Drug information for ORFADIN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 10MG Prescription  (Reference Drug) NITISINONE nitisinone RARE DIS 21232
2010-02-05 Letter
2010-02-04 Label
2002-01-18 Letter
2002-01-18 Label
2002-01-18 Review
CAPSULE; ORAL 2MG Prescription   NITISINONE nitisinone RARE DIS   "
CAPSULE; ORAL 5MG Prescription   NITISINONE nitisinone RARE DIS   "

Drug Adverse Effects information for ORFADIN

Role code Indications Reaction # Reports
PS TYROSINAEMIA ABASIA 1
PS TYROSINAEMIA ACUTE POLYNEUROPATHY 1
PS TYROSINAEMIA ALPHA 1 FOETOPROTEIN INCREASED 1
PS TYROSINAEMIA AMINO ACID LEVEL INCREASED 5
PS TYROSINAEMIA ANAEMIA 1
PS TYROSINAEMIA ASCITES 1
PS TYROSINAEMIA COGNITIVE DISORDER 2
PS TYROSINAEMIA DEATH 1
PS TYROSINAEMIA DEATH OF RELATIVE 1
PS TYROSINAEMIA DERMATITIS DIAPER 1
PS TYROSINAEMIA ECLAMPSIA 2
PS TYROSINAEMIA EDUCATIONAL PROBLEM 1
PS TYROSINAEMIA EPILEPSY 3
PS TYROSINAEMIA GASTROENTERITIS 1
PS TYROSINAEMIA HAEMATEMESIS 1
PS TYROSINAEMIA HAEMORRHAGE 2
PS TYROSINAEMIA HAEMORRHAGIC DIATHESIS 2
PS TYROSINAEMIA HEPATIC ADENOMA 1
PS TYROSINAEMIA HEPATIC FAILURE 2
PS TYROSINAEMIA HEPATIC NEOPLASM 1
PS TYROSINAEMIA HEPATIC NEOPLASM MALIGNANT 5
PS TYROSINAEMIA HEPATOMEGALY 1
PS TYROSINAEMIA HYPERBILIRUBINAEMIA 1
PS TYROSINAEMIA HYPERTENSION 2
PS TYROSINAEMIA HYPOREFLEXIA 1
PS TYROSINAEMIA HYPOTONIA 1
PS TYROSINAEMIA INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION 1
PS TYROSINAEMIA LIVER TRANSPLANT 7
PS TYROSINAEMIA MATERNAL EXPOSURE DURING PREGNANCY 1
PS TYROSINAEMIA MELAENA 1
PS TYROSINAEMIA MYALGIA 1
PS TYROSINAEMIA NEPHROPATHY 1
PS TYROSINAEMIA NEUROLOGICAL SYMPTOM 1
PS TYROSINAEMIA NO THERAPEUTIC RESPONSE 2
PS TYROSINAEMIA OBESITY 2
PS TYROSINAEMIA PARAESTHESIA 1
PS TYROSINAEMIA POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME 1
PS TYROSINAEMIA SOCIAL PROBLEM 1
PS TYROSINAEMIA SUCCINYLACETONE INCREASED 2
PS TYROSINAEMIA THERAPY CESSATION 1
PS TYROSINAEMIA THROMBOCYTOPENIA 1
PS TYROSINAEMIA TREATMENT NONCOMPLIANCE 5
PS TYROSINAEMIA URINARY TRACT INFECTION 1
PS TYROSINAEMIA VARICES OESOPHAGEAL 1
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