ALLOPURINOL

Allopurinol Adverse Events Reported to the FDA Over Time

How are Allopurinol adverse event reports trending over time?

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

Most Common Allopurinol Adverse Events Reported to the FDA

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

Drug Rash With Eosinophilia And Sys...	379 (1.92%)
Renal Failure Acute	369 (1.86%)
Pyrexia	365 (1.84%)
Stevens-johnson Syndrome	316 (1.6%)
Renal Failure	234 (1.18%)
Rash	227 (1.15%)
Toxic Epidermal Necrolysis	220 (1.11%)
Drug Interaction	181 (.91%)
Pruritus	177 (.89%)
Diarrhoea	160 (.81%)
Dyspnoea	152 (.77%)
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Alanine Aminotransferase Increased	151 (.76%)
Dehydration	133 (.67%)
Hypotension	130 (.66%)
Blood Creatinine Increased	125 (.63%)
Renal Impairment	125 (.63%)
Eosinophilia	123 (.62%)
Anaemia	120 (.61%)
Thrombocytopenia	120 (.61%)
Pneumonia	117 (.59%)
Asthenia	116 (.59%)
Aspartate Aminotransferase Increase...	112 (.57%)
Pancytopenia	112 (.57%)
Interstitial Lung Disease	110 (.56%)
Malaise	110 (.56%)
Sepsis	108 (.55%)
Oedema Peripheral	105 (.53%)
Nausea	104 (.53%)
Vomiting	103 (.52%)
Drug Eruption	99 (.5%)
Platelet Count Decreased	99 (.5%)
General Physical Health Deteriorati...	98 (.5%)
Erythema	95 (.48%)
Rash Maculo-papular	95 (.48%)
Rhabdomyolysis	94 (.48%)
Hepatotoxicity	90 (.45%)
Multi-organ Failure	90 (.45%)
Agranulocytosis	89 (.45%)
Condition Aggravated	85 (.43%)
Fatigue	85 (.43%)
Haemoglobin Decreased	84 (.42%)
Respiratory Failure	84 (.42%)
Blood Alkaline Phosphatase Increase...	83 (.42%)
Toxic Skin Eruption	82 (.41%)
Dermatitis Exfoliative	80 (.4%)
Drug Hypersensitivity	80 (.4%)
Liver Function Test Abnormal	79 (.4%)
Purpura	78 (.39%)
Skin Exfoliation	77 (.39%)
Gout	76 (.38%)
Hepatic Function Abnormal	74 (.37%)
Hyperkalaemia	74 (.37%)
International Normalised Ratio Incr...	74 (.37%)
Leukopenia	74 (.37%)
Gastrointestinal Haemorrhage	70 (.35%)
Rash Erythematous	70 (.35%)
Rash Generalised	69 (.35%)
Cholestasis	68 (.34%)
Cytolytic Hepatitis	68 (.34%)
Fall	68 (.34%)
Jaundice	68 (.34%)
Cardiac Failure	66 (.33%)
Blood Creatine Phosphokinase Increa...	64 (.32%)
Atrial Fibrillation	63 (.32%)
Blood Bilirubin Increased	61 (.31%)
Dilatation Intrahepatic Duct Acquir...	61 (.31%)
Renal Failure Chronic	61 (.31%)
Drug Ineffective	59 (.3%)
Liver Disorder	59 (.3%)
Arthralgia	58 (.29%)
Confusional State	58 (.29%)
Myalgia	57 (.29%)
Lymphadenopathy	56 (.28%)
Weight Decreased	56 (.28%)
White Blood Cell Count Increased	56 (.28%)
Abdominal Pain	55 (.28%)
Hyperuricaemia	55 (.28%)
Tachycardia	55 (.28%)
Blister	54 (.27%)
Blood Urea Increased	54 (.27%)
Eczema	54 (.27%)
Decreased Appetite	53 (.27%)
White Blood Cell Count Decreased	53 (.27%)
Rash Pruritic	52 (.26%)
Blood Lactate Dehydrogenase Increas...	51 (.26%)
Disseminated Intravascular Coagulat...	51 (.26%)
Loss Of Consciousness	51 (.26%)
Completed Suicide	50 (.25%)
Dizziness	50 (.25%)
Infection	50 (.25%)
Hepatitis	49 (.25%)
Conjunctivitis	48 (.24%)
Death	48 (.24%)
Hepatic Failure	48 (.24%)
Hypersensitivity	47 (.24%)
Neutropenia	47 (.24%)
Septic Shock	46 (.23%)
Stomatitis	46 (.23%)
Urticaria	46 (.23%)
Blood Uric Acid Increased	45 (.23%)
Gamma-glutamyltransferase Increased	45 (.23%)

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This graph shows the top adverse events submitted to the FDA for Allopurinol, 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 Allopurinol 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 Allopurinol

