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MYCOPHENOLATE MEFETIL

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Mycophenolate Mefetil Adverse Events Reported to the FDA Over Time

How are Mycophenolate Mefetil adverse event reports trending over time?

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

Most Common Mycophenolate Mefetil Adverse Events Reported to the FDA

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

Bronchiectasis
47 (3.27%)
Hypogammaglobulinaemia
46 (3.2%)
Diarrhoea
23 (1.6%)
Pyrexia
18 (1.25%)
Anaemia
16 (1.11%)
Leukopenia
16 (1.11%)
Transplant Rejection
13 (.9%)
Idiopathic Pneumonia Syndrome
12 (.83%)
Pain
12 (.83%)
Sepsis
12 (.83%)
Blood Creatinine Increased
10 (.69%)
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Diabetes Mellitus
10 (.69%)
Drug Ineffective
10 (.69%)
Pneumonia
10 (.69%)
Renal Impairment
10 (.69%)
Urinary Tract Infection
10 (.69%)
Vomiting
10 (.69%)
Cardiac Arrest
9 (.63%)
Cytomegalovirus Infection
9 (.63%)
Nausea
9 (.63%)
Abdominal Pain
8 (.56%)
Central Nervous System Lesion
8 (.56%)
Dyspnoea
8 (.56%)
Epstein-barr Virus Associated Lymph...
8 (.56%)
Graft Versus Host Disease
8 (.56%)
Hypertension
8 (.56%)
Lower Respiratory Tract Infection
8 (.56%)
Pancytopenia
8 (.56%)
Progressive Multifocal Leukoencepha...
8 (.56%)
C-reactive Protein Increased
7 (.49%)
Constipation
7 (.49%)
Death
7 (.49%)
Decreased Appetite
7 (.49%)
Erythema
7 (.49%)
Immune Reconstitution Syndrome
7 (.49%)
Multi-organ Failure
7 (.49%)
Muscular Weakness
7 (.49%)
Pneumocystis Jiroveci Pneumonia
7 (.49%)
Abortion Spontaneous
6 (.42%)
Alanine Aminotransferase Increased
6 (.42%)
Aspartate Aminotransferase Increase...
6 (.42%)
Complications Of Transplanted Kidne...
6 (.42%)
Drug Interaction
6 (.42%)
Drug Level Decreased
6 (.42%)
Faecaloma
6 (.42%)
Kidney Transplant Rejection
6 (.42%)
Musculoskeletal Pain
6 (.42%)
Myalgia
6 (.42%)
Myelitis Transverse
6 (.42%)
Pleural Fibrosis
6 (.42%)
Pulmonary Vasculitis
6 (.42%)
Renal Failure
6 (.42%)
Renal Failure Chronic
6 (.42%)
Respiratory Gas Exchange Disorder
6 (.42%)
Sensory Loss
6 (.42%)
Spirometry Abnormal
6 (.42%)
Thrombocytopenia
6 (.42%)
Urinary Retention
6 (.42%)
Urosepsis
6 (.42%)
Vasculitis
6 (.42%)
Bacteraemia
5 (.35%)
Basal Cell Carcinoma
5 (.35%)
Blood Immunoglobulin G Decreased
5 (.35%)
Bone Marrow Oedema
5 (.35%)
Cough
5 (.35%)
Failure To Thrive
5 (.35%)
Foot Fracture
5 (.35%)
Lymphocele
5 (.35%)
Neutropenia
5 (.35%)
Neutrophil Count Decreased
5 (.35%)
Nodule
5 (.35%)
Off Label Use
5 (.35%)
Pleural Effusion
5 (.35%)
Pneumonia Herpes Viral
5 (.35%)
Proteinuria
5 (.35%)
Respiratory Distress
5 (.35%)
White Blood Cell Count Decreased
5 (.35%)
Acanthamoeba Infection
4 (.28%)
Acute Myeloid Leukaemia Recurrent
4 (.28%)
Asthenia
4 (.28%)
Benign Intracranial Hypertension
4 (.28%)
Bronchitis
4 (.28%)
Confusional State
4 (.28%)
Convulsion
4 (.28%)
Cryptococcosis
4 (.28%)
Dehydration
4 (.28%)
Disease Progression
4 (.28%)
Drug Ineffective For Unapproved Ind...
4 (.28%)
Epstein-barr Virus Infection
4 (.28%)
Fatigue
4 (.28%)
Haemoglobin Decreased
4 (.28%)
Hepatic Enzyme Increased
4 (.28%)
Hepatic Lesion
4 (.28%)
Infection
4 (.28%)
Lip Swelling
4 (.28%)
Liver Transplant Rejection
4 (.28%)
Oedema Peripheral
4 (.28%)
Pneumonia Aspiration
4 (.28%)
Polyomavirus-associated Nephropathy
4 (.28%)
Postrenal Failure
4 (.28%)
Protein Urine Present
4 (.28%)

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

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

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

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

Renal Transplant
89
Immunosuppression
56
Prophylaxis Against Graft Versus Ho...
41
Product Used For Unknown Indication
41
Prophylaxis Against Transplant Reje...
35
Immunosuppressant Drug Therapy
27
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Liver Transplant
24
Stem Cell Transplant
8
Graft Versus Host Disease
6
Systemic Lupus Erythematosus
5
Polymyositis
5
Heart Transplant
4
Renal Vasculitis
4
Transplant
4
Anti-neutrophil Cytoplasmic Antibod...
3
Autoimmune Lymphoproliferative Synd...
3
Henoch-schonlein Purpura
2
Prophylaxis
2
Epidermolysis Bullosa
2
Lung Transplant
2
Iga Nephropathy
2
Drug Exposure During Pregnancy
2
Lupus Nephritis
2
Pemphigoid
2
Nephrotic Syndrome
1
Nephropathy
1
Transplant Rejection
1
Immune Tolerance Induction
1
Dermatitis Bullous
1
Liver Transplant Rejection
1
Tubulointerstitial Nephritis And Uv...
1
Glomerulonephritis Membranoprolifer...
1
Multiple Myeloma
1
Wegeners Granulomatosis
1
Pemphigus
1
Myelodysplastic Syndrome
1
Inflammation
1
Kidney Transplant Rejection
1
Glomerulonephritis Minimal Lesion
1
Autoimmune Hepatitis
1
Renal Failure Chronic
1
Allogenic Bone Marrow Transplantati...
1
Vasculitis
1
Uveitis
1

Mycophenolate Mefetil Case Reports

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

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About Results

This report contains aggregated drug side effects and adverse events for Mycophenolate Mefetil. 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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