DACTINOMYCIN Side Effects

5904817-3 | Focal Nodular Hyperplasia
on Sep 18, 2008 Male patient from JAPAN , child 8 years of age, was diagnosed with nephroblastoma and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: focal nodular hyperplasia. Dactinomycin dosage: . During the same period patient was treated with VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ).

5672533-1 | Cerebellar Haematoma, Cough, Decreased Appetite, Epistaxis, Haemoglobin Decreased, Headache, Loss Of Consciousness, Platelet Count Decreased, Posturing
Patient was taking Dactinomycin (View Usage). Patient had the following side effects: cerebellar haematoma, cough, decreased appetite, epistaxis, haemoglobin decreased, headache (What is headache?), loss of consciousness, platelet count decreased, posturing on Mar 18, 2008 from UNITED STATES Additional patient health information: Female patient , weighting 28.66 lb, . Dactinomycin dosage: .8 Mg. During the same period patient was treated with IFOSFAMIDE (3540 Mg) (View Ifosfamide Review and Ifosfamide Label ), VINCRISTINE SULFATE (.8 Mg) (View Vincristine Sulfate Review and Vincristine Sulfate Label ), AMOXICILLIN + CLAVULANATE POTASSIUM (View Amoxicillin + Clavulanate Potassium Review and Amoxicillin + Clavulanate Potassium Label ), ANCEF (View Ancef Review and Ancef Label ), CEFEPIME HYDROCHLORIDE (View Cefepime Hydrochloride Review and Cefepime Hydrochloride Label ), CODEINE SUL TAB (View Codeine Sul Tab Review and Codeine Sul Tab Label ), DEXAMETHASONE (View Dexamethasone Review and Dexamethasone Label ), DIPHENHYDRAMINE HCL (View Diphenhydramine Hcl Review and Diphenhydramine Hcl Label ). Patient was hospitalized.

5631869-0 | Coagulopathy, Dehydration, Gas Gangrene, Hyperbilirubinaemia, Ileus, Necrotising Fasciitis, Neutropenia, Oliguria, Pneumatosis
Adverse event was reported on Feb 19, 2008 by a Female patient taking Dactinomycin (View Usage) (Dosage: 2.3 Mg 0.045 Mg/kg/day X 1 Dose) . Location: UNITED STATES , weighting 114.0 lb, After Dactinomycin was administered, patient had the following side effects: coagulopathy, dehydration, gas gangrene, hyperbilirubinaemia, ileus, necrotising fasciitis, neutropenia, oliguria, pneumatosis. During the same period patient was treated with VINCRISTINE SULFATE (6 Mg 1.5 Mg/m2/day X 3 Doses) (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.

5626177-8 | Coagulation Test Abnormal, Dehydration, Diarrhoea, Gas Gangrene, Hyperbilirubinaemia, Ileus, Nausea, Necrotising Fasciitis, Neutropenia
on Feb 12, 2008 Female patient from CANADA , weighting 114.0 lb, was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: coagulation test abnormal, dehydration, diarrhoea, gas gangrene, hyperbilirubinaemia, ileus, nausea (What is 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 SULFATE (6 Mg; 1.5 Mg/m2/day X 3 Doses.) (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.


5619527-X | Blood Creatine Phosphokinase Increased, Coagulation Test Abnormal, Dehydration, Diarrhoea, Hyperbilirubinaemia, Ileus, Nausea, Necrotising Fasciitis, Neutropenia
on Feb 05, 2008 Female patient from CANADA , weighting 114.0 lb, was treated with Dactinomycin (View Usage). Patient had the following side effects: blood creatine phosphokinase increased, coagulation test abnormal, dehydration, diarrhoea, hyperbilirubinaemia, ileus, nausea (What is nausea?), necrotising fasciitis, neutropenia. Dactinomycin dosage: .045 Mg. During the same period patient was treated with VINCRISTINE SULFATE (4.5 Mg) (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.

