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Cosmegen Side Effects summary
Total Cosmegen reports: 7.Cosmegen FDA safety alerts: No.
Reported deaths: 7 .
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Cosmegen Side Effects: respiratory failure, pulmonary haemorrhage, pneumonia, disseminated intravascular coagulation, shock haemorrhagic, haematoma, flank pain, choriocarcinoma, adrenal neoplasm,
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Cosmegen Side Effects reported to FDA
Cosmegen Side Effects Report #5615732-7
Consumer or non-health professional from UNITED STATES reported COSMEGEN problem on Jan 22, 2008. Male patient, 42 years of age, was diagnosed with germ cell cancer and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: choriocarcinoma, febrile neutropenia, haemoglobin decreased, intra-abdominal haemorrhage, platelet count decreased, tumour necrosis, white blood cell count decreased. COSMEGEN dosage: 1.6 MG; Q2W; IV. During the same period patient was treated with CISPLATIN, ETOPOSIDE, METHOTREXATE, ACETAZOLAMIDE, DEXTROSE WITH POTASSIUM, FILGRASTIM, FOLINIC ACID. Patient died on 08/09/1998.
Cosmegen Side Effects Report #5615734-0
COSMEGEN problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 22, 2008. Male patient, 40 years of age, was diagnosed with germ cell cancer and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: blood albumin decreased, blood bicarbonate decreased, blood bilirubin increased, blood calcium decreased, blood chloride increased, blood creatine increased, blood phosphorus decreased, blood potassium decreased, febrile neutropenia. COSMEGEN dosage: 2 MG; Q2W; IV. During the same period patient was treated with CISPLATIN, ETOPOSIDE, METHOTREXATE, DEXTROSE WITH POTASSIUM BICARBONATE AND S, FILGRASTIM, FOLINIC ACID. Patient died on 06/20/1999.
Cosmegen Side Effects Report #5615740-6
Consumer or non-health professional from UNITED STATES reported COSMEGEN problem on Jan 22, 2008. Male patient, 32 years of age, was diagnosed with germ cell cancer and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, febrile neutropenia, haemoglobin decreased, neutropenic sepsis, platelet count decreased. COSMEGEN dosage: 1.6 MG/M**2; Q2W; IV. During the same period patient was treated with CISPLATIN, ETOPOSIDE, METHOTREXATE, ACETAZOLAMIDE, DEXTROSE WITH POTASSIUM BICARBONATE AND S, FILGRASTIM, FOLINIC ACID. Patient died on 05/07/2001.
Cosmegen Side Effects Report #5527385-7
COSMEGEN problem was reported by a Physician from UNITED STATES on Nov 09, 2007. Female patient was diagnosed with ewing's sarcoma metastatic and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: haemorrhage. COSMEGEN dosage: 1.25 MG/M**2; ; IV. During the same period patient was treated with VINCRISTINE, IFOSFAMIDE, ADRIAMYCIN PFS, ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient died.

Cosmegen Side Effects Report #5527386-9
Physician from UNITED STATES reported COSMEGEN problem on Nov 09, 2007. Female patient was diagnosed with ewing's sarcoma metastatic and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: bacterial sepsis. COSMEGEN dosage: 1.25 MG/M**2; ; IV. During the same period patient was treated with VINCRISTINE, IFOSFAMIDE, ADRIAMYCIN PFS, ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient died.
Cosmegen Side Effects Report #5527398-5
COSMEGEN problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 09, 2007. Female patient was diagnosed with ewing's sarcoma metastatic and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: fungal sepsis. COSMEGEN dosage: 1.25 MG/M**2;IV. During the same period patient was treated with VINCRISTINE, IFOSFAMIDE, ADRIAMYCIN PFS, ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient died.
Cosmegen Side Effects Report #5494850-0
Physician from JAPAN reported COSMEGEN problem on Oct 08, 2007. Female patient, 30 years of age, was diagnosed with benign hydatidiform mole, neutropenia and was treated with COSMEGEN. After drug was administered, patient experienced the following problems/side effects: bone marrow failure, diarrhoea, skin exfoliation, stomatitis. COSMEGEN dosage: unknown. During the same period patient was treated with METHOTREXATE, ETOPOSIDE, NEUPOGEN. Patient recovered.
Cosmegen Side Effects


