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Aripiprazole Orally Disintegrating side effects: what 41,097 FDA adverse event reports show

Aripiprazole Orally Disintegrating · Aripiprazole · 1,291 reaction terms · 171,434 drug–reaction co-reports · data 2026-09-14
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Drug class

Atypical Antipsychotic

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Aripiprazole

openFDA label

Who reports

41,097 reports · 85% serious · 3,316 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

FDA label, Description section

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 adverse reaction 2Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 4Lab value / disease marker 3Not in label — unassessed 23
What the badges mean

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.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Hypoprolactinaemia27565.2
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 — unassessedserious n=26 · 100% clinicianno trial arm names this drug
Blood prolactin abnormal423485.2
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 markerserious n=422 · ♀ 84% (drug 56%)no trial arm names this drug
Anosognosia356440.5
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 — unassessedserious n=355 · ♀ 86% (drug 56%)no trial arm names this drug
Bankruptcy143234.0
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 — unassessedserious n=141 · 100% consumerno trial arm names this drug
Antipsychotic drug level below therapeutic180178.7
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 markerserious n=179 · ♀ 10% (drug 56%) · 91% clinicianno trial arm names this drug
Schizoaffective disorder413152.9
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 hoarding70140.7
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 — unassessedserious n=68no trial arm names this drug
Acute myopia36136.0
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 — unassessedserious n=36 · ♀ 100% (drug 56%) · 100% clinicianno trial arm names this drug
Compulsive sexual behaviour162126.2
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 — unassessedserious n=160no trial arm names this drug
Refusal of examination26125.6
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 artifactserious n=26 · ♀ 100% (drug 56%) · 100% clinicianno trial arm names this drug
Victim of child abuse48123.0
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 artifactserious n=48 · ♀ 0% (drug 56%) · 100% clinicianno trial arm names this drug
Compulsive shopping395120.4
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=364no trial arm names this drug
Homeless85118.9
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 — unassessedserious n=77no trial arm names this drug
Delusion of grandeur84117.9
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 — unassessedserious n=84 · ♀ 0% (drug 56%) · 90% clinicianno trial arm names this drug
Child abuse45111.9
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 artifactserious n=45 · ♀ 0% (drug 56%) · 100% clinicianno trial arm names this drug
Shoplifting50110.7
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 — unassessedserious n=47no trial arm names this drug
Divorced78108.2
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 — unassessedserious n=76no trial arm names this drug
Epidural lipomatosis5595.6
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 — unassessedserious n=55 · ♀ 0% (drug 56%) · 100% clinicianno trial arm names this drug
Lactation insufficiency2890.8
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 — unassessedserious n=25 · ♀ 100% (drug 56%)no trial arm names this drug
Mycobacterium fortuitum infection2786.9
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 — unassessedserious n=27 · ♀ 0% (drug 56%)no trial arm names this drug
Oculogyric crisis30486.1
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=302no trial arm names this drug
Disturbance in social behaviour34185.8
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 artifactserious n=339 · ♀ 87% (drug 56%)no trial arm names this drug
Neutropenia neonatal3181.1
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 — unassessedserious n=31 · ♀ 0% (drug 56%) · 100% clinicianno trial arm names this drug
Excessive masturbation2671.8
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 — unassessedserious n=24 · ♀ 0% (drug 56%)no trial arm names this drug
Disinhibition19871.4
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 — unassessedserious n=197 · ♀ 14% (drug 56%)no trial arm names this drug
Hypersexuality21969.1
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 — unassessedserious n=192no trial arm names this drug
Drug-genetic interaction3866.7
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 — unassessedserious n=37 · 100% clinicianno trial arm names this drug
Neglect of personal appearance2866.0
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 — unassessedserious n=27 · 100% clinicianno trial arm names this drug
Antipsychotic drug level decreased5963.6
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 markerserious n=58 · ♀ 31% (drug 56%) · 100% clinicianno trial arm names this drug
Spasmodic dysphonia3262.1
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 — unassessedserious n=31 · ♀ 0% (drug 56%) · 100% clinicianno trial arm names this drug
Oppositional defiant disorder4361.5
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 — unassessedserious n=43 · ♀ 0% (drug 56%) · 100% clinicianno trial arm names this drug
Schizophrenia1,28560.2
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 37.4no trial arm names this drug
Sinus rhythm4558.3
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 — unassessedserious n=45 · ♀ 100% (drug 56%) · 100% clinicianno trial arm names this drug
Theft6857.6
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 — unassessedserious n=63no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Aripiprazole Orally Disintegrating (searched ARIPIPRAZOLE ORALLY DISINTEGRATING).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Drug ineffective (drug did not work)4,3291.7
1.6–1.7ROR 1.8 · χ² 1,265 / p 3e-277
1.7 EB05 1.6 · IC025 +0.7Reporting / coding artifactserious PRR 2.7no trial arm names this drug
Off label use (used outside approved label)2,8871.7
1.6–1.8ROR 1.8 · χ² 863 / p 5e-190
1.7 EB05 1.6 · IC025 +0.7Reporting / coding artifactserious PRR 1.9no trial arm names this drug
Product use in unapproved indication2,2434.7
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 artifactserious PRR 6.0no trial arm names this drug
Drug interaction2,2097.2
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 artifactserious PRR 5.2no trial arm names this drug
Weight increased (weight gain)2,1284.9
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 5.4no trial arm names this drug
Anxiety1,7683.2
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 2.9no trial arm names this drug
Condition aggravated1,6922.9
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 artifactserious PRR 2.8no trial arm names this drug
Suicide attempt1,55913.4
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 8.9no trial arm names this drug
Fatigue (tiredness)1,4951.0
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 1.0no trial arm names this drug
Suicidal ideation (thoughts of suicide)1,4238.0
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 5.5no trial arm names this drug
Nausea1,3550.9
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 1.0no trial arm names this drug
Somnolence (drowsiness)1,3233.4
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 3.5no trial arm names this drug
Schizophrenia1,28560.2
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 37.4no trial arm names this drug
Sedation1,28326.4
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 22.1no 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.

✓ 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

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.