Ruxolitinib topical (for the skin) is used as a short-term treatment of mild to moderate eczema (atopic dermatitis) in people 12 years and older.

This medicine should only be used when other drugs are not recommended or have not worked.

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

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• an infection;
• shingles;
• hepatitis B or C;
• skin cancer;
• low white or red blood cell counts;
• high cholesterol or triglycerides (types of fat in the blood); or
• if you've ever smoked.

Using ruxolitinib may increase your risk of developing skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ruxolitinib topical on the baby.

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

You should not breastfeed while you are using ruxolitinib, and for at least 4 weeks after your last dose.

Use Ruxolitinib Topical (Opzelura) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Call your doctor at once if you have:

• changes in the size, shape, or color of a mole or skin lesion;
• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg;
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

• pain or swelling in your nose or throat;
• diarrhea;
• bronchitis;
• high eosinophil (a type of white blood cell) count;
• hives;
• inflamed hair pores;
• swelling of the tonsils;
• runny nose; or
• ear infection--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

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.

Avoid getting this medicine in your eyes, mouth, or vagina.