Drug · FAERS side-effect profile with label screen
Galantamine Hydrobromide side effects: what 1,643 FDA adverse event reports show
Drug class
Cholinesterase inhibitor
FDA label, Indications wording
Who reports
1,643 reports · 94% serious · 135 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide is 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 hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known ch.
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 31 strongest signals
Labeled adverse reaction 6Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 16
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. 25 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 | 359 | 419.5 382.1–460.6ROR 536.6 · χ² 144,741 / p <1e-300 | 397.4 EB05 364.1 · IC025 +7.8 3/3 methods agree | Lab value / disease marker | serious PRR 312.4 · ♀ 100% (drug 65%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 403 | 301.8 276.8–328.9ROR 399.5 · χ² 117,779 / p <1e-300 | 290.6 EB05 267.6 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 206.2 · ♀ 100% (drug 65%) | no trial data cached |
| Sedation | 383 | 190.3 174.2–207.9ROR 247.8 · χ² 70,951 / p <1e-300 | 185.8 EB05 170.7 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 159.0 · ♀ 99% (drug 65%) | no trial data cached |
| Depressed level of consciousness | 378 | 123.4 112.9–134.9ROR 160.0 · χ² 45,408 / p <1e-300 | 121.5 EB05 111.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 77.2 · ♀ 97% (drug 65%) | no trial data cached |
| Cognitive disorder | 417 | 115.4 106.2–125.5ROR 154.4 · χ² 46,869 / p <1e-300 | 113.8 EB05 104.9 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 98.2 · ♀ 99% (drug 65%) | no trial data cached |
| Mobility decreased | 354 | 63.4 57.8–69.5ROR 80.5 · χ² 21,642 / p <1e-300 | 62.9 EB05 57.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 57.2 · ♀ 99% (drug 65%) | no trial data cached |
| Balance disorder | 405 | 60.0 55.1–65.3ROR 79.3 · χ² 23,415 / p <1e-300 | 59.5 EB05 54.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 59.1 · ♀ 98% (drug 65%) | no trial data cached |
| Hypotension (low blood pressure) | 405 | 25.9 23.8–28.1ROR 34.0 · χ² 9,727 / p <1e-300 | 25.8 EB05 23.7 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.5 · ♀ 97% (drug 65%) | no trial data cached |
| Toxicity to various agents | 337 | 25.7 23.3–28.2ROR 32.0 · χ² 8,016 / p <1e-300 | 25.6 EB05 23.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · ♀ 99% (drug 65%) | no trial data cached |
| Constipation | 418 | 24.7 22.7–26.8ROR 32.8 · χ² 9,561 / p <1e-300 | 24.6 EB05 22.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · ♀ 96% (drug 65%) | no trial data cached |
| Bladder disorder | 15 | 19.3 11.6–31.9ROR 19.4 · χ² 242 / p 9e-55 | 18.6 EB05 11.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Fall | 496 | 19.1 17.7–20.5ROR 26.9 · χ² 8,597 / p <1e-300 | 19.0 EB05 17.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 · ♀ 91% (drug 65%) | no trial data cached |
| Dementia | 36 | 16.5 12.0–22.8ROR 16.9 · χ² 509 / p 4e-113 | 16.3 EB05 12.2 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.9 | no trial data cached |
| Drug interaction | 182 | 14.7 12.8–16.8ROR 16.4 · χ² 2,317 / p <1e-300 | 14.6 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Myoclonus | 12 | 12.9 7.3–22.6ROR 12.9 · χ² 120 / p 4e-28 | 11.3 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Cardiomegaly | 10 | 10.3 5.5–19.1ROR 10.4 · χ² 75 / p 3e-18 | 8.2 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Pneumonia aspiration | 18 | 9.2 5.8–14.6ROR 9.3 · χ² 124 / p 4e-29 | 8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Bradycardia (slow heart rate) | 36 | 8.7 6.3–12.0ROR 8.8 · χ² 236 / p 1e-53 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Hallucination, visual | 13 | 7.9 4.6–13.6ROR 8.0 · χ² 72 / p 1e-17 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Drug abuse | 51 | 7.8 5.9–10.2ROR 8.0 · χ² 296 / p 1e-66 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 98% (drug 65%) · 94% clinician | no trial data cached |
| Pain | 364 | 7.6 6.9–8.3ROR 9.4 · χ² 2,125 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · ♀ 97% (drug 65%) | no trial data cached |
| Cerebral haemorrhage | 20 | 7.1 4.6–11.0ROR 7.2 · χ² 100 / p 9e-24 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Agitation | 38 | 6.6 4.8–9.0ROR 6.7 · χ² 175 / p 3e-40 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 39% (drug 65%) · 94% clinician | no trial data cached |
| Hallucination (hallucinations) | 37 | 6.3 4.6–8.7ROR 6.4 · χ² 160 / p 5e-37 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Convulsion (seizure) | 28 | 6.2 4.3–8.9ROR 6.3 · χ² 116 / p 2e-27 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · ♀ 38% (drug 65%) · 93% clinician | no trial data cached |
