What the label lists and what reports show
Sofpironium side effects
Sofpironium's FDA label: “Most common adverse reactions (incidence ≥2%) are dry mouth, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation ( 6.1 ).” FAERS holds 227 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 vision blurred (80 reports).
- No generic listed
Check it at the source: the sofpironium FDA label on DailyMed (effective September 22, 2025, Botanix SB Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of SOFDRA?SOFDRA can cause serious side effects, including: Urinary retention. People who use SOFDRA may develop urinary retention. 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 develop these symptoms, stop using SOFDRA and call your healthcare provider right away. Problems with control of your body temperature. SOFDRA can cause you to have decreased sweating in areas of your body other than the underarm area which could cause you to become overheated and to develop heat illness. When in hot or very warm temperatures, watch for lack of sweating on your body and stop using SOFDRA if you develop lack of sweating on your body. […]
Source: FDA drug label, Botanix SB Inc., effective September 22, 2025 (SPL set 78f86f4f-658c-468b-bd54-49182ddcc7ac), 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, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation ( 6.1 ).
Table 2: Local Skin Reactions Reported in ≥2% of Subjects with Primary Axillary Hyperhidrosis Treated with SOFDRA in Trials CARDIGAN 1 and 2
| Local Skin Adverse Reactions | SOFDRA (N = 353) n (%) | Vehicle (N = 347) n (%) |
|---|---|---|
| Pain | 29 (8%) | 6 (2%) |
| Erythema | 23 (7%) | 1 (0.3%) |
| Dermatitis | 21 (6%) | 1 (0.3%) |
| Pruritus | 16 (5%) | 2 (0.6%) |
| Irritation | 8 (2%) | 1 (0.3%) |
| Exfoliation | 7 (2%) | 1 (0.3%) |
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 clinically significant adverse reactions are described elsewhere in the labeling: Urinary Retention [See Warnings and Precautions (5.1) ]. Most common adverse reactions (incidence ≥2%) are dry mouth, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Botanix SB Inc. at 1-866-763-6337 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 (CARDIGAN 1 and CARDIGAN 2) of 700 subjects 10 to 76 years of age (353 subjects treated with SOFDRA and 347 subjects treated with vehicle), 44% of subjects were male, 79% were White, 21% were Black, and 1% were Asian. A total of 618 subjects completed at least 6 weeks of treatment, including 307 subjects treated with SOFDRA and 311 subjects treated with vehicle. Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with SOFDRA.
Source: FDA drug label, Botanix SB Inc., effective September 22, 2025 (SPL set 78f86f4f-658c-468b-bd54-49182ddcc7ac), via openFDA; the full label on DailyMed
What do FAERS reports show?
227 reports list sofpironium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 5 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 23 reactions below, 14 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.
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?
- Sofpironium: 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