MYCOPHENOLATE MOFETIL

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Mycophenolate Mofetil Adverse Events Reported to the FDA Over Time

How are Mycophenolate Mofetil adverse event reports trending over time?

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

Most Common Mycophenolate Mofetil Adverse Events Reported to the FDA

What are the most common Mycophenolate Mofetil adverse events reported to the FDA?

Cytomegalovirus Infection	691 (1.52%)
Pyrexia	656 (1.44%)
Diarrhoea	599 (1.32%)
Transplant Rejection	557 (1.23%)
Pneumonia	481 (1.06%)
Sepsis	479 (1.05%)
Death	462 (1.02%)
Blood Creatinine Increased	454 (1%)
Urinary Tract Infection	399 (.88%)
Kidney Transplant Rejection	386 (.85%)
Anaemia	354 (.78%)
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Renal Impairment	330 (.73%)
Renal Failure	323 (.71%)
Leukopenia	285 (.63%)
Renal Failure Acute	265 (.58%)
Nausea	259 (.57%)
Multi-organ Failure	256 (.56%)
Abdominal Pain	251 (.55%)
Hypertension	237 (.52%)
Vomiting	236 (.52%)
Pancytopenia	223 (.49%)
Pleural Effusion	213 (.47%)
Respiratory Failure	211 (.46%)
Complications Of Transplanted Kidne...	206 (.45%)
Infection	201 (.44%)
Drug Ineffective	197 (.43%)
Dyspnoea	193 (.42%)
Haemoglobin Decreased	187 (.41%)
Thrombocytopenia	186 (.41%)
Septic Shock	182 (.4%)
Haemodialysis	179 (.39%)
Neutropenia	163 (.36%)
Hypotension	160 (.35%)
Epstein-barr Virus Associated Lymph...	154 (.34%)
White Blood Cell Count Decreased	153 (.34%)
Dehydration	152 (.33%)
Weight Decreased	148 (.33%)
Herpes Zoster	147 (.32%)
Diabetes Mellitus	146 (.32%)
Pyelonephritis	146 (.32%)
Graft Dysfunction	145 (.32%)
Asthenia	139 (.31%)
Graft Versus Host Disease	138 (.3%)
Cardiac Arrest	137 (.3%)
Gastrointestinal Haemorrhage	134 (.29%)
Drug Toxicity	131 (.29%)
Staphylococcal Infection	131 (.29%)
Enterococcal Infection	130 (.29%)
Cough	128 (.28%)
Ascites	127 (.28%)
Proteinuria	127 (.28%)
Lymphocele	125 (.28%)
Aspergillosis	123 (.27%)
Convulsion	123 (.27%)
Disease Recurrence	120 (.26%)
Oedema Peripheral	119 (.26%)
General Physical Health Deteriorati...	118 (.26%)
Liver Transplant Rejection	118 (.26%)
Nephropathy Toxic	115 (.25%)
Hepatic Failure	114 (.25%)
Cytomegalovirus Viraemia	113 (.25%)
Lymphoproliferative Disorder	112 (.25%)
Decreased Appetite	109 (.24%)
Blood Bilirubin Increased	108 (.24%)
Haematuria	107 (.24%)
Peritonitis	107 (.24%)
Epstein-barr Virus Infection	105 (.23%)
Renal Tubular Necrosis	105 (.23%)
Myocardial Infarction	102 (.22%)
Headache	101 (.22%)
Oedema	101 (.22%)
Lymphadenopathy	99 (.22%)
Acute Respiratory Distress Syndrome	98 (.22%)
Cellulitis	98 (.22%)
Lung Infiltration	97 (.21%)
Pseudomonas Infection	97 (.21%)
Bronchopulmonary Aspergillosis	93 (.2%)
Febrile Neutropenia	93 (.2%)
Polyomavirus-associated Nephropathy	93 (.2%)
Pulmonary Embolism	93 (.2%)
Urosepsis	92 (.2%)
Drug Interaction	91 (.2%)
Aplasia Pure Red Cell	90 (.2%)
Bk Virus Infection	89 (.2%)
Cholestasis	89 (.2%)
Agranulocytosis	88 (.19%)
Gastrointestinal Disorder	88 (.19%)
Cardiac Failure	87 (.19%)
Malaise	87 (.19%)
Atrial Fibrillation	86 (.19%)
Back Pain	86 (.19%)
Post Procedural Complication	86 (.19%)
Hepatitis C	85 (.19%)
Thrombotic Microangiopathy	84 (.18%)
Neutrophil Pelger-huet Anomaly Pres...	83 (.18%)
Lung Infection	82 (.18%)
Chest Pain	81 (.18%)
Hepatic Function Abnormal	81 (.18%)
Respiratory Distress	81 (.18%)
Hypogammaglobulinaemia	80 (.18%)
Rash	80 (.18%)

Share/Embed Graph Export Data

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

What are the most common Mycophenolate Mofetil adverse events reported to the FDA?

