Drug · FAERS side-effect profile with label screen
Risperidone side effects: what 131,005 FDA adverse event reports show
Who reports
131,005 reports · 67% serious · 10,143 with death outcome · 36% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia.
FDA label, Indications and Usage
What it is
Risperidone is a member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.
PubChem CID 5073 (ChEBI)
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis.
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 2Labeled adverse reaction 8Labeled (related wording) 5Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 17
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). 1,238 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 |
|---|---|---|---|---|---|---|
| Gynaecomastia (male breast enlargement) | 24,650 | 614.0 597.5–630.9ROR 754.5 · calibrated p 6e-16 ✓ | 124.9 EB05 123.6 · IC025 +6.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 92.3 (89.9–94.8) | Labeled adverse reaction exact term | serious PRR 81.0 · ♀ 0% (drug 36%) · 92% consumer | not reported in cached trials |
| Abnormal weight gain | 9,452 | 513.3 492.5–535.1ROR 552.8 · calibrated p 2e-14 ✓ | 120.1 EB05 118.1 · IC025 +6.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 80.2 (76.8–83.7) | Labeled (related wording) related wording | serious n=1,568 · ♀ 1% (drug 36%) · 98% consumer | not reported in cached trials |
| Hyperprolactinaemia (high prolactin hormone) | 4,483 | 360.6 341.9–380.2ROR 373.2 · calibrated p 1e-12 ✓ | 109.3 EB05 106.7 · IC025 +6.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 23.9 (22.9–24.9) | Labeled — boxed warning exact term | serious n=2,027 · ♀ 16% (drug 36%) · 75% consumer | NCT00856583: 3/4,904 (0.1%) on Risperidone (serious AE) |
| Blood prolactin abnormal | 543 | 265.6 231.3–305.0ROR 266.7 · calibrated p 3e-11 ✓ | 98.4 EB05 91.6 · IC025 +6.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.0 (2.7–3.2) | Lab value / disease marker | serious n=496 · ♀ 71% (drug 36%) | not reported in cached trials |
| Galactorrhoea | 3,768 | 222.9 212.1–234.2ROR 229.4 · calibrated p 1e-10 ✓ | 92.2 EB05 89.7 · IC025 +6.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 35.4 (33.6–37.2) | Not in label — unassessed | serious n=1,169 · ♀ 15% (drug 36%) · 82% consumer | NCT00856583: 3/4,904 (0.1%) on Risperidone (serious AE) |
| Anosognosia | 446 | 219.5 190.1–253.5ROR 220.3 · calibrated p 2e-10 ✓ | 91.3 EB05 84.4 · IC025 +6.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.7 (2.4–3.0) | Not in label — unassessed | serious n=439 · ♀ 79% (drug 36%) | not reported in cached trials |
| Exposure to contaminated device | 132 | 156.7 123.1–199.6ROR 156.9 · calibrated p 5e-9 ✓ | 77.7 EB05 67.2 · IC025 +5.6 3/3 methods agree vs other Atypical Antipsychotics: only this drug | Not in label — unassessed | serious n=130 · ♀ 100% (drug 36%) · 100% clinician | not reported in cached trials |
| Total lung capacity increased | 97 | 87.2 68.0–111.8ROR 87.3 · calibrated p 5e-7 ✓ | 55.7 EB05 47.0 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 11.7 (9.1–15.0) | Not in label — unassessed | serious n=97 · ♀ 100% (drug 36%) · 100% clinician | not reported in cached trials |
| Blood prolactin increased | 1,533 | 76.2 71.7–80.9ROR 77.0 · calibrated p 8e-7 ✓ | 51.4 EB05 49.3 · IC025 +5.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 15.3 (14.3–16.3) | Labeled adverse reaction exact term | serious n=931 | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 209 | 68.2 57.9–80.2ROR 68.3 · calibrated p 2e-6 ✓ | 47.5 EB05 42.3 · IC025 +5.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.1 (2.7–3.6) | Lab value / disease marker | serious n=207 · ♀ 0% (drug 36%) | not reported in cached trials |
| Pleurothotonus | 227 | 52.5 45.1–61.0ROR 52.6 · calibrated p 1e-5 ✓ | 39.4 EB05 35.3 · IC025 +5.0 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.3 (7.2–9.7) | Not in label — unassessed | serious n=220 · 92% clinician | not reported in cached trials |
| Malignant catatonia | 62 | 50.0 37.5–66.5ROR 50.0 · calibrated p 2e-5 ✓ | 37.7 EB05 30.4 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 12.5 (9.1–17.2) | Labeled (related wording) related wording | serious n=62 · ♀ 0% (drug 36%) · 100% clinician | not reported in cached trials |
| Delusion of grandeur | 106 | 49.1 39.4–61.0ROR 49.1 · calibrated p 2e-5 ✓ | 37.3 EB05 31.7 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.2 (3.4–5.2) | Not in label — unassessed | serious n=106 · ♀ 0% (drug 36%) · 100% clinician | not reported in cached trials |
| Obesity | 3,717 | 48.1 46.3–49.8ROR 49.4 · calibrated p 1e-5 ✓ | 36.9 EB05 36.0 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.7 (13.2–14.3) | Labeled adverse reaction exact term | serious PRR 26.9 · ♀ 13% (drug 36%) · 77% consumer | not reported in cached trials |
| Cogwheel rigidity | 245 | 47.9 41.5–55.3ROR 48.0 · calibrated p 2e-5 ✓ | 36.8 EB05 33.1 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 7.6 (6.5–8.7) | Labeled adverse reaction exact term | serious n=235 · 90% clinician | not reported in cached trials |
| Disturbance in social behaviour | 547 | 47.5 43.2–52.3ROR 47.7 · calibrated p 2e-5 ✓ | 36.6 EB05 34.1 · IC025 +5.0 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.4 (3.1–3.7) | Reporting / coding artifact | serious n=508 · ♀ 71% (drug 36%) | not reported in cached trials |
| Spasmodic dysphonia | 65 | 44.7 34.0–58.9ROR 44.8 · calibrated p 4e-5 ✓ | 34.6 EB05 28.1 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 14.4 (10.5–19.8) | Not in label — unassessed | serious n=65 · ♀ 0% (drug 36%) · 100% clinician | not reported in cached trials |
| Delusional disorder, persecutory type | 92 | 43.9 34.8–55.3ROR 43.9 · calibrated p 4e-5 ✓ | 34.2 EB05 28.8 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.7 (5.3–8.5) | Not in label — unassessed | serious n=91 · ♀ 0% (drug 36%) | not reported in cached trials |
| Oculogyric crisis | 434 | 41.1 36.9–45.6ROR 41.2 · calibrated p 5e-5 ✓ | 32.7 EB05 30.2 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.8 (4.4–5.4) | Not in label — unassessed | serious n=432 | not reported in cached trials |
| Schizophrenia, paranoid type | 75 | 40.9 31.7–52.8ROR 41.0 · calibrated p 6e-5 ✓ | 32.4 EB05 26.7 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.1 (6.2–10.5) | Likely indication confounding shares a disease stem with the indications wording | serious n=71 · 100% clinician | NCT00206102: 3/496 (0.6%) on Risperidone (serious AE) |
| Emotional disorder | 5,959 | 37.6 36.6–38.7ROR 39.3 · calibrated p 6e-5 ✓ | 30.5 EB05 29.8 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 58.4 (55.6–61.3) | Not in label — unassessed | age-adj. PRR 17.9 · serious PRR 9.4 · ♀ 2% (drug 36%) · 88% consumer | not reported in cached trials |
| Neuroleptic malignant syndrome | 2,246 | 36.8 35.2–38.5ROR 37.4 · calibrated p 8e-5 ✓ | 30.0 EB05 28.9 · IC025 +4.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.2 (5.0–5.5) | Labeled — boxed warning exact term | age-adj. PRR 34.0 · serious PRR 26.0 · 90% clinician | NCT00856583: 2/4,904 (0.0%) on Risperidone (serious AE) |
| Oromandibular dystonia | 136 | 36.7 30.5–44.3ROR 36.8 · calibrated p 1e-4 ✓ | 29.8 EB05 25.8 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 14.4 (11.6–17.9) | Not in label — unassessed | serious n=127 | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 97 | 36.2 29.0–45.1ROR 36.2 · calibrated p 1e-4 ✓ | 29.4 EB05 24.8 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 11.7 (9.1–15.0) | Labeled (related wording) related wording | serious n=97 · ♀ 100% (drug 36%) · 100% clinician | not reported in cached trials |
