Aripiprazole Orally Disintegrating side effects: what 41,097 FDA adverse event reports show
Brand names
Aripiprazole
Who reports
41,097 reports · 85% serious · 3,316 with death outcome · 56% female
Used for
Aripiprazole orally disintegrating tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [ see Clinical Studies (14.2) ] Adjunctive Treatm.
What it is
Aripiprazole is an atypical antipsychotic drug that is available as Aripiprazole Orally Disintegrating Tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1piperazinyl]butoxy]-3,4-dihydrocarbostyril.
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.
Causality screen of the 40 strongest signals
What the badges mean
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,251 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Negative symptoms in schizophrenia | 34 | 569.4 348.5–930.2ROR 569.8 · χ² 8,777 / p <1e-300 | 232.6 EB05 174.1 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=32 | no trial arm names this drug |
| Hypoprolactinaemia | 27 | 565.2 326.1–979.4ROR 565.5 · χ² 6,892 / p <1e-300 | 224.3 EB05 161.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | no trial arm names this drug |
| Blood prolactin abnormal | 423 | 485.2 424.6–554.3ROR 490.2 · χ² 103,729 / p <1e-300 | 244.6 EB05 225.6 · IC025 +7.4 3/3 methods agree | Lab value / disease marker | serious n=422 · ♀ 84% (drug 56%) | no trial arm names this drug |
| Anosognosia | 356 | 440.5 382.2–507.7ROR 444.3 · χ² 82,945 / p <1e-300 | 232.2 EB05 212.7 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=355 · ♀ 86% (drug 56%) | no trial arm names this drug |
| Dystonic tremor | 33 | 312.8 202.6–483.0ROR 313.0 · χ² 6,130 / p <1e-300 | 173.9 EB05 129.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=33 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Bankruptcy | 143 | 234.0 191.9–285.3ROR 234.8 · χ² 22,476 / p <1e-300 | 156.6 EB05 136.3 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=141 · 100% consumer | no trial arm names this drug |
| Gambling disorder | 734 | 189.5 174.2–206.2ROR 192.9 · χ² 99,804 / p <1e-300 | 137.4 EB05 129.2 · IC025 +6.9 3/3 methods agree | Labeled (related wording) related wording | serious n=643 | no trial arm names this drug |
| Antipsychotic drug level below therapeutic | 180 | 178.7 150.8–211.8ROR 179.5 · χ² 23,332 / p <1e-300 | 130.3 EB05 115.1 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=179 · ♀ 10% (drug 56%) · 91% clinician | no trial arm names this drug |
| Schizoaffective disorder | 413 | 152.9 137.0–170.6ROR 154.4 · χ² 47,668 / p <1e-300 | 116.8 EB05 107.7 · IC025 +6.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=412 · ♀ 79% (drug 56%) | no trial arm names this drug |
| Compulsive hoarding | 70 | 140.7 107.9–183.3ROR 140.9 · χ² 7,475 / p <1e-300 | 107.0 EB05 87.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=68 | no trial arm names this drug |
| Acute myopia | 36 | 136.0 94.1–196.5ROR 136.1 · χ² 3,690 / p <1e-300 | 101.6 EB05 76.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 56%) · 100% clinician | no trial arm names this drug |
| Compulsive sexual behaviour | 162 | 126.2 106.2–149.9ROR 126.7 · χ² 15,980 / p <1e-300 | 99.9 EB05 87.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=160 | no trial arm names this drug |
| Refusal of examination | 26 | 125.6 81.7–193.0ROR 125.7 · χ² 2,472 / p <1e-300 | 93.9 EB05 67.4 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=26 · ♀ 100% (drug 56%) · 100% clinician | no trial arm names this drug |
| Victim of child abuse | 48 | 123.0 89.7–168.7ROR 123.2 · χ² 4,569 / p <1e-300 | 95.4 EB05 74.8 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=48 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Compulsive shopping | 395 | 120.4 107.9–134.3ROR 121.6 · χ² 37,639 / p <1e-300 | 96.9 EB05 89.1 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=364 | no trial arm names this drug |
| Homeless | 85 | 118.9 93.9–150.6ROR 119.2 · χ² 7,943 / p <1e-300 | 94.4 EB05 78.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=77 | no trial arm names this drug |
