Sofdra Side Effects

Generic name: sofpironium topical

Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.

Note: This document provides detailed information about Sofdra Side Effects associated with sofpironium topical. Some dosage forms listed on this page may not apply specifically to the brand name Sofdra.

Applies to sofpironium topical: topical gel.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Stop using sofpironium topical (the active ingredient contained in Sofdra) and call your doctor at once if you have:

• little or no sweating in hot conditions (such as during exercise or while exposed to high heat);

• fever, hot or red skin;

• rapid or shallow breathing;

• weak and rapid pulse;

• a light-headed feeling, like you might pass out.

• trouble urinating (or you have a weak stream of urine);

• increased urination; or

• painful urination.

Common side effects may include:

• problems with urination;

• dry mouth;

• dilated pupils, blurred vision; or

• pain, redness, swelling, itching, or irritation where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to sofpironium topical: topical gel.

Cardiovascular adverse events

• Common (1% to 10%): Hypertension^[Ref]

Dermatologic

• Very common (10% or more): Pruritus (up to 17%), dermatitis (up to 11%), application site pain (up to 15%)
• Common (1% to 10%): Application site erythema, application site irritation, application site exfoliation, application site rash, application site folliculitis, application site dryness^[Ref]

Gastrointestinal

• Very common (10% or more): Dry mouth (17%)^[Ref]

Genitourinary

• Common (1% to 10%): Urinary retention^[Ref]

Nervous system

• Common (1% to 10%): Headache^[Ref]

Ocular

• Very common (10% or more): Vision blurred (up to 19%)
• Common (1% to 10%): Mydriasis, dry eye^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, influenza^[Ref]

See also:

Further information

Sofdra side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer