Rivastigmine side effects: what 18,729 FDA adverse event reports show
Drug class
Cholinesterase Inhibitor
Who reports
18,729 reports · 85% serious · 4,741 with death outcome · 51% female
Used for
Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: Mild, moderate, and severe dementia of the Alzheimer's type (AD) ( 1.1 ) Mild-to-moderate dementia associated with Parkinson's disease (PD) ( 1.2 ) 1.1 Alzheimer’s Disease Rivastigmine transdermal system is indicated for the treatment of dementia of the Alzheimer's type (AD).
What it is
Rivastigmine transdermal system contains rivastigmine USP, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino)ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C 14 H 22 N 2 O 2 as the base and a molecular weight of 250.34 g/mol (as the base).
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,070 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 |
|---|---|---|---|---|---|---|
| Mini mental status examination abnormal | 14 | 230.7 129.7–410.2ROR 230.8 · χ² 2,461 / p <1e-300 | 151.9 EB05 96.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=14 | not reported in cached trials |
| Medical device site dryness | 10 | 204.4 104.1–401.3ROR 204.5 · χ² 1,540 / p <1e-300 | 130.4 EB05 75.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Urinary casts present | 11 | 133.4 71.4–249.4ROR 133.5 · χ² 1,174 / p 1e-257 | 99.2 EB05 59.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Vascular encephalopathy | 30 | 130.9 89.7–191.1ROR 131.1 · χ² 3,342 / p <1e-300 | 109.2 EB05 80.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 51%) | not reported in cached trials |
| Blood cholinesterase decreased | 27 | 121.6 81.8–181.0ROR 121.8 · χ² 2,802 / p <1e-300 | 101.9 EB05 73.6 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=27 · ♀ 31% (drug 51%) · 100% clinician | not reported in cached trials |
| Tobacco interaction | 11 | 121.4 65.2–226.3ROR 121.5 · χ² 1,077 / p 1e-236 | 92.4 EB05 55.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Dementia alzheimer's type | 160 | 116.7 99.2–137.3ROR 117.7 · χ² 16,499 / p <1e-300 | 104.4 EB05 91.5 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=157 · 75% consumer | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Stoma site induration | 11 | 113.5 61.0–211.0ROR 113.5 · χ² 1,012 / p 2e-222 | 87.8 EB05 52.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Stoma site discomfort | 20 | 110.4 69.7–174.8ROR 110.5 · χ² 1,873 / p <1e-300 | 91.9 EB05 62.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Stoma site reaction | 56 | 100.8 76.7–132.5ROR 101.1 · χ² 4,981 / p <1e-300 | 89.7 EB05 71.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 30% (drug 51%) | not reported in cached trials |
| Stoma site erythema | 146 | 94.8 80.1–112.2ROR 95.5 · χ² 12,394 / p <1e-300 | 86.4 EB05 75.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=139 | not reported in cached trials |
| Stoma site discharge | 189 | 82.9 71.5–96.0ROR 83.7 · χ² 14,148 / p <1e-300 | 76.6 EB05 67.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=175 | not reported in cached trials |
| Freezing phenomenon | 246 | 82.2 72.3–93.5ROR 83.3 · χ² 18,289 / p <1e-300 | 76.1 EB05 68.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=222 | not reported in cached trials |
| On and off phenomenon | 354 | 80.7 72.5–89.8ROR 82.2 · χ² 25,894 / p <1e-300 | 75.0 EB05 68.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=338 | not reported in cached trials |
| Stoma site odour | 15 | 80.0 47.4–135.1ROR 80.1 · χ² 1,019 / p 9e-224 | 68.4 EB05 44.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Stoma site irritation | 34 | 74.2 52.4–104.9ROR 74.3 · χ² 2,232 / p <1e-300 | 67.1 EB05 50.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Dementia with lewy bodies | 66 | 74.0 57.7–95.0ROR 74.3 · χ² 4,388 / p <1e-300 | 68.1 EB05 55.4 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=65 | not reported in cached trials |