5616343-X | Coagulation Test Abnormal, Dehydration, Gas Gangrene, Ileus, Necrotising Fasciitis, Neutropenia, Oliguria, Pneumatosis, Pyrexia
Patient was taking Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: coagulation test abnormal, dehydration, gas gangrene, ileus, necrotising fasciitis, neutropenia, oliguria, pneumatosis, pyrexia on Feb 06, 2008 from UNITED STATES Additional patient health information: Female patient , weighting 114.0 lb, . Dactinomycin dosage: 0.45 Mg 0.045 Mg/kg/day X 1 Dose. During the same period patient was treated with VINCRISTINE SULFATE (4.5 Mg 1.5 Mg/m2/day X 3 Doses) (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.

5609084-6 | Coagulopathy, Dehydration, Hyperbilirubinaemia, Ileus, Necrotising Fasciitis, Neutropenia, Oliguria, Pyrexia, Rash
Adverse event was reported on Jan 30, 2008 by a Female patient taking Dactinomycin (View Usage) (Dosage: .045 Ml) . Location: UNITED STATES , weighting 114.0 lb, Patient experienced the following unwanted or unexpected effects: coagulopathy, dehydration, hyperbilirubinaemia, ileus, necrotising fasciitis, neutropenia, oliguria, pyrexia, rash (What is rash?). During the same period patient was treated with VINCRISTINE SULFATE (4.5 Mg) (View Vincristine Sulfate Review and Vincristine Sulfate Label ). Patient was hospitalized.

5607390-2 | Dehydration, Diarrhoea, Haemolytic Uraemic Syndrome, Hyperbilirubinaemia, Ileus, Liver Disorder, Necrotising Fasciitis, Neutropenia, Pyrexia
on Jan 28, 2008 Female patient from UNITED STATES , weighting 121.3 lb, was treated with Dactinomycin (View Usage). Patient had the following 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 (4.5 Mg) (View Vincristine Review and Vincristine Label ). Patient was hospitalized.

5601898-1 | Venoocclusive Disease
on Feb 15, 2007 Male patient from UNITED STATES , weighting 99.21 lb, was diagnosed with rhabdomyosarcoma and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: venoocclusive disease. Dactinomycin dosage: 2 Mg;q6w;iv. During the same period patient was treated with CYCLOPHOSPHAMIDE (Iv) (View Cyclophosphamide Review and Cyclophosphamide Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), CELEBREX (View Celebrex Review and Celebrex Label ), MIRALAX (View Miralax Review and Miralax Label ), PALONOSETRON (View Palonosetron Review and Palonosetron Label ), VALTREX (View Valtrex Review and Valtrex Label ). Patient was hospitalized.

5601897-X | Febrile Neutropenia
Patient was taking Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: febrile neutropenia on Dec 11, 2006 from UNITED STATES Additional patient health information: Female patient , 16 years of age, was diagnosed with fibrosarcoma, prophylaxis of nausea and vomiting and. Dactinomycin dosage: 2300 Ug;qd;iv ; 2300 Ug;qd; Iv ; 2300 Ug;qd;iv ; 2300 Ug;qd;iv ; 2300 Ug;qd;iv. During the same period patient was treated with CAP APREPITANT (See Image) (View Cap Aprepitant Review and Cap Aprepitant Label ). Patient was hospitalized.

5503615-2 | Condition Aggravated, Dental Caries, Gingival Disorder, Loose Tooth, Microgenia, Quality Of Life Decreased, Tooth Development Disorder, Tooth Disorder, Tooth Extraction
Adverse event was reported on Oct 25, 2007 by a Female patient taking Dactinomycin (View Usage) (Dosage: Iv) was diagnosed with primitive neuroectodermal tumour and. Location: JAPAN , child 8 years of age, Patient had the following side effects: condition aggravated, dental caries, gingival disorder, loose tooth, microgenia, quality of life decreased, tooth development disorder, tooth disorder (What is tooth disorder?), tooth extraction. During the same period patient was treated with CISPLATIN (Iv) (View Cisplatin Review and Cisplatin Label ).

5491276-0 | Dental Caries, Dental Pulp Disorder, Hypoaesthesia Facial, Loose Tooth, Strabismus, Tooth Discolouration, Tooth Hypoplasia
on Oct 03, 2007 Female patient from JAPAN , child 3 years of age, was diagnosed with rhabdomyosarcoma and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: dental caries, dental pulp disorder, hypoaesthesia facial, loose tooth, strabismus, tooth discolouration, tooth hypoplasia. Dactinomycin dosage: ; Iv. During the same period patient was treated with ONCOVIN (; Iv) (View Oncovin Review and Oncovin Label ), CYCLOPHOSPHAMIDE (; Iv) (View Cyclophosphamide Review and Cyclophosphamide Label ).