Infections - Pathogen Unspecified	3598 (7.92%)
Viral Infectious	2151 (4.73%)
Renal Disorders	1575 (3.47%)
Immune	1565 (3.44%)
Bacterial Infectious	1510 (3.32%)
Procedural And Device Related Injur...	1231 (2.71%)
Respiratory	1119 (2.46%)
Gastrointestinal Signs	1047 (2.3%)
Hepatic And Hepatobiliary	918 (2.02%)
Fungal Infectious	868 (1.91%)
Hematology Investigations	857 (1.89%)
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Anemias Nonhemolytic And Marrow Dep...	830 (1.83%)
Neurological	754 (1.66%)
White Blood Cell	752 (1.65%)
Gastrointestinal Motility And Defec...	721 (1.59%)
Renal And Urinary Tract Investigati...	687 (1.51%)
Body Temperature Conditions	677 (1.49%)
Lower Respiratory Tract Disorders	600 (1.32%)
Cardiac Arrhythmias	565 (1.24%)
Nephropathies	507 (1.12%)
Fatal Outcomes	498 (1.1%)
Hepatobiliary	467 (1.03%)
Epidermal And Dermal Conditions	460 (1.01%)
Therapeutic And Nontherapeutic Effe...	447 (.98%)
Electrolyte And Fluid Balance Condi...	410 (.9%)
Urinary Tract Signs	398 (.88%)
Peritoneal And Retroperitoneal Cond...	345 (.76%)
Microbiology And Serology	333 (.73%)
Hematological And Lymphoid Tissue T...	328 (.72%)
Hematopoietic Neoplasms	320 (.7%)
Injuries	319 (.7%)
Pleural	308 (.68%)
Central Nervous System Vascular	300 (.66%)
Appetite And General Nutritional	297 (.65%)
Gastrointestinal Hemorrhages	291 (.64%)
Glucose Metabolism Disorders	276 (.61%)
Tissue	268 (.59%)
Bile Duct	264 (.58%)
Decreased And Nonspecific Blood Pre...	263 (.58%)
Vascular Hypertensive	262 (.58%)
Chemical Injury And Poisoning	259 (.57%)
Therapeutic Procedures And Supporti...	257 (.57%)
Seizures	256 (.56%)
Gastrointestinal Ulceration And Per...	255 (.56%)
Musculoskeletal And Connective Tiss...	243 (.53%)
Physical Examination Topics	233 (.51%)
Coronary Artery	230 (.51%)
Gastrointestinal Inflammatory Condi...	228 (.5%)
Heart Failures	225 (.5%)
Platelet	224 (.49%)
Muscle	222 (.49%)
Pulmonary Vascular	196 (.43%)
Movement Disorders	194 (.43%)
Myocardial	191 (.42%)
Vascular	189 (.42%)
Coagulopathies And Bleeding Diathes...	188 (.41%)
Cardiac And Vascular Investigations	186 (.41%)
Renal And Urinary Tract Therapeutic...	168 (.37%)
Embolism And Thrombosis	167 (.37%)
Gastrointestinal Conditions	165 (.36%)
Musculoskeletal And Connective Tiss...	161 (.35%)
Mycobacterial Infectious	158 (.35%)
Bone And Joint Injuries	155 (.34%)
Encephalopathies	154 (.34%)
Spleen, Lymphatic And Reticulendoth...	154 (.34%)
Immunodeficiency Syndromes	151 (.33%)
Miscellaneous And Site Unspecified ...	151 (.33%)
Gastrointestinal Stenosis And Obstr...	150 (.33%)
Bone Disorders	148 (.33%)
Enzyme	148 (.33%)
Ear And Labyrinthine Disorders Cong...	146 (.32%)
Lymphatic Vessel	140 (.31%)
Protein And Chemistry Analyses	136 (.3%)
Vascular Hemorrhagic	134 (.29%)
Cardiac And Vascular Disorders Cong...	132 (.29%)
Metabolic, Nutritional And Blood Ga...	129 (.28%)
Joint	127 (.28%)
Gallbladder	125 (.28%)
Lipid Metabolism	125 (.28%)
Gastrointestinal Therapeutic Proced...	123 (.27%)
Toxicology And Therapeutic Drug Mon...	122 (.27%)
Cardiac Valve	114 (.25%)
Arteriosclerosis, Stenosis, Vascula...	113 (.25%)
Respiratory And Mediastinal Neoplas...	113 (.25%)
Vision	112 (.25%)
Protozoal Infectious	111 (.24%)
Skin And Subcutaneous Tissue	111 (.24%)
Exocrine Pancreas Conditions	110 (.24%)
Leukemias	110 (.24%)
Gastrointestinal Tract Disorders Co...	108 (.24%)
Headaches	108 (.24%)
Skin Neoplasms Malignant And Unspec...	107 (.24%)
Deliria	102 (.22%)
Oral Soft Tissue Conditions	102 (.22%)
Ureteric	99 (.22%)
Skin Appendage Conditions	97 (.21%)
Cardiac Disorder Signs	94 (.21%)
Immunology And Allergy	94 (.21%)
Vascular Inflammations	93 (.2%)
Water, Electrolyte And Mineral	91 (.2%)
Eye Disorders Congenital	90 (.2%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Mycophenolate Mofetil, 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 Mycophenolate Mofetil 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 Mycophenolate Mofetil According to Those Reporting Adverse Events

