Pimavanserin side effects: what 54,981 FDA adverse event reports show
Drug class
Atypical antipsychotic
Who reports
54,981 reports · 51% serious · 14,132 with death outcome · 39% female
Used for
Pimavanserin capsule is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis . Pimavanserin capsule is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. (1)
What it is
Pimavanserin capsule contains pimavanserin, an atypical antipsychotic, which is present as pimavanserin tartrate salt with the chemical name, urea, N-[(4-fluorophenyl)methyl]-N-(1-methyl-4-piperidinyl)-N’-[[4-(2-methylpropoxy)phenyl]methyl]-,(2R,3R)-2,3-dihydroxybutanedioate (2:1).
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. Pimavanserin is not approve.
Causality screen of the 40 strongest signals
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.
- 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.
- 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). 968 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 |
|---|---|---|---|---|---|---|
| Speech-language therapy | 11 | 825.8 286.9–2,376.7ROR 826.0 · calibrated p 4e-11 ✓ | 179.0 EB05 106.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=7 | not reported in cached trials |
| Occupational therapy | 18 | 250.2 137.8–454.3ROR 250.3 · calibrated p 1e-9 ✓ | 130.1 EB05 87.1 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=9 | not reported in cached trials |
| Dementia with lewy bodies | 413 | 243.4 215.1–275.4ROR 245.2 · calibrated p 7e-11 ✓ | 147.0 EB05 135.5 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=365 · 77% consumer | not reported in cached trials |
| Patient elopement | 104 | 166.8 132.4–210.1ROR 167.1 · calibrated p 3e-9 ✓ | 113.4 EB05 96.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=68 · 85% consumer | not reported in cached trials |
| Nonspecific reaction | 1,156 | 104.2 97.7–111.2ROR 106.4 · calibrated p 7e-8 ✓ | 81.7 EB05 77.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=517 · 72% consumer | not reported in cached trials |
| Delusion | 2,770 | 83.1 79.8–86.5ROR 87.4 · calibrated p 3e-7 ✓ | 68.2 EB05 66.1 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 47.4 · 74% consumer | not reported in cached trials |
| Physiotherapy | 90 | 81.2 64.7–102.0ROR 81.3 · calibrated p 7e-7 ✓ | 66.0 EB05 55.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=51 · 97% consumer | not reported in cached trials |
| Hallucination (hallucinations) | 12,702 | 77.8 76.5–79.2ROR 100.9 · calibrated p 1e-7 ✓ | 64.6 EB05 63.7 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 48.8 · 74% consumer | not reported in cached trials |
| Rapid eye movement sleep behaviour disorder | 56 | 62.2 46.9–82.5ROR 62.3 · calibrated p 5e-6 ✓ | 52.6 EB05 42.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Metabolic function test abnormal | 44 | 59.2 43.1–81.3ROR 59.2 · calibrated p 8e-6 ✓ | 50.2 EB05 39.0 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | 100% clinician | not reported in cached trials |
| Hallucination, visual | 2,322 | 47.4 45.4–49.5ROR 49.5 · calibrated p 1e-5 ✓ | 42.2 EB05 40.8 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 32.6 · 82% consumer | not reported in cached trials |
| Hallucination, tactile | 72 | 46.7 36.5–59.6ROR 46.7 · calibrated p 3e-5 ✓ | 41.2 EB05 33.8 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=42 · 86% consumer | not reported in cached trials |
| Medical device battery replacement | 12 | 39.2 21.6–71.0ROR 39.2 · calibrated p 2e-4 ✓ | 33.8 EB05 20.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Belligerence | 39 | 37.7 27.1–52.4ROR 37.8 · calibrated p 1e-4 ✓ | 33.9 EB05 25.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Confusional arousal | 14 | 36.7 21.2–63.6ROR 36.8 · calibrated p 2e-4 ✓ | 32.2 EB05 20.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Hallucinations, mixed | 353 | 34.9 31.3–38.9ROR 35.1 · calibrated p 1e-4 ✓ | 31.9 EB05 29.2 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=202 · 91% consumer | not reported in cached trials |
