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Serzone Safety Reports submitted to FDA

Total Serzone reports: 8.
Serzone FDA safety alerts: 2002 2003 2004 2005 .
   Reported hospitalizations: 2.
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Reported Serzone Side Effects: liver transplant, hepatic failure, hepatitis fulminant, eczema, impaired work ability, hallucination, auditory, exaggerated startle response, coma, amnesia, prostatitis, cystitis interstitial.
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Serzone Side Effects Report #5217511-1
Consumer or non-health professional from UNITED STATES reported SERZONE problem on Aug 11, 2006. Female patient, weighting 169.8 lb, was diagnosed with depression and was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, anorexia, cognitive disorder, constipation, insomnia, multiple sclerosis, paraesthesia, weight decreased. SERZONE dosage: unknown. Patient recovered.

Serzone Side Effects Report #5217512-3
SERZONE problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 12, 2006. Female patient, 70 years of age, weighting 99.21 lb, was diagnosed with insomnia and was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal. SERZONE dosage: unknown. During the same period patient was treated with DYAZIDE. Patient recovered.

Serzone Side Effects Report #5217516-0
Physician from UNITED STATES reported SERZONE problem on Nov 09, 2006. Male patient, 29 years of age, weighting 229.3 lb, was diagnosed with depression and was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: infertility. SERZONE dosage: unknown. Patient recovered.

Serzone Side Effects Report #5221830-2
SERZONE problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 23, 2007. Female patient, 36 years of age, weighting 259.0 lb, was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: blood cholesterol abnormal, blood triglycerides increased, cholecystectomy, diabetes mellitus, hypertension, metabolic disorder, obesity, weight increased. SERZONE dosage: unknown. During the same period patient was treated with ZYPREXA. Patient was hospitalized. Patient recovered.

Serzone Side Effects Report #5288067-2
Consumer or non-health professional from UNITED STATES reported SERZONE problem on Apr 03, 2007. Male patient, 52 years of age, weighting 200.6 lb, was diagnosed with depression and was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: cystitis interstitial, prostatitis. SERZONE dosage: PT. USED 100MG,1XDAILY 2 WKS,150MG 1XDAILY FOR 1 WK.VERSION2-DURATION 2-3 WEEKS. During the same period patient was treated with ATENOLOL, KLONOPIN, LAMICTAL, STELAZINE, ZOCOR. Patient recovered.

Serzone Side Effects Report #5336861-1
SERZONE problem was reported by a Health Professional from UNITED STATES on May 24, 2007. Female patient, 44 years of age, weighting 260.0 lb, was diagnosed with depression and was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: amnesia, coma, exaggerated startle response, hallucination, auditory, impaired work ability. SERZONE dosage: unknown. Patient recovered.

Serzone Side Effects Report #5047288-4
Consumer or non-health professional from CANADA reported SERZONE problem on June 21, 2006. Female patient was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: eczema, hepatitis fulminant. SERZONE dosage: unknown. Patient recovered.

Serzone Side Effects Report #5047549-9
SERZONE problem was reported by a Consumer or non-health professional from UNITED STATES on June 21, 2006. Female patient was diagnosed with depression and was treated with SERZONE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, liver transplant. SERZONE dosage: 200 MILLIGRAM, ORAL. During the same period patient was treated with SYNTHROID, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.


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abdominal discomfort, anorexia, cognitive disorder, constipation, insomnia, multiple sclerosis, paraesthesia, weight decreased, was diagnosed with depression and was diagnosed with insomnia and was diagnosed with depression and