Molecule
Sofpironium is a prescription medicine indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. It is available as gel for topical use. MedsAcross supplies Sofpironium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Sofpironium bromide is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands. Sofpironium bromide indirectly reduces the rate of sweating by preventing the stimulation of these receptors.
Source: US FDA prescribing information
Do not shave armpits at least 8 hours before applying SOFDRA. Do not shower at least 30 minutes before applying SOFDRA. Apply SOFDRA to clean, dry skin once a day at bedtime. Apply a single pump actuation to the top of the supplied applicator. Spread the entire amount to cover 1 underarm. Apply a separate, single pump actuation to the top of the supplied applicator. Apply the entire amount to the second underarm. Allow to dry completely (5 minutes) before putting on clothing. Wash hands immediately with soap. For topical use only. Avoid fire, flame, and smoking during and immediately following application. Do not shower or wash underarms for at least 8 hours after application. Do not touch underarms after applying SOFDRA. Do not use more than once daily. Avoid transfer of SOFDRA to the periocular area. Do not apply SOFDRA to broken skin. Avoid using SOFDRA with occlusive dressings.
Source: US FDA prescribing information
SOFDRA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of sofpironium bromide (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome). Medical conditions that can be exacerbated by the anticholinergic effect of SOFDRA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren's syndrome).
Source: US FDA prescribing information
Urinary Retention: Use with caution in patients with a history or presence of documented urinary retention. Discontinue use immediately and consult a healthcare provider should any signs or symptoms of urinary retention develop. Control of Body Temperature: Watch for generalized lack of sweating when in hot or very warm environmental temperatures and avoid using SOFDRA if not sweating under these conditions. Operating Machinery or an Automobile: Transient blurred vision may occur with use of SOFDRA. If blurred vision occurs, discontinue use and avoid operating a motor vehicle or other machinery until symptoms resolve.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Urinary Retention. 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.
Source: US FDA prescribing information
Anticholinergics: Coadministration of SOFDRA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of SOFDRA with other anticholinergic-containing drugs. Strong Inhibitors of CYP2D6: Avoid co-administration of SOFDRA with drugs that are strong inhibitors of CYP2D6.
Source: US FDA prescribing information
Store upright at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Sofpironium, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Sofdra 87 mg/0.67 mL gelTopical | Botanix SB | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 18 June 2024 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Sofpironium and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Sofpironium, including Sofdra.
Yes. The US FDA first approved Sofpironium on 18 June 2024, according to Drugs@FDA.
No listed presentation of Sofpironium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.