| Patient uncooperative | 32 | 28.1 19.6–40.3ROR 28.1 · calibrated p 5e-4 ✓ | 25.9 EB05 19.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Feeding tube user | 25 | 28.0 18.7–42.1ROR 28.0 · calibrated p 6e-4 ✓ | 25.7 EB05 18.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 · 80% consumer | not reported in cached trials |
| Deep brain stimulation | 39 | 27.4 19.8–37.9ROR 27.4 · calibrated p 6e-4 ✓ | 25.3 EB05 19.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=30 · 87% consumer | not reported in cached trials |
| Prescribed underdose | 1,184 | 24.0 22.7–25.5ROR 24.5 · calibrated p 7e-4 ✓ | 22.6 EB05 21.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 | not reported in cached trials |
| Posture abnormal | 187 | 23.2 20.0–26.9ROR 23.3 · calibrated p 0.001 ✓ | 21.9 EB05 19.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=75 | not reported in cached trials |
| Sleep talking | 92 | 21.7 17.6–26.7ROR 21.7 · calibrated p 0.002 ✓ | 20.5 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=55 · 77% consumer | not reported in cached trials |
| Defiant behaviour | 16 | 21.1 12.8–35.0ROR 21.2 · calibrated p 0.003 ✓ | 19.5 EB05 12.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Adult failure to thrive | 11 | 21.0 11.4–38.5ROR 21.0 · calibrated p 0.004 ✓ | 18.9 EB05 10.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Freezing phenomenon | 184 | 20.5 17.7–23.8ROR 20.6 · calibrated p 0.002 ✓ | 19.5 EB05 17.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=87 · 74% consumer | not reported in cached trials |
| Dementia | 1,393 | 20.0 19.0–21.1ROR 20.5 · calibrated p 0.002 ✓ | 19.1 EB05 18.2 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 18.0 · 78% consumer | not reported in cached trials |
| Stubbornness | 21 | 19.3 12.5–30.0ROR 19.3 · calibrated p 0.004 ✓ | 18.0 EB05 12.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=8 · 90% consumer | not reported in cached trials |
| Multiple system atrophy | 17 | 19.3 11.8–31.4ROR 19.3 · calibrated p 0.004 ✓ | 17.9 EB05 11.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Hallucination, olfactory | 20 | 18.6 11.9–29.1ROR 18.6 · calibrated p 0.004 ✓ | 17.3 EB05 11.6 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 · 90% consumer | not reported in cached trials |
| Suture insertion | 25 | 17.2 11.5–25.6ROR 17.2 · calibrated p 0.005 ✓ | 16.1 EB05 11.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 · 100% consumer | not reported in cached trials |
| Soliloquy | 37 | 17.1 12.3–23.8ROR 17.1 · calibrated p 0.005 ✓ | 16.2 EB05 12.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 · 76% consumer | not reported in cached trials |
| Trance | 14 | 15.1 8.8–25.7ROR 15.1 · calibrated p 0.011 ✓ | 13.5 EB05 7.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Abnormal behaviour | 1,501 | 14.9 14.1–15.7ROR 15.3 · calibrated p 0.006 ✓ | 14.3 EB05 13.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | not reported in cached trials |
| Medical device change | 20 | 14.8 9.5–23.1ROR 14.8 · calibrated p 0.011 ✓ | 13.6 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=15 · 90% consumer | not reported in cached trials |
| Resting tremor | 24 | 14.6 9.7–22.0ROR 14.6 · calibrated p 0.010 ✓ | 13.6 EB05 9.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=17 · 100% consumer | not reported in cached trials |
| Paranoia | 639 | 14.6 13.5–15.8ROR 14.7 · calibrated p 0.008 ✓ | 14.1 EB05 13.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 73% consumer | not reported in cached trials |
| Drooling | 231 | 13.2 11.6–15.1ROR 13.3 · calibrated p 0.012 ✓ | 12.8 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=94 | not reported in cached trials |
| Bradykinesia | 191 | 12.9 11.2–14.9ROR 12.9 · calibrated p 0.013 ✓ | 12.4 EB05 11.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=102 · 94% consumer | not reported in cached trials |
| Illusion | 54 | 12.7 9.7–16.7ROR 12.7 · calibrated p 0.015 ✓ | 12.1 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=23 · 78% consumer | not reported in cached trials |
| Slow speech | 77 | 12.6 10.0–15.8ROR 12.6 · calibrated p 0.015 ✓ | 12.1 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=40 · 94% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Pimavanserin 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 (0 of 40 signal terms matched).
