Dactinomycin Safety Reports submitted to FDA
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More Rx Information: A B C D E F G H I J K L M N O P Q R S T U V W X Y ZTotal Dactinomycin reports: 43.
Dactinomycin FDA safety alerts: No.
Reported deaths: 12 Reported hospitalizations: 23.
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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 #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.
Dactinomycin Side Effects Report #5291418-6
DACTINOMYCIN problem was reported by a Health Professional from JAPAN 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
Physician from JAPAN reported DACTINOMYCIN problem 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
DACTINOMYCIN problem was reported by a Health Professional from UNITED KINGDOM 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
Physician from JAPAN reported DACTINOMYCIN problem 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 #5341724-1
DACTINOMYCIN problem was reported by a Consumer or non-health professional from FRANCE 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
Consumer or non-health professional from JAPAN reported DACTINOMYCIN problem 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 #5348476-X
DACTINOMYCIN problem was reported by a Consumer or non-health professional from JAPAN 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
Health Professional from FRANCE reported DACTINOMYCIN problem 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
DACTINOMYCIN problem was reported by a Health Professional from JAPAN 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
Health Professional from JAPAN reported DACTINOMYCIN problem 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 #5059240-3
DACTINOMYCIN problem was reported by a Health Professional from JAPAN on July 12, 2006. Female patient, child 4 years of age, was diagnosed with lung neoplasm and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: asthenia, malignant neoplasm of thorax, multiple sclerosis, optic neuritis, recurrent cancer, stem cell transplant. DACTINOMYCIN dosage: 0.45 MG/KG. During the same period patient was treated with CISPLATIN, DOXORUBICIN, CYCLOPHOSPHAMIDE, VINCRISTINE, THIOTEPA, TOPOTECAN. Patient recovered.
Dactinomycin Side Effects Report #5067405-X
Physician from JAPAN reported DACTINOMYCIN problem on July 17, 2006. Female patient, 37 years of age, was diagnosed with choriocarcinoma, lung neoplasm and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: arthralgia, bone marrow failure, infusion related reaction, mouth ulceration, nephropathy toxic, respiratory distress, stomatitis, therapeutic response decreased. DACTINOMYCIN dosage: unknown. During the same period patient was treated with ETOPOSIDE, METHOTREXATE, CYCLOPHOSPHAMIDE, ONCOVIN. Patient recovered.
Dactinomycin Side Effects Report #5074325-3
DACTINOMYCIN problem was reported by a Physician from JAPAN on July 26, 2006. Male patient, 78 years of age, was diagnosed with rhabdomyosarcoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: anorexia, ear haemorrhage, platelet count decreased, staphylococcal infection. DACTINOMYCIN dosage: 0.4 MG; QD; IV. During the same period patient was treated with ONCOVIN, FAMOTIDINE, PRIMPERAN, ZOFRAN. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5114792-X
Physician from FRANCE reported DACTINOMYCIN problem on Sept 06, 2006. Male patient, child 2 years of age, was diagnosed with nephroblastoma, hypertension, prophylaxis of nausea and vomiting and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: erythema, injection site inflammation, injection site swelling, oedema peripheral. DACTINOMYCIN dosage: unknown. During the same period patient was treated with VINCRISTINE SULPHATE, NICARDIPINE, LABETOLOL, ONDANSETRON. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5127538-6
DACTINOMYCIN problem was reported by a Physician from GERMANY on July 28, 2006. Female patient was diagnosed with nephroblastoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: venoocclusive disease. DACTINOMYCIN dosage: unknown. During the same period patient was treated with VINCRISTINE SULPHATE. Patient died.
Dactinomycin Side Effects Report #5128185-2
Physician from CANADA reported DACTINOMYCIN problem on Sept 25, 2006. Female patient was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: pain. DACTINOMYCIN dosage: 1.25 MG/M**2;Q2W;IV. Patient recovered.
Dactinomycin Side Effects Report #5128187-6
DACTINOMYCIN problem was reported by a Physician from GERMANY on July 28, 2006. Female patient was diagnosed with nephroblastoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: venoocclusive disease. DACTINOMYCIN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, VINCRISTINE SULPHATE. Patient died.
Dactinomycin Side Effects Report #5128188-8
Physician from GERMANY reported DACTINOMYCIN problem on July 28, 2006. Female patient was diagnosed with nephroblastoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: venoocclusive disease. DACTINOMYCIN dosage: unknown. During the same period patient was treated with VINCRISTINE SULPHATE. Patient died.
Dactinomycin Side Effects Report #5139524-0
DACTINOMYCIN problem was reported by a Consumer or non-health professional from JAPAN on Oct 13, 2006. Female patient, 31 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, respiratory failure. DACTINOMYCIN dosage: 0.5 MG; DAY 1 FOR 7 CYCLES; SEE IMAGE. During the same period patient was treated with METHOTREXATE, VINCRISTINE, CYCLOPHOSPHAMIDE, ETOPOSIDE, LEUCOVORIN CALCIUM. Patient recovered.
Dactinomycin Side Effects Report #5140734-7
Physician from FRANCE reported DACTINOMYCIN problem on Oct 12, 2006. Male patient was diagnosed with renal neoplasm and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: lichenoid keratosis, pyrexia. DACTINOMYCIN dosage: 0.015 MG/KG; EVERYDAY FOR 3 DAYS; UNK. During the same period patient was treated with VINCRISTINE. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5141195-4
DACTINOMYCIN problem was reported by a Physician from EGYPT on Oct 15, 2006. Female patient was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: neutropenic sepsis. DACTINOMYCIN dosage: 0.5 MG;1X;IV. During the same period patient was treated with ETOPOSIDE, METHOTREXATE, CISPLATINUM, LEUCOVORIN CALCIUM. Patient died.
Dactinomycin Side Effects Report #5141196-6
Physician from EGYPT reported DACTINOMYCIN problem on Oct 15, 2006. Female patient was diagnosed with gestational trophoblastic tumour and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: neutropenic sepsis. DACTINOMYCIN dosage: 0.5 MG;1X;IV. During the same period patient was treated with ETOPOSIDE, METHOTREXATE, CISPLATINUM, LEUCOVORIN CALCIUM. Patient died.
Dactinomycin Side Effects Report #5148174-1
DACTINOMYCIN problem was reported by a Physician from JAPAN on Oct 25, 2006. Female patient, 31 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, respiratory failure. DACTINOMYCIN dosage: unknown. During the same period patient was treated with METHOTREXATE, VINCRISTINE, CYCLOPHOSPHAMIDE, ETOPOSIDE, LEUCOVORIN CALCIUM. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5148669-0
Consumer or non-health professional from JAPAN reported DACTINOMYCIN problem on Oct 25, 2006. Female patient, 31 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, hypoxia, interstitial lung disease, pyrexia, respiratory failure. DACTINOMYCIN dosage: 0.5 MG;DAY 2 FOR 7 CYCLES; 0.5 MG; DAY 2 FOR 7 CYCLES. During the same period patient was treated with LEUCOVORIN CALCIUM, METHOTREXATE, VINCRISTINE, CYCLOPHOSPHAMIDE, ETOPOSIDE. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5159006-X
DACTINOMYCIN problem was reported by a Physician from UNITED STATES on Nov 06, 2006. Male patient, child 6 years of age, was diagnosed with astrocytoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: convulsion, inappropriate antidiuretic hormone secretion, myelodysplastic syndrome, neuropathy peripheral, pyrexia. DACTINOMYCIN dosage: unknown. During the same period patient was treated with VINCRISTINE. Patient recovered.
Dactinomycin Side Effects Report #5166393-5
Physician from UNITED STATES reported DACTINOMYCIN problem on Nov 14, 2006. Male patient, child 12 years of age, was diagnosed with prophylaxis of nausea and vomiting and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood culture positive, cystitis haemorrhagic, febrile neutropenia, haemoglobin decreased, platelet count decreased, staphylococcal infection. DACTINOMYCIN dosage: 2.45 MG; QD; IV. During the same period patient was treated with APREPITANT. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5192169-9
DACTINOMYCIN problem was reported by a Physician from UNITED STATES on Dec 05, 2006. Male patient, child 12 years of age, was diagnosed with prophylaxis of nausea and vomiting and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: blood culture positive, cystitis haemorrhagic, febrile neutropenia, haemoglobin decreased, red blood cell count decreased, staphylococcal infection, white blood cell count decreased. DACTINOMYCIN dosage: 2.45 MG; QD; IV. During the same period patient was treated with APREPITANT. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5199306-0
Physician from UNITED STATES reported DACTINOMYCIN problem on Dec 15, 2006. Female patient, 23 years of age, was diagnosed with choriocarcinoma and was treated with DACTINOMYCIN. After drug was administered, patient experienced the following problems/side effects: exfoliative rash, hyperkeratosis, mucosal inflammation, skin hyperpigmentation, skin lesion, skin toxicity. DACTINOMYCIN dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient was hospitalized. Patient recovered.
Dactinomycin Side Effects Report #5398774-9
DACTINOMYCIN problem was reported by a Pharmacist from FRANCE 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
Health Professional from GERMANY reported DACTINOMYCIN problem 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 #5416511-6
DACTINOMYCIN problem was reported by a Pharmacist from FRANCE 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
Health Professional from UNITED KINGDOM reported DACTINOMYCIN problem 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
DACTINOMYCIN problem was reported by a Pharmacist from FRANCE 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
Health Professional from POLAND reported DACTINOMYCIN problem 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 #5467072-7
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 #5467108-3
Consumer or non-health professional 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: 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
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 #5467116-2
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 #5467119-8
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 #5467671-2
Physician from JAPAN reported DACTINOMYCIN problem 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.
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