5485941-9 | Dental Caries, Hypoaesthesia Facial, Strabismus, Tooth Discolouration, Tooth Hypoplasia, Tooth Malformation
on Sep 28, 2007 Female patient from JAPAN , child 3 years of age, was diagnosed with rhabdomyosarcoma and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: dental caries, hypoaesthesia facial, strabismus, tooth discolouration, tooth hypoplasia, tooth malformation. Dactinomycin dosage: Iv. During the same period patient was treated with ONCOVIN (Iv) (View Oncovin Review and Oncovin Label ), CYCLOPHOSPHAMIDE (Iv) (View Cyclophosphamide Review and Cyclophosphamide Label ).

5485940-7 | Hypodontia, Loose Tooth, Tooth Disorder, Tooth Hypoplasia, Tooth Loss
Patient was taking Dactinomycin (View Usage). Patient had the following side effects: hypodontia, loose tooth, tooth disorder (What is tooth disorder?), tooth hypoplasia, tooth loss on Sep 28, 2007 from JAPAN Additional patient health information: Female patient , child 5 years of age, was diagnosed with primitive neuroectodermal tumour and. Dactinomycin dosage: Iv. During the same period patient was treated with CISPLATIN (Iv) (View Cisplatin Review and Cisplatin Label ).

5485297-1 | Continuous Haemodiafiltration, Venoocclusive Liver Disease
Adverse event was reported on Oct 10, 2007 by a Male patient taking Dactinomycin (View Usage) (Dosage: 0.6 Mg - 0.045 Mg/kg Every 3 Weeks Iv) was diagnosed with nephroblastoma and. Location: UNITED STATES , weighting 30.42 lb, After Dactinomycin was administered, patient had the following side effects: continuous haemodiafiltration, venoocclusive liver disease. During the same period patient was treated with VINCRISTINE (View Vincristine Review and Vincristine Label ), ONDANSETRON (View Ondansetron Review and Ondansetron Label ), MIRALAX (View Miralax Review and Miralax Label ), BACTRIM (View Bactrim Review and Bactrim Label ), NIFEREX (View Niferex Review and Niferex Label ), CEPHALEXIN (View Cephalexin Review and Cephalexin Label ).

5467671-2 | Rash
on Sep 12, 2007 Female patient from JAPAN , 36 years of age, was diagnosed with renal neoplasm and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: rash (What is rash?). Dactinomycin dosage: Iv. During the same period patient was treated with METHOTREXATE (Iv) (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

5428305-6 | No Therapeutic Response, Pleurisy, Respiratory Disorder, Superinfection
on Aug 15, 2007 Female patient from FRANCE , 36 years of age, was diagnosed with gestational trophoblastic tumour and was treated with Dactinomycin (View Usage). Patient had the following side effects: no therapeutic response, pleurisy, respiratory disorder, superinfection. Dactinomycin dosage: 500 Ug; Qd; Iv. Patient was hospitalized.

5422362-9 | Blood Alkaline Phosphatase Increased, Blood Creatinine Increased, Febrile Neutropenia, Graft Complication, Hypokalaemia, Metastases To Bone, Procedural Pain, Stress Fracture
Patient was taking Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: blood alkaline phosphatase increased, blood creatinine increased, febrile neutropenia, graft complication, hypokalaemia, metastases to bone, procedural pain, stress fracture on Aug 09, 2007 from UNITED KINGDOM Additional patient health information: Female patient , 33 years of age, was diagnosed with ewing's sarcoma and. Dactinomycin dosage: 0.75 Mg/m**2; Qd;. During the same period patient was treated with IFOSFAMIDE (View Ifosfamide Review and Ifosfamide Label ), VINCRISTINE SULFATE (1 Mg/m**2;) (View Vincristine Sulfate Review and Vincristine Sulfate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ). Patient was hospitalized.

5416511-6 | Pleurisy, Pyrexia, Respiratory Disorder
Adverse event was reported on Jul 31, 2007 by a Female patient taking Dactinomycin (View Usage) (Dosage: 500 Ug;qd;iv) was diagnosed with gestational trophoblastic tumour and. Location: FRANCE , 36 years of age, Patient experienced the following unwanted or unexpected effects: pleurisy, pyrexia, respiratory disorder. Patient was hospitalized.

5399918-5 | Multi-organ Failure
on Jul 11, 2007 Female patient from GERMANY , 82 years of age, was diagnosed with malignant melanoma and was treated with Dactinomycin (View Usage). Patient had the following side effects: multi-organ failure. Dactinomycin dosage: . During the same period patient was treated with MELPHALAN (MELPHALAN) (View Melphalan (melphalan) Review and Melphalan (melphalan) Label ).

5398774-9 | Iatrogenic Injury, Pleural Fistula, Pleurisy, Pyrexia
on Jul 16, 2007 Female patient from FRANCE , 36 years of age, was diagnosed with gestational trophoblastic tumour and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: iatrogenic injury, pleural fistula, pleurisy, pyrexia. Dactinomycin dosage: 500 Ug; Qd; Iv. Patient was hospitalized.

5368766-4 | Metrorrhagia
Patient was taking Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: metrorrhagia on Jun 11, 2007 from JAPAN Additional patient health information: Female patient , 32 years of age, was diagnosed with choriocarcinoma and. Dactinomycin dosage: See Image. During the same period patient was treated with METHOTREXATE (See Image) (View Methotrexate Review and Methotrexate Label ), ESTOPOSIDE (ETOPOSIDE) (See Image) (View Estoposide (etoposide) Review and Estoposide (etoposide) Label ). Patient was hospitalized.

5354788-6 | Choriocarcinoma, Condition Aggravated, Tumour Invasion, Tumour Necrosis, Uterine Haemorrhage
Adverse event was reported on May 30, 2007 by a Female patient taking Dactinomycin (View Usage) (Dosage: See Image; Iv) was diagnosed with choriocarcinoma and. Location: JAPAN , 32 years of age, Patient had the following side effects: choriocarcinoma, condition aggravated, tumour invasion, tumour necrosis, uterine haemorrhage. During the same period patient was treated with METHOTREXATE (See Image; Iv) (View Methotrexate Review and Methotrexate Label ), ETOPOSIDE (See Image; Iv) (View Etoposide Review and Etoposide Label ). Patient was hospitalized.

5341727-7 | Tumour Necrosis, Uterine Haemorrhage
on May 17, 2007 Female patient from JAPAN , 32 years of age, was diagnosed with choriocarcinoma and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: tumour necrosis, uterine haemorrhage. Dactinomycin dosage: Iv. During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ), ETOPOSIDE (View Etoposide Review and Etoposide Label ). Patient was hospitalized.

5309390-9 | Blister, Erythema Multiforme, Haemoglobin Decreased, Hepatic Function Abnormal, Nausea, Neutropenia, Pruritus, Toxic Skin Eruption
on Apr 11, 2007 Female patient from JAPAN , 35 years of age, was diagnosed with benign hydatidiform mole, antiemetic supportive care and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: blister, erythema multiforme, haemoglobin decreased, hepatic function abnormal, nausea (What is nausea?), neutropenia, pruritus, toxic skin eruption. Dactinomycin dosage: See Image. During the same period patient was treated with CYCLOPHOSPHAMIDE (See Image) (View Cyclophosphamide Review and Cyclophosphamide Label ), DECADRON (8 Mg; Q3d; Po) (View Decadron Review and Decadron Label ). Patient was hospitalized.

5306511-9 | Beta Haemolytic Streptococcal Infection, Candida Serology Positive, Febrile Neutropenia, Mucosal Inflammation, No Therapeutic Response, Pneumothorax, Radiation Pneumonitis
Patient was taking Dactinomycin (View Usage). Patient had the following side effects: beta haemolytic streptococcal infection, candida serology positive, febrile neutropenia, mucosal inflammation, no therapeutic response, pneumothorax, radiation pneumonitis on Apr 03, 2007 from UNITED KINGDOM Additional patient health information: Female patient , child 6 years of age, was diagnosed with rhabdomyosarcoma and. Dactinomycin dosage: . During the same period patient was treated with IFOSFAMIDE (View Ifosfamide Review and Ifosfamide Label ), VINCRISTINE (View Vincristine Review and Vincristine Label ), CARBOPLATIN (View Carboplatin Review and Carboplatin Label ), EPIRUBICIN (View Epirubicin Review and Epirubicin Label ), ETOPOSIDE (View Etoposide Review and Etoposide Label ).