- NCT03121586 — Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia (N=995, PHASE3; 17 AE terms posted; arms: Rollover From ACP-103-034; Rollover From ACP-103-038; Rollover From ACP-103-064)
- NCT03575052 — A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to (N=784, PHASE3; 20 AE terms posted; arms: Placebo; Pimavanserin 34 mg)
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 |
|---|---|---|---|---|---|---|
| Hallucination (hallucinations) | 12,702 | 77.8 76.5–79.2ROR 100.9 · calibrated p 1e-7 ✓ | 64.6 EB05 63.7 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 48.8 · 74% consumer | not reported in cached trials |
| Death | 10,828 | 4.8 4.8–4.9ROR 5.8 · calibrated p 0.165 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 5.4 | not reported in cached trials |
| Drug ineffective (drug did not work) | 6,353 | 1.8 1.8–1.9ROR 2.0 · calibrated p 0.919 | 1.8 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 1.8 · 70% consumer | not reported in cached trials |
| Product dose omission issue | 4,354 | 5.9 5.7–6.1ROR 6.3 · calibrated p 0.130 | 5.8 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 11.0 · 88% consumer | not reported in cached trials |
| Confusional state (confusion) | 4,287 | 10.3 10.1–10.7ROR 11.1 · calibrated p 0.022 ✓ | 10.1 EB05 9.8 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 71% consumer | not reported in cached trials |
| Fall | 4,005 | 4.6 4.5–4.8ROR 4.9 · calibrated p 0.243 | 4.6 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 72% consumer | NCT03575052: 1/392 (0.3%) on Pimavanserin; 1/392 (0.3%) control (serious AE) |
| Delusion | 2,770 | 83.1 79.8–86.5ROR 87.4 · calibrated p 3e-7 ✓ | 68.2 EB05 66.1 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 47.4 · 74% consumer | not reported in cached trials |
| Condition aggravated | 2,430 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.570 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 86% consumer | not reported in cached trials |
| Hallucination, visual | 2,322 | 47.4 45.4–49.5ROR 49.5 · calibrated p 1e-5 ✓ | 42.2 EB05 40.8 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 32.6 · 82% consumer | not reported in cached trials |
| Gait disturbance | 2,192 | 4.4 4.2–4.6ROR 4.5 · calibrated p 0.291 | 4.4 EB05 4.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 74% consumer | not reported in cached trials |
| Urinary tract infection (bladder infection) | 1,809 | 4.1 3.9–4.3ROR 4.2 · calibrated p 0.343 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 73% consumer | NCT03575052: 25/392 (6.4%) on Pimavanserin; 16/392 (4.1%) control |
| Somnolence (drowsiness) | 1,733 | 3.3 3.2–3.5ROR 3.4 · calibrated p 0.514 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | not reported in cached trials |
| Adverse drug reaction | 1,662 | 7.2 6.9–7.6ROR 7.4 · calibrated p 0.084 | 7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · 72% consumer | not reported in cached trials |
| Peripheral swelling | 1,650 | 4.1 3.9–4.3ROR 4.2 · calibrated p 0.337 | 4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | not reported in cached trials |
| Product use issue | 1,607 | 3.3 3.1–3.5ROR 3.4 · calibrated p 0.519 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 87% consumer | not reported in cached trials |
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.
- Dementia with lewy bodies — n=413, PRR 243.4
- Patient elopement — n=104, PRR 166.8
- Nonspecific reaction — n=1,156, PRR 104.2
- Physiotherapy — n=90, PRR 81.2
- Rapid eye movement sleep behaviour disorder — n=56, PRR 62.2
- Belligerence — n=39, PRR 37.7
- Patient uncooperative — n=32, PRR 28.1
- Feeding tube user — n=25, PRR 28.0
- Deep brain stimulation — n=39, PRR 27.4
- Prescribed underdose — n=1,184, PRR 24.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Pimavanserin Tartrate ↔ Hallucination.
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 Pimavanserin?
In FDA FAERS, the most frequently co-reported reaction terms for Pimavanserin are hallucination, confusional state, fall, delusion, hallucination, visual, gait disturbance. 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 Pimavanserin 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. Pimavanserin is not approve.
Do FAERS signals prove that Pimavanserin 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 403b6540-c53d-4e92-91b4-36ca6338b2b1, effective 20231101; matched on
openfda.generic_name.exact:"PIMAVANSERIN") - 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, 1,008 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
PIMAVANSERIN, 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.