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

Renal Transplant	2196
Immunosuppression	1137
Prophylaxis Against Transplant Reje...	1057
Prophylaxis Against Graft Versus Ho...	617
Product Used For Unknown Indication	499
Liver Transplant	460
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Drug Use For Unknown Indication	398
Immunosuppressant Drug Therapy	334
Heart Transplant	324
Systemic Lupus Erythematosus	184
Lupus Nephritis	161
Lung Transplant	154
Graft Versus Host Disease	136
Stem Cell Transplant	109
Transplant Rejection	71
Anti-neutrophil Cytoplasmic Antibod...	56
Kidney Transplant Rejection	48
Transplant	48
Prophylaxis	47
Renal And Pancreas Transplant	42
Nephrotic Syndrome	38
Wegeners Granulomatosis	35
Uveitis	35
Cord Blood Transplant Therapy	34
Pemphigus	33
Liver Transplant Rejection	33
Vasculitis	32
Evans Syndrome	32
Chronic Graft Versus Host Disease	32
Bone Marrow Transplant	30
Myasthenia Gravis	30
Acute Graft Versus Host Disease	28
Pyoderma Gangrenosum	26
Drug Exposure During Pregnancy	26
Acute Myeloid Leukaemia	21
Autoimmune Hepatitis	20
Dermatitis Atopic	19
Autoimmune Disorder	19
Organ Transplant	13
Behcets Syndrome	13
Pancreas Transplant	12
Foetal Exposure During Pregnancy	12
Ill-defined Disorder	12
Multiple Myeloma	12
Crohns Disease	11
Dermatomyositis	11
Renal Vasculitis	10
Multiple Sclerosis	10
Rheumatoid Arthritis	10
Scleroderma	9
Idiopathic Thrombocytopenic Purpura	8

Drug Labels

Label	Labeler	Effective
Mycophenolate Mofetil	UDL Laboratories, Inc.	02-APR-10
Mycophenolate Mofetil	Greenstone LLC	16-SEP-10
Mycophenolate Mofetil	Zydus Pharmaceuticals (USA) Inc.	28-APR-11
Mycophenolate Mofetil	Cadila Healthcare Limited	29-APR-11
Cellcept	Rebel Distributors Corp	13-MAY-11
Cellcept	Cardinal Health	09-JUN-11
Mycophenolate Mofetil	American Health Packaging	10-AUG-11
Cellcept	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	05-DEC-11
Cellcept	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	22-MAY-12
Mycophenolate Mofetil	Accord Healthcare Inc	01-JUL-12
Mycophenolate Mofetil	Mylan Pharmaceuticals Inc.	02-JUL-12
Cellcept	Genentech, Inc.	05-JUL-12
Mycophenolate Mofetil	Qualitest Pharmaceuticals	17-JUL-12
Mycophenolate Mofetil	Qualitest Pharmaceuticals	23-JUL-12
Mycophenolate Mofetil	Ascend Laboratories, LLC	24-JUL-12
Mycophenolate Mofetil	American Health Packaging	24-JUL-12
Mycophenolate Mofetil	Apotex Corp	26-JUL-12
Mycophenolate Mofetil	Roxane Laboratories, Inc	31-JUL-12
Mycophenolate Mofetil	Sandoz Inc	08-AUG-12
Mycophenolate Mofetil	Sandoz Inc	14-AUG-12
Mycophenolate Mofetil	Teva Pharmaceuticals USA Inc	27-DEC-12
Mycophenolate Mofetil	Roxane Laboratories, Inc	14-FEB-13
Mycophenolate Mofetil	Cardinal Health	08-MAR-13

Mycophenolate Mofetil Case Reports

What Mycophenolate Mofetil 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 Mycophenolate Mofetil. 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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