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Review Oracea Safety Reports submitted to FDA

Total Oracea reports: 5.
Oracea FDA safety alerts: No.
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FDA Reported Oracea Side Effects: headache, anaphylactic reaction, tinnitus, deafness, contusion, chest discomfort, muscular weakness, gastric disorder, fear, bowel sounds abnormal, palpitations.
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Oracea Side Effects Report #5730950-5
Consumer or non-health professional from UNITED STATES reported ORACEA problem on Apr 21, 2008. Male patient was diagnosed with erythema and was treated with ORACEA. After drug was administered, patient experienced the following problems/side effects: keratoconjunctivitis sicca, retinal detachment, retinal tear. ORACEA dosage: (40 MG QD ORAL). Patient recovered.

Oracea Side Effects Report #5361745-2
ORACEA problem was reported by a Consumer or non-health professional from UNITED STATES on June 05, 2007. Female patient, 24 years of age, weighting 150.0 lb, was diagnosed with rosacea and was treated with ORACEA. After drug was administered, patient experienced the following problems/side effects: alcohol use, burning sensation, hypersensitivity, hypoaesthesia oral, memory impairment, paraesthesia oral, skin discolouration. ORACEA dosage: 40 MG, QD. Patient recovered.

Oracea Side Effects Report #5327298-X
Consumer or non-health professional from UNITED STATES reported ORACEA problem on Apr 10, 2007. Male patient, 61 years of age, weighting 250.0 lb, was diagnosed with rosacea and was treated with ORACEA. After drug was administered, patient experienced the following problems/side effects: anger, contusion, deafness, headache, tinnitus. ORACEA dosage: 40MG, QD, PO. During the same period patient was treated with FLEXERIL, FISH OIL, RED RICE YEAST. Patient recovered.

Oracea Side Effects Report #5305177-1
ORACEA problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 03, 2007. Male patient, 61 years of age, weighting 250.0 lb, was diagnosed with rosacea and was treated with ORACEA. After drug was administered, patient experienced the following problems/side effects: contusion, deafness, headache, tinnitus. ORACEA dosage: 40MG, QD, PO. During the same period patient was treated with FLEXERIL. Patient recovered.


Oracea Side Effects Report #5255875-3
Consumer or non-health professional from UNITED STATES reported ORACEA problem on Feb 16, 2007. Female patient, 80 years of age, weighting 135.0 lb, was diagnosed with dermatitis and was treated with ORACEA. After drug was administered, patient experienced the following problems/side effects: chest discomfort, hypertension. ORACEA dosage: unknown. Patient recovered.


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