SIDE EFFECTS OF OPZELURA
The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever.
These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-10881-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-34631-855-463-3463.
- OPZELURA was studied in children as young as 12 years old. It is not known if OPZELURA is safe or effective in children under 12 years of age.
- OPZELURA is for use on the skin only. Do not use in your eyes, mouth, or vagina.
- Do not start OPZELURA if you have any infections as it may lower your ability to fight them. OPZELURA may cause serious side effects including serious infections, cancer and immune system problems, blood clots, low blood cell counts, and increases in cholesterol.
- In people 50 years of age and older who have at least 1 heart disease risk factor, an increased risk of death has happened after taking JAK inhibitors by mouth.
- After taking JAK inhibitors by mouth, people 50 years of age and older had an increased risk of major cardiovascular events—especially among those who were current or past smokers.
- Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.
It’s important to discuss both the benefits and the safety considerations with your healthcare provider before starting any medication. Please read the Important Safety Information for OPZELURA below.
APPROVED FOR PATIENTS 12 YEARS OLD AND OVER
11% of trial participants were 12–17 years of age. No clinically meaningful differences in safety or effectiveness were observed between adult and adolescent participants.
DON’T FORGET TO CONSULT YOUR HEALTHCARE PROVIDER
As part of your pursuit for pigment, talk with your healthcare provider and work out a plan for how you can apply OPZELURA safely and consistently (twice daily).