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Review Fareston Safety Reports submitted to FDA

Total Fareston reports: 4.
Fareston FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 2.
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FDA Reported Fareston Side Effects: bone trimming, bone disorder, back pain, abdominal pain upper, abdominal pain, abscess jaw, computerised tomogram abnormal, cholelithiasis, carotid artery stenosis, abscess, arteriosclerosis.
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Fareston Side Effects Report #5615257-9
Consumer or non-health professional from JAPAN reported FARESTON problem on Jan 07, 2008. Female patient, 57 years of age, was diagnosed with breast cancer and was treated with FARESTON. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal. FARESTON dosage: 40 MG ORAL. Patient was hospitalized. Patient recovered.

Fareston Side Effects Report #5642659-7
FARESTON problem was reported by a Consumer or non-health professional from JAPAN on Feb 05, 2008. Female patient, 35 years of age, was diagnosed with breast cancer and was treated with FARESTON. After drug was administered, patient experienced the following problems/side effects: acute hepatic failure. FARESTON dosage: 120 MG ORAL. Patient was hospitalized. Patient recovered.

Fareston Side Effects Report #5486022-0
Consumer or non-health professional from SWITZERLAND reported FARESTON problem on Sept 17, 2007. Female patient, 70 years of age, was diagnosed with breast cancer and was treated with FARESTON. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia. FARESTON dosage: unknown. Patient died.

Fareston Side Effects Report #5450982-4
FARESTON problem was reported by a Consumer or non-health professional from JAPAN on Aug 31, 2007. Female patient, 79 years of age, was diagnosed with breast cancer and was treated with FARESTON. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. FARESTON dosage: 120 MG, ORAL. During the same period patient was treated with XELODA, FAMOTIDINE, BERIZYM, MAZULENE. Patient recovered.


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hepatic function abnormal, acute hepatic failure, acute myeloid leukaemia, blood glucose increased, , was diagnosed with breast cancer and was diagnosed with breast cancer and was diagnosed with breast cancer and