85/100 · Critical
Manufactured by Genentech, Inc.
Mycophenolate Mofetil Hydrochloride: High Incidence of Serious Infections and Renal Issues
257,534 FDA adverse event reports analyzed
Last updated: 2026-05-12
MYCOPHENOLATE MOFETIL HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 257,534 FDA adverse event reports, MYCOPHENOLATE MOFETIL HYDROCHLORIDE 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 HYDROCHLORIDE 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 HYDROCHLORIDE.
Mycophenolate Mofetil Hydrochloride 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 257,534 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 frequency of serious infections and renal issues reported.
Significant number of drug interactions and intolerances noted. Common off-label use and ineffective treatment reported.
Patients taking Mycophenolate Mofetil Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Mycophenolate Mofetil Hydrochloride can interact with various drugs, leading to increased toxicity or reduced efficacy. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mycophenolate Mofetil Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 91.5% serious event ratio across 128,246 classified reports. The score accounts for 257,534 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: 55,658, Female: 54,424, Unknown: 644. The most frequently reported age groups are age 43 (2,512 reports), age 44 (2,234 reports), age 60 (2,202 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 128,246 classified reports for MYCOPHENOLATE MOFETIL HYDROCHLORIDE:
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 Hydrochloride can interact with various drugs, leading to increased toxicity or reduced efficacy. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Mycophenolate Mofetil Hydrochloride, 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. Inform your healthcare provider about any pre-existing conditions, especially infections or kidney issues, before starting Mycophenolate Mofetil Hydrochloride. Report any adverse reactions to your healthcare provider immediately. 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 the safety of Mycophenolate Mofetil Hydrochloride and has issued several warnings regarding its use, particularly in transplant patients and those with immunosuppressed conditions.
The FDA has received approximately 257,534 adverse event reports associated with Mycophenolate Mofetil Hydrochloride. 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 Hydrochloride include Off Label Use, Drug Ineffective, Product Use In Unapproved Indication, Diarrhoea, Pyrexia. By volume, the top reported reactions are: Off Label Use (18,023 reports), Drug Ineffective (10,629 reports), Product Use In Unapproved Indication (7,071 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 Hydrochloride.
Out of 128,246 classified reports, 117,326 (91.5%) were classified as serious and 10,920 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 Hydrochloride break down by patient sex as follows: Male: 55,658, Female: 54,424, 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 Hydrochloride adverse events are: age 43: 2,512 reports, age 44: 2,234 reports, age 60: 2,202 reports, age 57: 2,143 reports, age 64: 2,082 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 frequency of serious infections and renal issues reported.
Key safety signals identified in Mycophenolate Mofetil Hydrochloride's adverse event data include: Serious infections (Pneumonia, Cytomegalovirus Infection) are frequently reported.. Renal impairment and acute kidney injury are common adverse events.. Drug interactions and intolerances are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Mycophenolate Mofetil Hydrochloride can interact with various drugs, leading to increased toxicity or reduced efficacy. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mycophenolate Mofetil Hydrochloride.
Inform your healthcare provider about any pre-existing conditions, especially infections or kidney issues, before starting Mycophenolate Mofetil Hydrochloride. Report any adverse reactions to your healthcare provider immediately.
Mycophenolate Mofetil Hydrochloride has 257,534 adverse event reports on file with the FDA. Significant number of drug interactions and intolerances noted. The volume of reports for Mycophenolate Mofetil Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Mycophenolate Mofetil Hydrochloride and has issued several warnings regarding its use, particularly in transplant patients and those with immunosuppressed conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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