| Delusion of grandeur | 84 | 117.9 93.0–149.5ROR 118.1 · χ² 7,790 / p <1e-300 | 93.7 EB05 78.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=84 · ♀ 0% (drug 56%) · 90% clinician | no trial arm names this drug |
| Child abuse | 45 | 111.9 81.0–154.6ROR 112.0 · χ² 3,955 / p <1e-300 | 88.4 EB05 68.7 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=45 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Shoplifting | 50 | 110.7 81.5–150.3ROR 110.8 · χ² 4,363 / p <1e-300 | 87.9 EB05 69.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=47 | no trial arm names this drug |
| Divorced | 78 | 108.2 84.8–138.2ROR 108.5 · χ² 6,731 / p <1e-300 | 87.4 EB05 72.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=76 | no trial arm names this drug |
| Epidural lipomatosis | 55 | 95.6 71.7–127.5ROR 95.7 · χ² 4,247 / p <1e-300 | 78.4 EB05 62.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Lactation insufficiency | 28 | 90.8 60.7–135.7ROR 90.8 · χ² 2,030 / p <1e-300 | 73.3 EB05 53.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 56%) | no trial arm names this drug |
| Psychotic symptom | 304 | 89.4 79.1–100.9ROR 90.0 · χ² 22,478 / p <1e-300 | 75.7 EB05 68.8 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=303 | no trial arm names this drug |
| Mycobacterium fortuitum infection | 27 | 86.9 57.8–130.8ROR 87.0 · χ² 1,883 / p <1e-300 | 70.7 EB05 51.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Oculogyric crisis | 304 | 86.1 76.3–97.2ROR 86.7 · χ² 21,756 / p <1e-300 | 73.3 EB05 66.7 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=302 | no trial arm names this drug |
| Disturbance in social behaviour | 341 | 85.8 76.5–96.2ROR 86.5 · χ² 24,347 / p <1e-300 | 73.2 EB05 66.9 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious n=339 · ♀ 87% (drug 56%) | no trial arm names this drug |
| Neutropenia neonatal | 31 | 81.1 55.5–118.5ROR 81.2 · χ² 2,043 / p <1e-300 | 67.2 EB05 49.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Excessive masturbation | 26 | 71.8 47.6–108.2ROR 71.8 · χ² 1,526 / p <1e-300 | 60.3 EB05 43.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 56%) | no trial arm names this drug |
| Disinhibition | 198 | 71.4 61.5–82.8ROR 71.7 · χ² 11,974 / p <1e-300 | 62.3 EB05 55.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=197 · ♀ 14% (drug 56%) | no trial arm names this drug |
| Orthostatic hypertension | 70 | 69.2 53.9–88.9ROR 69.3 · χ² 4,077 / p <1e-300 | 60.0 EB05 49.1 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=70 | no trial arm names this drug |
| Hypersexuality | 219 | 69.1 60.0–79.6ROR 69.5 · χ² 12,863 / p <1e-300 | 60.6 EB05 54.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=192 | no trial arm names this drug |
| Drug-genetic interaction | 38 | 66.7 47.6–93.6ROR 66.8 · χ² 2,115 / p <1e-300 | 57.4 EB05 43.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | no trial arm names this drug |
| Neglect of personal appearance | 28 | 66.0 44.5–97.9ROR 66.1 · χ² 1,528 / p <1e-300 | 56.4 EB05 40.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | no trial arm names this drug |
| Decreased eye contact | 34 | 64.5 45.1–92.1ROR 64.5 · χ² 1,827 / p <1e-300 | 55.6 EB05 41.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=34 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Antipsychotic drug level decreased | 59 | 63.6 48.5–83.4ROR 63.7 · χ² 3,172 / p <1e-300 | 55.6 EB05 44.7 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=58 · ♀ 31% (drug 56%) · 100% clinician | no trial arm names this drug |
| Spasmodic dysphonia | 32 | 62.1 43.0–89.6ROR 62.1 · χ² 1,657 / p <1e-300 | 53.7 EB05 39.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Oppositional defiant disorder | 43 | 61.5 44.8–84.5ROR 61.6 · χ² 2,228 / p <1e-300 | 53.7 EB05 41.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 0% (drug 56%) · 100% clinician | no trial arm names this drug |
| Schizophrenia | 1,285 | 60.2 56.9–63.8ROR 62.1 · χ² 66,820 / p <1e-300 | 53.8 EB05 51.4 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 37.4 | no trial arm names this drug |
