Glycopyrronium side effects: what 1,514 FDA adverse event reports show
Drug class
Anticholinergic
Brand names
Qbrexza
Who reports
1,514 reports · 51% serious · 94 with death outcome · 59% female
Used for
Qbrexza is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. Qbrexza is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).
What it is
Qbrexza (glycopyrronium) cloth, 2.4% is an anticholinergic drug available as a clear, colorless to pale yellow solution on a single-use pre-moistened cloth (an absorbent polypropylene pad) packaged in a pouch for topical administration.
Boxed warning
None in the current label
Causality screen of the 26 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.
- 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.
- 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. 28 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 |
|---|---|---|---|---|---|---|
| Mydriasis | 271 | 299.2 268.2–333.7ROR 364.2 · χ² 78,563 / p <1e-300 | 286.8 EB05 259.3 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 55.8 | no trial data cached |
| Dry throat | 39 | 53.4 39.2–72.8ROR 54.8 · χ² 1,947 / p <1e-300 | 51.9 EB05 39.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=7 | no trial data cached |
| Dry mouth | 236 | 40.5 36.0–45.5ROR 47.8 · χ² 9,055 / p <1e-300 | 40.2 EB05 36.1 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 | no trial data cached |
| Urinary retention | 85 | 35.5 28.8–43.6ROR 37.5 · χ² 2,809 / p <1e-300 | 35.1 EB05 29.3 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 | no trial data cached |
| Vision blurred (blurred vision) | 184 | 18.7 16.3–21.4ROR 21.1 · χ² 3,077 / p <1e-300 | 18.6 EB05 16.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Dysuria (painful urination) | 47 | 17.7 13.3–23.4ROR 18.2 · χ² 724 / p 1e-159 | 17.5 EB05 13.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Intentional product misuse | 94 | 15.0 12.3–18.3ROR 15.9 · χ² 1,218 / p 3e-267 | 14.9 EB05 12.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Oral candidiasis (oral thrush) | 14 | 14.9 8.9–25.1ROR 15.0 · χ² 168 / p 1e-38 | 13.9 EB05 8.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 | no trial data cached |
| Obstructive airways disorder | 11 | 13.7 7.6–24.6ROR 13.8 · χ² 117 / p 2e-27 | 12.0 EB05 6.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Hypomagnesaemia | 13 | 13.0 7.6–22.3ROR 13.1 · χ² 132 / p 7e-31 | 11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Photophobia (light sensitivity) | 17 | 12.6 7.9–20.3ROR 12.8 · χ² 170 / p 3e-39 | 11.6 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Dry eye | 44 | 12.6 9.4–16.8ROR 12.9 · χ² 458 / p 5e-102 | 12.3 EB05 9.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Conjunctivitis | 16 | 12.1 7.4–19.7ROR 12.2 · χ² 152 / p 4e-35 | 10.9 EB05 6.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.5 | no trial data cached |
| Serotonin syndrome | 15 | 10.9 6.6–18.0ROR 11.0 · χ² 125 / p 3e-29 | 9.5 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Generalised tonic-clonic seizure | 12 | 10.2 5.8–17.9ROR 10.2 · χ² 90 / p 1e-21 | 8.4 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 | no trial data cached |
| Feeding disorder | 14 | 9.7 5.8–16.4ROR 9.8 · χ² 101 / p 4e-24 | 8.2 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Thirst | 11 | 8.5 4.7–15.4ROR 8.6 · χ² 66 / p 2e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Oropharyngeal pain (sore throat) | 49 | 7.3 5.6–9.7ROR 7.5 · χ² 263 / p 2e-59 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Lower respiratory tract infection | 22 | 6.7 4.4–10.2ROR 6.8 · χ² 102 / p 3e-24 | 6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 20% (drug 59%) · 90% clinician | no trial data cached |
| Metabolic acidosis | 15 | 6.6 4.0–10.9ROR 6.6 · χ² 65 / p 3e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Bradycardia (slow heart rate) | 25 | 6.5 4.4–9.6ROR 6.6 · χ² 112 / p 2e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 29% (drug 59%) · 100% clinician | no trial data cached |
| Application site pain | 10 | 6.3 3.4–11.7ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Chronic obstructive pulmonary disease | 23 | 6.1 4.1–9.2ROR 6.2 · χ² 93 / p 2e-22 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 91% clinician | no trial data cached |
| Accidental exposure to product | 39 | 5.4 4.0–7.4ROR 5.5 · χ² 136 / p 8e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 | no trial data cached |
| Dry skin | 43 | 4.5 3.4–6.1ROR 4.6 · χ² 115 / p 3e-27 | 4.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Wrong technique in product usage process | 54 | 3.7 2.9–4.8ROR 3.8 · χ² 105 / p 7e-25 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Mydriasis | 271 | 299.2 268.2–333.7ROR 364.2 · χ² 78,563 / p <1e-300 | 286.8 EB05 259.3 · IC025 +7.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 55.8 | no trial data cached |
| Dry mouth | 236 | 40.5 36.0–45.5ROR 47.8 · χ² 9,055 / p <1e-300 | 40.2 EB05 36.1 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 | no trial data cached |
| Vision blurred (blurred vision) | 184 | 18.7 16.3–21.4ROR 21.1 · χ² 3,077 / p <1e-300 | 18.6 EB05 16.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Intentional product misuse | 94 | 15.0 12.3–18.3ROR 15.9 · χ² 1,218 / p 3e-267 | 14.9 EB05 12.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Urinary retention | 85 | 35.5 28.8–43.6ROR 37.5 · χ² 2,809 / p <1e-300 | 35.1 EB05 29.3 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 | no trial data cached |
| Wrong technique in product usage process | 54 | 3.7 2.9–4.8ROR 3.8 · χ² 105 / p 7e-25 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Oropharyngeal pain (sore throat) | 49 | 7.3 5.6–9.7ROR 7.5 · χ² 263 / p 2e-59 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Dysuria (painful urination) | 47 | 17.7 13.3–23.4ROR 18.2 · χ² 724 / p 1e-159 | 17.5 EB05 13.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Dry eye | 44 | 12.6 9.4–16.8ROR 12.9 · χ² 458 / p 5e-102 | 12.3 EB05 9.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Dry skin | 43 | 4.5 3.4–6.1ROR 4.6 · χ² 115 / p 3e-27 | 4.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Accidental exposure to product | 39 | 5.4 4.0–7.4ROR 5.5 · χ² 136 / p 8e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 | no trial data cached |
| Dry throat | 39 | 53.4 39.2–72.8ROR 54.8 · χ² 1,947 / p <1e-300 | 51.9 EB05 39.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=7 | no trial data cached |
| Bradycardia (slow heart rate) | 25 | 6.5 4.4–9.6ROR 6.6 · χ² 112 / p 2e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 29% (drug 59%) · 100% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 23 | 6.1 4.1–9.2ROR 6.2 · χ² 93 / p 2e-22 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 91% clinician | no trial data cached |
| Lower respiratory tract infection | 22 | 6.7 4.4–10.2ROR 6.8 · χ² 102 / p 3e-24 | 6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 20% (drug 59%) · 90% 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.
- Dysuria — n=47, PRR 17.7
- Lower respiratory tract infection — n=22, PRR 6.7
- Bradycardia — n=25, PRR 6.5
- Chronic obstructive pulmonary disease — n=23, PRR 6.1
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 Glycopyrronium?
In FDA FAERS, the most frequently co-reported reaction terms for Glycopyrronium are mydriasis, dry mouth, vision blurred, urinary retention, oropharyngeal pain, dysuria. 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 Glycopyrronium have an FDA boxed warning?
No. The FDA label retrieved for Glycopyrronium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Glycopyrronium 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 5b372650-e56e-47a5-93e2-c0c292017059, effective 20260521; matched on
openfda.generic_name.exact:"GLYCOPYRRONIUM") - 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, 54 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.