Atypical Antipsychotic side effects compared: 14 drugs, 674,223 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Risperidone | 131,005 | 67% | 10,143 | boxed | Gynaecomastia; Abnormal weight gain; Hyperprolactinaemia | Emotional disorder; Galactorrhoea |
| Clozapine | 124,826 | 95% | 22,310 | boxed | Granulocytopenia; Myocarditis; Salivary hypersecretion | Anosognosia; Psychiatric decompensation |
| Aripiprazole | 121,713 | 67% | 6,758 | boxed | Akathisia; Gambling disorder; Compulsive shopping | Obsessive-compulsive disorder; Compulsive sexual behaviour |
| Olanzapine | 106,808 | 86% | 13,180 | boxed | Neuroleptic malignant syndrome; Schizophrenia; Akathisia | Catatonia; Anosognosia |
| Aripiprazole | 41,097 | 85% | 3,316 | boxed | Gambling disorder; Compulsive shopping; Psychotic symptom | Anosognosia; Hypersexuality |
| Aripiprazole Orally Disintegrating (Aripiprazole) | 41,097 | 85% | 3,316 | boxed | Gambling disorder; Compulsive shopping; Psychotic symptom | Anosognosia; Hypersexuality |
| Olanzapine | 40,695 | 77% | 4,492 | boxed | Diabetes mellitus; Metabolic disorder; Blood triglycerides increased | Obesity; Anosognosia |
| Paliperidone | 23,177 | 49% | 827 | boxed | Gynaecomastia; Abnormal weight gain; Hyperprolactinaemia | Injury; Galactorrhoea |
| Brexpiprazole (Rexulti) | 16,503 | 42% | 1,085 | boxed | Akathisia; Tardive dyskinesia; Inability to afford medication | Hallucination, auditory; Insurance issue |
| Cariprazine (Vraylar) | 9,250 | 36% | 244 | boxed | Akathisia; Tardive dyskinesia; Extrapyramidal disorder | Hallucination, auditory; Bruxism |
| Asenapine | 8,612 | 48% | 415 | boxed | Sedation; Suicide attempt; Dyskinesia | Sexual dysfunction; Anosognosia |
| Lumateperone (Caplyta) | 7,085 | 28% | 61 | boxed | Somnolence; Sedation; Suicidal ideation | Mania; Agitation |
| Iloperidone (Fanapt) | 1,469 | 49% | 60 | boxed | Dyskinesia; Aggression; Orthostatic hypotension | Suicidal ideation; Speech disorder |
| Asenapine | 886 | 79% | 138 | boxed | Sedation; Suicidal ideation; Dystonia | Toxicity to various agents; Myocarditis |
Class-wide signals (flagged in at least 7 of 14 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Schizophrenia | 13/14 | 34.9 | 15,614 | 2/13 members' labels |
| Schizoaffective disorder | 11/14 | 81.3 | 3,301 | 2/11 members' labels |
| Anosognosia | 9/14 | 440.5 | 3,837 | 0/9 members' labels |
| Akathisia | 9/14 | 38.9 | 6,971 | 9/9 members' labels |
| Psychotic symptom | 9/14 | 37.1 | 2,264 | 7/9 members' labels |
| Oculogyric crisis | 8/14 | 50.2 | 2,059 | 6/8 members' labels |
| Delusion of grandeur | 7/14 | 62.4 | 618 | 0/7 members' labels |
| Orthostatic hypertension | 7/14 | 55.2 | 493 | 7/7 members' labels |
| Neuroleptic malignant syndrome | 7/14 | 28.1 | 5,933 | 7/7 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Benign ethnic neutropenia | Clozapine | 114 | 1,565.3 | Labeled — boxed warning |
| Radiation inflammation | Clozapine | 50 | 274.6 | Not in label — unassessed |
| Rhesus incompatibility | Aripiprazole | 68 | 216.8 | Not in label — unassessed |
| Exposure to contaminated device | Risperidone | 132 | 156.7 | Not in label — unassessed |
| Acetonaemia | Olanzapine | 55 | 146.9 | Not in label — unassessed |
| Neutrophilia | Clozapine | 2,602 | 142.9 | Likely indication confounding |
| Granulocytopenia | Clozapine | 2,616 | 141.2 | Labeled adverse reaction |
| Stubbornness | Aripiprazole | 174 | 115.3 | Not in label — unassessed |
| Withdrawal catatonia | Clozapine | 91 | 114.5 | Not in label — unassessed |
| Inspiratory capacity decreased | Olanzapine | 98 | 108.5 | Not in label — unassessed |
| Psychosexual disorder | Aripiprazole | 111 | 105.4 | Not in label — unassessed |
| Rebound psychosis | Clozapine | 79 | 99.4 | Labeled (related wording) |
| Camptocormia | Olanzapine | 75 | 89.8 | Not in label — unassessed |
| Central nervous system lupus | Olanzapine | 65 | 84.1 | Labeled (related wording) |
| Trichotillomania | Aripiprazole | 172 | 70.9 | Not in label — unassessed |
| Sexually transmitted disease | Aripiprazole | 125 | 69.0 | Not in label — unassessed |
| Injury | Paliperidone | 4,329 | 59.0 | Not in label — unassessed |
| Endocrine disorder | Olanzapine | 128 | 57.3 | Not in label — unassessed |
| Hypoaesthesia oral | Asenapine | 338 | 55.9 | Not in label — unassessed |
| Dermatillomania | Aripiprazole | 142 | 55.3 | Not in label — unassessed |
| Ketonuria | Olanzapine | 75 | 52.4 | Not in label — unassessed |
| Inability to afford medication | Brexpiprazole | 360 | 48.3 | Labeled (related wording) |
| Breast discharge | Paliperidone | 79 | 42.7 | Not in label — unassessed |
| Dyslipidaemia | Asenapine | 85 | 41.4 | Labeled — boxed warning |
| Neuropsychiatric symptoms | Aripiprazole | 178 | 41.4 | Not 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.