| Sinus rhythm | 45 | 58.3 42.8–79.3ROR 58.3 · χ² 2,218 / p <1e-300 | 51.2 EB05 39.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 100% (drug 56%) · 100% clinician | no trial arm names this drug |
| Theft | 68 | 57.6 44.8–74.0ROR 57.7 · χ² 3,343 / p <1e-300 | 51.1 EB05 41.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=63 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
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) | 4,329 | 1.7 1.6–1.7ROR 1.8 · χ² 1,265 / p 3e-277 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.7 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,887 | 1.7 1.6–1.8ROR 1.8 · χ² 863 / p 5e-190 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.9 | no trial arm names this drug |
| Product use in unapproved indication | 2,243 | 4.7 4.5–4.9ROR 4.9 · χ² 6,584 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial arm names this drug |
| Drug interaction | 2,209 | 7.2 6.9–7.5ROR 7.5 · χ² 11,686 / p <1e-300 | 7.1 EB05 6.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial arm names this drug |
| Weight increased (weight gain) | 2,128 | 4.9 4.7–5.1ROR 5.1 · χ² 6,629 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.4 | no trial arm names this drug |
| Anxiety | 1,768 | 3.2 3.0–3.3ROR 3.3 · χ² 2,651 / p <1e-300 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial arm names this drug |
| Condition aggravated | 1,692 | 2.9 2.7–3.0ROR 2.9 · χ² 2,076 / p <1e-300 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial arm names this drug |
| Suicide attempt | 1,559 | 13.4 12.8–14.1ROR 13.9 · χ² 17,477 / p <1e-300 | 13.1 EB05 12.5 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.9 | no trial arm names this drug |
| Fatigue (tiredness) | 1,495 | 1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.237 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial arm names this drug |
| Suicidal ideation (thoughts of suicide) | 1,423 | 8.0 7.6–8.5ROR 8.3 · χ² 8,651 / p <1e-300 | 7.9 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.5 | no trial arm names this drug |
| Toxicity to various agents | 1,392 | 4.3 4.0–4.5ROR 4.4 · χ² 3,466 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 92% clinician | no trial arm names this drug |
| Nausea | 1,355 | 0.9 0.8–0.9ROR 0.9 · χ² 25 / p 4e-7 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial arm names this drug |
| Somnolence (drowsiness) | 1,323 | 3.4 3.2–3.6ROR 3.5 · χ² 2,212 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial arm names this drug |
| Schizophrenia | 1,285 | 60.2 56.9–63.8ROR 62.1 · χ² 66,820 / p <1e-300 | 53.8 EB05 51.4 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 37.4 | no trial arm names this drug |
| Sedation | 1,283 | 26.4 24.9–27.9ROR 27.2 · χ² 29,763 / p <1e-300 | 25.1 EB05 24.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.1 | no trial arm names this drug |
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.
- Hypoprolactinaemia — n=27, PRR 565.2
- Anosognosia — n=356, PRR 440.5
- Bankruptcy — n=143, PRR 234.0
- Compulsive hoarding — n=70, PRR 140.7
- Acute myopia — n=36, PRR 136.0
- Compulsive sexual behaviour — n=162, PRR 126.2
- Homeless — n=85, PRR 118.9
- Delusion of grandeur — n=84, PRR 117.9
- Shoplifting — n=50, PRR 110.7
- Divorced — n=78, PRR 108.2
✓ 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 Orally Disintegrating?
In FDA FAERS, the most frequently co-reported reaction terms for Aripiprazole Orally Disintegrating are weight increased, anxiety, suicide attempt, fatigue, suicidal ideation, toxicity to various agents. 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 Orally Disintegrating 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 Orally Disintegrating 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 4bcfd5a7-bec7-4426-9314-17daaf715cad, effective 20241113; matched on
openfda.generic_name.exact:"ARIPIPRAZOLE ORALLY DISINTEGRATING") - 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, 1,291 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 ORALLY DISINTEGRATING, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. 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.