This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cosmegen (Dactinomycin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (13)
Death (3)
Reports by Reaction Type
Ototoxicity (4),
Breast Cancer in Situ (2),
Death (2),
Agitation (1),
Infection (1),
Tachycardia (1),
Neoplasm Progression (1),
Osteomyelitis (1),
Liver Disorder (1),
Rickets (1),
Nephroblastoma (1),
Chest Discomfort (1)
Possible Cosmegen side effects in 24 month old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06
Patient: 24 month old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Cosmegen
Dosage: 1.5 mg/m2 milligram(s)/sq.meter, 1 in 1 d
Indication: Chemotherapy
Doxorubicin HCL
Dosage: 37.5 m/m2 milligram(s)/sq.1 in 1 d
Indication: Chemotherapy
Cisplatin
Dosage: 75 mg/m2 milligram(s)/sq. meter, 1 in 1 d
Indication: Chemotherapy
Other drugs received by patient: Ifosfamide; Etoposide; Cyclophosphamide; Therapeutic Radiopharmaceuticals (Therapeutic Radiopharmaceuticals); Vincristine
Possible Cosmegen side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-12
Patient: male
Reactions: Fanconi Syndrome, Rickets, Myopathy
Drug(s) suspected as cause:
Etoposide
Dosage: 1 df dosage
Carboplatin
Dosage: 2.275 g gram(s), intravenous (not otherwise specified)
Vincristine Sulfate
Adriamycin PFS
Cyclophosphamide
Dosage: , intravenous (not otherwise specified)
Cosmegen
Dosage: , intravenous (not otherwise specified)
Other drugs received by patient: Ifosfamide(ifosfamide)(powder FOR Solution FOR Injection)
Possible Cosmegen side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06
Patient:
Reactions: Ototoxicity
Drug(s) suspected as cause:
Methotrexate Sodium
Dosage: 300 mg/m2 milligram (s) /sq.meter, day 8
Indication: Gestational Trophoblastic Tumour
Etoposide
Dosage: 150;100 mg/m2 sq.meter, day 1;8
Indication: Gestational Trophoblastic Tumour
Cosmegen
Dosage: 0.5 mg, day, intravenous, day 8,
Indication: Gestational Trophoblastic Tumour
Cisplatin
Dosage: 75 mg/m2 milligram (s)/sq.meter, day 1, intravenous infusion
Indication: Gestational Trophoblastic Tumour
Possible Cosmegen side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-06
Patient:
Reactions: Ototoxicity
Drug(s) suspected as cause:
Cisplatin
Dosage: 75 mg/m2 milligram(s) / sq. meter, day 1, intravenous (not otherwise specified)
Indication: Gestational Trophoblastic Tumour
Etoposide
Dosage: 150 mg/m2 milligram(s) /sq. meter, day 1; 100 mg/m2 milligram(s) / sq. meter, day 8
Indication: Gestational Trophoblastic Tumour
Methotrexate Sodium
Dosage: 300 mg/m2 milligram(s) / sq. meter, day 8
Indication: Gestational Trophoblastic Tumour
Cosmegen
Dosage: 0.5 mg milligram(s), day 8, intravenous (not otherwise specified)
Indication: Gestational Trophoblastic Tumour
Possible Cosmegen side effects in
Reported by a individual with unspecified qualification from United States on 2012-07-06
Patient:
Reactions: Gestational Trophoblastic Tumour, Neoplasm Progression, Ototoxicity
Drug(s) suspected as cause:
Cisplatin
Dosage: 75 mg/m2 milligram(s) / sq. meter, day 1, intravenous (not otherwise specified)
Indication: Gestational Trophoblastic Tumour
Etoposide
Dosage: 150 mg/m2 milligram(s) / sq. meter, day 1; 100 mg/m2 milligram(s) / sq. meter, day 8
Indication: Gestational Trophoblastic Tumour
Methotrexate Sodium
Dosage: 300 mg/m2 milligram(s) / sq. meter, day 8
Indication: Gestational Trophoblastic Tumour
Cosmegen
Dosage: 0.5 mg milligram(s), day 8, intravenous (not otherwise specified)
Indication: Gestational Trophoblastic Tumour
Possible Cosmegen side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06
Patient:
Reactions: Ototoxicity
Drug(s) suspected as cause:
Cosmegen
Dosage: 0.5 mg milligram(s), day 8, intravenous (not otherwise specified)
Indication: Gestational Trophoblastic Tumour
Etoposide
Dosage: 150 mg/m2 milligram(s) / sq. meter, day 1; 200 mg/m2 milligram(s) / sq. meter, day 8
Indication: Gestational Trophoblastic Tumour
Cisplatin
