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Review Alfuzosin Safety Reports submitted to FDA

Total Alfuzosin reports: 5.
Alfuzosin FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Alfuzosin Side Effects: toxic epidermal necrolysis, septic shock, renal failure acute, bacteraemia, cerebral haemorrhage, dry mouth, pseudomonal bacteraemia, syncope, blood pressure diastolic decreased, vision blurred, dizziness.
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Alfuzosin Side Effects Report #5623355-9
Health Professional from JAPAN reported ALFUZOSIN problem on Jan 31, 2008. Male patient, weighting 169.8 lb, was diagnosed with benign prostatic hyperplasia, tinea cruris, nasopharyngitis, gastritis prophylaxis, sciatica, constipation, insomnia, diabetes mellitus and was treated with ALFUZOSIN. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. ALFUZOSIN dosage: unknown. During the same period patient was treated with BIFONAZOLE, KAKKONTO, REBAMIPIDE, LIMAPROST ALFADEX, LOXOPROFEN, MAGNESIUM OXIDE, BROTIZOLAM, GLIMEPIRIDE. Patient was hospitalized. Patient recovered.

Alfuzosin Side Effects Report #5503632-2
ALFUZOSIN problem was reported by a Health Professional from KOREA, REPUBLIC OF on Oct 23, 2007. Male patient, 56 years of age, was diagnosed with benign prostatic hyperplasia and was treated with ALFUZOSIN. After drug was administered, patient experienced the following problems/side effects: cholestasis, eosinophilia, jaundice, liver injury, pruritus, rash erythematous. ALFUZOSIN dosage: unknown. Patient was hospitalized. Patient recovered.

Alfuzosin Side Effects Report #5481783-9
Health Professional from KOREA, REPUBLIC OF reported ALFUZOSIN problem on Oct 01, 2007. Male patient, 56 years of age, was diagnosed with benign prostatic hyperplasia and was treated with ALFUZOSIN. After drug was administered, patient experienced the following problems/side effects: liver injury. ALFUZOSIN dosage: unknown. Patient recovered.

Alfuzosin Side Effects Report #5415378-X
ALFUZOSIN problem was reported by a Pharmacist from UNITED STATES on Aug 14, 2007. Male patient, 62 years of age, was diagnosed with benign prostatic hyperplasia and was treated with ALFUZOSIN. After drug was administered, patient experienced the following problems/side effects: dry mouth. ALFUZOSIN dosage: 10MG QD PO. During the same period patient was treated with RANITIDINE, DILTIAZEM. Patient recovered.

Alfuzosin Side Effects Report #5421117-9
Health Professional from JAPAN reported ALFUZOSIN problem on Aug 10, 2007. Male patient, weighting 169.8 lb, was diagnosed with benign prostatic hyperplasia, tinea cruris, hypertension, nasopharyngitis, gastritis prophylaxis, sciatica, constipation and was treated with ALFUZOSIN. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. ALFUZOSIN dosage: unknown. During the same period patient was treated with BIFONAZOLE, CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL, KAKKONTO, REBAMIPIDE, LIMAPROST ALFADEX, LOXOPROFEN, MAGNESIUM OXIDE. Patient was hospitalized. Patient recovered.


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cerebral haemorrhage, cholestasis, eosinophilia, jaundice, liver injury, pruritus, rash erythematous, , was diagnosed with benign prostatic hyperplasia, tinea cruris, nasopharyngitis, gastritis prophylaxis, sciatica, constipation, insomnia, diabetes mellitus and