Drug · FAERS side-effect profile with label screen
Glycopyrrolate side effects: what 5,519 FDA adverse event reports show
Drug class
Not stated in label
Who reports
5,519 reports · 84% serious · 660 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
FDA label, Indications and Usage
What it is
Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide.
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 1Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 33
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.
- 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. 487 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 |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 266 | 92.7 82.3–104.4ROR 97.4 · χ² 23,478 / p <1e-300 | 89.9 EB05 81.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 64.4 | no trial data cached |
| Full blood count abnormal | 231 | 85.1 74.9–96.7ROR 88.8 · χ² 18,696 / p <1e-300 | 82.7 EB05 74.1 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 75.3 | no trial data cached |
| Sputum discoloured | 179 | 73.3 63.4–84.8ROR 75.7 · χ² 12,458 / p <1e-300 | 71.4 EB05 63.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 64.4 | no trial data cached |
| Sleep disorder due to a general medical condition | 225 | 53.6 47.1–61.0ROR 55.8 · χ² 11,405 / p <1e-300 | 52.6 EB05 47.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 71.3 | no trial data cached |
| Wheezing | 712 | 46.3 43.2–49.6ROR 53.0 · χ² 31,193 / p <1e-300 | 45.7 EB05 42.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 43.1 | no trial data cached |
| Schizophrenia | 103 | 32.4 26.8–39.3ROR 33.0 · χ² 3,082 / p <1e-300 | 32.0 EB05 27.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 100% (drug 55%) · 92% clinician | no trial data cached |
| Emphysema | 82 | 31.0 25.0–38.5ROR 31.5 · χ² 2,334 / p <1e-300 | 30.6 EB05 25.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · ♀ 30% (drug 55%) | no trial data cached |
| Asthma | 836 | 28.5 26.8–30.4ROR 33.5 · χ² 22,138 / p <1e-300 | 28.3 EB05 26.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 | no trial data cached |
| Productive cough (cough with phlegm) | 342 | 27.6 24.9–30.6ROR 29.4 · χ² 8,710 / p <1e-300 | 27.4 EB05 25.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Chronic obstructive pulmonary disease | 359 | 26.3 23.8–29.1ROR 28.1 · χ² 8,684 / p <1e-300 | 26.1 EB05 23.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.8 | no trial data cached |
| Secretion discharge | 82 | 25.4 20.5–31.5ROR 25.7 · χ² 1,884 / p <1e-300 | 25.1 EB05 20.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 28.3 | no trial data cached |
| Pulmonary congestion | 77 | 22.2 17.8–27.8ROR 22.5 · χ² 1,531 / p <1e-300 | 22.0 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · ♀ 76% (drug 55%) | no trial data cached |
| Flank pain | 53 | 21.6 16.5–28.3ROR 21.8 · χ² 1,017 / p 2e-223 | 21.4 EB05 17.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · ♀ 84% (drug 55%) | no trial data cached |
| Dyspnoea exertional | 203 | 20.7 18.0–23.6ROR 21.4 · χ² 3,763 / p <1e-300 | 20.5 EB05 18.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 | no trial data cached |
| Loss of personal independence in daily activities | 241 | 19.3 17.1–21.9ROR 20.2 · χ² 4,162 / p <1e-300 | 19.2 EB05 17.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 | no trial data cached |
| Middle insomnia | 89 | 18.3 14.8–22.4ROR 18.5 · χ² 1,429 / p <1e-300 | 18.1 EB05 15.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 | no trial data cached |
| Hepatotoxicity (liver damage) | 104 | 17.9 14.8–21.7ROR 18.2 · χ² 1,637 / p <1e-300 | 17.8 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 98% (drug 55%) · 93% clinician | no trial data cached |
| Vasculitis | 54 | 17.7 13.5–23.1ROR 17.8 · χ² 829 / p 1e-182 | 17.5 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 0% (drug 55%) | no trial data cached |
| Salivary hypersecretion | 44 | 16.8 12.5–22.6ROR 16.9 · χ² 636 / p 2e-140 | 16.6 EB05 12.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · ♀ 28% (drug 55%) | no trial data cached |
| Therapeutic product effect incomplete | 308 | 16.6 14.9–18.5ROR 17.5 · χ² 4,500 / p <1e-300 | 16.5 EB05 15.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.9 | no trial data cached |
| Pulmonary mass | 63 | 16.2 12.6–20.7ROR 16.3 · χ² 878 / p 4e-193 | 16.0 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 31% (drug 55%) | no trial data cached |
| Respiratory disorder | 124 | 15.8 13.2–18.8ROR 16.1 · χ² 1,695 / p <1e-300 | 15.7 EB05 13.5 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.1 | no trial data cached |
| Seasonal allergy | 58 | 15.7 12.1–20.2ROR 15.8 · χ² 779 / p 1e-171 | 15.5 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=56 | no trial data cached |
| Blood pressure systolic increased | 79 | 15.4 12.3–19.1ROR 15.6 · χ² 1,044 / p 2e-229 | 15.2 EB05 12.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 11.3 | no trial data cached |
| Nasal congestion (stuffy nose) | 234 | 15.2 13.4–17.3ROR 15.9 · χ² 3,096 / p <1e-300 | 15.2 EB05 13.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · ♀ 84% (drug 55%) | no trial data cached |
| Blood bilirubin increased | 107 | 15.1 12.5–18.2ROR 15.3 · χ² 1,387 / p <1e-300 | 14.9 EB05 12.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 11.8 · ♀ 98% (drug 55%) · 93% clinician | no trial data cached |
| Lung neoplasm malignant | 162 | 15.0 12.8–17.4ROR 15.4 · χ² 2,091 / p <1e-300 | 14.9 EB05 13.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 90% (drug 55%) | no trial data cached |
