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Orfadin (Nitisinone) - Hepatic Neoplasm Malignant - Suspected Cause - Side Effect Reports

 
 



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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