ORFADIN

Orfadin Adverse Events Reported to the FDA Over Time

How are Orfadin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Orfadin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Orfadin is flagged as the suspect drug causing the adverse event.

Most Common Orfadin Adverse Events Reported to the FDA

What are the most common Orfadin adverse events reported to the FDA?

Liver Transplant	69 (9.27%)
Hepatic Neoplasm Malignant	35 (4.7%)
Hepatic Failure	22 (2.96%)
Alpha 1 Foetoprotein Increased	21 (2.82%)
Treatment Noncompliance	21 (2.82%)
Hepatic Cirrhosis	19 (2.55%)
Drug Ineffective	14 (1.88%)
Amino Acid Level Increased	13 (1.75%)
Death	12 (1.61%)
Diarrhoea	9 (1.21%)
Hepatic Adenoma	9 (1.21%)
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Hepatic Neoplasm	8 (1.08%)
Cognitive Disorder	7 (.94%)
Condition Aggravated	7 (.94%)
Haemoglobin Decreased	7 (.94%)
Hypotonia	7 (.94%)
No Therapeutic Response	7 (.94%)
Sepsis	7 (.94%)
Thrombocytopenia	7 (.94%)
Ascites	6 (.81%)
Developmental Delay	6 (.81%)
Gastroenteritis	6 (.81%)
General Physical Health Deteriorati...	6 (.81%)
Haemorrhage	6 (.81%)
Renal Failure	6 (.81%)
Vomiting	6 (.81%)
Bronchitis	5 (.67%)
Epilepsy	5 (.67%)
Multi-organ Failure	5 (.67%)
Platelet Count Decreased	5 (.67%)
Pruritus	5 (.67%)
Pyrexia	5 (.67%)
Abasia	4 (.54%)
Acute Polyneuropathy	4 (.54%)
Anaemia	4 (.54%)
Complications Of Transplanted Liver	4 (.54%)
Cytolytic Hepatitis	4 (.54%)
Dehydration	4 (.54%)
Disease Progression	4 (.54%)
Educational Problem	4 (.54%)
Gastrointestinal Haemorrhage	4 (.54%)
Hepatomegaly	4 (.54%)
Hyporeflexia	4 (.54%)
Liver Disorder	4 (.54%)
Malignant Neoplasm Progression	4 (.54%)
Mental Retardation	4 (.54%)
Myalgia	4 (.54%)
Off Label Use	4 (.54%)
Paraesthesia	4 (.54%)
Respiratory Distress	4 (.54%)
Aspartate Aminotransferase Increase...	3 (.4%)
Dermatitis Atopic	3 (.4%)
Economic Problem	3 (.4%)
Haemorrhagic Diathesis	3 (.4%)
Hepatic Enzyme Increased	3 (.4%)
Hepatic Fibrosis	3 (.4%)
Hepatic Function Abnormal	3 (.4%)
Hypertension	3 (.4%)
Learning Disorder	3 (.4%)
Mucosal Inflammation	3 (.4%)
Nephropathy	3 (.4%)
Nervous System Disorder	3 (.4%)
Neutropenia	3 (.4%)
Nosocomial Infection	3 (.4%)
Opisthotonus	3 (.4%)
Pneumonia	3 (.4%)
Polyneuropathy	3 (.4%)
Portal Hypertension	3 (.4%)
Prothrombin Time Prolonged	3 (.4%)
Quadriparesis	3 (.4%)
Rash Maculo-papular	3 (.4%)
Speech Disorder Developmental	3 (.4%)
Tachypnoea	3 (.4%)
Varices Oesophageal	3 (.4%)
Abdominal Pain	2 (.27%)
Activated Partial Thromboplastin Ti...	2 (.27%)
Acute Hepatic Failure	2 (.27%)
Agitation Postoperative	2 (.27%)
Alanine Aminotransferase Increased	2 (.27%)
Apnoea	2 (.27%)
Blood Creatine Phosphokinase Increa...	2 (.27%)
Brain Oedema	2 (.27%)
Cardio-respiratory Arrest	2 (.27%)
Confusion Postoperative	2 (.27%)
Cyanosis	2 (.27%)
Disseminated Intravascular Coagulat...	2 (.27%)
Drug Level Decreased	2 (.27%)
Drug Toxicity	2 (.27%)
Dry Skin	2 (.27%)
Eclampsia	2 (.27%)
Epistaxis	2 (.27%)
Eye Pain	2 (.27%)
Fluid Overload	2 (.27%)
Glioblastoma Multiforme	2 (.27%)
Hallucination, Visual	2 (.27%)
Hepatic Encephalopathy	2 (.27%)
Hepatorenal Syndrome	2 (.27%)
Hepatosplenomegaly	2 (.27%)
Hypovolaemic Shock	2 (.27%)
Immunosuppressant Drug Level Increa...	2 (.27%)
Intestinal Obstruction	2 (.27%)

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This graph shows the top adverse events submitted to the FDA for Orfadin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Orfadin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Orfadin

What are the most common Orfadin adverse events reported to the FDA?

