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