + Bupropion-S; Augmenting: Antidepressant + Aripiprazol)
- NCT00261443 — A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania (N=1270, PHASE4; 46 AE terms posted; arms: Single-Blind Aripiprazole; Double-Blind Placebo; Double-Blind Aripiprazole; Extension Phase Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 8,374 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.375 | 1.1 EB05 1.1 · IC025 +0.1 vs other Atypical Antipsychotics: PRR 5.1 (5.0–5.2) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.8 | not reported in cached trials |
| Weight increased (weight gain) | 7,848 | 6.3 6.1–6.4ROR 6.6 · calibrated p 0.115 | 6.1 EB05 6.0 · IC025 +2.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.3 (5.2–5.4) | Labeled — boxed warning synonym match | age-adj. PRR 5.2 · serious PRR 5.9 | NCT00261443: 1/23 (4.3%) on Aripiprazole; 11/166 (6.6%) control |
| Off label use (used outside approved label) | 7,604 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.673 | 1.5 EB05 1.5 · IC025 +0.6 vs other Atypical Antipsychotics: PRR 4.6 (4.5–4.7) | Reporting / coding artifact | age-adj. PRR 1.4 · serious PRR 1.7 | not reported in cached trials |
| Product use in unapproved indication | 5,347 | 3.8 3.7–3.9ROR 4.0 · calibrated p 0.384 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.0 (6.8–7.2) | Reporting / coding artifact | age-adj. PRR 3.6 · serious PRR 5.9 | not reported in cached trials |
| Anxiety | 5,150 | 3.1 3.1–3.2ROR 3.2 · calibrated p 0.552 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.0 (6.8–7.2) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 3.1 | NCT01421342: 1/505 (0.2%) on Aripiprazole (serious AE) |
| Fatigue (tiredness) | 4,306 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.276 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Atypical Antipsychotics: PRR 6.3 (6.1–6.5) | Labeled adverse reaction exact term | age-adj. PRR 0.9 · serious PRR 1.1 | not reported in cached trials |
| Suicidal ideation (thoughts of suicide) | 4,106 | 8.0 7.8–8.3ROR 8.3 · calibrated p 0.060 | 7.7 EB05 7.5 · IC025 +2.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.1 (6.9–7.4) | Labeled — boxed warning synonym match | age-adj. PRR 5.6 · serious PRR 6.8 | NCT01421342: 5/505 (1.0%) on Aripiprazole (serious AE) |
| Nausea | 4,055 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.231 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Atypical Antipsychotics: PRR 6.0 (5.8–6.2) | Labeled adverse reaction exact term | age-adj. PRR 0.8 · serious PRR 1.0 | NCT00261443: 5/167 (3.0%) on Aripiprazole; 4/166 (2.4%) control |
| Depression | 4,048 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.576 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.2 (7.0–7.5) | Labeled — boxed warning synonym match | age-adj. PRR 2.5 · serious PRR 2.8 | NCT00261443: 1/167 (0.6%) on Aripiprazole; 2/166 (1.2%) control (serious AE) |
| Insomnia (trouble sleeping) | 3,934 | 2.6 2.5–2.6ROR 2.6 · calibrated p 0.765 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.7 (6.5–6.9) | Labeled adverse reaction exact term | age-adj. PRR 2.4 · serious PRR 2.8 | NCT00261443: 2/23 (8.7%) on Aripiprazole; 16/166 (9.6%) control |
| Tremor (shaking) | 3,737 | 3.9 3.8–4.1ROR 4.0 · calibrated p 0.372 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.6 (6.4–6.8) | Labeled adverse reaction exact term | age-adj. PRR 3.9 · serious PRR 3.5 | NCT00261443: 1/23 (4.3%) on Aripiprazole; 4/166 (2.4%) control |
| Drug interaction | 3,726 | 4.1 4.0–4.3ROR 4.2 · calibrated p 0.340 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.1 (4.0–4.3) | Reporting / coding artifact | age-adj. PRR 4.2 · serious PRR 3.6 | not reported in cached trials |
| Suicide attempt | 3,592 | 10.8 10.4–11.1ROR 11.1 · calibrated p 0.023 ✓ | 10.2 EB05 9.9 · IC025 +3.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.3 (5.1–5.5) | Labeled — boxed warning synonym match | age-adj. PRR 6.5 · serious PRR 8.8 | NCT01421342: 3/505 (0.6%) on Aripiprazole (serious AE) |
| Somnolence (drowsiness) | 3,580 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.574 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.4 (4.2–4.5) | Labeled adverse reaction exact term | age-adj. PRR 3.0 · serious PRR 3.3 | NCT00261443: 1/167 (0.6%) on Aripiprazole; 3/166 (1.8%) control |
| Condition aggravated | 3,263 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.885 | 1.9 EB05 1.8 · IC025 +0.8 vs other Atypical Antipsychotics: PRR 5.0 (4.8–5.2) | Reporting / coding artifact | age-adj. PRR 1.6 · serious PRR 2.2 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Bankruptcy — n=387, PRR 1,038.0
- Compulsive hoarding — n=245, PRR 552.0
- Compulsive sexual behaviour — n=601, PRR 493.0
- Shoplifting — n=184, PRR 334.3
- Divorced — n=282, PRR 301.6
- Homeless — n=274, PRR 272.3
- Anosognosia — n=468, PRR 269.0
- Rhesus incompatibility — n=68, PRR 216.8
- Stubbornness — n=174, PRR 115.3
- Psychosexual disorder — n=111, PRR 105.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Aripiprazole (antipsychotics) ↔ Akathisia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aripiprazole?
In FDA FAERS, the most frequently co-reported reaction terms for Aripiprazole are weight increased, anxiety, fatigue, suicidal ideation, nausea, depression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aripiprazole have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Do FAERS signals prove that Aripiprazole causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 06529caf-698f-41da-81ec-d0ba5ab200d7, effective 20240930; matched on
openfda.generic_name.exact:"ARIPIPRAZOLE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 60795 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,273 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
ARIPIPRAZOLE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.