5297333-6 | Blister, Erythema Multiforme, Haemoglobin Decreased, Hepatic Function Abnormal, Nausea, Neutropenia, White Blood Cell Count Decreased
Adverse event was reported on Mar 26, 2007 by a Female patient taking Dactinomycin (View Usage) (Dosage: See Image) was diagnosed with benign hydatidiform mole and. Location: JAPAN , 35 years of age, After Dactinomycin was administered, patient had the following side effects: blister, erythema multiforme, haemoglobin decreased, hepatic function abnormal, nausea (What is nausea?), neutropenia, white blood cell count decreased. During the same period patient was treated with CYCLOPHOSPHAMIDE (See Image) (View Cyclophosphamide Review and Cyclophosphamide Label ), DECADRON (8 Mg; Q3d; Po) (View Decadron Review and Decadron Label ), METHOTREXATE (See Image) (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

5291418-6 | Optic Neuropathy
on Mar 21, 2007 Female patient from JAPAN , 32 years of age, was diagnosed with benign hydatidiform mole and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: optic neuropathy. Dactinomycin dosage: Inj.

5281236-7 | Blister, Erythema Multiforme, Hepatic Function Abnormal, Nausea, Neutropenia
on Mar 13, 2007 Female patient from JAPAN , 35 years of age, was diagnosed with benign hydatidiform mole and was treated with Dactinomycin (View Usage). Patient had the following side effects: blister, erythema multiforme, hepatic function abnormal, nausea (What is nausea?), neutropenia. Dactinomycin dosage: See Image. During the same period patient was treated with CYCLOPHOSPHAMIDE (See Image) (View Cyclophosphamide Review and Cyclophosphamide Label ), KYTRIL (View Kytril Review and Kytril Label ), MEYLON (View Meylon Review and Meylon Label ). Patient was hospitalized.

5275896-4 | Sepsis, Undifferentiated Sarcoma
Patient was taking Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: sepsis (What is sepsis?), undifferentiated sarcoma on Mar 14, 2007 from JAPAN Additional patient health information: Male patient , 15 years of age, was diagnosed with undifferentiated sarcoma and. Dactinomycin dosage: . During the same period patient was treated with ONCOVIN (View Oncovin Review and Oncovin Label ), ENDOXAN (View Endoxan Review and Endoxan Label ), TACROLIMUS (View Tacrolimus Review and Tacrolimus Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ). Patient was hospitalized.

5257306-6 | Optic Neuropathy, Scotoma
Adverse event was reported on Feb 20, 2007 by a Female patient taking Dactinomycin (View Usage) (Dosage: Inj) was diagnosed with benign hydatidiform mole and. Location: JAPAN , 32 years of age, Patient experienced the following unwanted or unexpected effects: optic neuropathy, scotoma.

5199306-0 | Exfoliative Rash, Hyperkeratosis, Mucosal Inflammation, Skin Hyperpigmentation, Skin Lesion, Skin Toxicity
on Dec 15, 2006 Female patient from UNITED STATES , 23 years of age, was diagnosed with choriocarcinoma and was treated with Dactinomycin (View Usage). Patient had the following side effects: exfoliative rash, hyperkeratosis, mucosal inflammation, skin hyperpigmentation, skin lesion, skin toxicity. Dactinomycin dosage: . During the same period patient was treated with METHOTREXATE (View Methotrexate Review and Methotrexate Label ). Patient was hospitalized.

5192169-9 | Blood Culture Positive, Cystitis Haemorrhagic, Febrile Neutropenia, Haemoglobin Decreased, Red Blood Cell Count Decreased, Staphylococcal Infection, White Blood Cell Count Decreased
on Dec 05, 2006 Male patient from UNITED STATES , child 12 years of age, was diagnosed with prophylaxis of nausea and vomiting and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: blood culture positive, cystitis haemorrhagic, febrile neutropenia, haemoglobin decreased, red blood cell count decreased, staphylococcal infection (What is staphylococcal infection?), white blood cell count decreased. Dactinomycin dosage: 2.45 Mg; Qd; Iv. During the same period patient was treated with APREPITANT (See Image) (View Aprepitant Review and Aprepitant Label ). Patient was hospitalized.

5166393-5 | Blood Culture Positive, Cystitis Haemorrhagic, Febrile Neutropenia, Haemoglobin Decreased, Platelet Count Decreased, Staphylococcal Infection
Patient was taking Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: blood culture positive, cystitis haemorrhagic, febrile neutropenia, haemoglobin decreased, platelet count decreased, staphylococcal infection (What is staphylococcal infection?) on Nov 14, 2006 from UNITED STATES Additional patient health information: Male patient , child 12 years of age, was diagnosed with prophylaxis of nausea and vomiting and. Dactinomycin dosage: 2.45 Mg; Qd; Iv. During the same period patient was treated with APREPITANT (See Image) (View Aprepitant Review and Aprepitant Label ). Patient was hospitalized.

5159006-X | Convulsion, Inappropriate Antidiuretic Hormone Secretion, Myelodysplastic Syndrome, Neuropathy Peripheral, Pyrexia
Adverse event was reported on Nov 06, 2006 by a Male patient taking Dactinomycin (View Usage) (Dosage: 15 Ug/kg; Qd;) was diagnosed with astrocytoma and. Location: UNITED STATES , child 6 years of age, Patient had the following side effects: convulsion, inappropriate antidiuretic hormone secretion, myelodysplastic syndrome, neuropathy peripheral, pyrexia. During the same period patient was treated with VINCRISTINE (1.5 Mg/m**2; Qw;) (View Vincristine Review and Vincristine Label ).

5148669-0 | C-reactive Protein Increased, Hypoxia, Interstitial Lung Disease, Pyrexia, Respiratory Failure
on Oct 25, 2006 Female patient from JAPAN , 31 years of age, was diagnosed with choriocarcinoma and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following 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 (View Leucovorin Calcium Review and Leucovorin Calcium Label ), METHOTREXATE (100 Mg/m2; Then 200mg/m2 Over 12hr On Day 1) (View Methotrexate Review and Methotrexate Label ), VINCRISTINE (1 Mg; On Day 8 For 7 Cycles) (View Vincristine Review and Vincristine Label ), CYCLOPHOSPHAMIDE (600 Mg/m2;day 8 For 7 Cycles) (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (100 Mg/m2; Days 1 + 2 For 7 Cycles) (View Etoposide Review and Etoposide Label ). Patient was hospitalized.

5148174-1 | Interstitial Lung Disease, Respiratory Failure
on Oct 25, 2006 Female patient from JAPAN , 31 years of age, was diagnosed with choriocarcinoma and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: interstitial lung disease, respiratory failure. Dactinomycin dosage: See Image. During the same period patient was treated with METHOTREXATE (100 Mg/m2;then 200mg/m2 Over 12hr On Day1 For 7 Cycles) (View Methotrexate Review and Methotrexate Label ), VINCRISTINE (1 Mg;on Day 8 For 7 Cycles) (View Vincristine Review and Vincristine Label ), CYCLOPHOSPHAMIDE (600 Mg/m2;day 8 For 7 Cycles) (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (100 Mg/m2;days 1 + 2 For 7 Cycles) (View Etoposide Review and Etoposide Label ), LEUCOVORIN CALCIUM (View Leucovorin Calcium Review and Leucovorin Calcium Label ). Patient was hospitalized.

5139524-0 | Interstitial Lung Disease, Respiratory Failure
Patient was taking Dactinomycin (View Usage). Patient had the following side effects: interstitial lung disease, respiratory failure on Oct 13, 2006 from JAPAN Additional patient health information: Female patient , 31 years of age, was diagnosed with choriocarcinoma and. Dactinomycin dosage: 0.5 Mg; Day 1 For 7 Cycles; See Image. During the same period patient was treated with METHOTREXATE (100 Mg/m2; Then 200mg/m2 Over 12hr On Day1 For 7 Cycles) (View Methotrexate Review and Methotrexate Label ), VINCRISTINE (1 Mg; On Day 8 For 7 Cycles) (View Vincristine Review and Vincristine Label ), CYCLOPHOSPHAMIDE (600 Mg/m2; Day 8 For 7 Cycles) (View Cyclophosphamide Review and Cyclophosphamide Label ), ETOPOSIDE (100 Mg/m2; Days 1 + 2 For 7 Cycles) (View Etoposide Review and Etoposide Label ), LEUCOVORIN CALCIUM (View Leucovorin Calcium Review and Leucovorin Calcium Label ).

5114792-X | Erythema, Injection Site Inflammation, Injection Site Swelling, Oedema Peripheral
Adverse event was reported on Sep 06, 2006 by a Male patient taking Dactinomycin (View Usage) (Dosage: 540 Microgram; Iv) was diagnosed with nephroblastoma, hypertension, prophylaxis of nausea and vomiting and. Location: FRANCE , child 2 years of age, After Dactinomycin was administered, patient had the following side effects: erythema, injection site inflammation, injection site swelling, oedema peripheral. During the same period patient was treated with VINCRISTINE SULFATE (0.8 Mg; Iv) (View Vincristine Sulfate Review and Vincristine Sulfate Label ), NICARDIPINE (NICARDIPINE) (1 Mg; Iv) (View Nicardipine (nicardipine) Review and Nicardipine (nicardipine) Label ), LABETOLOL (LABETOLOL) (1 Mg; Iv) (View Labetolol (labetolol) Review and Labetolol (labetolol) Label ), ONDANSETRON HCL (4 Mg; Iv) (View Ondansetron Hcl Review and Ondansetron Hcl Label ). Patient was hospitalized.

5074325-3 | Anorexia, Ear Haemorrhage, Platelet Count Decreased, Staphylococcal Infection
on Jul 26, 2006 Male patient from JAPAN , 78 years of age, was diagnosed with rhabdomyosarcoma and was treated with Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: anorexia, ear haemorrhage, platelet count decreased, staphylococcal infection (What is staphylococcal infection?). Dactinomycin dosage: 0.4 Mg; Qd; Iv. During the same period patient was treated with ONCOVIN (1 Mg; Qd; Iv) (View Oncovin Review and Oncovin Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ), PRIMPERAN TAB (View Primperan Tab Review and Primperan Tab Label ), ZOFRAN (View Zofran Review and Zofran Label ). Patient was hospitalized.

5067405-X | Arthralgia, Bone Marrow Failure, Infusion Related Reaction, Mouth Ulceration, Nephropathy Toxic, Respiratory Distress, Stomatitis, Therapeutic Response Decreased
on Jul 17, 2006 Female patient from JAPAN , 37 years of age, was diagnosed with choriocarcinoma, lung neoplasm and was treated with Dactinomycin (View Usage). Patient had the following side effects: arthralgia, bone marrow failure, infusion related reaction, mouth ulceration, nephropathy toxic, respiratory distress, stomatitis, therapeutic response decreased. Dactinomycin dosage: Inj. During the same period patient was treated with ETOPOSIDE (View Etoposide Review and Etoposide Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ONCOVIN (Inj) (View Oncovin Review and Oncovin Label ).

5059240-3 | Asthenia, Malignant Neoplasm Of Thorax, Multiple Sclerosis, Optic Neuritis, Recurrent Cancer, Stem Cell Transplant
Patient was taking Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: asthenia, malignant neoplasm of thorax, multiple sclerosis (What is multiple sclerosis?), optic neuritis, recurrent cancer, stem cell transplant on Jul 12, 2006 from JAPAN Additional patient health information: Female patient , child 4 years of age, was diagnosed with lung neoplasm and. Dactinomycin dosage: 0.45 Mg/kg. During the same period patient was treated with CISPLATIN (525 Mg/m**2) (View Cisplatin Review and Cisplatin Label ), DOXORUBICIN HCL (See Image) (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), CYCLOPHOSPHAMIDE (See Image) (View Cyclophosphamide Review and Cyclophosphamide Label ), VINCRISTINE (2400 Mg/m**2) (View Vincristine Review and Vincristine Label ), THIOTEPA (See Image) (View Thiotepa Review and Thiotepa Label ), TOPOTECAN (TOPOTECAN) (0.75 Mg/m**2) (View Topotecan (topotecan) Review and Topotecan (topotecan) Label ).

