Drug · FAERS side-effect profile with label screen
Galantamine side effects: what 1,632 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,632 reports · 85% serious · 207 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine Tables are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type ( 1 )
FDA label, Indications and Usage
What it is
Galantamine Tablets, USP contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide.
FDA label, Description section
Boxed warning
None in the current 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 adverse reaction 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 28
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 31 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 |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 234 | 272.2 241.4–306.9ROR 317.5 · χ² 61,656 / p <1e-300 | 260.8 EB05 233.9 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious PRR 226.1 · ♀ 100% (drug 60%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 284 | 212.6 191.1–236.5ROR 257.2 · χ² 58,660 / p <1e-300 | 206.2 EB05 186.8 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 161.4 · ♀ 100% (drug 60%) | no trial data cached |
| Sedation | 267 | 133.0 119.1–148.5ROR 158.8 · χ² 34,516 / p <1e-300 | 130.4 EB05 117.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 122.1 · ♀ 98% (drug 60%) | no trial data cached |
| Cognitive disorder | 311 | 86.5 78.2–95.6ROR 106.6 · χ² 26,070 / p <1e-300 | 85.5 EB05 77.8 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 80.9 · ♀ 96% (drug 60%) | no trial data cached |
| Depressed level of consciousness | 249 | 81.6 72.7–91.5ROR 96.1 · χ² 19,643 / p <1e-300 | 80.6 EB05 72.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 56.5 · ♀ 98% (drug 60%) | no trial data cached |
| Balance disorder | 291 | 43.3 39.0–48.1ROR 52.5 · χ² 12,000 / p <1e-300 | 43.1 EB05 39.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 46.8 · ♀ 98% (drug 60%) | no trial data cached |
| Mobility decreased | 231 | 41.6 36.9–46.9ROR 48.3 · χ² 9,108 / p <1e-300 | 41.3 EB05 37.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 · ♀ 97% (drug 60%) | no trial data cached |
| Bladder disorder | 31 | 40.2 28.3–56.9ROR 40.9 · χ² 1,142 / p 2e-250 | 39.1 EB05 28.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=31 · ♀ 96% (drug 60%) | no trial data cached |
| Dementia | 57 | 26.4 20.4–34.0ROR 27.3 · χ² 1,364 / p 7e-299 | 26.1 EB05 20.9 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.9 | no trial data cached |
| Toxicity to various agents | 253 | 19.4 17.3–21.7ROR 22.8 · χ² 4,425 / p <1e-300 | 19.3 EB05 17.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 94% (drug 60%) · 91% clinician | no trial data cached |
| Hypotension (low blood pressure) | 288 | 18.5 16.7–20.5ROR 22.3 · χ² 4,789 / p <1e-300 | 18.5 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.6 · ♀ 92% (drug 60%) | no trial data cached |
| Constipation | 296 | 17.6 15.9–19.5ROR 21.3 · χ² 4,659 / p <1e-300 | 17.6 EB05 15.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · ♀ 94% (drug 60%) | no trial data cached |
| Myoclonus | 15 | 16.2 9.8–26.8ROR 16.3 · χ² 199 / p 2e-45 | 15.4 EB05 9.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Fall | 381 | 14.7 13.5–16.1ROR 18.9 · χ² 4,939 / p <1e-300 | 14.7 EB05 13.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 · ♀ 80% (drug 60%) | no trial data cached |
| Hallucination (hallucinations) | 77 | 13.2 10.6–16.4ROR 13.8 · χ² 859 / p 4e-189 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
| Sudden death | 10 | 12.0 6.5–22.3ROR 12.1 · χ² 90 / p 1e-21 | 10.0 EB05 5.1 · IC025 +1.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 8.2 | no trial data cached |
| Sinus tachycardia | 12 | 10.9 6.2–19.1ROR 11.0 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Delusion | 13 | 10.8 6.3–18.6ROR 10.9 · χ² 106 / p 4e-25 | 9.2 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Muscle rigidity | 10 | 10.8 5.8–20.0ROR 10.8 · χ² 79 / p 3e-19 | 8.7 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Drug interaction | 129 | 10.5 8.9–12.3ROR 11.3 · χ² 1,101 / p 1e-241 | 10.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · ♀ 89% (drug 60%) | no trial data cached |
| Pneumonia aspiration | 18 | 9.3 5.9–14.7ROR 9.4 · χ² 125 / p 3e-29 | 8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 23 | 8.7 5.8–13.1ROR 8.8 · χ² 150 / p 9e-35 | 7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Hepatitis (liver inflammation) | 17 | 8.5 5.3–13.7ROR 8.6 · χ² 106 / p 4e-25 | 7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Aphasia (loss of speech) | 19 | 8.1 5.2–12.6ROR 8.1 · χ² 111 / p 3e-26 | 7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Hallucination, visual | 13 | 8.0 4.6–13.7ROR 8.0 · χ² 72 / p 9e-18 | 6.5 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Hemiparesis | 10 | 7.5 4.1–14.0ROR 7.6 · χ² 50 / p 6e-13 | 5.9 EB05 3.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Electrocardiogram qt prolonged | 21 | 7.5 4.9–11.5ROR 7.6 · χ² 112 / p 2e-26 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Paranoia | 10 | 7.4 4.0–13.8ROR 7.5 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Dystonia | 11 | 7.3 4.0–13.1ROR 7.3 · χ² 53 / p 1e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Haemorrhoids | 11 | 7.2 4.0–13.0ROR 7.3 · χ² 53 / p 2e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Gait inability | 17 | 6.6 4.1–10.6ROR 6.7 · χ² 75 / p 2e-18 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Aggression | 25 | 6.4 4.3–9.5ROR 6.5 · χ² 109 / p 8e-26 | 5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 21% (drug 60%) | no trial data cached |
| Drug abuse | 40 | 6.1 4.5–8.3ROR 6.3 · χ² 168 / p 1e-38 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · ♀ 100% (drug 60%) · 92% clinician | no trial data cached |
| Disorientation | 18 | 5.8 3.7–9.2ROR 5.9 · χ² 67 / p 1e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Fibromyalgia | 11 | 5.8 3.2–10.5ROR 5.9 · χ² 39 / p 2e-10 | 4.8 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Liver function test abnormal | 13 | 5.7 3.3–9.8ROR 5.7 · χ² 46 / p 6e-12 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Agitation | 32 | 5.6 4.0–7.9ROR 5.7 · χ² 116 / p 2e-27 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hip fracture | 13 | 5.2 3.0–8.9ROR 5.2 · χ² 40 / p 1e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Abnormal behaviour | 16 | 5.2 3.2–8.4ROR 5.2 · χ² 50 / p 9e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Mucosal inflammation | 10 | 4.9 2.7–9.1ROR 5.0 · χ² 28 / p 8e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Fall | 381 | 14.7 13.5–16.1ROR 18.9 · χ² 4,939 / p <1e-300 | 14.7 EB05 13.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.9 · ♀ 80% (drug 60%) | no trial data cached |
| Cognitive disorder | 311 | 86.5 78.2–95.6ROR 106.6 · χ² 26,070 / p <1e-300 | 85.5 EB05 77.8 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 80.9 · ♀ 96% (drug 60%) | no trial data cached |
| Constipation | 296 | 17.6 15.9–19.5ROR 21.3 · χ² 4,659 / p <1e-300 | 17.6 EB05 15.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · ♀ 94% (drug 60%) | no trial data cached |
| Balance disorder | 291 | 43.3 39.0–48.1ROR 52.5 · χ² 12,000 / p <1e-300 | 43.1 EB05 39.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 46.8 · ♀ 98% (drug 60%) | no trial data cached |
| Hypotension (low blood pressure) | 288 | 18.5 16.7–20.5ROR 22.3 · χ² 4,789 / p <1e-300 | 18.5 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.6 · ♀ 92% (drug 60%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 284 | 212.6 191.1–236.5ROR 257.2 · χ² 58,660 / p <1e-300 | 206.2 EB05 186.8 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 161.4 · ♀ 100% (drug 60%) | no trial data cached |
| Sedation | 267 | 133.0 119.1–148.5ROR 158.8 · χ² 34,516 / p <1e-300 | 130.4 EB05 117.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 122.1 · ♀ 98% (drug 60%) | no trial data cached |
| Toxicity to various agents | 253 | 19.4 17.3–21.7ROR 22.8 · χ² 4,425 / p <1e-300 | 19.3 EB05 17.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 94% (drug 60%) · 91% clinician | no trial data cached |
| Depressed level of consciousness | 249 | 81.6 72.7–91.5ROR 96.1 · χ² 19,643 / p <1e-300 | 80.6 EB05 72.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 56.5 · ♀ 98% (drug 60%) | no trial data cached |
| Blood calcium decreased | 234 | 272.2 241.4–306.9ROR 317.5 · χ² 61,656 / p <1e-300 | 260.8 EB05 233.9 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious PRR 226.1 · ♀ 100% (drug 60%) | no trial data cached |
| Mobility decreased | 231 | 41.6 36.9–46.9ROR 48.3 · χ² 9,108 / p <1e-300 | 41.3 EB05 37.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 · ♀ 97% (drug 60%) | no trial data cached |
| Drug interaction | 129 | 10.5 8.9–12.3ROR 11.3 · χ² 1,101 / p 1e-241 | 10.3 EB05 8.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · ♀ 89% (drug 60%) | no trial data cached |
| Hallucination (hallucinations) | 77 | 13.2 10.6–16.4ROR 13.8 · χ² 859 / p 4e-189 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
| Overdose | 73 | 4.3 3.5–5.4ROR 4.5 · χ² 186 / p 1e-42 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 93% clinician | no trial data cached |
| Dementia | 57 | 26.4 20.4–34.0ROR 27.3 · χ² 1,364 / p 7e-299 | 26.1 EB05 20.9 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.9 | no trial data cached |
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.
- Orthostatic hypotension — n=284, PRR 212.6
- Sedation — n=267, PRR 133.0
- Depressed level of consciousness — n=249, PRR 81.6
- Balance disorder — n=291, PRR 43.3
- Mobility decreased — n=231, PRR 41.6
- Toxicity to various agents — n=253, PRR 19.4
- Constipation — n=296, PRR 17.6
- Transient ischaemic attack — n=23, PRR 8.7
- Electrocardiogram qt prolonged — n=21, PRR 7.5
- Aggression — n=25, PRR 6.4
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 Galantamine?
In FDA FAERS, the most frequently co-reported reaction terms for Galantamine are fall, cognitive disorder, constipation, balance disorder, hypotension, orthostatic hypotension. 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 Galantamine have an FDA boxed warning?
No. The FDA label retrieved for Galantamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Galantamine 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 10497273-d907-0514-e063-6294a90a1362, effective 20260601; matched on
openfda.generic_name.exact:"GALANTAMINE") - 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, 71 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
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.