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Orfadin (Nitisinone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Orfadin (Nitisinone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (44)
Death (16)
Life Threatening Events (2)

Reports by Reaction Type

Liver Transplant (19)Hepatic Neoplasm Malignant (12)Amino Acid Level Increased (8)Treatment Noncompliance (6)Hepatic Failure (5)Death (4)Hepatic Cirrhosis (4)Epilepsy (4)Haemorrhage (3)Cognitive Disorder (3)Hepatic Neoplasm (3)Hepatic Function Abnormal (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Orfadin (Nitisinone). For a complete list or a specific selection of reports, please use the links above.

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 2 year old female

Reported by a individual with unspecified qualification from Chile on 2012-07-20

Patient: 2 year old female

Reactions: Pulmonary Haemorrhage, Liver Transplant

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 3 month old male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-11

Patient: 3 month old male

Reactions: Metabolic Acidosis, Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-07-06

Patient: male

Reactions: Death

Adverse event resulted in: death

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 10 month old male

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-06-07

Patient: 10 month old male

Reactions: Pneumonia, Sepsis, Nervous System Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in male

Reported by a individual with unspecified qualification from Tunisia on 2012-06-07

Patient: male

Reactions: Liver Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in female

Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-05-25

Patient: female

Reactions: Multi-Organ Failure, General Physical Health Deterioration, Hepatic Failure, Hepatic Haemorrhage, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-05-18

Patient: female

Reactions: Hepatic Function Abnormal, Amino Acid Level Increased, 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 Turkey on 2012-05-18

Patient: male

Reactions: Pneumonia, Sepsis, Nervous System Disorder, Nosocomial Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 3 month old male

Reported by a individual with unspecified qualification from Romania on 2012-04-30

Patient: 3 month old male

Reactions: Hepatic Failure, Hepatic Cirrhosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 4 year old male

Reported by a individual with unspecified qualification from United Kingdom on 2012-04-30

Patient: 4 year old male

Reactions: Cholelithiasis, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 1 year old male

Reported by a individual with unspecified qualification from Algeria on 2012-04-25

Patient: 1 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin

Other drugs received by patient: Vitamin D; Vitamin A, D, E, K Complex; Lasilix (Furosemide); Vitamin K TAB; Aldactone



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

Reported by a health professional (non-physician/pharmacist) from India on 2012-03-23

Patient:

Reactions: Death

Adverse event resulted in: death

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

Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-02-13

Patient: 1 year old

Reactions: Pneumonia Aspiration

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 15 month old male

Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-02-10

Patient: 15 month old male

Reactions: Hepatic Neoplasm, Liver Transplant, Hepatic Cirrhosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 12 year old male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-02-08

Patient: 12 year old male

Reactions: Drug Ineffective, Amino Acid Level Decreased, Amino Acid Level Increased, Cognitive Disorder, Epilepsy

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 female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-24

Patient: female

Reactions: Liver Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 7 month old female

Reported by a individual with unspecified qualification from Algeria on 2012-01-17

Patient: 7 month old female

Reactions: Portal Hypertension, Hepatic Encephalopathy, Coma, Hepatic Failure, Hepatic Cirrhosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 18 year old male

Reported by a individual with unspecified qualification from Lebanon on 2012-01-12

Patient: 18 year old male

Reactions: Obstruction Gastric, Irritability, General Physical Health Deterioration, Gastric Neoplasm, Gastric Disorder

Adverse event resulted in: death

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 9 year old male

Reported by a individual with unspecified qualification from Portugal on 2012-01-12

Patient: 9 year old male, weighing 54.5 kg (119.9 pounds)

Reactions: Liver Transplant, Hepatic Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 15 month old male

Reported by a health professional (non-physician/pharmacist) from Thailand on 2011-12-29

Patient: 15 month old male

Reactions: Liver Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 1 year old male

Reported by a health professional (non-physician/pharmacist) from Czech Republic on 2011-12-29

Patient: 1 year old male

Reactions: Succinylacetone Increased, Liver Transplant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in 8 month old male

Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2011-12-29

Patient: 8 month old male

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orfadin



Possible Orfadin side effects in female

Reported by a health professional (non-physician/pharmacist) from Libyan Arab Jamahiriya on 2011-12-29

Patient: female

Reactions: Anaemia, Hepatic Failure, Varices Oesophageal, Dermatitis Diaper, Haematemesis, NO Therapeutic Response, Haemorrhagic Diathesis, Melaena, Thrombocytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Orfadin

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