| Stoma site hypergranulation | 38 | 71.6 51.6–99.3ROR 71.7 · χ² 2,418 / p <1e-300 | 65.2 EB05 49.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=37 | not reported in cached trials |
| Agnosia | 14 | 70.9 41.3–121.7ROR 70.9 · χ² 842 / p 2e-185 | 61.4 EB05 38.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Fibroma | 55 | 70.4 53.6–92.5ROR 70.6 · χ² 3,474 / p <1e-300 | 64.8 EB05 51.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=53 | not reported in cached trials |
| Stoma site inflammation | 42 | 67.0 49.1–91.4ROR 67.1 · χ² 2,512 / p <1e-300 | 61.5 EB05 47.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=41 | not reported in cached trials |
| Hyperkinesia | 118 | 66.9 55.6–80.6ROR 67.4 · χ² 7,164 / p <1e-300 | 62.6 EB05 53.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=116 | not reported in cached trials |
| Stoma site extravasation | 22 | 66.7 43.4–102.6ROR 66.8 · χ² 1,282 / p 6e-281 | 59.9 EB05 41.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Aspiration bronchial | 16 | 63.3 38.3–104.8ROR 63.4 · χ² 870 / p 2e-191 | 56.1 EB05 36.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Application site hypersensitivity | 64 | 62.7 48.7–80.6ROR 62.9 · χ² 3,618 / p <1e-300 | 58.4 EB05 47.3 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=59 | not reported in cached trials |
| Cholinergic syndrome | 31 | 56.7 39.6–81.4ROR 56.8 · χ² 1,562 / p <1e-300 | 52.4 EB05 38.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=31 · ♀ 81% (drug 51%) · 100% clinician | not reported in cached trials |
| Stoma site pain | 66 | 52.9 41.3–67.7ROR 53.1 · χ² 3,156 / p <1e-300 | 49.8 EB05 40.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=62 | not reported in cached trials |
| Anticholinergic syndrome | 68 | 49.9 39.1–63.6ROR 50.1 · χ² 3,070 / p <1e-300 | 47.2 EB05 38.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=68 | not reported in cached trials |
| Reduced facial expression | 41 | 47.7 34.9–65.2ROR 47.8 · χ² 1,754 / p <1e-300 | 44.9 EB05 34.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 17% (drug 51%) | not reported in cached trials |
| Senile dementia | 26 | 45.8 31.0–67.9ROR 45.9 · χ² 1,052 / p 4e-231 | 42.8 EB05 30.7 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · 75% consumer | NCT00506415: 1/1,582 (0.1%) on Rivastigmine (serious AE) |
| Stoma site infection | 50 | 45.0 33.9–59.7ROR 45.1 · χ² 2,026 / p <1e-300 | 42.6 EB05 33.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 26% (drug 51%) | not reported in cached trials |
| Euthanasia | 12 | 44.0 24.7–78.3ROR 44.0 · χ² 445 / p 6e-99 | 39.9 EB05 24.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Parkinsonian gait | 23 | 43.0 28.3–65.1ROR 43.0 · χ² 867 / p 6e-191 | 40.1 EB05 28.2 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=23 | not reported in cached trials |
| Bradykinesia | 210 | 41.8 36.5–47.9ROR 42.3 · χ² 8,022 / p <1e-300 | 40.2 EB05 35.8 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=198 | not reported in cached trials |
| Enteral nutrition | 20 | 41.2 26.4–64.3ROR 41.2 · χ² 718 / p 2e-158 | 38.4 EB05 26.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 30% (drug 51%) | not reported in cached trials |
| Akinesia | 71 | 39.8 31.4–50.4ROR 39.9 · χ² 2,553 / p <1e-300 | 38.1 EB05 31.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=71 | not reported in cached trials |
| Patient elopement | 11 | 37.1 20.4–67.7ROR 37.2 · χ² 340 / p 3e-76 | 34.0 EB05 20.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Suspiciousness | 21 | 34.8 22.5–53.6ROR 34.8 · χ² 635 / p 2e-140 | 32.8 EB05 22.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Basal ganglia infarction | 10 | 33.1 17.7–62.2ROR 33.2 · χ² 272 / p 2e-61 | 30.5 EB05 17.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Repetitive speech | 16 | 32.9 20.0–54.1ROR 32.9 · χ² 450 / p 4e-100 | 30.9 EB05 20.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | 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 Rivastigmine 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 (2 of 40 signal terms matched).