Hepatic And Hepatobiliary	75 (10.08%)
Hepatobiliary Therapeutic Procedure...	69 (9.27%)
Hepatobiliary Neoplasms Malignant A...	45 (6.05%)
Protein And Chemistry Analyses	36 (4.84%)
Lifestyle Issues	27 (3.63%)
Infections - Pathogen Unspecified	26 (3.49%)
Hematology Investigations	22 (2.96%)
Therapeutic And Nontherapeutic Effe...	22 (2.96%)
Neurological	21 (2.82%)
Epidermal And Dermal Conditions	15 (2.02%)
Fatal Outcomes	14 (1.88%)
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Respiratory	14 (1.88%)
Mental Impairment	13 (1.75%)
Gastrointestinal Signs	11 (1.48%)
Renal Disorders	11 (1.48%)
Gastrointestinal Motility And Defec...	10 (1.34%)
Hepatic And Biliary Neoplasms Benig...	10 (1.34%)
Procedural And Device Related Injur...	9 (1.21%)
Gastrointestinal Hemorrhages	8 (1.08%)
Hepatobiliary	8 (1.08%)
Peripheral Neuropathies	8 (1.08%)
Anemias Nonhemolytic And Marrow Dep...	7 (.94%)
Coagulopathies And Bleeding Diathes...	7 (.94%)
Movement Disorders	7 (.94%)
Neuromuscular	7 (.94%)
Peritoneal And Retroperitoneal Cond...	7 (.94%)
Platelet	7 (.94%)
Electrolyte And Fluid Balance Condi...	6 (.81%)
Seizures	6 (.81%)
Vascular Hemorrhagic	6 (.81%)
Body Temperature Conditions	5 (.67%)
Therapeutic Procedures And Supporti...	5 (.67%)
White Blood Cell	5 (.67%)
Appetite And General Nutritional	4 (.54%)
Decreased And Nonspecific Blood Pre...	4 (.54%)
Gastrointestinal Vascular Condition...	4 (.54%)
Metabolic And Nutritional Disorders...	4 (.54%)
Metastases	4 (.54%)
Miscellaneous And Site Unspecified ...	4 (.54%)
Muscle	4 (.54%)
Nephropathies	4 (.54%)
Nervous System Neoplasms Malignant ...	4 (.54%)
Toxicology And Therapeutic Drug Mon...	4 (.54%)
Acid-base	3 (.4%)
Ancillary Infectious Topics	3 (.4%)
Anterior Eye Structural Change, Dep...	3 (.4%)
Bacterial Infectious	3 (.4%)
Cardiac Arrhythmias	3 (.4%)
Chemical Injury And Poisoning	3 (.4%)
Cognitive And Attention Disorders	3 (.4%)
Economic And Housing Issues	3 (.4%)
Gastrointestinal Stenosis And Obstr...	3 (.4%)
Lower Respiratory Tract Disorders	3 (.4%)
Ocular Infections, Irritations And ...	3 (.4%)
Vascular Hypertensive	3 (.4%)
Cardiac Disorder Signs	2 (.27%)
Disturbances In Thinking	2 (.27%)
Encephalopathies	2 (.27%)
Enzyme	2 (.27%)
Eye	2 (.27%)
Gastrointestinal Ulceration And Per...	2 (.27%)
Increased Intracranial Pressure And...	2 (.27%)
Lymphomas	2 (.27%)
Maternal Complications Of Pregnancy	2 (.27%)
Metabolic, Nutritional And Blood Ga...	2 (.27%)
Metabolism	2 (.27%)
Musculoskeletal And Connective Tiss...	2 (.27%)
Neonatal And Perinatal Conditions	2 (.27%)
Neonatal Respiratory	2 (.27%)
Neurological, Special Senses And Ps...	2 (.27%)
Oral Soft Tissue Conditions	2 (.27%)
Penile And Scrotal Disorders	2 (.27%)
Physical Examination Topics	2 (.27%)
Renal And Urinary Tract Investigati...	2 (.27%)
Skin Vascular Abnormalities	2 (.27%)
Spleen, Lymphatic And Reticulendoth...	2 (.27%)
Upper Respiratory Tract Disorders	2 (.27%)
Viral Infectious	2 (.27%)
Vision	2 (.27%)
Water, Electrolyte And Mineral	2 (.27%)
Bone And Joint Injuries	1 (.13%)
Central Nervous System Vascular	1 (.13%)
Family Issues	1 (.13%)
Gallbladder	1 (.13%)
Gastrointestinal Conditions	1 (.13%)
Gastrointestinal Inflammatory Condi...	1 (.13%)
Gastrointestinal Neoplasms Malignan...	1 (.13%)
Head And Neck Therapeutic Procedure...	1 (.13%)
Heart Failures	1 (.13%)
Hematological	1 (.13%)
Hemolyses And Related Conditions	1 (.13%)
Hypothalamus And Pituitary Gland	1 (.13%)
Immune	1 (.13%)
Medication Errors	1 (.13%)
Miscellaneous And Site Unspecified ...	1 (.13%)
Mood Disorders	1 (.13%)
Musculoskeletal And Connective Tiss...	1 (.13%)
Myocardial	1 (.13%)
Protein And Amino Acid Metabolism	1 (.13%)
Psychiatric	1 (.13%)
Psychiatric And Behavioural Symptom...	1 (.13%)

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This graph shows the top categories of adverse events submitted to the FDA for Orfadin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Orfadin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.