Causality assessment · Expected pharmacological effect

Rivastigmine and Vomiting: is the FAERS signal real?

n=907 co-reports · PRR 2.2 · ROR 2.2

Rivastigmine side-effect profile All assessments See in the full list

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Expected pharmacological effect

Rivastigmine ↔ Vomiting

n=907 co-reports · PRR 2.2 · ROR 2.2

Rivastigmine is a cholinesterase inhibitor for Alzheimer's and Parkinson's-disease dementia; by raising acetylcholine it commonly causes nausea, vomiting, and diarrhoea, especially during dose titration and with the transdermal patch if a previous patch is not removed (vomiting 907 co-reports, PRR 2.2). The GI effects are the classic cholinergic class toxicity and are managed by slow titration.

Regulatory basis: rivastigmine prescribing information — nausea/vomiting; cholinergic class effects; patch-application errors.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Vomiting during titration
Strength	met	PRR 2.2, modest
Consistency	met	Consistent across cholinesterase inhibitors
Specificity	partial	Shared across the class
Biological gradient	met	Dose-related
Plausibility	met	Cholinergic excess
Coherence	met	Fits the pharmacology
Experiment	met	Trials recorded GI effects
Analogy	met	Analogous to donepezil and galantamine

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease (NCT00423085)

Adverse event	Placebo (24 Weeks) (n=286) · Rivastigmine 5 cm^2 (24 Weeks) (n=282) · Rivastigmine 10 cm^2 (24 Weeks) (n=287) · Open-Label Extension (52 Weeks) (n=637)
Vomiting	0/286	0/282	0/287	2/637

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →