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MYCOPHENOLIC ACID

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Mycophenolic Acid Adverse Events Reported to the FDA Over Time

How are Mycophenolic Acid adverse event reports trending over time?

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

Most Common Mycophenolic Acid Adverse Events Reported to the FDA

What are the most common Mycophenolic Acid adverse events reported to the FDA?

Blood Creatinine Increased
66 (1.73%)
Diarrhoea
63 (1.65%)
Pyrexia
58 (1.52%)
Cytomegalovirus Infection
53 (1.39%)
Kidney Transplant Rejection
51 (1.33%)
Renal Failure Acute
49 (1.28%)
Leukopenia
42 (1.1%)
Renal Impairment
42 (1.1%)
Renal Failure
40 (1.05%)
Nausea
35 (.92%)
Dyspnoea
32 (.84%)
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Drug Ineffective
31 (.81%)
Abdominal Pain
30 (.78%)
Complications Of Transplanted Kidne...
28 (.73%)
Sepsis
28 (.73%)
Anaemia
25 (.65%)
Lung Disorder
25 (.65%)
Vomiting
25 (.65%)
Urinary Tract Infection
24 (.63%)
Cough
23 (.6%)
Bronchiectasis
22 (.58%)
Pancytopenia
22 (.58%)
Pneumonia
22 (.58%)
Respiratory Failure
22 (.58%)
Neutropenia
21 (.55%)
Hypotension
20 (.52%)
Skin Lesion
20 (.52%)
Oedema Peripheral
19 (.5%)
Proteinuria
19 (.5%)
Septic Shock
19 (.5%)
Hypertension
18 (.47%)
Asthenia
17 (.44%)
Febrile Neutropenia
17 (.44%)
Headache
17 (.44%)
Pyelonephritis Acute
17 (.44%)
Urosepsis
17 (.44%)
Cytolytic Hepatitis
16 (.42%)
Drug Resistance
16 (.42%)
Fatigue
16 (.42%)
General Physical Health Deteriorati...
16 (.42%)
Haemoglobin Decreased
16 (.42%)
Lymphocele
15 (.39%)
Nephropathy Toxic
15 (.39%)
Wound Dehiscence
15 (.39%)
Chest Pain
14 (.37%)
Concomitant Disease Progression
14 (.37%)
Diabetes Mellitus
14 (.37%)
Oropharyngeal Pain
14 (.37%)
Surgery
14 (.37%)
Dehydration
13 (.34%)
Hypogammaglobulinaemia
13 (.34%)
Pharyngitis
13 (.34%)
Pseudomonas Infection
13 (.34%)
Transplant Rejection
13 (.34%)
C-reactive Protein Increased
12 (.31%)
Dizziness
12 (.31%)
Drug Interaction
12 (.31%)
Hydrocele Male Infected
12 (.31%)
Liver Function Test Abnormal
12 (.31%)
Lung Infection
12 (.31%)
Upper Respiratory Tract Infection
12 (.31%)
Agranulocytosis
11 (.29%)
Bacteraemia
11 (.29%)
Death
11 (.29%)
Hepatic Encephalopathy
11 (.29%)
Hepatic Failure
11 (.29%)
Malaise
11 (.29%)
Multi-organ Failure
11 (.29%)
Pain In Extremity
11 (.29%)
Urinary Retention
11 (.29%)
Acute Hepatic Failure
10 (.26%)
Acute Prerenal Failure
10 (.26%)
Deep Vein Thrombosis
10 (.26%)
Femur Fracture
10 (.26%)
Pyelocaliectasis
10 (.26%)
Respiratory Distress
10 (.26%)
Weight Decreased
10 (.26%)
Ascites
9 (.24%)
Cytomegalovirus Colitis
9 (.24%)
Disease Progression
9 (.24%)
Graft Versus Host Disease
9 (.24%)
Immune Reconstitution Syndrome
9 (.24%)
Liver Transplant Rejection
9 (.24%)
Osteoporosis
9 (.24%)
Peritonitis
9 (.24%)
Pyelonephritis
9 (.24%)
Thrombotic Microangiopathy
9 (.24%)
Abdominal Pain Lower
8 (.21%)
Abdominal Pain Upper
8 (.21%)
Bronchopneumonia
8 (.21%)
Diverticulitis
8 (.21%)
Drug Toxicity
8 (.21%)
Escherichia Infection
8 (.21%)
Haematuria
8 (.21%)
Hepatitis C
8 (.21%)
Tremor
8 (.21%)
Abdominal Distension
7 (.18%)
Aplasia Pure Red Cell
7 (.18%)
Aspartate Aminotransferase Increase...
7 (.18%)
Atrial Fibrillation
7 (.18%)
Azotaemia
7 (.18%)

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

What are the most common Mycophenolic Acid adverse events reported to the FDA?

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

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

Renal Transplant
351
Immunosuppression
76
Pancreas Transplant
31
Prophylaxis Against Transplant Reje...
31
Graft Versus Host Disease
30
Stem Cell Transplant
21
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Pemphigus
18
Liver Transplant
17
Lung Transplant
11
Product Used For Unknown Indication
10
Immunosuppressant Drug Therapy
10
Heart Transplant
9
Transplant
9
Systemic Lupus Erythematosus
9
Wegeners Granulomatosis
6
Chronic Graft Versus Host Disease
5
Prophylaxis Against Graft Versus Ho...
4
Renal Failure Chronic
4
Pyoderma Gangrenosum
4
Ill-defined Disorder
4
Lupus Nephritis
3
Drug Use For Unknown Indication
3
Renal And Pancreas Transplant
3
Heart And Lung Transplant
2
Kidney Transplant Rejection
2
Nephrotic Syndrome
2
Vasculitis
2
Organ Transplant
2
Nephropathy
2
Intermediate Uveitis
2
Transplant Rejection
1
Behcets Syndrome
1
Postoperative Care
1
Cryoglobulinaemia
1
Aplastic Anaemia
1
Dermatitis Atopic
1
Hiv Infection
1
Aplasia Pure Red Cell
1
Evans Syndrome
1
Balance Disorder
1
Myasthenia Gravis
1
Haematological Malignancy
1

Mycophenolic Acid Case Reports

What Mycophenolic Acid 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 Mycophenolic Acid. 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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