What the label lists and what reports show
Glycopyrrolate side effects
Glycopyrrolate's FDA label lists its adverse reactions in its own words. FAERS holds 5,520 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (1,041 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the glycopyrrolate FDA label on DailyMed (effective October 9, 2025, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAnticholinergics, including Glycopyrrolate Injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy and retention; blurred vision and photophobia due to mydriasis (dilation of the pupil); cycloplegia; increased ocular tension; tachycardia; palpitation; decreased sweating; loss of taste; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; severe allergic reactions including anaphylactic/anaphylactoid reactions; hypersensitivity; urticaria, pruritus, dry skin, and other dermal manifestations; some degree of mental confusion and/or excitement, especially in elderly persons. …
Table 2: Adverse Reactions Occurring in ≥ 15% of CUVPOSA-Treated Subjects and at a Greater Frequency than Placebo in Study 1
This table is printed in the Cuvposa label published by Merz Pharmaceuticals, LLC of December 19, 2024; the label quoted above does not print one.
| Reaction | CUVPOSA (N=20) n (%) | Placebo (N=18) n (%) |
|---|---|---|
| Dry Mouth | 8 (40%) | 2 (11%) |
| Vomiting | 8 (40%) | 2 (11%) |
| Constipation | 7 (35%) | 4 (22%) |
| Flushing | 6 (30%) | 3 (17%) |
| Nasal Congestion | 6 (30%) | 2 (11%) |
| Headache | 3 (15%) | 1 (6%) |
| Sinusitis | 3 (15%) | 1 (6%) |
| Upper Respiratory Tract Infection | 3 (15%) | 0 |
| Urinary Retention | 3 (15%) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective October 9, 2025 (SPL set 960d2dd0-008d-4ec1-ba2e-9388b28b23e2), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,520 reports list glycopyrrolate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 660 are coded as a death and 2,343 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Glycopyrrolate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions