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Dactinomycin Side Effects submitted to FDA

Total Dactinomycin reports: 41.
Dactinomycin FDA safety alerts: No.
Reported deaths: 11    Reported hospitalizations: 25.
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FDA Reported Dactinomycin Side Effects: pyrexia, sepsis, febrile neutropenia, haemoglobin decreased, erythema multiforme, pleurisy, respiratory failure, interstitial lung disease, venoocclusive disease, staphylococcal infection, choriocarcinoma,
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Dactinomycin Side Effects Report #5672533-1
Consumer or non-health professional from UNITED STATES reported DACTINOMYCIN problem on Mar 18, 2008. Female patient, weighting 28.66 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: cerebellar haematoma, cough, decreased appetite, epistaxis, haemoglobin decreased, headache, loss of consciousness, platelet count decreased, posturing. DACTINOMYCIN dosage: .8 MG. During the same period patient was treated with IFOSFAMIDE, VINCRISTINE SULPHATE, AMOXICILLIN, ANCEF, CEFEPIME HYDROCHLORIDE, CODEINE SUL, DEXAMETHASONE, DIPHENHYDRAMINE. Patient was hospitalized. Patient died on 03/10/2008.



Dactinomycin Side Effects Report #5616343-X
DACTINOMYCIN problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 06, 2008. Female patient, weighting 114.0 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: coagulation test abnormal, dehydration, gas gangrene, ileus, necrotising fasciitis, neutropenia, oliguria, pneumatosis, pyrexia. DACTINOMYCIN dosage: 0.45 MG 0.045 MG/KG/DAY X 1 DOSE. During the same period patient was treated with VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5619527-X
Consumer or non-health professional from CANADA reported DACTINOMYCIN problem on Feb 05, 2008. Female patient, weighting 114.0 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, coagulation test abnormal, dehydration, diarrhoea, hyperbilirubinaemia, ileus, nausea, necrotising fasciitis, neutropenia. DACTINOMYCIN dosage: .045 MG. During the same period patient was treated with VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5626177-8
DACTINOMYCIN problem was reported by a Consumer or non-health professional from CANADA on Feb 12, 2008. Female patient, weighting 114.0 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: coagulation test abnormal, dehydration, diarrhoea, gas gangrene, hyperbilirubinaemia, ileus, nausea, necrotising fasciitis, neutropenia. DACTINOMYCIN dosage: 2.3 MG 0.045 MG/KG/DAY X1 DOSE. During the same period patient was treated with VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.




Dactinomycin Side Effects Report #5631869-0
Consumer or non-health professional from UNITED STATES reported DACTINOMYCIN problem on Feb 19, 2008. Female patient, weighting 114.0 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: coagulopathy, dehydration, gas gangrene, hyperbilirubinaemia, ileus, necrotising fasciitis, neutropenia, oliguria, pneumatosis. DACTINOMYCIN dosage: 2.3 MG 0.045 MG/KG/DAY X 1 DOSE. During the same period patient was treated with VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5601897-X
DACTINOMYCIN problem was reported by a Physician from UNITED STATES on Dec 11, 2006. Female patient, 16 years of age, was diagnosed with fibrosarcoma, prophylaxis of nausea and vomiting and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CAP APREPITANT, CAP APREPITANT, CAP APREPITANT, CAP APREPITANT. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5601898-1
Consumer or non-health professional from UNITED STATES reported DACTINOMYCIN problem on Feb 15, 2007. Male patient, weighting 99.21 lb, was diagnosed with rhabdomyosarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: venoocclusive disease. DACTINOMYCIN dosage: 2 MG;Q6W;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, BACTRIM DS, CELEBREX, MIRALAX, PALONOSETRON, VALTREX. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5607390-2
DACTINOMYCIN problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 28, 2008. Female patient, weighting 121.3 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: dehydration, diarrhoea, haemolytic uraemic syndrome, hyperbilirubinaemia, ileus, liver disorder, necrotising fasciitis, neutropenia, pyrexia. DACTINOMYCIN dosage: .045 MG. During the same period patient was treated with VINCRISTINE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5609084-6
Consumer or non-health professional from UNITED STATES reported DACTINOMYCIN problem on Jan 30, 2008. Female patient, weighting 114.0 lb, was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: coagulopathy, dehydration, hyperbilirubinaemia, ileus, necrotising fasciitis, neutropenia, oliguria, pyrexia, rash. DACTINOMYCIN dosage: .045 ML. During the same period patient was treated with VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.




Dactinomycin Side Effects Report #5485297-1
DACTINOMYCIN problem was reported by a Pharmacist from UNITED STATES on Oct 10, 2007. Male patient, weighting 30.42 lb, was diagnosed with nephroblastoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: continuous haemodiafiltration, venoocclusive liver disease. DACTINOMYCIN dosage: 0.6 MG - 0.045 MG/KG EVERY 3 WEEKS IV. During the same period patient was treated with VINCRISTINE, ONDANSETRON, MIRALAX, BACTRIM, NIFEREX, CEPHALEXIN. Patient recovered.



Dactinomycin Side Effects Report #5485940-7
Physician from JAPAN reported DACTINOMYCIN problem on Sept 28, 2007. Female patient, child 5 years of age, was diagnosed with primitive neuroectodermal tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: hypodontia, loose tooth, tooth disorder, tooth hypoplasia, tooth loss. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CISPLATIN. Patient recovered.



Dactinomycin Side Effects Report #5485941-9
DACTINOMYCIN problem was reported by a Physician from JAPAN on Sept 28, 2007. Female patient, child 3 years of age, was diagnosed with rhabdomyosarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: dental caries, hypoaesthesia facial, strabismus, tooth discolouration, tooth hypoplasia, tooth malformation. DACTINOMYCIN dosage: unknown. During the same period patient was treated with ONCOVIN, CYCLOPHOSPHAMIDE. Patient recovered.



Dactinomycin Side Effects Report #5491276-0
Physician from JAPAN reported DACTINOMYCIN problem on Oct 03, 2007. Female patient, child 3 years of age, was diagnosed with rhabdomyosarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: dental caries, dental pulp disorder, hypoaesthesia facial, loose tooth, strabismus, tooth discolouration, tooth hypoplasia. DACTINOMYCIN dosage: unknown. During the same period patient was treated with ONCOVIN, CYCLOPHOSPHAMIDE. Patient recovered.



Dactinomycin Side Effects Report #5503615-2
DACTINOMYCIN problem was reported by a Physician from JAPAN on Oct 25, 2007. Female patient, child 8 years of age, was diagnosed with primitive neuroectodermal tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dental caries, gingival disorder, loose tooth, microgenia, quality of life decreased, tooth development disorder, tooth disorder, tooth extraction. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CISPLATIN. Patient recovered.




Dactinomycin Side Effects Report #5467072-7
Physician from UNITED KINGDOM reported DACTINOMYCIN problem on Sept 06, 2007. Female patient was diagnosed with germ cell cancer and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: sepsis. DACTINOMYCIN dosage: 1 MG/M**2;. During the same period patient was treated with METHOTREXATE, ETOPOSIDE, CISPLATIN. Patient died.



Dactinomycin Side Effects Report #5467108-3
DACTINOMYCIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 06, 2007. Female patient was diagnosed with germ cell cancer and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: choriocarcinoma, intra-abdominal haemorrhage. DACTINOMYCIN dosage: 1 MG/M**2. During the same period patient was treated with METHOTREXATE, ETOPOSIDE, CISPLATIN. Patient died.



Dactinomycin Side Effects Report #5467112-5
Physician from UNITED KINGDOM reported DACTINOMYCIN problem on Sept 06, 2007. Female patient was diagnosed with germ cell cancer and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: sepsis. DACTINOMYCIN dosage: 1 MG/M**2. During the same period patient was treated with METHOTREXATE, ETOPOSIDE, CISPLATIN. Patient died.



Dactinomycin Side Effects Report #5467116-2
DACTINOMYCIN problem was reported by a Physician from UNITED KINGDOM on Sept 06, 2007. Female patient was diagnosed with germ cell cancer and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: sepsis. DACTINOMYCIN dosage: 1 MG/M**2. During the same period patient was treated with METHOTREXATE, ETOPOSIDE, CISPLATIN. Patient died.



Dactinomycin Side Effects Report #5467119-8
Physician from UNITED KINGDOM reported DACTINOMYCIN problem on Sept 06, 2007. Female patient was diagnosed with germ cell cancer and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: sepsis. DACTINOMYCIN dosage: 1 MG/M**2. During the same period patient was treated with METHOTREXATE, ETOPOSIDE, CISPLATIN. Patient died.




Dactinomycin Side Effects Report #5467671-2
DACTINOMYCIN problem was reported by a Physician from JAPAN on Sept 12, 2007. Female patient, 36 years of age, was diagnosed with renal neoplasm and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: rash. DACTINOMYCIN dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5416511-6
Pharmacist from FRANCE reported DACTINOMYCIN problem on July 31, 2007. Female patient, 36 years of age, was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: pleurisy, pyrexia, respiratory disorder. DACTINOMYCIN dosage: unknown. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5422362-9
DACTINOMYCIN problem was reported by a Health Professional from UNITED KINGDOM on Aug 09, 2007. Female patient, 33 years of age, was diagnosed with ewing's sarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, blood creatinine increased, febrile neutropenia, graft complication, hypokalaemia, metastases to bone, procedural pain, stress fracture. DACTINOMYCIN dosage: 0.75 MG/M**2; QD;. During the same period patient was treated with IFOSFAMIDE, VINCRISTINE SULPHATE, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5428305-6
Pharmacist from FRANCE reported DACTINOMYCIN problem on Aug 15, 2007. Female patient, 36 years of age, was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: no therapeutic response, pleurisy, respiratory disorder, superinfection. DACTINOMYCIN dosage: unknown. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5428306-8
DACTINOMYCIN problem was reported by a Health Professional from POLAND on Aug 13, 2007. Female patient was diagnosed with nephroblastoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: renal failure, renal transplant. DACTINOMYCIN dosage: unknown. Patient recovered.



Dactinomycin Side Effects Report #5398774-9
Pharmacist from FRANCE reported DACTINOMYCIN problem on July 16, 2007. Female patient, 36 years of age, was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: iatrogenic injury, pleural fistula, pleurisy, pyrexia. DACTINOMYCIN dosage: unknown. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5399918-5
DACTINOMYCIN problem was reported by a Health Professional from GERMANY on July 11, 2007. Female patient, 82 years of age, was diagnosed with malignant melanoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. DACTINOMYCIN dosage: unknown. During the same period patient was treated with MELPHALAN. Patient died.



Dactinomycin Side Effects Report #5398774-9
Pharmacist from FRANCE reported DACTINOMYCIN problem on July 16, 2007. Female patient, 36 years of age, was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: iatrogenic injury, pleural fistula, pleurisy, pyrexia. DACTINOMYCIN dosage: unknown. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5399918-5
DACTINOMYCIN problem was reported by a Health Professional from GERMANY on July 11, 2007. Female patient, 82 years of age, was diagnosed with malignant melanoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. DACTINOMYCIN dosage: unknown. During the same period patient was treated with MELPHALAN. Patient died.



