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Important Safety Information
Indication: ORACEA® is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. 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). 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.

©2013 Galderma Laboratories, L.P. United States, All Rights Reserved. All trademarks are the property of their respective owners. This site intended for U.S. audiences only. Information in this website is not intended as medical advice. Talk to your doctor about medical concerns.