IMURAN

Adverse Events

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Imuran Adverse Events Reported to the FDA Over Time

How are Imuran adverse event reports trending over time?

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

Most Common Imuran Adverse Events Reported to the FDA

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

Pyrexia	407 (1.68%)
Pancytopenia	269 (1.11%)
Diarrhoea	227 (.94%)
Leukopenia	227 (.94%)
Sepsis	227 (.94%)
Pneumonia	226 (.93%)
Drug Ineffective	221 (.91%)
Vomiting	204 (.84%)
Nausea	203 (.84%)
Anaemia	193 (.8%)
Drug Interaction	171 (.71%)
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Drug Exposure During Pregnancy	159 (.66%)
Fatigue	141 (.58%)
Weight Decreased	141 (.58%)
Abdominal Pain	133 (.55%)
Basal Cell Carcinoma	131 (.54%)
Epstein-barr Virus Infection	129 (.53%)
Thrombocytopenia	125 (.52%)
Cytomegalovirus Infection	122 (.5%)
Condition Aggravated	119 (.49%)
Haemoglobin Decreased	119 (.49%)
Pancreatitis	118 (.49%)
Dyspnoea	117 (.48%)
Malaise	115 (.47%)
Asthenia	114 (.47%)
Respiratory Failure	110 (.45%)
Renal Failure	105 (.43%)
Neutropenia	104 (.43%)
Renal Impairment	100 (.41%)
Blood Creatinine Increased	99 (.41%)
Herpes Zoster	97 (.4%)
Arthralgia	96 (.4%)
Hepatosplenic T-cell Lymphoma	95 (.39%)
Multi-organ Failure	95 (.39%)
Bone Marrow Failure	94 (.39%)
Squamous Cell Carcinoma	91 (.38%)
Platelet Count Decreased	89 (.37%)
White Blood Cell Count Decreased	88 (.36%)
Renal Failure Acute	87 (.36%)
Epstein-barr Virus Associated Lymph...	83 (.34%)
Headache	83 (.34%)
Histiocytosis Haematophagic	83 (.34%)
Progressive Multifocal Leukoencepha...	83 (.34%)
Rash	80 (.33%)
Hypotension	79 (.33%)
Lymphoproliferative Disorder	78 (.32%)
Pleural Effusion	74 (.31%)
Pneumocystis Jiroveci Pneumonia	73 (.3%)
Myalgia	72 (.3%)
Chills	70 (.29%)
Liver Function Test Abnormal	70 (.29%)
Ascites	69 (.28%)
Colitis Ulcerative	66 (.27%)
Death	65 (.27%)
Aspartate Aminotransferase Increase...	64 (.26%)
C-reactive Protein Increased	64 (.26%)
Septic Shock	64 (.26%)
Hepatitis	62 (.26%)
Alanine Aminotransferase Increased	60 (.25%)
Aspergillosis	60 (.25%)
Dehydration	59 (.24%)
Pancreatitis Acute	59 (.24%)
Oedema Peripheral	58 (.24%)
Urinary Tract Infection	58 (.24%)
Infection	57 (.24%)
Lymphadenopathy	57 (.24%)
Staphylococcal Infection	57 (.24%)
Cough	56 (.23%)
Drug Hypersensitivity	56 (.23%)
Muscular Weakness	56 (.23%)
Pain	56 (.23%)
Premature Baby	56 (.23%)
Transplant Rejection	55 (.23%)
Blood Alkaline Phosphatase Increase...	53 (.22%)
Jaundice	53 (.22%)
Bronchiectasis	52 (.21%)
Hypertension	51 (.21%)
Liver Disorder	51 (.21%)
Interstitial Lung Disease	50 (.21%)
Disease Recurrence	49 (.2%)
Cholestasis	48 (.2%)
Hepatitis Cholestatic	48 (.2%)
Nodular Regenerative Hyperplasia	48 (.2%)
Tachycardia	48 (.2%)
Acute Myeloid Leukaemia	47 (.19%)
Acute Febrile Neutrophilic Dermatos...	46 (.19%)
Diffuse Large B-cell Lymphoma	46 (.19%)
Hepatic Enzyme Increased	46 (.19%)
Hypogammaglobulinaemia	46 (.19%)
Abdominal Pain Upper	45 (.19%)
Skin Lesion	45 (.19%)
White Blood Cell Count Increased	45 (.19%)
Alopecia	44 (.18%)
Colitis	44 (.18%)
Haemodialysis	44 (.18%)
Back Pain	43 (.18%)
Blood Lactate Dehydrogenase Increas...	43 (.18%)
Lymphoma	43 (.18%)
Transaminases Increased	43 (.18%)
Convulsion	42 (.17%)
General Physical Health Deteriorati...	42 (.17%)