| Sinus tachycardia | 55 | 14.8 11.4–19.3ROR 14.9 · χ² 691 / p 1e-152 | 14.6 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 82% (drug 55%) | no trial data cached |
| Hypercholesterolaemia | 37 | 14.7 10.7–20.3ROR 14.8 · χ² 459 / p 5e-102 | 14.4 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · ♀ 0% (drug 55%) | no trial data cached |
| Sleep apnoea syndrome | 73 | 14.5 11.6–18.3ROR 14.7 · χ² 905 / p 4e-199 | 14.4 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Cholelithiasis | 125 | 14.5 12.2–17.3ROR 14.8 · χ² 1,558 / p <1e-300 | 14.4 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 92% (drug 55%) | no trial data cached |
| Psychotic disorder | 112 | 14.5 12.0–17.4ROR 14.7 · χ² 1,386 / p <1e-300 | 14.3 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · ♀ 93% (drug 55%) | no trial data cached |
| Cardiomyopathy | 54 | 13.9 10.7–18.1ROR 14.0 · χ² 632 / p 8e-140 | 13.7 EB05 10.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · ♀ 8% (drug 55%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 286 | 13.6 12.1–15.2ROR 14.3 · χ² 3,325 / p <1e-300 | 13.5 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Lower respiratory tract infection | 152 | 12.8 10.9–15.0ROR 13.1 · χ² 1,637 / p <1e-300 | 12.7 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 91% (drug 55%) | no trial data cached |
| Chest discomfort | 332 | 12.4 11.2–13.8ROR 13.1 · χ² 3,475 / p <1e-300 | 12.3 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 142 | 11.7 10.0–13.8ROR 12.0 · χ² 1,380 / p <1e-300 | 11.6 EB05 10.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Body temperature decreased | 30 | 11.5 8.1–16.5ROR 11.6 · χ² 277 / p 2e-62 | 10.9 EB05 7.7 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.4 | no trial data cached |
| Sneezing | 66 | 11.2 8.8–14.3ROR 11.4 · χ² 604 / p 9e-134 | 11.0 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Obesity | 46 | 11.0 8.2–14.6ROR 11.1 · χ² 406 / p 1e-90 | 10.6 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 19% (drug 55%) | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,041 | 7.0 6.6–7.4ROR 8.4 · χ² 5,489 / p <1e-300 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Asthma | 836 | 28.5 26.8–30.4ROR 33.5 · χ² 22,138 / p <1e-300 | 28.3 EB05 26.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 | no trial data cached |
| Wheezing | 712 | 46.3 43.2–49.6ROR 53.0 · χ² 31,193 / p <1e-300 | 45.7 EB05 42.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 43.1 | no trial data cached |
| Cough | 659 | 9.0 8.3–9.6ROR 10.0 · χ² 4,708 / p <1e-300 | 8.9 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Pneumonia (lung infection) | 579 | 6.8 6.3–7.4ROR 7.5 · χ² 2,907 / p <1e-300 | 6.8 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Fatigue (tiredness) | 371 | 1.8 1.6–2.0ROR 1.9 · χ² 140 / p 1e-32 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Malaise (feeling unwell) | 360 | 3.1 2.8–3.4ROR 3.3 · χ² 525 / p 2e-116 | 3.1 EB05 2.8 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Chronic obstructive pulmonary disease | 359 | 26.3 23.8–29.1ROR 28.1 · χ² 8,684 / p <1e-300 | 26.1 EB05 23.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.8 | no trial data cached |
| Productive cough (cough with phlegm) | 342 | 27.6 24.9–30.6ROR 29.4 · χ² 8,710 / p <1e-300 | 27.4 EB05 25.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Chest discomfort | 332 | 12.4 11.2–13.8ROR 13.1 · χ² 3,475 / p <1e-300 | 12.3 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Condition aggravated | 321 | 4.0 3.6–4.5ROR 4.2 · χ² 742 / p 1e-163 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · ♀ 78% (drug 55%) | no trial data cached |
| Weight decreased (weight loss) | 315 | 4.3 3.9–4.8ROR 4.5 · χ² 802 / p 1e-176 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 76% (drug 55%) | no trial data cached |
| Pyrexia (fever) | 311 | 3.4 3.1–3.8ROR 3.6 · χ² 537 / p 4e-119 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Therapeutic product effect incomplete | 308 | 16.6 14.9–18.5ROR 17.5 · χ² 4,500 / p <1e-300 | 16.5 EB05 15.0 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.9 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 286 | 13.6 12.1–15.2ROR 14.3 · χ² 3,325 / p <1e-300 | 13.5 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | 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.
- Obstructive airways disorder — n=266, PRR 92.7
- Sputum discoloured — n=179, PRR 73.3
- Sleep disorder due to a general medical condition — n=225, PRR 53.6
- Wheezing — n=712, PRR 46.3
- Schizophrenia — n=103, PRR 32.4
- Emphysema — n=82, PRR 31.0
- Asthma — n=836, PRR 28.5
- Productive cough — n=342, PRR 27.6
- Secretion discharge — n=82, PRR 25.4
- Pulmonary congestion — n=77, PRR 22.2
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 Glycopyrrolate?
In FDA FAERS, the most frequently co-reported reaction terms for Glycopyrrolate are dyspnoea, asthma, wheezing, cough, pneumonia, fatigue. 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 Glycopyrrolate have an FDA boxed warning?
No. The FDA label retrieved for Glycopyrrolate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glycopyrrolate 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 098c7654-a352-47ee-bf23-6a81f8601266, effective 20260505; matched on
openfda.generic_name.exact:"GLYCOPYRROLATE") - 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, 527 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.