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Full Prescribing Information  Important Safety Information

Important Safety Information

Oracea® (doxycycline, USP, 30 mg immediate release, 10 mg delayed release beads) is indicated for the treatment of only inflammatory lesions [papules and pustules] of rosacea in adult patients.

In clinical trials, the most common adverse events reported were gastrointestinal upsets, nasopharyngitis/pain, and nasal congestion/sinusitis. Oracea® should not be used to treat microbial infections, and should be used only as indicated. This drug is contraindicated in people who have shown hypersensitivity to any of the tetracyclines and, like other tetracycline drugs, may cause fetal harm when administered to a pregnant woman. Oracea® should not be used 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. All contraindications, warnings, and precautions associated with tetracyclines must be considered before prescribing Oracea®. The safety of Oracea® treatment beyond 9 months has 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.

Prescribe the #1 oral therapy for the
inflammatory lesions of rosacea1

Rosacea is INFLAMMATORY.
Oracea® is ANTI-INFLAMMATORY,
Not antimicrobial.

The first and only oral therapy approved by the FDA for the management of rosacea.

Oracea® is an ideal treatment option that provides anti-inflammatory, not antimicrobial, effects, with the added convenience of once-daily dosing.

Significantly reduce inflammatory lesions. Click here for results you can see.

Oracea® exerts anti-inflammatory activity and no antimicrobial effect, and should not be used to treat infections. To avoid risks of antimicrobial-related effects, including increased risk of resistance and/or side effects, do not substitute other tetracyclines for Oracea. Oracea has no bioequivalent.