4941873-3 | Aphagia, Aphasia, Aphthous Stomatitis, Glossitis, Oral Mucosa Erosion, Swollen Tongue
Adverse event was reported on Feb 22, 2006 by a Male patient taking Dactinomycin (View Usage) (Dosage: 0.73 Mg; Qd; Iv) was diagnosed with rhabdomyosarcoma and. Location: JAPAN , 14 years of age, Patient experienced the following unwanted or unexpected effects: aphagia, aphasia (What is aphasia?), aphthous stomatitis, glossitis, oral mucosa erosion, swollen tongue. During the same period patient was treated with ETOPOSIDE (150 Mg;) (View Etoposide Review and Etoposide Label ), IFOSFAMIDE (2700 Mg; Iv) (View Ifosfamide Review and Ifosfamide Label ), VINCRISTINE (2 Mg;) (View Vincristine Review and Vincristine Label ), CISPLATIN (View Cisplatin Review and Cisplatin Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), PIRARUBICIN (View Pirarubicin Review and Pirarubicin Label ). Patient was hospitalized.

4867198-2 | Metastases To Bone Marrow, Metastases To Lymph Nodes, Post Procedural Nausea, Post Procedural Vomiting, Rhabdomyosarcoma Recurrent
on Dec 16, 2005 Male patient from UNITED STATES , 17 years of age, was diagnosed with rhabdomyosarcoma and was treated with Dactinomycin (View Usage). Patient had the following side effects: metastases to bone marrow, metastases to lymph nodes, post procedural nausea, post procedural vomiting, rhabdomyosarcoma recurrent. Dactinomycin dosage: Inj. During the same period patient was treated with IFOSFAMIDE (View Ifosfamide Review and Ifosfamide Label ), DOXORUBICIN HCL (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

4849319-0 | Adenovirus Infection, Cardiac Failure, Haematuria, Hepatic Failure, Pericarditis, White Blood Cell Count Decreased
on Nov 23, 2005 Male patient from UNITED STATES , child 3 years of age, was diagnosed with rhabdomyosarcoma and was treated with Dactinomycin (View Usage). After Dactinomycin was administered, patient had the following side effects: adenovirus infection, cardiac failure, haematuria, hepatic failure, pericarditis, white blood cell count decreased. Dactinomycin dosage: Iv. During the same period patient was treated with VINCRISTINE SULFATE (Iv) (View Vincristine Sulfate Review and Vincristine Sulfate Label ), CYCLOPHOSPHAMIDE (Iv) (View Cyclophosphamide Review and Cyclophosphamide Label ), RIBAVIRIN (View Ribavirin Review and Ribavirin Label ).

4849318-9 | Alveolar Soft Part Sarcoma Metastatic, Post Procedural Nausea, Post Procedural Vomiting, Rhabdomyosarcoma Recurrent
Patient was taking Dactinomycin (View Usage). Patient experienced the following unwanted or unexpected effects: alveolar soft part sarcoma metastatic, post procedural nausea, post procedural vomiting, rhabdomyosarcoma recurrent on Nov 23, 2005 from UNITED STATES Additional patient health information: Male patient , 17 years of age, was diagnosed with rhabdomyosarcoma and. Dactinomycin dosage: Inj. During the same period patient was treated with IFOSFAMIDE (View Ifosfamide Review and Ifosfamide Label ), DOXORUBICIN HCL (View Doxorubicin Hcl Review and Doxorubicin Hcl Label ), VINCRISTINE SULFATE (View Vincristine Sulfate Review and Vincristine Sulfate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

4712952-0 | Venoocclusive Disease
Adverse event was reported on Jul 12, 2005 by a Male patient taking Dactinomycin (View Usage) (Dosage: 2 Mg Q 6 Weeks Intravenou) was diagnosed with rhabdomyosarcoma and. Location: UNITED STATES , weighting 99.21 lb, Patient had the following side effects: venoocclusive disease. During the same period patient was treated with CYCLOPHOSPHAMIDE (Intravenou) (View Cyclophosphamide Review and Cyclophosphamide Label ), ABDOMINAL RADIATION (View Abdominal Radiation Review and Abdominal Radiation Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), MIRALAX (View Miralax Review and Miralax Label ), CELEBREX (View Celebrex Review and Celebrex Label ), PALONOSETRON (View Palonosetron Review and Palonosetron Label ), VALTREX (View Valtrex Review and Valtrex Label ). Patient was hospitalized.