85/100 · Critical
Manufactured by Genentech, Inc.
Mycophenolate Mofetil Adverse Events: High Seriousness and Diverse Reactions
256,184 FDA adverse event reports analyzed
Last updated: 2026-05-12
MYCOPHENOLATE MOFETIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 256,184 FDA adverse event reports, MYCOPHENOLATE MOFETIL has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for MYCOPHENOLATE MOFETIL include OFF LABEL USE, DRUG INEFFECTIVE, PRODUCT USE IN UNAPPROVED INDICATION, DIARRHOEA, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MYCOPHENOLATE MOFETIL.
Mycophenolate Mofetil has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 256,184 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Product Use In Unapproved Indication. Of classified reports, 91.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (91.5%) indicates significant safety concerns.
Diverse range of reactions, including infections, renal impairment, and graft rejection, highlight the drug's broad potential risks. Report volume is substantial, with over 256,000 reports, providing a comprehensive dataset for analysis.
Patients taking Mycophenolate Mofetil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Mycophenolate Mofetil can interact with other immunosuppressants and may increase the risk of infections and other adverse events. Warnings include monitoring for drug interactions and infections. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mycophenolate Mofetil received a safety concern score of 85/100 (high concern). This is based on a 91.5% serious event ratio across 128,019 classified reports. The score accounts for 256,184 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 55,598, Female: 54,295, Unknown: 644. The most frequently reported age groups are age 43 (2,507 reports), age 44 (2,224 reports), age 60 (2,199 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 128,019 classified reports for MYCOPHENOLATE MOFETIL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Mycophenolate Mofetil can interact with other immunosuppressants and may increase the risk of infections and other adverse events. Warnings include monitoring for drug interactions and infections.
If you are taking Mycophenolate Mofetil, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, product use in unapproved indication, diarrhoea, pyrexia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring for signs of infection, renal function, and graft rejection is crucial. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Mycophenolate Mofetil for safety, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information.
The FDA has received approximately 256,184 adverse event reports associated with Mycophenolate Mofetil. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Mycophenolate Mofetil include Off Label Use, Drug Ineffective, Product Use In Unapproved Indication, Diarrhoea, Pyrexia. By volume, the top reported reactions are: Off Label Use (17,971 reports), Drug Ineffective (10,593 reports), Product Use In Unapproved Indication (7,053 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mycophenolate Mofetil.
Out of 128,019 classified reports, 117,114 (91.5%) were classified as serious and 10,905 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Mycophenolate Mofetil break down by patient sex as follows: Male: 55,598, Female: 54,295, Unknown: 644. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Mycophenolate Mofetil adverse events are: age 43: 2,507 reports, age 44: 2,224 reports, age 60: 2,199 reports, age 57: 2,132 reports, age 55: 2,073 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Mycophenolate Mofetil adverse event reports is Genentech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Mycophenolate Mofetil include: Pneumonia, Cytomegalovirus Infection, Nausea, Fatigue, Condition Aggravated. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Mycophenolate Mofetil to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Mycophenolate Mofetil has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (91.5%) indicates significant safety concerns.
Key safety signals identified in Mycophenolate Mofetil's adverse event data include: High incidence of infections (Pneumonia, Cytomegalovirus Infection, Sepsis, etc.). Renal impairment and failure are frequently reported, indicating potential nephrotoxicity.. Graft rejection and transplant complications are significant concerns, especially in transplant patients.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Mycophenolate Mofetil can interact with other immunosuppressants and may increase the risk of infections and other adverse events. Warnings include monitoring for drug interactions and infections. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mycophenolate Mofetil.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring for signs of infection, renal function, and graft rejection is crucial.
Mycophenolate Mofetil has 256,184 adverse event reports on file with the FDA. Diverse range of reactions, including infections, renal impairment, and graft rejection, highlight the drug's broad potential risks. The volume of reports for Mycophenolate Mofetil reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Mycophenolate Mofetil for safety, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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