Share/Embed Graph Export Data

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

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

Infections - Pathogen Unspecified	1424 (5.88%)
Viral Infectious	877 (3.62%)
Gastrointestinal Signs	780 (3.22%)
Hepatic And Hepatobiliary	769 (3.17%)
Hematology Investigations	679 (2.8%)
Anemias Nonhemolytic And Marrow Dep...	676 (2.79%)
Bacterial Infectious	588 (2.43%)
Respiratory	584 (2.41%)
Epidermal And Dermal Conditions	576 (2.38%)
Therapeutic And Nontherapeutic Effe...	565 (2.33%)
White Blood Cell	474 (1.96%)
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Neurological	469 (1.94%)
Fungal Infectious	458 (1.89%)
Renal Disorders	432 (1.78%)
Body Temperature Conditions	417 (1.72%)
Hepatobiliary	366 (1.51%)
Lower Respiratory Tract Disorders	318 (1.31%)
Hematopoietic Neoplasms	280 (1.16%)
Gastrointestinal Motility And Defec...	279 (1.15%)
Skin Neoplasms Malignant And Unspec...	255 (1.05%)
Procedural And Device Related Injur...	253 (1.04%)
Chemical Injury And Poisoning	226 (.93%)
Physical Examination Topics	219 (.9%)
Immune	213 (.88%)
Joint	205 (.85%)
Exocrine Pancreas Conditions	203 (.84%)
Muscle	201 (.83%)
Miscellaneous And Site Unspecified ...	189 (.78%)
Gastrointestinal Hemorrhages	188 (.78%)
Gastrointestinal Inflammatory Condi...	185 (.76%)
Musculoskeletal And Connective Tiss...	185 (.76%)
Renal And Urinary Tract Investigati...	173 (.71%)
Cardiac Arrhythmias	169 (.7%)
Lymphomas Non-hodgkins T-cell	169 (.7%)
Platelet	156 (.64%)
Leukemias	148 (.61%)
Microbiology And Serology	144 (.59%)
Decreased And Nonspecific Blood Pre...	142 (.59%)
Electrolyte And Fluid Balance Condi...	140 (.58%)
Enzyme	139 (.57%)
Metastases	136 (.56%)
Urinary Tract Signs	136 (.56%)
Peritoneal And Retroperitoneal Cond...	135 (.56%)
Skin Appendage Conditions	131 (.54%)
Tissue	120 (.5%)
Appetite And General Nutritional	119 (.49%)
Allergic Conditions	117 (.48%)
Gastrointestinal Ulceration And Per...	116 (.48%)
Central Nervous System Vascular	114 (.47%)
Mycobacterial Infectious	113 (.47%)
Pleural	113 (.47%)
Immunodeficiency Syndromes	112 (.46%)
Protein And Chemistry Analyses	112 (.46%)
Spleen, Lymphatic And Reticulendoth...	111 (.46%)
Cardiac And Vascular Investigations	106 (.44%)
Hematological And Lymphoid Tissue T...	104 (.43%)
Injuries	104 (.43%)
Headaches	99 (.41%)
Lymphomas Non-hodgkins B-cell	97 (.4%)
Nephropathies	93 (.38%)
Immunology And Allergy	91 (.38%)
Toxicology And Therapeutic Drug Mon...	89 (.37%)
Gastrointestinal Neoplasms Malignan...	88 (.36%)
Vision	88 (.36%)
Therapeutic Procedures And Supporti...	87 (.36%)
Gastrointestinal Stenosis And Obstr...	86 (.35%)
Gastrointestinal Conditions	85 (.35%)
Neonatal And Perinatal Conditions	82 (.34%)
Bone Disorders	80 (.33%)
Skin And Subcutaneous Tissue	80 (.33%)
Obstetric And Gynecological Therape...	79 (.33%)
Abortions And Stillbirth	78 (.32%)
Movement Disorders	78 (.32%)
Cardiac And Vascular Disorders Cong...	77 (.32%)
Glucose Metabolism Disorders	77 (.32%)
Oral Soft Tissue Conditions	76 (.31%)
Seizures	76 (.31%)
Coagulopathies And Bleeding Diathes...	75 (.31%)
Water, Electrolyte And Mineral	75 (.31%)
Gastrointestinal Therapeutic Proced...	74 (.31%)
Metabolic, Nutritional And Blood Ga...	74 (.31%)
Fatal Outcomes	73 (.3%)
Musculoskeletal And Connective Tiss...	73 (.3%)
Medication Errors	69 (.28%)
Bronchial Disorders	68 (.28%)
Vascular	68 (.28%)
Renal And Urinary Tract Neoplasms M...	67 (.28%)
Upper Respiratory Tract Disorders	67 (.28%)
Bone And Joint Injuries	66 (.27%)
Myocardial	65 (.27%)
Encephalopathies	62 (.26%)
Ocular Infections, Irritations And ...	62 (.26%)
Coronary Artery	60 (.25%)
Connective Tissue Disorders	58 (.24%)
Gallbladder	57 (.24%)
Embolism And Thrombosis	56 (.23%)
Lymphomas	56 (.23%)
Heart Failures	55 (.23%)
Respiratory And Mediastinal Neoplas...	54 (.22%)
Lifestyle Issues	53 (.22%)
Pregnancy, Labour, Delivery And Pos...	53 (.22%)

Share/Embed Graph Export Data

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

Common Uses of Imuran According to Those Reporting Adverse Events

Why are people taking Imuran, according to those reporting adverse events to the FDA?

Crohns Disease	3646
Product Used For Unknown Indication	1167
Colitis Ulcerative	941
Drug Use For Unknown Indication	854
Immunosuppression	615
Rheumatoid Arthritis	589
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Renal Transplant	555
Systemic Lupus Erythematosus	275
Immunosuppressant Drug Therapy	206
Lung Transplant	191
Heart Transplant	155
Prophylaxis Against Transplant Reje...	122
Autoimmune Hepatitis	100
Liver Transplant	100
Myasthenia Gravis	92
Pemphigus	78
Colitis	78
Multiple Sclerosis	77
Idiopathic Thrombocytopenic Purpura	70
Arthritis	68
Behcets Syndrome	65
Inflammatory Bowel Disease	65
Wegeners Granulomatosis	60
Organ Transplant	52
Drug Exposure During Pregnancy	47
Lupus Nephritis	47
Polymyositis	45
Vasculitis	44
Interstitial Lung Disease	35
Dermatomyositis	31
Idiopathic Pulmonary Fibrosis	27
Dermatitis Atopic	26
Psoriasis	24
Relapsing-remitting Multiple Sclero...	22
Sarcoidosis	22
Uveitis	21
Pemphigoid	21
Ankylosing Spondylitis	20
Psoriatic Arthropathy	19
Ill-defined Disorder	18
Connective Tissue Disorder	18
Prophylaxis	18
Nephrotic Syndrome	18
Juvenile Arthritis	18
Heart And Lung Transplant	17
Foetal Exposure During Pregnancy	16
Allergic Granulomatous Angiitis	16
Anti-neutrophil Cytoplasmic Antibod...	16
Transplant	15
Immune System Disorder	15
Autoimmune Disorder	15

Drug Labels

Label	Labeler	Effective
Imuran	Prometheus Laboratories Inc.	31-MAY-11

Imuran Case Reports

What Imuran safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Imuran. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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