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Index of reports
> Cases with Hepatic Neoplasm Malignant (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Orfadin (Nitisinone) where reactions include hepatic neoplasm malignant. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Orfadin side effects in female
Reported by a individual with unspecified qualification from Italy on 2012-07-20
Patient: female
Reactions: Hepatic Function Abnormal, Hepatic Neoplasm Malignant, Amino Acid Level Increased, Liver Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in 8 year old male
Reported by a health professional (non-physician/pharmacist) from Chile on 2012-07-05
Patient: 8 year old male
Reactions: Hepatic Neoplasm Malignant, Liver Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-15
Patient: male
Reactions: Hepatic Neoplasm Malignant, Hepatic Cirrhosis, Liver Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orfadin
Other drugs received by patient: Targocid; Augmentin '125'
Possible Orfadin side effects in 9 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-12
Patient: 9 year old male
Reactions: Hepatic Neoplasm Malignant, Liver Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in 11 year old
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-05
Patient: 11 year old
Reactions: Hepatic Neoplasm Malignant, Metastases To Skin, Metastases To Muscle, Liver Transplant
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in 1 year old female
Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-02-08
Patient: 1 year old female
Reactions: Hepatic Neoplasm Malignant, Cholestasis, Haemodynamic Instability
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in 12 year old male
Reported by a individual with unspecified qualification from Portugal on 2012-01-12
Patient: 12 year old male, weighing 55.7 kg (122.5 pounds)
Reactions: Complications of Transplanted Liver, Renal Tubular Disorder, Renal Failure, Hepatic Neoplasm Malignant, Metastatic Choriocarcinoma, Liver Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in male
Reported by a health professional (non-physician/pharmacist) from Libyan Arab Jamahiriya on 2011-12-29
Patient: male
Reactions: Hepatic Neoplasm Malignant, NO Therapeutic Response, Haemorrhagic Diathesis, Hepatic Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Orfadin
Other drugs received by patient: Vitamin K TAB; Phosphate Sandoz (Sodium Phosphate) (Tablets); Aldactone; Sodium Bicarbonate (Sodium Bicarbonate) (Tablets); Vitamin D
Possible Orfadin side effects in 21 year old male
Reported by a individual with unspecified qualification from France on 2011-12-21
Patient: 21 year old male
Reactions: Hepatic Neoplasm Malignant, Haemorrhage, Amino Acid Level Increased, Succinylacetone Increased, Treatment Noncompliance
Drug(s) suspected as cause:
Orfadin
Other drugs received by patient: Vitamin K TAB; Vitamin D
Possible Orfadin side effects in 21 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-12-20
Patient: 21 year old male
Reactions: Haemorrhage, Hepatic Neoplasm Malignant, Cognitive Disorder, Treatment Noncompliance
Drug(s) suspected as cause:
Orfadin
Other drugs received by patient: Vitamin D (Vitamin D) (Solution FOR Injection); Vitamin K (Vitamin K) (Solution FOR Injection)
Possible Orfadin side effects in 19 year old male
Reported by a health professional (non-physician/pharmacist) from Czech Republic on 2011-11-23
Patient: 19 year old male
Reactions: Hepatic Adenoma, Hepatic Neoplasm Malignant, Alpha 1 Foetoprotein Increased, Amino Acid Level Increased, Nephropathy, Liver Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orfadin
Possible Orfadin side effects in 11 year old male
Reported by a health professional (non-physician/pharmacist) from Italy on 2011-10-28
Patient: 11 year old male
Reactions: Hepatic Neoplasm Malignant, Amino Acid Level Increased, Liver Transplant
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orfadin
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