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Uses

What is Sofdra used for?

Sofdra (sofpironium) is commonly used to treat excessive sweating in the armpits. 

Sofdra may also be used for other conditions as determined by your healthcare provider.

How does Sofdra work (mechanism of action)?

Sofdra works by preventing the stimulation of sweat glands. This lowers the amount of sweating, helping keep your armpits dry.

How is Sofdra supplied (dosage forms)?

Sofdra is available as a 12.45% topical gel that is applied to the skin.

How should I store Sofdra?

Sofdra should be stored upright and at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Do not store near flames or fire.

Side Effects

What are the most common side effects of Sofdra?

The most common side effects of Sofdra are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Dry mouth
  • Blurred vision (see below)
  • Pain, redness, swelling, itching and irritation in the underarm area
  • Dilation of the pupils of your eyes 
  • Problems with peeing

There may be other side effects of Sofdra that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Sofdra?

While less common, the most serious side effects of Sofdra are described below, along with what to do if they happen.

Severe Allergic Reactions. Sofdra may cause allergic reactions, which can be serious. Stop using Sofdra and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Inability to Empty Bladder (Urinary Retention). Sofdra might make it harder to empty your bladder, especially if you already have prostate or bladder problems. Call your healthcare provider right away if you have any of the following symptoms.

  • Problems peeing
  • Frequent peeing
  • Weak urine (pee) stream or dribbling
  • Problems emptying your bladder

Body Temperature Regulation. Sofdra can decrease sweating in different parts of your body, not just the underarms. If it is hot outside, Sofdra can make it harder for your body to sweat and cool down. This can lead to you overheating and developing heat illness. Stop using Sofdra and call your healthcare provider right away if you have any of the following symptoms of heat illness.

  • Hot, red skin
  • Decreased alertness or passing out
  • Fast, weak heartbeat 
  • Fast, shallow breathing
  • Fever 

Blurred Vision. Sofdra might cause your vision to become blurry. If this happens, stop using Sofdra and call your healthcare provider right away. Avoid driving, operating heavy machinery, or performing hazardous work until your vision becomes normal again. 

Warnings & Precautions

Who should not use Sofdra?

Allergies to Ingredients. People who are allergic to any of the following should not use Sofdra.

  • Sofdra
  • Sofpironium
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Sofdra.

Glaucoma.Glaucoma is a condition that may lead to trouble seeing or blindness because of damage to the optic nerve in your eye. Sofdra can make this condition worse.

Slowed Gut Movement. Paralytic ileus is a type of ileus where your intestines are unable to move food through them. Sofdra can make this condition worse. 

Severe Ulcerative Colitis. Ulcerative colitis is an inflammatory bowel disease that can cause pain and sores in the lining of your large intestine. Sofdra can make this condition worse.

Myasthenia gravis. Myasthenia gravis is a condition that can cause muscle weakness. Sofdra can make this condition worse. It should not be used if you have a history of this condition.

Sjögren’s syndrome.Sjögren’s syndrome is a condition that leads to dry eyes and dry mouth because your body does not make enough tears and saliva. Sofdra can make this condition worse. 

What should I know about Sofdra before using it?

Do not use Sofdra unless it has been prescribed to you by a healthcare provider. Use it as prescribed.

Sofdra is for use on the skin only. It should only be applied to the skin in the underarm area. 

Apply Sofdra at bedtime. Wait at least 30 minutes to apply Sofdra after exercising, showering, or washing your underarm area. 

Do not apply Sofdra if you have shaved your armpits or applied deodorant in the last 8 hours. 

Do not shower or wash your underarms for at least 8 hours after applying Sofdra.

Do not share Sofdra with other people, even if they have the same condition as you. It may harm them.

Keep Sofdra out of the reach of children.

Avoid fire or flames, including smoking, during and right after applying Sofdra to your skin. Sofdra is flammable. 

Wash your hands with soap and water right away after using Sofdra. If Sofdra gets on your hands and you touch your eyes after using it, Sofdra can cause your vision to get blurry. Do not drive, operate machinery, or do hazardous work until your vision returns to normal.

What should I tell my healthcare provider before using Sofdra?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Sofdra is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Prostate or bladder problems 
  • Trouble passing urine
  • Kidney problems

Other Medicines and Supplements. Sofdra may interact with other medicines and supplements. Before using Sofdra, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Sofdra could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Sofdra passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Sofdra?

For more information about Sofdra, you can visit the manufacturer’s website at www.sofdra.com or call them at 866-763-6337.

Interactions

Does Sofdra interact with foods or drinks?

There are no known interactions between Sofdra and foods or drinks.

It is unknown if drinking alcohol will affect Sofdra.

Does Sofdra interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss any other anticholinergic medicine, which includes antihistamines and certain medicines for overactive bladder, Parkinson’s disease, stomach problems, motion sickness, and others.

Some other medicines may alter the blood levels of Sofdra. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Sofdra. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Sofdra?

If you or someone else has used too much Sofdra, wash Sofdra off right away with soap and water, and call your healthcare provider or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Sofdra?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.