OpenClaim

Sofpironium Side Effects

The most commonly reported side effects of sofpironium include vision blurred, dry mouth, and mydriasis, based on 131 FDA adverse event reports from 2024 to 2025. 9.9% of reports found the drug to be ineffective.

Sofpironium side effects

Percentages show how often each reaction appears relative to total reports for sofpironium.

1
Vision Blurred38.2%50
2
Dry Mouth27.5%36
3
Mydriasis16.0%21
4
Application Site Irritation11.5%15
5
Application Site Pain11.5%15
6
Urinary Retention9.9%13
7
Drug Ineffective9.9%13
8
Application Site Rash8.4%11
9
Dysuria6.1%8
10
Off Label Use6.1%8
11
Application Site Erythema5.3%7
12
Dry Eye4.6%6
13
Urticaria3.8%5
14
Headache3.8%5
15
Erythema3.1%4

These are voluntary reports and do not establish that sofpironium caused these reactions.

Report severity

13.0%Serious17 reports
2.3%Hospitalizations3 reports
0.0%Fatal0 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sofpironium drug interactions

Other drugs that appear in adverse event reports alongside sofpironium. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Desloratadine0.8%1
2
Amitriptyline-hydrochloride0.8%1
3
Valproate-sodium0.8%1
4
Ferrous-fumarate0.8%1
5
Isosorbide0.8%1
6
Bimekizumab-bkzx0.8%1
7
Upadacitinib0.8%1

Taken alongside

1
Ergocalciferol2.3%3
2
Pantoprazole-sodium1.5%2
3
Glycopyrronium-tosylate1.5%2
4
Clindamycin1.5%2
5
Isotretinoin1.5%2
6
Fexofenadine-hydrochloride1.5%2
7
Spironolactone1.5%2
8
Glycopyrrolate0.8%1
9
Chlorhexidine-gluconate0.8%1
10
Lisdexamfetamine-dimesylate0.8%1
11
Roflumilast0.8%1
12
Lumateperone0.8%1
13
Prazosin-hydrochloride0.8%1
14
Gabapentin0.8%1
15
Clomipramine-hydrochloride0.8%1

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sofpironium side effects

68.7% of sofpironium adverse event reports involve female patients and 26.7% involve male patients. The largest age group is adult at 79%. These figures reflect who reports side effects, not underlying risk.

Sex

Female68.7%
Male26.7%
Unknown4.6%

Age group

< 20.0%
2–110.0%
12–1721.2%
18–6478.8%
65+0.0%

What is sofpironium used for

Conditions and purposes for which patients were taking sofpironium when the adverse event was reported.

HyperhidrosisProduct Used For Unknown Indication

Sofpironium brand names and reporting trend

Sofpironium is sold under the brand name Sofdra.

Brand names

Sofdra3

Quarterly reports (20242025)

20242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sofpironium with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.