What the label lists and what reports show
Glycopyrronium side effects
Glycopyrronium's FDA label: “Most common adverse reactions (incidence ≥2%) are dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, vision blurred, nasal dryness, dry throat, dry eye, dry skin, constipation.” FAERS holds 1,514 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 mydriasis (271 reports).
- No generic listed
Check it at the source: the glycopyrronium FDA label on DailyMed (effective May 21, 2026, Journey Medical Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Qbrexza?Qbrexza can cause serious side effects, including: New or worsened urinary retention. People who use Qbrexza may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include: difficulty urinating urinating frequently urination in a weak stream or drips full bladder or difficulty emptying your bladder (distended bladder) If you have these symptoms, stop using Qbrexza and call your healthcare provider right away. Problems with control of your body temperature. Qbrexza can cause you to have decreased sweating in areas other than the underarm area which could cause you to become overheated and to develop heat illness. […]
Source: FDA drug label, Journey Medical Corporation, effective May 21, 2026 (SPL set 5b372650-e56e-47a5-93e2-c0c292017059), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥2%) are dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, vision blurred, nasal dryness, dry throat, dry eye, dry skin, constipation.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
| Adverse Reactions | Qbrexza (N=459) n (%) | Vehicle (N=232) n (%) |
|---|---|---|
| Dry mouth | 111 (24.2%) | 13 (5.6%) |
| Mydriasis | 31 (6.8%) | 0 |
| Oropharyngeal pain | 26 (5.7%) | 3 (1.3%) |
| Headache | 23 (5.0%) | 5 (2.2%) |
| Urinary hesitation | 16 (3.5%) | 0 |
| Vision blurred | 16 (3.5%) | 0 |
| Nasal dryness | 12 (2.6%) | 1 (0.4%) |
| Dry throat | 12 (2.6%) | 0 |
| Dry eye | 11 (2.4%) | 1 (0.4%) |
| Dry skin | 10 (2.2%) | 0 |
| Constipation | 9 (2.0%) | 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.
From the label: adverse reactions, continuedThe following adverse reactions are described in greater detail in other sections • New or Worsening Urinary Retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥2%) are dry mouth, mydriasis, oropharyngeal pain, headache, urinary hesitation, vision blurred, nasal dryness, dry throat, dry eye, dry skin, constipation. Local skin reactions, including erythema, burning/stinging and pruritus were also common (>5%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corp. at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with Qbrexza once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively. Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with Qbrexza.
Source: FDA drug label, Journey Medical Corporation, effective May 21, 2026 (SPL set 5b372650-e56e-47a5-93e2-c0c292017059), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,514 reports list glycopyrronium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 94 are coded as a death and 406 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 19 reactions below, 10 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?
- Glycopyrronium: 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