Dactinomycin Side Effects Report #5348476-X
Consumer or non-health professional from JAPAN reported DACTINOMYCIN problem on May 21, 2007. Female patient was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: choriocarcinoma, metastases to lung, metrorrhagia, uterine haemorrhage. DACTINOMYCIN dosage: 0.5 MG; UNK; IV. During the same period patient was treated with METHOTREXATE, ETOPOSIDE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5348486-2
DACTINOMYCIN problem was reported by a Health Professional from FRANCE on May 31, 2007. Male patient was diagnosed with rhabdomyosarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: febrile bone marrow aplasia, stomatitis. DACTINOMYCIN dosage: 1.5 MG/M**2; ; IV. During the same period patient was treated with VINCRISTINE SULPHATE, VINCRISTINE SULPHATE, DOXORUBICIN, IFOSFAMIDE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5354788-6
Health Professional from JAPAN reported DACTINOMYCIN problem on May 30, 2007. Female patient, 32 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: choriocarcinoma, condition aggravated, tumour invasion, tumour necrosis, uterine haemorrhage. DACTINOMYCIN dosage: unknown. During the same period patient was treated with METHOTREXATE, ETOPOSIDE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5368766-4
DACTINOMYCIN problem was reported by a Health Professional from JAPAN on June 11, 2007. Female patient, 32 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: metrorrhagia. DACTINOMYCIN dosage: unknown. During the same period patient was treated with METHOTREXATE, ESTOPOSIDE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5341724-1
Consumer or non-health professional from FRANCE reported DACTINOMYCIN problem on May 17, 2007. Female patient was diagnosed with nephroblastoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: peliosis hepatis. DACTINOMYCIN dosage: unknown. During the same period patient was treated with VINCRISTINE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5341727-7
DACTINOMYCIN problem was reported by a Consumer or non-health professional from JAPAN on May 17, 2007. Female patient, 32 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: tumour necrosis, uterine haemorrhage. DACTINOMYCIN dosage: unknown. During the same period patient was treated with METHOTREXATE, ETOPOSIDE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5291418-6
Health Professional from JAPAN reported DACTINOMYCIN problem on Mar 21, 2007. Female patient, 32 years of age, was diagnosed with benign hydatidiform mole and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: optic neuropathy. DACTINOMYCIN dosage: unknown. Patient recovered.



Dactinomycin Side Effects Report #5297333-6
DACTINOMYCIN problem was reported by a Physician from JAPAN on Mar 26, 2007. Female patient, 35 years of age, was diagnosed with benign hydatidiform mole and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blister, erythema multiforme, haemoglobin decreased, hepatic function abnormal, nausea, neutropenia, vomiting, white blood cell count decreased. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, DECADRON, METHOTREXATE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5306511-9
Health Professional from UNITED KINGDOM reported DACTINOMYCIN problem on Apr 03, 2007. Female patient, child 6 years of age, was diagnosed with rhabdomyosarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: beta haemolytic streptococcal infection, candida serology positive, febrile neutropenia, mucosal inflammation, no therapeutic response, pneumothorax, radiation pneumonitis. DACTINOMYCIN dosage: unknown. During the same period patient was treated with IFOSFAMIDE, VINCRISTINE, CARBOPLATIN, EPIRUBICIN, ETOPOSIDE. Patient died.



Dactinomycin Side Effects Report #5309390-9
DACTINOMYCIN problem was reported by a Physician from JAPAN on Apr 11, 2007. Female patient, 35 years of age, was diagnosed with benign hydatidiform mole, antiemetic supportive care and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blister, erythema multiforme, haemoglobin decreased, hepatic function abnormal, nausea, neutropenia, pruritus, toxic skin eruption, vomiting. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, DECADRON. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5257306-6
Health Professional from JAPAN reported DACTINOMYCIN problem on Feb 20, 2007. Female patient, 32 years of age, was diagnosed with benign hydatidiform mole and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: optic neuropathy, scotoma. DACTINOMYCIN dosage: unknown. Patient recovered.



Dactinomycin Side Effects Report #5275896-4
DACTINOMYCIN problem was reported by a Physician from JAPAN on Mar 14, 2007. Male patient, 15 years of age, was diagnosed with undifferentiated sarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: sepsis, undifferentiated sarcoma. DACTINOMYCIN dosage: unknown. During the same period patient was treated with ONCOVIN, ENDOXAN, TACROLIMUS, CYCLOSPORINE. Patient was hospitalized. Patient recovered.



Dactinomycin Side Effects Report #5281236-7
Physician from JAPAN reported DACTINOMYCIN problem on Mar 13, 2007. Female patient, 35 years of age, was diagnosed with benign hydatidiform mole and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blister, erythema multiforme, hepatic function abnormal, nausea, neutropenia, vomiting. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, KYTRIL, MEYLON. Patient was hospitalized. Patient recovered.




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