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Review Pradif Safety Reports submitted to FDA

Total Pradif reports: 4.
Pradif FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Pradif Side Effects: syncope, sinoatrial block, hypotension, bradycardia, rash erythematous, photosensitivity reaction, dermatitis exfoliative, thrombocytopenia, normochromic normocytic anaemia, anaemia, penis deviation.
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Pradif Side Effects Report #5551781-5
Physician from reported PRADIF problem on Nov 27, 2007. Male patient, weighting 194.0 lb, was diagnosed with benign prostatic hyperplasia, hypertension and was treated with PRADIF. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. PRADIF dosage: unknown. During the same period patient was treated with DIOVAN HCT, ATENOLOL. Patient recovered.

Pradif Side Effects Report #5426891-3
PRADIF problem was reported by a Physician from on Aug 16, 2007. Male patient, 70 years of age, was diagnosed with benign prostatic hyperplasia, essential hypertension and was treated with PRADIF. After drug was administered, patient experienced the following problems/side effects: bradycardia, hypotension, sinoatrial block, syncope. PRADIF dosage: unknown. During the same period patient was treated with SIRDALUD, CANDESARTAN CILEXETIL. Patient was hospitalized. Patient recovered.

Pradif Side Effects Report #5395169-9
Physician from reported PRADIF problem on July 19, 2007. Male patient, 62 years of age, was diagnosed with prostatic disorder, hiv infection, gastritis, epilepsy, pain and was treated with PRADIF. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative, photosensitivity reaction, rash erythematous. PRADIF dosage: unknown. During the same period patient was treated with STOCRIN, PANTOPRAZOLE, LAMIVUDINE, VIREAD, KEPPRA, DURAGESIC, VALCYTE. Patient was hospitalized. Patient recovered.

Pradif Side Effects Report #5395169-9
PRADIF problem was reported by a Physician from on July 19, 2007. Male patient, 62 years of age, was diagnosed with prostatic disorder, hiv infection, gastritis, epilepsy, pain and was treated with PRADIF. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative, photosensitivity reaction, rash erythematous. PRADIF dosage: unknown. During the same period patient was treated with STOCRIN, PANTOPRAZOLE, LAMIVUDINE, VIREAD, KEPPRA, DURAGESIC, VALCYTE. Patient was hospitalized. Patient recovered.


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