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

Epidermal And Dermal Conditions	2687 (13.58%)
Renal Disorders	921 (4.65%)
Hepatic And Hepatobiliary	774 (3.91%)
Hematology Investigations	701 (3.54%)
Infections - Pathogen Unspecified	644 (3.25%)
Respiratory	605 (3.06%)
Hepatobiliary	528 (2.67%)
White Blood Cell	442 (2.23%)
Neurological	424 (2.14%)
Cardiac Arrhythmias	410 (2.07%)
Body Temperature Conditions	401 (2.03%)
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Anemias Nonhemolytic And Marrow Dep...	392 (1.98%)
Electrolyte And Fluid Balance Condi...	381 (1.93%)
Gastrointestinal Signs	371 (1.87%)
Therapeutic And Nontherapeutic Effe...	304 (1.54%)
Lower Respiratory Tract Disorders	254 (1.28%)
Renal And Urinary Tract Investigati...	250 (1.26%)
Oral Soft Tissue Conditions	223 (1.13%)
Muscle	222 (1.12%)
Enzyme	215 (1.09%)
Bacterial Infectious	212 (1.07%)
Decreased And Nonspecific Blood Pre...	206 (1.04%)
Injuries	195 (.99%)
Cardiac And Vascular Investigations	190 (.96%)
Gastrointestinal Motility And Defec...	190 (.96%)
Skin Vascular Abnormalities	151 (.76%)
Gastrointestinal Hemorrhages	149 (.75%)
Metabolic, Nutritional And Blood Ga...	144 (.73%)
Musculoskeletal And Connective Tiss...	143 (.72%)
Platelet	141 (.71%)
Allergic Conditions	140 (.71%)
Ocular Infections, Irritations And ...	133 (.67%)
Viral Infectious	133 (.67%)
Purine And Pyrimidine Metabolism	132 (.67%)
Physical Examination Topics	130 (.66%)
Joint	126 (.64%)
Heart Failures	125 (.63%)
Medication Errors	124 (.63%)
Appetite And General Nutritional	117 (.59%)
Water, Electrolyte And Mineral	109 (.55%)
Deliria	98 (.5%)
Glucose Metabolism Disorders	98 (.5%)
Acid-base	97 (.49%)
Skin Appendage Conditions	95 (.48%)
Central Nervous System Vascular	90 (.45%)
Suicidal And Self-injurious Behavio...	90 (.45%)
Fungal Infectious	88 (.44%)
Angiedema And Urticaria	87 (.44%)
Urinary Tract Signs	87 (.44%)
Nephropathies	86 (.43%)
Hematological And Lymphoid Tissue T...	80 (.4%)
Spleen, Lymphatic And Reticulendoth...	80 (.4%)
Bronchial Disorders	77 (.39%)
Coagulopathies And Bleeding Diathes...	77 (.39%)
Vascular	76 (.38%)
Microbiology And Serology	75 (.38%)
Bile Duct	72 (.36%)
Lifestyle Issues	63 (.32%)
Chemical Injury And Poisoning	62 (.31%)
Fatal Outcomes	62 (.31%)
Movement Disorders	62 (.31%)
Protein And Chemistry Analyses	58 (.29%)
Coronary Artery	57 (.29%)
Exocrine Pancreas Conditions	56 (.28%)
Eye	56 (.28%)
Peripheral Neuropathies	56 (.28%)
Upper Respiratory Tract Disorders	56 (.28%)
Anxiety Disorders	52 (.26%)
Pleural	52 (.26%)
Gastrointestinal Inflammatory Condi...	51 (.26%)
Myocardial	49 (.25%)
Skin And Subcutaneous Tissue	47 (.24%)
Vascular Hemorrhagic	46 (.23%)
Immunology And Allergy	44 (.22%)
Gastrointestinal Ulceration And Per...	42 (.21%)
Headaches	42 (.21%)
Vision	42 (.21%)
Seizures	41 (.21%)
Aneurysms And Artery Dissections	39 (.2%)
Embolism And Thrombosis	39 (.2%)
Cardiac Disorder Signs	37 (.19%)
Gastrointestinal Neoplasms Malignan...	37 (.19%)
Toxicology And Therapeutic Drug Mon...	37 (.19%)
Encephalopathies	36 (.18%)
Vascular Inflammations	36 (.18%)
Cornification And Dystrophic Skin	35 (.18%)
Peritoneal And Retroperitoneal Cond...	35 (.18%)
Sleep Disorders	35 (.18%)
Tongue Conditions	35 (.18%)
Gallbladder	33 (.17%)
Hemolyses And Related Conditions	31 (.16%)
Musculoskeletal And Connective Tiss...	30 (.15%)
Pulmonary Vascular	30 (.15%)
Bone, Calcium, Magnesium And Phosph...	29 (.15%)
Lipid Analyses	26 (.13%)
Procedural And Device Related Injur...	26 (.13%)
Protein And Amino Acid Metabolism	26 (.13%)
Psychiatric	26 (.13%)
Tissue	25 (.13%)
Vascular Hypertensive	25 (.13%)
Eye Disorders Congenital	24 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Allopurinol, 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 Allopurinol 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.