Possible side effects of
Tri-Luma® Cream

Some patients may have very severe allergic reactions to Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) due to the sulfites contained in the product. In some cases, these allergic reactions may result in severe asthma attacks, which can be life threatening.

While you use Tri-Luma® Cream, your skin may develop mild-to-moderate redness, peeling, burning, dryness, or itching.

Tri-Luma® Cream contains a corticosteroid medicine as one of its active components. The following side effects have been reported with application of corticosteroid medicines to the skin: itching, irritation, dryness, infection of the hair follicle, acne, changes in skin color, inflammation around the mouth, allergic skin reaction, skin infection, skin thinning, stretch marks and sweat problems. In addition, Tri-Luma® Cream contains a corticosteroid that may produce reversible effects on the adrenal gland called hypothalamic-pituitary-adrenal (HPA) axis suppression, so tell your doctor if you have any condition that may affect your adrenal function, such as Addison's disease.

Some patients using Tri-Luma® Cream develop dark spots on their skin, tingling, increased skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, skin bumps, blisters, or tiny red lines or blood vessels showing through the skin. Tri-Luma® Cream may also cause a gradual blue-black darkening of your skin; if this happens, stop using the product immediately and speak to your doctor.

If you are concerned about how your skin is reacting to Tri-Luma® Cream, call your doctor.

You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.