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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