Taking BRINSUPRI

The most common side effects of BRINSUPRI

The safety results below were seen in the ASPEN study.

People taking BRINSUPRI 10 mg (582 people)/25 mg (574 people)

People taking placebo (563 people)

Upper respiratory tract infection^a

27%/29%

25%

Headache

7%/9%

Rash^b

4%/6%

Dry skin^c

3%/4%

Small areas of skin thickening^d

1%/3%

High blood pressure

5%/2%

^aUpper respiratory tract infection includes coronavirus infection, COVID-19, flu, upper respiratory tract infection, viral infection, and viral upper respiratory tract infection.

^bRash includes different types of rashes, like those with flat discolored spots or small raised bumps, those that are itchy, those that are red or make your skin red, or those that cause skin inflammation.

^cDry skin includes different skin effects that could include dry or cracked skin, shedding of dead skin cells, and chapped, dry, or inflamed lips.

^dSmall areas of skin thickening includes skin thickening or extra skin growth in different areas, like the skin on the palms and soles of the feet.

The safety of BRINSUPRI was also evaluated in the WILLOW study and was generally similar to the table above, but with more dental side effects. These side effects were experienced by 9.9% of people taking the 10-mg dose, 10.1% of people taking the 25-mg dose, and 2.4% of those taking placebo.

Additional safety considerations

Before using BRINSUPRI, tell your doctor if you are to receive any live vaccines, are pregnant (or planning to be), or are breastfeeding.

BRINSUPRI may cause serious side effects including:

Skin problems. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination, if needed.

Dental problems. Get regular dental checkups while taking BRINSUPRI. Brush and clean your teeth as recommended by your dentist. Tell your healthcare provider and contact your dentist if you experience new gum (gingival) or teeth (dental) symptoms.

Less common side effects include abnormal liver blood test, hair loss (alopecia), and skin cancers.

These are not all of the possible side effects of BRINSUPRI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not change or stop your medicines unless your healthcare provider tells you to.

Call your doctor or pharmacist for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.