| Unresponsive to stimuli | 12 | 6.0 3.4–10.5ROR 6.0 · χ² 45 / p 1e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Aggression | 20 | 5.1 3.3–7.9ROR 5.1 · χ² 62 / p 2e-15 | 4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · ♀ 35% (drug 65%) | no trial data cached |
| Abnormal behaviour | 13 | 4.2 2.4–7.2ROR 4.2 · χ² 28 / p 6e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Overdose | 67 | 3.9 3.1–5.0ROR 4.1 · χ² 146 / p 6e-34 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · ♀ 90% (drug 65%) | no trial data cached |
| Accidental overdose | 11 | 3.8 2.1–6.9ROR 3.9 · χ² 20 / p 3e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Gastric disorder | 10 | 3.7 2.0–6.8ROR 3.7 · χ² 17 / p 2e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 4.8 | 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 | 496 | 19.1 17.7–20.5ROR 26.9 · χ² 8,597 / p <1e-300 | 19.0 EB05 17.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 · ♀ 91% (drug 65%) | no trial data cached |
| Constipation | 418 | 24.7 22.7–26.8ROR 32.8 · χ² 9,561 / p <1e-300 | 24.6 EB05 22.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · ♀ 96% (drug 65%) | no trial data cached |
| Cognitive disorder | 417 | 115.4 106.2–125.5ROR 154.4 · χ² 46,869 / p <1e-300 | 113.8 EB05 104.9 · IC025 +6.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 98.2 · ♀ 99% (drug 65%) | no trial data cached |
| Hypotension (low blood pressure) | 405 | 25.9 23.8–28.1ROR 34.0 · χ² 9,727 / p <1e-300 | 25.8 EB05 23.7 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.5 · ♀ 97% (drug 65%) | no trial data cached |
| Balance disorder | 405 | 60.0 55.1–65.3ROR 79.3 · χ² 23,415 / p <1e-300 | 59.5 EB05 54.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 59.1 · ♀ 98% (drug 65%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 403 | 301.8 276.8–328.9ROR 399.5 · χ² 117,779 / p <1e-300 | 290.6 EB05 267.6 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 206.2 · ♀ 100% (drug 65%) | no trial data cached |
| Sedation | 383 | 190.3 174.2–207.9ROR 247.8 · χ² 70,951 / p <1e-300 | 185.8 EB05 170.7 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 159.0 · ♀ 99% (drug 65%) | no trial data cached |
| Depressed level of consciousness | 378 | 123.4 112.9–134.9ROR 160.0 · χ² 45,408 / p <1e-300 | 121.5 EB05 111.5 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 77.2 · ♀ 97% (drug 65%) | no trial data cached |
| Pain | 364 | 7.6 6.9–8.3ROR 9.4 · χ² 2,125 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · ♀ 97% (drug 65%) | no trial data cached |
| Blood calcium decreased | 359 | 419.5 382.1–460.6ROR 536.6 · χ² 144,741 / p <1e-300 | 397.4 EB05 364.1 · IC025 +7.8 3/3 methods agree | Lab value / disease marker | serious PRR 312.4 · ♀ 100% (drug 65%) | no trial data cached |
| Mobility decreased | 354 | 63.4 57.8–69.5ROR 80.5 · χ² 21,642 / p <1e-300 | 62.9 EB05 57.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 57.2 · ♀ 99% (drug 65%) | no trial data cached |
| Toxicity to various agents | 337 | 25.7 23.3–28.2ROR 32.0 · χ² 8,016 / p <1e-300 | 25.6 EB05 23.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 · ♀ 99% (drug 65%) | no trial data cached |
| Drug interaction | 182 | 14.7 12.8–16.8ROR 16.4 · χ² 2,317 / p <1e-300 | 14.6 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Overdose | 67 | 3.9 3.1–5.0ROR 4.1 · χ² 146 / p 6e-34 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · ♀ 90% (drug 65%) | no trial data cached |
| Drug abuse | 51 | 7.8 5.9–10.2ROR 8.0 · χ² 296 / p 1e-66 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 98% (drug 65%) · 94% clinician | 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=403, PRR 301.8
- Sedation — n=383, PRR 190.3
- Depressed level of consciousness — n=378, PRR 123.4
- Mobility decreased — n=354, PRR 63.4
- Balance disorder — n=405, PRR 60.0
- Toxicity to various agents — n=337, PRR 25.7
- Constipation — n=418, PRR 24.7
- Cerebral haemorrhage — n=20, PRR 7.1
- Agitation — n=38, PRR 6.6
- Aggression — n=20, PRR 5.1
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 Hydrobromide?
In FDA FAERS, the most frequently co-reported reaction terms for Galantamine Hydrobromide are fall, constipation, cognitive disorder, hypotension, balance disorder, 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 Hydrobromide have an FDA boxed warning?
No. The FDA label retrieved for Galantamine Hydrobromide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Galantamine Hydrobromide 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 0f74a146-f6ee-4910-82a3-177153526dd0, effective 20250912; matched on
openfda.generic_name.exact:"GALANTAMINE HYDROBROMIDE") - 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, 56 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.