| Self injurious behaviour | 549 | 34.1 31.1–37.4ROR 34.2 · calibrated p 1e-4 ✓ | 28.1 EB05 26.2 · IC025 +4.6 3/3 methods agree vs other Atypical Antipsychotics: PRR 22.0 (19.6–24.9) | Not in label — unassessed | serious n=543 | NCT00206102: 1/586 (0.2%) on Risperidone (serious AE) |
| Schizophrenia | 2,145 | 33.8 32.3–35.5ROR 34.4 · calibrated p 1e-4 ✓ | 28.0 EB05 27.0 · IC025 +4.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.2 (3.1–3.4) | Likely indication confounding term in indications; also in warnings | serious PRR 24.5 | NCT00206102: 20/496 (4.0%) on Risperidone (serious AE) |
| Psychiatric decompensation | 329 | 32.0 28.5–36.1ROR 32.1 · calibrated p 2e-4 ✓ | 26.7 EB05 24.4 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 4.5 (4.0–5.0) | Not in label — unassessed | serious n=319 | not reported in cached trials |
| Schizoaffective disorder | 292 | 30.7 27.1–34.8ROR 30.8 · calibrated p 2e-4 ✓ | 25.8 EB05 23.4 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.0 (1.8–2.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=288 | NCT00206102: 14/496 (2.8%) on Risperidone (serious AE) |
| Catatonia | 829 | 29.9 27.7–32.2ROR 30.0 · calibrated p 3e-4 ✓ | 25.2 EB05 23.8 · IC025 +4.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.8 (5.4–6.3) | Labeled adverse reaction exact term | serious n=807 | NCT00206102: 1/586 (0.2%) on Risperidone (serious AE) |
| Grandiosity | 56 | 28.7 21.6–38.2ROR 28.8 · calibrated p 4e-4 ✓ | 24.2 EB05 19.4 · IC025 +3.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 381.6 (119.4–1,219.0) | Not in label — unassessed | serious n=53 · ♀ 0% (drug 36%) · 100% clinician | not reported in cached trials |
| Psychotic symptom | 310 | 28.3 25.1–32.0ROR 28.4 · calibrated p 4e-4 ✓ | 24.1 EB05 21.9 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.2 (2.8–3.6) | Likely indication confounding term in indications; also in warnings | serious n=302 | not reported in cached trials |
| Anticholinergic syndrome | 229 | 26.5 23.0–30.5ROR 26.5 · calibrated p 5e-4 ✓ | 22.8 EB05 20.4 · IC025 +4.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 12.8 (10.8–15.0) | Not in label — unassessed | serious n=227 · 91% clinician | not reported in cached trials |
| Breast enlargement | 463 | 25.9 23.5–28.6ROR 26.0 · calibrated p 6e-4 ✓ | 22.3 EB05 20.7 · IC025 +4.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 26.1 (22.8–30.0) | Labeled adverse reaction exact term | serious n=186 · 82% consumer | not reported in cached trials |
| Wrong patient | 69 | 25.7 20.0–33.2ROR 25.8 · calibrated p 7e-4 ✓ | 22.1 EB05 18.1 · IC025 +3.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 15.5 (11.3–21.2) | Reporting / coding artifact | serious n=69 | not reported in cached trials |
| Disinhibition | 225 | 25.6 22.3–29.5ROR 25.7 · calibrated p 6e-4 ✓ | 22.1 EB05 19.8 · IC025 +4.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.4 (3.0–3.9) | Not in label — unassessed | serious n=223 · ♀ 0% (drug 36%) | not reported in cached trials |
| Extrapyramidal disorder | 3,471 | 25.4 24.5–26.3ROR 26.0 · calibrated p 5e-4 ✓ | 21.9 EB05 21.3 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.6 (8.2–8.9) | Labeled adverse reaction exact term | age-adj. PRR 47.0 · serious PRR 16.5 | NCT00856583: 1/4,904 (0.0%) on Risperidone (serious AE) |
| Metabolic syndrome | 216 | 23.9 20.7–27.6ROR 23.9 · calibrated p 9e-4 ✓ | 20.8 EB05 18.6 · IC025 +4.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 3.4 (2.9–3.9) | Labeled (related wording) related wording | serious n=197 | not reported in cached trials |
| Water intoxication | 65 | 23.0 17.8–29.9ROR 23.0 · calibrated p 0.001 ✓ | 20.1 EB05 16.3 · IC025 +3.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 22.9 (16.1–32.6) | Labeled adverse reaction exact term | serious n=65 · ♀ 0% (drug 36%) · 100% clinician | not reported in cached trials |
| Soliloquy | 109 | 22.9 18.8–28.1ROR 23.0 · calibrated p 0.001 ✓ | 20.1 EB05 17.1 · IC025 +3.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.7 (6.9–10.8) | Not in label — unassessed | serious n=90 | not reported in cached trials |
| Metabolic disorder | 732 | 22.8 21.1–24.6ROR 22.9 · calibrated p 0.001 ✓ | 20.0 EB05 18.8 · IC025 +4.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 2.9 (2.7–3.2) | Labeled (related wording) related wording | serious n=703 · ♀ 67% (drug 36%) | 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 | 9,731 | 16.215.9–16.5 | signal |
| Suicidality | 7,890 | 5.35.2–5.4 | signal |
| Rhabdomyolysis / myopathy | 2,038 | 4.13.9–4.3 | signal |
| Hyponatraemia | 1,439 | 2.92.7–3.0 | signal |
| Hyperglycaemia / diabetes | 6,134 | 2.92.8–2.9 | signal |
| Seizure | 2,577 | 2.12.0–2.2 | signal |
| Pancreatitis | 1,055 | 2.12.0–2.2 | raised |
| Depression | 3,327 | 1.91.8–2.0 | raised |
| Arrhythmia / qt | 2,150 | 1.81.7–1.9 | raised |
| Liver injury | 2,370 | 1.31.2–1.3 | raised |
| Severe cutaneous reaction | 581 | 1.31.2–1.4 | raised |
| Fall / fracture | 2,958 | 1.21.2–1.3 | raised |
| Hypoglycaemia | 717 | 1.21.1–1.3 | raised |
| Venous thromboembolism | 1,564 | 1.21.1–1.2 | raised |
| Kidney injury | 3,039 | 1.11.0–1.1 | raised |
| Neutropenia / agranulocytosis | 1,614 | 1.01.0–1.1 | no difference |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Risperidone 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 (9 of 40 signal terms matched).
- NCT00856583 — Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use (N=9809, PHASE3; 271 AE terms posted; arms: Sertindole; Risperidone)
- NCT00206102 — A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizo (N=1098, PHASE4; 151 AE terms posted; arms: Quetiapine Fumarate; Risperidone)
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 |
|---|---|---|---|---|---|---|
| Gynaecomastia (male breast enlargement) | 24,650 | 614.0 597.5–630.9ROR 754.5 · calibrated p 6e-16 ✓ | 124.9 EB05 123.6 · IC025 +6.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 92.3 (89.9–94.8) | Labeled adverse reaction exact term | serious PRR 81.0 · ♀ 0% (drug 36%) · 92% consumer | not reported in cached trials |
| Off label use (used outside approved label) | 12,512 | 2.3 2.3–2.3ROR 2.4 · calibrated p 0.838 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.8 (8.6–8.9) | Reporting / coding artifact | age-adj. PRR 1.9 · serious PRR 1.7 | not reported in cached trials |
| Abnormal weight gain | 9,452 | 513.3 492.5–535.1ROR 552.8 · calibrated p 2e-14 ✓ | 120.1 EB05 118.1 · IC025 +6.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 80.2 (76.8–83.7) | Labeled (related wording) related wording | serious n=1,568 · ♀ 1% (drug 36%) · 98% consumer | not reported in cached trials |
| Weight increased (weight gain) | 9,217 | 6.8 6.7–6.9ROR 7.2 · calibrated p 0.089 | 6.6 EB05 6.4 · IC025 +2.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 6.5 (6.3–6.6) | Labeled — boxed warning synonym match | age-adj. PRR 5.0 · serious PRR 5.4 | NCT00856583: 1/4,905 (0.0%) on Risperidone (serious AE) |
| Drug ineffective (drug did not work) | 7,687 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.256 | 0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Atypical Antipsychotics: PRR 4.6 (4.5–4.6) | Reporting / coding artifact | age-adj. PRR 1.2 · serious PRR 1.7 | not reported in cached trials |
| Product use in unapproved indication | 6,003 | 4.0 3.9–4.1ROR 4.1 · calibrated p 0.357 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.2 (8.0–8.4) | Reporting / coding artifact | age-adj. PRR 3.6 · serious PRR 2.9 · ♀ 12% (drug 36%) · 72% consumer | not reported in cached trials |
| Emotional disorder | 5,959 | 37.6 36.6–38.7ROR 39.3 · calibrated p 6e-5 ✓ | 30.5 EB05 29.8 · IC025 +4.9 3/3 methods agree vs other Atypical Antipsychotics: PRR 58.4 (55.6–61.3) | Not in label — unassessed | age-adj. PRR 17.9 · serious PRR 9.4 · ♀ 2% (drug 36%) · 88% consumer | not reported in cached trials |
