Demonstrated Safety and Tolerability

ORACEA® Capsules Provide Multiple Benefits Over Doxycycline 100 mg1,2

ORACEA Capsules Doxycycline 100 mg
Favorable GI tolerability compared to 100 mg1
  • In a head-to-head clinical study, no nausea, diarrhea, or vomiting were reported for ORACEA Capsules (vs 17.3%, 4.3%, and 4.3% for doxycycline 100 mg)1
  • In pivotal clinical studies, the most common treatment-related adverse events (>2%) were nasopharyngitis (4.8%), diarrhea (4.5%), hypertension (3%), sinusitis (2.6%), and aspartate aminotransferase increase (2.2%).3
No evidence of bacterial resistance2In a 9-month study
No photosensitivity or vaginal candidiasis reported in controlled clinical studies2

As with other tetracycline-class products, ORACEA Capsules should not be used in people with known hypersensitivity to any of the tetracyclines and may cause fetal harm when administered to pregnant women. patients taking ORACEA Capsules should minimize or avoid exposure to natural or artificial sunlight.3

References:
  1. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573-576.
  2. Del Rosso JQ, Webster GF, Jackson M, et al. Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. J Am Acad Dermatol. 2007;56(5):791-802.
  3. ORACEA® [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P.; 2013.
ORACEA CAPSULES ARE THE ONLY FDA-APPROVED ORAL THERAPY FOR THE PAPULES AND PUSTULES (INFLAMMATORY LESIONS) OF ROSACEA.

What Are ORACEA Capsules?

ORACEA Capsules are the #1 rosacea brand among dermatologists

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Visible Results

ORACEA Capsules are formulated for an effective anti-inflammatory response

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Patient Savings

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Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules 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 Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.

*30 mg immediate release & 10 mg delayed release beads

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.

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Important Safety Information

Indication: ORACEA® (doxycycline, USP) 40 mg* Capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. ORACEA Capsules do not lessen the facial redness caused by rosacea. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (>2%) in patients treated with ORACEA Capsules were nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. Warnings/Precautions: ORACEA Capsules should not be used to treat or prevent infections. ORACEA Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ORACEA Capsules 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 Capsules patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ORACEA Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.

*30 mg immediate release & 10 mg delayed release beads