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Drug class · FAERS comparison

Atypical Antipsychotic side effects compared: 14 drugs, 674,223 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Risperidone131,00567%10,143boxedGynaecomastia; Abnormal weight gain; HyperprolactinaemiaEmotional disorder; Galactorrhoea
Clozapine124,82695%22,310boxedGranulocytopenia; Myocarditis; Salivary hypersecretionAnosognosia; Psychiatric decompensation
Aripiprazole121,71367%6,758boxedAkathisia; Gambling disorder; Compulsive shoppingObsessive-compulsive disorder; Compulsive sexual behaviour
Olanzapine106,80886%13,180boxedNeuroleptic malignant syndrome; Schizophrenia; AkathisiaCatatonia; Anosognosia
Aripiprazole41,09785%3,316boxedGambling disorder; Compulsive shopping; Psychotic symptomAnosognosia; Hypersexuality
Aripiprazole Orally Disintegrating (Aripiprazole)41,09785%3,316boxedGambling disorder; Compulsive shopping; Psychotic symptomAnosognosia; Hypersexuality
Olanzapine40,69577%4,492boxedDiabetes mellitus; Metabolic disorder; Blood triglycerides increasedObesity; Anosognosia
Paliperidone23,17749%827boxedGynaecomastia; Abnormal weight gain; HyperprolactinaemiaInjury; Galactorrhoea
Brexpiprazole (Rexulti)16,50342%1,085boxedAkathisia; Tardive dyskinesia; Inability to afford medicationHallucination, auditory; Insurance issue
Cariprazine (Vraylar)9,25036%244boxedAkathisia; Tardive dyskinesia; Extrapyramidal disorderHallucination, auditory; Bruxism
Asenapine8,61248%415boxedSedation; Suicide attempt; DyskinesiaSexual dysfunction; Anosognosia
Lumateperone (Caplyta)7,08528%61boxedSomnolence; Sedation; Suicidal ideationMania; Agitation
Iloperidone (Fanapt)1,46949%60boxedDyskinesia; Aggression; Orthostatic hypotensionSuicidal ideation; Speech disorder
Asenapine88679%138boxedSedation; Suicidal ideation; DystoniaToxicity to various agents; Myocarditis

Class-wide signals (flagged in at least 7 of 14 members)

ReactionMembers flaggedMedian PRRReports (sum)In label
Schizophrenia13/1434.915,6142/13 members' labels
Schizoaffective disorder11/1481.33,3012/11 members' labels
Anosognosia9/14440.53,8370/9 members' labels
Akathisia9/1438.96,9719/9 members' labels
Psychotic symptom9/1437.12,2647/9 members' labels
Oculogyric crisis8/1450.22,0596/8 members' labels
Delusion of grandeur7/1462.46180/7 members' labels
Orthostatic hypertension7/1455.24937/7 members' labels
Neuroleptic malignant syndrome7/1428.15,9337/7 members' labels

Member-specific signals (flagged in exactly one drug)

ReactionDrugReportsPRRLabel screen
Benign ethnic neutropeniaClozapine1141,565.3Labeled — boxed warning
Radiation inflammationClozapine50274.6Not in label — unassessed
Rhesus incompatibilityAripiprazole68216.8Not in label — unassessed
Exposure to contaminated deviceRisperidone132156.7Not in label — unassessed
AcetonaemiaOlanzapine55146.9Not in label — unassessed
NeutrophiliaClozapine2,602142.9Likely indication confounding
GranulocytopeniaClozapine2,616141.2Labeled adverse reaction
StubbornnessAripiprazole174115.3Not in label — unassessed
Withdrawal catatoniaClozapine91114.5Not in label — unassessed
Inspiratory capacity decreasedOlanzapine98108.5Not in label — unassessed
Psychosexual disorderAripiprazole111105.4Not in label — unassessed
Rebound psychosisClozapine7999.4Labeled (related wording)
CamptocormiaOlanzapine7589.8Not in label — unassessed
Central nervous system lupusOlanzapine6584.1Labeled (related wording)
TrichotillomaniaAripiprazole17270.9Not in label — unassessed
Sexually transmitted diseaseAripiprazole12569.0Not in label — unassessed
InjuryPaliperidone4,32959.0Not in label — unassessed
Endocrine disorderOlanzapine12857.3Not in label — unassessed
Hypoaesthesia oralAsenapine33855.9Not in label — unassessed
DermatillomaniaAripiprazole14255.3Not in label — unassessed
KetonuriaOlanzapine7552.4Not in label — unassessed
Inability to afford medicationBrexpiprazole36048.3Labeled (related wording)
Breast dischargePaliperidone7942.7Not in label — unassessed
DyslipidaemiaAsenapine8541.4Labeled — boxed warning
Neuropsychiatric symptomsAripiprazole17841.4Not in label — unassessed

Common questions

Which atypical antipsychotic has the most FDA adverse event reports?

Risperidone has the most FAERS co-reports in this class (131,005), followed by Clozapine (124,826). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across atypical antipsychotic drugs?

Reaction terms flagged in at least half of the 14 members include schizophrenia, schizoaffective disorder, anosognosia, akathisia, psychotic symptom. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.