| Injury | 4,631 | 11.1 10.7–11.4ROR 11.4 · calibrated p 0.020 ✓ | 10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree vs other Atypical Antipsychotics: PRR 11.2 (10.8–11.5) | Not in label — unassessed | age-adj. PRR 1.0 · serious PRR 0.7 · ♀ 6% (drug 36%) · 97% consumer | NCT00856583: 1/4,905 (0.0%) on Risperidone (serious AE) |
| Drug interaction | 4,549 | 4.7 4.5–4.8ROR 4.8 · calibrated p 0.259 | 4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.3 (5.1–5.4) | Reporting / coding artifact | age-adj. PRR 5.2 · serious PRR 4.3 | not reported in cached trials |
| Hyperprolactinaemia (high prolactin hormone) | 4,483 | 360.6 341.9–380.2ROR 373.2 · calibrated p 1e-12 ✓ | 109.3 EB05 106.7 · IC025 +6.7 3/3 methods agree vs other Atypical Antipsychotics: PRR 23.9 (22.9–24.9) | Labeled — boxed warning exact term | serious n=2,027 · ♀ 16% (drug 36%) · 75% consumer | NCT00856583: 3/4,904 (0.1%) on Risperidone (serious AE) |
| Somnolence (drowsiness) | 4,421 | 3.5 3.4–3.7ROR 3.6 · calibrated p 0.453 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree vs other Atypical Antipsychotics: PRR 5.7 (5.5–5.9) | Labeled adverse reaction exact term | age-adj. PRR 3.7 · serious PRR 4.3 | NCT00206102: 64/496 (12.9%) on Risperidone |
| Galactorrhoea | 3,768 | 222.9 212.1–234.2ROR 229.4 · calibrated p 1e-10 ✓ | 92.2 EB05 89.7 · IC025 +6.5 3/3 methods agree vs other Atypical Antipsychotics: PRR 35.4 (33.6–37.2) | Not in label — unassessed | serious n=1,169 · ♀ 15% (drug 36%) · 82% consumer | NCT00856583: 3/4,904 (0.1%) on Risperidone (serious AE) |
| Obesity | 3,717 | 48.1 46.3–49.8ROR 49.4 · calibrated p 1e-5 ✓ | 36.9 EB05 36.0 · IC025 +5.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 13.7 (13.2–14.3) | Labeled adverse reaction exact term | serious PRR 26.9 · ♀ 13% (drug 36%) · 77% consumer | not reported in cached trials |
| Emotional distress | 3,531 | 4.7 4.6–4.9ROR 4.8 · calibrated p 0.255 | 4.6 EB05 4.5 · IC025 +2.1 3/3 methods agree vs other Atypical Antipsychotics: PRR 18.0 (17.2–18.8) | Not in label — unassessed | age-adj. PRR 7.6 · serious PRR 1.4 · ♀ 6% (drug 36%) · 81% consumer | not reported in cached trials |
| Extrapyramidal disorder | 3,471 | 25.4 24.5–26.3ROR 26.0 · calibrated p 5e-4 ✓ | 21.9 EB05 21.3 · IC025 +4.4 3/3 methods agree vs other Atypical Antipsychotics: PRR 8.6 (8.2–8.9) | Labeled adverse reaction exact term | age-adj. PRR 47.0 · serious PRR 16.5 | NCT00856583: 1/4,904 (0.0%) on Risperidone (serious AE) |
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.
- Galactorrhoea — n=3,768, PRR 222.9 (also seen in trial arm)
- Anosognosia — n=446, PRR 219.5
- Exposure to contaminated device — n=132, PRR 156.7
- Total lung capacity increased — n=97, PRR 87.2
- Pleurothotonus — n=227, PRR 52.5
- Delusion of grandeur — n=106, PRR 49.1
- Spasmodic dysphonia — n=65, PRR 44.7
- Delusional disorder, persecutory type — n=92, PRR 43.9
- Oculogyric crisis — n=434, PRR 41.1
- Emotional disorder — n=5,959, PRR 37.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Risperidone ↔ Gynaecomastia.
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 Risperidone?
In FDA FAERS, the most frequently co-reported reaction terms for Risperidone are gynaecomastia, abnormal weight gain, weight increased, emotional disorder, injury, hyperprolactinaemia. 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 Risperidone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone tablets are not approved for the treatment of patients with dementia-related psychosis.
Do FAERS signals prove that Risperidone 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 095630bd-a77e-434e-94ee-f13da445d8f2, effective 20250916; matched on
openfda.generic_name.exact:"RISPERIDONE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5073 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, 1,278 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
RISPERIDONE, 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.