65/100 · Elevated
Manufactured by Genzyme Corporation
Teriflunomide Adverse Events: Moderate Safety Concerns
108,080 FDA adverse event reports analyzed
Last updated: 2026-05-12
TERIFLUNOMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genzyme Corporation. Based on analysis of 108,080 FDA adverse event reports, TERIFLUNOMIDE has a safety score of 65 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 TERIFLUNOMIDE include ALOPECIA, MULTIPLE SCLEROSIS RELAPSE, FATIGUE, DIARRHOEA, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TERIFLUNOMIDE.
Teriflunomide has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 108,080 adverse event reports for this medication, which is primarily manufactured by Genzyme Corporation.
The most commonly reported adverse events include Alopecia, Multiple Sclerosis Relapse, Fatigue. Of classified reports, 43.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include alopecia, fatigue, and gastrointestinal issues, indicating a broad spectrum of potential side effects.
Serious adverse events, such as falls, depression, and hospitalization, account for nearly 43% of reports, suggesting significant safety concerns. The drug is associated with cognitive and neurological issues, including memory impairment and paraesthesia, which may impact quality of life. Drug interactions and dose omissions are frequently reported, highlighting the need for careful monitoring and adherence. The safety profile shows a high incidence of psychiatric and neurological symptoms, which may require close monitoring in patients.
Patients taking Teriflunomide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Teriflunomide is associated with multiple drug interactions, and patients should be cautious about potential interactions with other medications. Dose omissions and misuse are common, necessitating strict adherence to prescribed dosing. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Teriflunomide received a safety concern score of 65/100 (elevated concern). This is based on a 43.2% serious event ratio across 44,666 classified reports. The score accounts for 108,080 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: 33,098, Male: 8,020, Unknown: 215. The most frequently reported age groups are age 55 (997 reports), age 54 (987 reports), age 56 (970 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 44,666 classified reports for TERIFLUNOMIDE:
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.
Teriflunomide is associated with multiple drug interactions, and patients should be cautious about potential interactions with other medications. Dose omissions and misuse are common, necessitating strict adherence to prescribed dosing.
If you are taking Teriflunomide, here are important things to know. The most commonly reported side effects include alopecia, multiple sclerosis relapse, fatigue, diarrhoea, fall. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for cognitive and psychiatric symptoms, such as depression and confusion, and report any changes to your healthcare provider. Be aware of potential falls and balance issues, especially if you are elderly or have pre-existing mobility concerns. 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.
Regulatory oversight is ongoing, with the FDA monitoring adverse events and adjusting safety guidelines as necessary. Patients should report any adverse reactions promptly and follow prescribed dosing instructions closely.
The FDA has received approximately 108,080 adverse event reports associated with Teriflunomide. 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 Teriflunomide include Alopecia, Multiple Sclerosis Relapse, Fatigue, Diarrhoea, Fall. By volume, the top reported reactions are: Alopecia (6,066 reports), Multiple Sclerosis Relapse (5,211 reports), Fatigue (4,755 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Teriflunomide.
Out of 44,666 classified reports, 19,306 (43.2%) were classified as serious and 25,360 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 Teriflunomide break down by patient sex as follows: Female: 33,098, Male: 8,020, Unknown: 215. 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 Teriflunomide adverse events are: age 55: 997 reports, age 54: 987 reports, age 56: 970 reports, age 52: 957 reports, age 58: 950 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 Teriflunomide adverse event reports is Genzyme Corporation. 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 Teriflunomide include: Hypoaesthesia, Headache, Drug Ineffective, Paraesthesia, Nausea. 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 Teriflunomide 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.
Teriflunomide has a safety concern score of 65 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 adverse reactions include alopecia, fatigue, and gastrointestinal issues, indicating a broad spectrum of potential side effects.
Key safety signals identified in Teriflunomide's adverse event data include: Falls and balance disorders are notable safety signals, especially in older patients.. Cognitive and psychiatric symptoms, such as depression and confusion, are frequent and may require regular assessment.. Neurological symptoms, including paraesthesia and peripheral neuropathy, are common and may indicate potential long-term effects.. Serious adverse events like hospitalization and death are reported, indicating a need for vigilance.. Drug dose omissions and use issues are frequently reported, suggesting potential misuse or misunderstanding of the medication.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Teriflunomide is associated with multiple drug interactions, and patients should be cautious about potential interactions with other medications. Dose omissions and misuse are common, necessitating strict adherence to prescribed dosing. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Teriflunomide.
Monitor for cognitive and psychiatric symptoms, such as depression and confusion, and report any changes to your healthcare provider. Be aware of potential falls and balance issues, especially if you are elderly or have pre-existing mobility concerns.
Teriflunomide has 108,080 adverse event reports on file with the FDA. Serious adverse events, such as falls, depression, and hospitalization, account for nearly 43% of reports, suggesting significant safety concerns. The volume of reports for Teriflunomide reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA monitoring adverse events and adjusting safety guidelines as necessary. Patients should report any adverse reactions promptly and follow prescribed dosing instructions closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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