- NCT00506415 — Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer (N=1584, PHASE3; 307 AE terms posted; arms: Initial Open Label: Rivastigmine (5 cm^2; Double Blind: Rivastigmine (10 cm^2); Double Blind: Rivastigmine (15 cm^2); Extended Open Label: Rivastigmine (10 cm)
- NCT00423085 — Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease (N=859, PHASE3; 117 AE terms posted; arms: Placebo (24 Weeks); Rivastigmine 5 cm^2 (24 Weeks); Rivastigmine 10 cm^2 (24 Weeks); Open-Label Extension (52 Weeks))
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 |
|---|---|---|---|---|---|---|
| Death | 2,310 | 3.0 2.9–3.1ROR 3.3 · χ² 3,219 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.0 | not reported in cached trials |
| Fall | 1,744 | 5.9 5.6–6.2ROR 6.4 · χ² 7,167 / p <1e-300 | 5.9 EB05 5.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | NCT00506415: 3/280 (1.1%) on Rivastigmine (serious AE) |
| Hallucination (hallucinations) | 1,445 | 22.0 20.9–23.1ROR 23.7 · χ² 28,470 / p <1e-300 | 21.6 EB05 20.7 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.5 | NCT00506415: 2/1,582 (0.1%) on Rivastigmine (serious AE) |
| Confusional state (confusion) | 1,306 | 9.1 8.6–9.6ROR 9.7 · χ² 9,400 / p <1e-300 | 9.0 EB05 8.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Drug ineffective (drug did not work) | 946 | 0.8 0.8–0.9ROR 0.8 · χ² 48 / p 2e-12 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Vomiting | 907 | 2.2 2.0–2.3ROR 2.2 · χ² 582 / p 8e-129 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · ♀ 74% (drug 51%) | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Nausea | 849 | 1.2 1.1–1.3ROR 1.2 · χ² 31 / p 2e-8 | 1.2 EB05 1.1 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Dizziness | 803 | 1.8 1.7–1.9ROR 1.8 · χ² 295 / p 2e-66 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Gait disturbance | 737 | 4.3 4.0–4.6ROR 4.4 · χ² 1,881 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Pneumonia (lung infection) | 715 | 2.5 2.3–2.7ROR 2.5 · χ² 638 / p 4e-141 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 | NCT00506415: 1/1,582 (0.1%) on Rivastigmine (serious AE) |
| Somnolence (drowsiness) | 676 | 3.8 3.5–4.1ROR 3.9 · χ² 1,384 / p <1e-300 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | not reported in cached trials |
| Malaise (feeling unwell) | 670 | 1.7 1.6–1.8ROR 1.7 · χ² 200 / p 1e-45 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.8 | NCT00506415: 1/1,582 (0.1%) on Rivastigmine (serious AE) |
| Fatigue (tiredness) | 661 | 1.0 0.9–1.0ROR 1.0 · χ² 2 / p 0.105 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Diarrhoea (diarrhea) | 656 | 1.1 1.1–1.2ROR 1.1 · χ² 12 / p 3e-4 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.1 | NCT00506415: 1/457 (0.2%) on Rivastigmine (serious AE) |
| Urinary tract infection (bladder infection) | 636 | 4.2 3.9–4.5ROR 4.3 · χ² 1,554 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | NCT00506415: 2/457 (0.4%) on Rivastigmine (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.
- Vascular encephalopathy — n=30, PRR 130.9
- Stoma site discomfort — n=20, PRR 110.4
- Stoma site reaction — n=56, PRR 100.8
- Stoma site erythema — n=146, PRR 94.8
- Stoma site discharge — n=189, PRR 82.9
- Freezing phenomenon — n=246, PRR 82.2
- On and off phenomenon — n=354, PRR 80.7
- Stoma site irritation — n=34, PRR 74.2
- Stoma site hypergranulation — n=38, PRR 71.6
- Fibroma — n=55, PRR 70.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Rivastigmine ↔ Vomiting.
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 Rivastigmine?
In FDA FAERS, the most frequently co-reported reaction terms for Rivastigmine are fall, hallucination, confusional state, vomiting, nausea, dizziness. 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 Rivastigmine have an FDA boxed warning?
No. The FDA label retrieved for Rivastigmine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rivastigmine 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 64dad603-2389-456b-8c18-d1d40b7e7419, effective 20240527; matched on
openfda.generic_name.exact:"RIVASTIGMINE") - 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, 1,110 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
RIVASTIGMINE, results-bearing studies sorted by enrollment)
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.