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Review Flutamide Safety Reports submitted to FDA

Total Flutamide reports: 8.
Flutamide FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 7.
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FDA Reported Flutamide Side Effects: confusional state, depression, blood sodium decreased, retinitis, weight increased, somnolence, impaired driving ability, disturbance in attention, anxiety, major depression, thinking abnormal.
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Flutamide Side Effects Report #5661183-9
Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA reported FLUTAMIDE problem on Feb 20, 2008. Male patient, 78 years of age, was diagnosed with prostate cancer and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure, hepatitis. FLUTAMIDE dosage: 750 MG;DAILY. During the same period patient was treated with LUTEINIZING HORMONE. Patient was hospitalized. Patient died.

Flutamide Side Effects Report #5574035-X
FLUTAMIDE problem was reported by a Consumer or non-health professional from SPAIN on Nov 02, 2007. Male patient, 78 years of age, was diagnosed with prostate cancer and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, hepatitis acute, hepatotoxicity. FLUTAMIDE dosage: 750 MG;NULL_1_DAY. During the same period patient was treated with CYPROTERONE, LEUPRORELIN. Patient was hospitalized. Patient recovered.

Flutamide Side Effects Report #5734317-5
Pharmacist from UNITED STATES reported FLUTAMIDE problem on Apr 25, 2008. Male patient, weighting 180.0 lb, was diagnosed with prostate examination abnormal and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: dizziness, eye pain, headache, hypertensive crisis. FLUTAMIDE dosage: (125 MG 2X ORAL). During the same period patient was treated with LISINOPRIL AND HYDROCHLOROTHIAZIDE, METOPROLOL SUCCINATE, NORVASC. Patient recovered.

Flutamide Side Effects Report #5750599-8
FLUTAMIDE problem was reported by a Consumer or non-health professional from CANADA on May 23, 2008. Male patient, weighting 156.3 lb, was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: anorexia, asthenia, blood count abnormal, blood creatinine increased, diarrhoea, weight decreased. FLUTAMIDE dosage: 25500 MG. During the same period patient was treated with LEUPROLIDE ACETATE. Patient was hospitalized. Patient recovered.


Flutamide Side Effects Report #5711529-8
Consumer or non-health professional from SPAIN reported FLUTAMIDE problem on Mar 31, 2008. Male patient, 78 years of age, was diagnosed with prostate cancer and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: cross sensitivity reaction, hepatic failure, hepatitis acute. FLUTAMIDE dosage: 750 MG ORAL. During the same period patient was treated with CYPROTERONE, LEUPROLERIDE ACETATE. Patient was hospitalized. Patient recovered.

Flutamide Side Effects Report #5355442-7
FLUTAMIDE problem was reported by a Physician from UNITED STATES on June 11, 2007. Female patient, weighting 120.0 lb, was diagnosed with acne and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: major depression. FLUTAMIDE dosage: 125 MG TWICE DAILY ORAL. Patient was hospitalized. Patient recovered.

Flutamide Side Effects Report #5370515-0
Health Professional from UNITED STATES reported FLUTAMIDE problem on June 25, 2007. Male patient, 74 years of age, weighting 172.0 lb, was diagnosed with prostate cancer metastatic and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: anxiety, confusional state, depression, disturbance in attention, impaired driving ability, somnolence, weight increased. FLUTAMIDE dosage: unknown. Patient recovered.

Flutamide Side Effects Report #5327449-7
FLUTAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on May 14, 2007. Female patient, weighting 110.0 lb, was diagnosed with acne and was treated with FLUTAMIDE. After drug was administered, patient experienced the following problems/side effects: delusion, depression, psychotic disorder, schizophrenia, thinking abnormal. FLUTAMIDE dosage: 125 MG 2X DAILY PO. Patient was hospitalized. Patient recovered.


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