Drug · FAERS side-effect profile with label screen

Glycopyrrolate and Formoterol side effects: what 1,938 FDA adverse event reports show

Glycopyrrolate And Formoterol Fumarate · 61 reaction terms · 2,642 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Glycopyrrolate (Glycopyrrolate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,938 reports · 41% serious · 232 with death outcome · 59% 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 37 strongest signals

Labeled adverse reaction 4Labeled (related wording) 2Reporting / coding artifact 14Not in label — unassessed 17

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. 24 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Device use issue	81	50.8 41.0–62.9ROR 52.9 · χ² 3,888 / p <1e-300	50.0 EB05 41.5 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious n=19 · 96% consumer	no trial data cached
Device delivery system issue	93	38.6 31.6–47.1ROR 40.5 · χ² 3,359 / p <1e-300	38.2 EB05 32.1 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious n=25 · 98% consumer	no trial data cached
Body height decreased	35	35.1 25.3–48.7ROR 35.7 · χ² 1,122 / p 3e-246	34.4 EB05 25.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=9 · 94% consumer	no trial data cached
Wrong technique in device usage process	148	35.1 30.0–41.0ROR 37.9 · χ² 4,860 / p <1e-300	34.8 EB05 30.4 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious n=38 · 94% consumer	no trial data cached
Chronic obstructive pulmonary disease	153	31.8 27.3–37.0ROR 34.4 · χ² 4,530 / p <1e-300	31.6 EB05 27.6 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 32.6	no trial data cached
Device failure	41	29.3 21.6–39.6ROR 29.9 · χ² 1,089 / p 4e-239	28.8 EB05 22.2 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 13.5 · 91% consumer	no trial data cached
Incorrect dose administered by device	64	27.3 21.4–34.7ROR 28.2 · χ² 1,593 / p <1e-300	27.0 EB05 21.9 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=13 · 93% consumer	no trial data cached
Device malfunction	156	25.1 21.6–29.2ROR 27.2 · χ² 3,594 / p <1e-300	25.0 EB05 21.9 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 32.2 · 93% consumer	no trial data cached
Emphysema	19	20.3 13.0–31.8ROR 20.5 · χ² 329 / p 7e-74	19.8 EB05 13.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Device issue	144	17.9 15.3–20.9ROR 19.2 · χ² 2,280 / p <1e-300	17.8 EB05 15.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 21.6 · 93% consumer	no trial data cached
Candida infection (yeast infection)	25	16.2 11.0–23.9ROR 16.4 · χ² 341 / p 2e-76	15.8 EB05 11.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.2 · 80% consumer	no trial data cached
Device defective	22	14.7 9.7–22.3ROR 14.9 · χ² 267 / p 2e-60	14.2 EB05 9.5 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious n=5 · 86% consumer	no trial data cached
Intentional product misuse	118	14.7 12.3–17.5ROR 15.6 · χ² 1,497 / p <1e-300	14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.8 · 87% consumer	no trial data cached
Secretion discharge	14	12.3 7.3–20.7ROR 12.3 · χ² 134 / p 3e-31	10.9 EB05 6.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Product dose omission	73	11.9 9.5–14.9ROR 12.3 · χ² 721 / p 4e-159	11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 14.2 · 94% consumer	no trial data cached
Insurance issue	16	11.6 7.1–19.0ROR 11.7 · χ² 145 / p 1e-33	10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.2	no trial data cached
Inability to afford medication	10	11.0 5.9–20.4ROR 11.0 · χ² 81 / p 1e-19	8.9 EB05 4.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Feeling jittery	17	9.6 6.0–15.5ROR 9.7 · χ² 123 / p 7e-29	8.4 EB05 5.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Circumstance or information capable of leading to medication error	28	9.0 6.2–13.0ROR 9.1 · χ² 192 / p 6e-44	8.3 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=5 · 87% consumer	no trial data cached
Glaucoma	16	9.0 5.5–14.6ROR 9.0 · χ² 106 / p 5e-25	7.7 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.2	no trial data cached
Dysphonia	47	8.7 6.6–11.5ROR 8.9 · χ² 313 / p 2e-70	8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.4 · 75% consumer	no trial data cached
Productive cough (cough with phlegm)	37	8.4 6.1–11.6ROR 8.6 · χ² 236 / p 1e-53	7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.6 · ♀ 38% (drug 59%) · 82% consumer	no trial data cached
Urinary retention	22	7.1 4.7–10.8ROR 7.2 · χ² 110 / p 4e-26	6.3 EB05 4.4 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.0	no trial data cached
Wheezing	39	7.1 5.2–9.7ROR 7.3 · χ² 200 / p 1e-45	6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · 80% consumer	no trial data cached
Dyspnoea (shortness of breath)	371	7.1 6.5–7.8ROR 8.5 · χ² 1,987 / p <1e-300	7.0 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.6 · 79% consumer	no trial data cached
Dyspnoea exertional	22	6.3 4.2–9.6ROR 6.4 · χ² 94 / p 2e-22	5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Cough	163	6.3 5.4–7.3ROR 6.8 · χ² 730 / p 4e-161	6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Wrong technique in product usage process	113	6.0 5.1–7.2ROR 6.4 · χ² 475 / p 1e-105	5.9 EB05 5.0 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · 97% consumer	no trial data cached
