IMPORTANT SAFETY INFORMATION

Indication: ORACEA® (doxycycline) 40 mg* capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA does not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in subjects treated with ORACEA were nasopharyngitis, diarrhea, hypertension and sinusitis. Warnings/Precautions: ORACEA should not be used to treat or prevent infections. ORACEA should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years) and may cause reversible inhibition of bone growth. If Clostridium difficile associated diarrhea (CDAD) occurs, may need to discontinue ORACEA. Although photosensitivity was not observed in clinical trials, ORACEA patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA treatment beyond 16 weeks and safety beyond 9 months have not been established.

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

*30 mg immediate release and 10 mg delayed release beads

1. ORACEA [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; 2021
2. Del Rosso JQ, Oet al. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol 2008;7(8):573–576
3. Bhatia N. ORACEA 40 mg capsules for papulopustular rosacea. The Dermatologist. 2013;6(21s):1–4. Available at: https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/oracea-40-mg-capsules-papulopustular-rosacea-1. Last accessed: September 2021
4. Theobald K, et al. Anti-inflammatory dose doxycycline (40 mg controlled-release) confers maximum anti-inflammatory efficacy in rosacea. Skinmed. 2007;6(5):221–226
5. Wise RD. Sub microbial doxycycline and rosacea. Compr Ther. 2007;33(2):78–81