Dosage: 75 mg/m2 milligram(s) /sq. meter, day 1, intravenous (not otherwise specified)
Indication: Gestational Trophoblastic Tumour
Methotrexate Sodium
Dosage: 300 mg/m2 milligram(s) /sq. meter, day 8
Indication: Gestational Trophoblastic Tumour
Possible Cosmegen side effects in 4 year old female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 4 year old female
Reactions: Osteomyelitis, Periostitis
Drug(s) suspected as cause:
Cosmegen
Possible Cosmegen side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-06
Patient: female, weighing 6.3 kg (13.9 pounds)
Reactions: Venoocclusive Liver Disease, Encephalopathy, Liver Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Cosmegen
Other drugs received by patient: Ciprofloxacin; Fluconazole; Ondansetron; Total Parenteral Nutrition (Nutrition Care Cartaq 10); Neolab Cotrimoxazole (Bactrim); Enoxaparin Sodium; Fentanyl; Vincristine; Cyclophosphamide; Granulocyte-Colony Stimulating (Granulocyte Colony Stimulating Factor); Meropenem
Possible Cosmegen side effects in 44 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-30
Patient: 44 year old male
Reactions: Cachexia, Infection
Drug(s) suspected as cause:
Vincristine
Indication: Rhabdomyosarcoma
Cosmegen
Indication: Rhabdomyosarcoma
Epirubicin
Indication: Rhabdomyosarcoma
Etoposide
Indication: Rhabdomyosarcoma
Carboplatin
Indication: Rhabdomyosarcoma
Other drugs received by patient: Irradiation (Other Therapeutic Radiopharmaceuticals)
Possible Cosmegen side effects in 24 month old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-11
Patient: 24 month old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Vincristine
Dosage: 0.065 mg/kg milligram(s) / kilogram, frequency not reported
Cisplatin
Dosage: 75 mg/m2 milligram(s) / sq. meter, frequency not reported
Cyclophosphamide
Dosage: 65 mg/m2 milligram(s) / sq. meter, frequency not reported; 2200 mg/m2 milligram(s)/sq.meter, frequen
Doxorubicin HCL
Dosage: 37.5 mg/m2 milligram(s) / sq. meter, frequency not reported
Cosmegen
Dosage: 1.5 mg/m2 milligram(s) / sq. meter, frequency not reported
Etoposide
Dosage: 100 mg/m2 milligram(s) /sq.meter, frequency not reported
Ifosfamide
Dosage: 2.4 mg/m2 milligram(s) / sq. meter, frequency not reported
Therapeutic Radiopharmaceuticals (Therapeutic Radiopharmaceuticals)
Dosage: frequency not reported
Possible Cosmegen side effects in 21 year old female
Reported by a physician from United States on 2011-10-13
Patient: 21 year old female
Reactions: Bone Marrow Transplant, Recurrent Cancer, Nephroblastoma, Breast Cancer in Situ
Drug(s) suspected as cause:
Doxorubicin HCL
Indication: Nephroblastoma
Thiotepa
Indication: Nephroblastoma
Cosmegen
Indication: Nephroblastoma
Vincristine
Indication: Nephroblastoma
Etoposide
Indication: Nephroblastoma
Cyclophosphamide
Indication: Nephroblastoma
Carboplatin
Indication: Nephroblastoma
Possible Cosmegen side effects in 21 year old female
Reported by a physician from United States on 2011-10-12
Patient: 21 year old female
Reactions: Fibrocystic Breast Disease, Breast Cancer in Situ
Drug(s) suspected as cause:
Cosmegen
Indication: Nephroblastoma
Carboplatin
Indication: Nephroblastoma
Vincristine
Indication: Nephroblastoma
Doxorubicin HCL
Indication: Nephroblastoma
Cyclophosphamide
Indication: Nephroblastoma
Etoposide
Indication: Nephroblastoma
Thiotepa
Indication: Nephroblastoma
Possible Cosmegen side effects in 56 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-11
Patient: 56 year old female
Reactions: Agitation, Back Pain, Hypersensitivity, Chest Discomfort, Nausea, Tachycardia, Anaphylactic Reaction, Rash Macular, Flushing, NO Therapeutic Response, Infusion Related Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cosmegen
Indication: Product Used FOR Unknown Indication
Etoposide
Indication: Gestational Trophoblastic Tumour
Start date: 2011-09-22
Etoposide
Indication: Gestational Trophoblastic Tumour
Start date: 2011-09-23
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