Drug · FAERS side-effect profile with label screen

Sofpironium side effects: what 227 FDA adverse event reports show

Sofpironium Bromide · 9 reaction terms · 270 drug–reaction co-reports · data 2026-09-14

Drug class

Anticholinergic

FDA label, Indications wording of the closest related product

Label matched

Sofpironium Bromide (Sofdra)

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

Who reports

227 reports · 12% serious · 0 with death outcome · 73% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).

FDA label, Indications and Usage

What it is

SOFDRA (sofpironium) topical gel is an anticholinergic drug. Sofpironium bromide drug substance is a white to off white powder with the chemical name 3'(R)-[2(R) cyclopentylphenylhydroxy-aceto.

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 9 strongest signals

Labeled adverse reaction 9

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.
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. 0 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
Mydriasis	28	202.2 142.9–286.1ROR 230.5 · χ² 5,398 / p <1e-300	177.5 EB05 128.9 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 174.1 · 79% consumer	no trial data cached
Application site irritation	21	156.1 103.8–234.8ROR 172.0 · χ² 3,080 / p <1e-300	136.8 EB05 94.4 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=4 · 86% consumer	no trial data cached
Application site pain	32	134.4 97.5–185.4ROR 156.3 · χ² 4,104 / p <1e-300	124.4 EB05 92.3 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=3 · 91% consumer	no trial data cached
Application site rash	19	127.4 82.8–195.9ROR 138.9 · χ² 2,256 / p <1e-300	113.0 EB05 76.5 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Dry mouth	52	59.3 46.7–75.4ROR 76.7 · χ² 2,934 / p <1e-300	58.1 EB05 46.0 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 116.2 · 83% consumer	no trial data cached
Vision blurred (blurred vision)	80	54.1 45.4–64.6ROR 83.0 · χ² 4,143 / p <1e-300	53.4 EB05 44.3 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 96.6 · 82% consumer	no trial data cached
Urinary retention	19	52.8 34.3–81.2ROR 57.5 · χ² 915 / p 3e-201	50.2 EB05 34.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 247.6	no trial data cached
Application site pruritus	9	36.6 19.3–69.5ROR 38.1 · χ² 278 / p 1e-62	34.2 EB05 19.2 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site erythema	10	35.1 19.2–64.4ROR 36.7 · χ² 298 / p 4e-67	33.1 EB05 19.1 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	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
Vision blurred (blurred vision)	80	54.1 45.4–64.6ROR 83.0 · χ² 4,143 / p <1e-300	53.4 EB05 44.3 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 96.6 · 82% consumer	no trial data cached
Dry mouth	52	59.3 46.7–75.4ROR 76.7 · χ² 2,934 / p <1e-300	58.1 EB05 46.0 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 116.2 · 83% consumer	no trial data cached
Application site pain	32	134.4 97.5–185.4ROR 156.3 · χ² 4,104 / p <1e-300	124.4 EB05 92.3 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=3 · 91% consumer	no trial data cached
Mydriasis	28	202.2 142.9–286.1ROR 230.5 · χ² 5,398 / p <1e-300	177.5 EB05 128.9 · IC025 +4.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 174.1 · 79% consumer	no trial data cached
Application site irritation	21	156.1 103.8–234.8ROR 172.0 · χ² 3,080 / p <1e-300	136.8 EB05 94.4 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=4 · 86% consumer	no trial data cached
Urinary retention	19	52.8 34.3–81.2ROR 57.5 · χ² 915 / p 3e-201	50.2 EB05 34.0 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 247.6	no trial data cached
Application site rash	19	127.4 82.8–195.9ROR 138.9 · χ² 2,256 / p <1e-300	113.0 EB05 76.5 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Application site erythema	10	35.1 19.2–64.4ROR 36.7 · χ² 298 / p 4e-67	33.1 EB05 19.1 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Application site pruritus	9	36.6 19.3–69.5ROR 38.1 · χ² 278 / p 1e-62	34.2 EB05 19.2 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Sofpironium?

In FDA FAERS, the most frequently co-reported reaction terms for Sofpironium are vision blurred, dry mouth, application site pain, mydriasis, application site irritation, urinary retention. 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 Sofpironium have an FDA boxed warning?

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

Do FAERS signals prove that Sofpironium 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 78f86f4f-658c-468b-bd54-49182ddcc7ac, effective 20250922; matched on openfda.generic_name.exact:"SOFPIRONIUM BROMIDE")
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, 9 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.