55/100 · Moderate
Manufactured by Biogen Inc.
Dimethyl Fumurate Adverse Events: Common Mild Reactions with Some Serious Cases
232,901 FDA adverse event reports analyzed
Last updated: 2026-05-12
DIMETHYL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Biogen Inc.. Based on analysis of 232,901 FDA adverse event reports, DIMETHYL FUMARATE has a safety score of 55 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for DIMETHYL FUMARATE include FLUSHING, NAUSEA, DIARRHOEA, MULTIPLE SCLEROSIS RELAPSE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIMETHYL FUMARATE.
Dimethyl Fumarate has a safety concern score of 55 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 232,901 adverse event reports for this medication, which is primarily manufactured by Biogen Inc..
The most commonly reported adverse events include Flushing, Nausea, Diarrhoea. Of classified reports, 33.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions are flushing, nausea, and diarrhea, which are generally mild to moderate.
Serious adverse events, including falls and seizures, account for about 33% of reports. The majority of reactions are non-serious, but the diversity of reactions indicates a complex safety profile.
Patients taking Dimethyl Fumarate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dimethyl fumarate can cause falls and seizures, and patients should be monitored for these symptoms, especially in elderly patients. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dimethyl Fumarate received a safety concern score of 55/100 (elevated concern). This is based on a 33.2% serious event ratio across 121,679 classified reports. The score accounts for 232,901 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 90,106, Male: 24,405, Unknown: 477. The most frequently reported age groups are age 53 (1,900 reports), age 51 (1,889 reports), age 52 (1,887 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 121,679 classified reports for DIMETHYL FUMARATE:
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.
Dimethyl fumarate can cause falls and seizures, and patients should be monitored for these symptoms, especially in elderly patients.
If you are taking Dimethyl Fumarate, here are important things to know. The most commonly reported side effects include flushing, nausea, diarrhoea, multiple sclerosis relapse, fatigue. 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 unusual symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse reactions. 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 dimethyl fumarate, and updates will be provided as necessary.
The FDA has received approximately 232,901 adverse event reports associated with Dimethyl Fumarate. 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 Dimethyl Fumarate include Flushing, Nausea, Diarrhoea, Multiple Sclerosis Relapse, Fatigue. By volume, the top reported reactions are: Flushing (17,057 reports), Nausea (8,956 reports), Diarrhoea (8,268 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dimethyl Fumarate.
Out of 121,679 classified reports, 40,367 (33.2%) were classified as serious and 81,312 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 Dimethyl Fumarate break down by patient sex as follows: Female: 90,106, Male: 24,405, Unknown: 477. 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 Dimethyl Fumarate adverse events are: age 53: 1,900 reports, age 51: 1,889 reports, age 52: 1,887 reports, age 55: 1,879 reports, age 50: 1,843 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 Dimethyl Fumarate adverse event reports is Biogen 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 Dimethyl Fumarate include: Multiple Sclerosis, Vomiting, Memory Impairment, Gastric Disorder, Abdominal Pain Upper. 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 Dimethyl Fumarate 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.
Dimethyl Fumarate has a safety concern score of 55 out of 100 (elevated 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. The most common reactions are flushing, nausea, and diarrhea, which are generally mild to moderate.
Key safety signals identified in Dimethyl Fumarate's adverse event data include: Falls and seizures are key safety signals, indicating potential neurological risks.. Decreased white blood cell count and lymphocyte count are also notable, suggesting potential immunosuppressive effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dimethyl fumarate can cause falls and seizures, and patients should be monitored for these symptoms, especially in elderly patients. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dimethyl Fumarate.
Patients should report any unusual symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to minimize the risk of adverse reactions.
Dimethyl Fumarate has 232,901 adverse event reports on file with the FDA. Serious adverse events, including falls and seizures, account for about 33% of reports. The volume of reports for Dimethyl Fumarate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of dimethyl fumarate, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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