Generic name: sofpironium topical
Brand name: Sofdra
Dosage form: topical gel (12.45%)
Drug class: Miscellaneous topical agents

Medically reviewed by Drugs.com on Feb 18, 2025. Written by Cerner Multum.

What is sofpironium topical?

Sofpironium topical is used on underarm skin to treat excessive sweating (hyperhidrosis) in adults and children who are at least 9 years old.

Sofpironium topical may also be used for purposes not listed in this medication guide.

Sofpironium topical side effects

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

Sofpironium topical may cause serious side effects. Stop using sofpironium topical 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 of sofpironium topical 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. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use sofpironium topical topical if you have:

• severe ulcerative colitis or other serious bowel problems;

• glaucoma;

• myasthenia gravis; or

• Sjogren's syndrome.

Tell your doctor if you have or have ever had:

• prostate, bladder, or urination problems; or

• kidney disease.

It is not known if sofpironium topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using sofpironium topical.

How should I use sofpironium topical?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Sofpironium topical is usually applied once daily at bedtime.

Do not take by mouth. Topical medicine is for use only on the underarm skin.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not apply sofpironium topical if the underarms have been shaved or deodorant has been applied within the last 8 hours.

Wait at least 30 minutes before applying sofpironium topical if you have exercised, showered, or washed the underarm skin.

Apply 1 pump of medicine clean, dry underarm skin. Do not use on open wounds or broken skin.

Do not cover treated skin with a bandage or with plastic.

Do not cover treated areas with clothing for at least 5 minutes after applying sofpironium topical.

Wash your hands after applying this medicine. Any medicine on your hands could cause blurred vision if you later touch your eyes.

Store in an upright position at room temperature, away from moisture and heat.

Sofpironium topical gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Sofpironium topical dosing information

Usual Adult Dose for Hyperhidrosis:

Maintenance dose: 1 pump under each arm once daily at bedtime

Use: For the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

Usual Pediatric Dose for Hyperhidrosis:

9 to 18 years:
Maintenance dose: 1 pump under each arm once daily

Use: For the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

What happens if I miss a dose?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using taking sofpironium topical?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Sofpironium topical decreases sweating, and you may be more prone to heat stroke.

Avoid showering, or washing the area where the medicine was applied for at least 8 hours after applying sofpironium topical.

sofpironium topical may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

What other drugs will affect sofpironium topical?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;

• medicine to treat overactive bladder; or

• medicine to treat Parkinson's disease.

Other drugs may affect sofpironium topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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