Chest discomfort	55	5.8 4.5–7.6ROR 6.0 · χ² 216 / p 3e-49	5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · 80% consumer	no trial data cached
Throat irritation	23	5.6 3.7–8.3ROR 5.6 · χ² 82 / p 8e-20	5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.6	no trial data cached
Product dose omission issue	135	5.1 4.4–6.0ROR 5.4 · χ² 450 / p 4e-100	5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.1 · 90% consumer	no trial data cached
Product use issue	84	4.9 3.9–6.0ROR 5.0 · χ² 255 / p 8e-58	4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 84% consumer	no trial data cached
Drug dose omission by device	32	4.5 3.2–6.4ROR 4.6 · χ² 84 / p 2e-20	4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=4 · 93% consumer	no trial data cached
Lung neoplasm malignant	17	4.4 2.8–7.1ROR 4.5 · χ² 42 / p 4e-11	4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Nervousness	21	4.3 2.8–6.6ROR 4.4 · χ² 50 / p 6e-13	4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4 · ♀ 85% (drug 59%) · 75% consumer	no trial data cached
Hip fracture	11	3.7 2.1–6.7ROR 3.7 · χ² 19 / p 6e-6	3.3 EB05 2.0 · IC025 +0.7	Labeled (related wording) related wording	serious PRR 5.3	no trial data cached
Drug dose omission	38	2.4 1.8–3.4ROR 2.5 · χ² 31 / p 1e-8	2.4 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 4.3 · 94% consumer	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)	371	7.1 6.5–7.8ROR 8.5 · χ² 1,987 / p <1e-300	7.0 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.6 · 79% consumer	no trial data cached
Cough	163	6.3 5.4–7.3ROR 6.8 · χ² 730 / p 4e-161	6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Device malfunction	156	25.1 21.6–29.2ROR 27.2 · χ² 3,594 / p <1e-300	25.0 EB05 21.9 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 32.2 · 93% consumer	no trial data cached
Chronic obstructive pulmonary disease	153	31.8 27.3–37.0ROR 34.4 · χ² 4,530 / p <1e-300	31.6 EB05 27.6 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 32.6	no trial data cached
Wrong technique in device usage process	148	35.1 30.0–41.0ROR 37.9 · χ² 4,860 / p <1e-300	34.8 EB05 30.4 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious n=38 · 94% consumer	no trial data cached
Device issue	144	17.9 15.3–20.9ROR 19.2 · χ² 2,280 / p <1e-300	17.8 EB05 15.5 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 21.6 · 93% consumer	no trial data cached
Product dose omission issue	135	5.1 4.4–6.0ROR 5.4 · χ² 450 / p 4e-100	5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.1 · 90% consumer	no trial data cached
Intentional product misuse	118	14.7 12.3–17.5ROR 15.6 · χ² 1,497 / p <1e-300	14.6 EB05 12.5 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.8 · 87% consumer	no trial data cached
Wrong technique in product usage process	113	6.0 5.1–7.2ROR 6.4 · χ² 475 / p 1e-105	5.9 EB05 5.0 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · 97% consumer	no trial data cached
Device delivery system issue	93	38.6 31.6–47.1ROR 40.5 · χ² 3,359 / p <1e-300	38.2 EB05 32.1 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious n=25 · 98% consumer	no trial data cached
Product use issue	84	4.9 3.9–6.0ROR 5.0 · χ² 255 / p 8e-58	4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 84% consumer	no trial data cached
Device use issue	81	50.8 41.0–62.9ROR 52.9 · χ² 3,888 / p <1e-300	50.0 EB05 41.5 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious n=19 · 96% consumer	no trial data cached
Product dose omission	73	11.9 9.5–14.9ROR 12.3 · χ² 721 / p 4e-159	11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 14.2 · 94% consumer	no trial data cached
Incorrect dose administered by device	64	27.3 21.4–34.7ROR 28.2 · χ² 1,593 / p <1e-300	27.0 EB05 21.9 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=13 · 93% consumer	no trial data cached
Chest discomfort	55	5.8 4.5–7.6ROR 6.0 · χ² 216 / p 3e-49	5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · 80% consumer	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.

Body height decreased — n=35, PRR 35.1
Candida infection — n=25, PRR 16.2
Circumstance or information capable of leading to medication error — n=28, PRR 9.0
Dysphonia — n=47, PRR 8.7
Productive cough — n=37, PRR 8.4
Wheezing — n=39, PRR 7.1
Dyspnoea — n=371, PRR 7.1
Dyspnoea exertional — n=22, PRR 6.3
Cough — n=163, PRR 6.3
Chest discomfort — n=55, PRR 5.8

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.

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 and Formoterol?

In FDA FAERS, the most frequently co-reported reaction terms for Glycopyrrolate and Formoterol are dyspnoea, cough, chronic obstructive pulmonary disease, chest discomfort. 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 and Formoterol have an FDA boxed warning?

No. The FDA label retrieved for Glycopyrrolate and Formoterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Glycopyrrolate and Formoterol 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, field patient.drug.openfda.generic_name.exact, 61 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.