65/100 · Elevated
Manufactured by Apotex Corp
Moderate Safety Concerns with Modafinil Based on FDA Adverse Event Data
65,856 FDA adverse event reports analyzed
Last updated: 2026-05-12
MODAFINIL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp. Based on analysis of 65,856 FDA adverse event reports, MODAFINIL 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 MODAFINIL include FATIGUE, NAUSEA, DRUG INEFFECTIVE, HEADACHE, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MODAFINIL.
Modafinil 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 65,856 adverse event reports for this medication, which is primarily manufactured by Apotex Corp.
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 57.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most frequently reported adverse events, with over 2,900 and 2,200 reports respectively.
Serious adverse events, including falls, depression, and suicidal ideation, account for nearly 58% of all reports. The highest number of reports is from individuals aged 50-57, indicating potential age-related safety concerns. Drug interactions and hypersensitivity reactions are notable safety signals, with over 490 and 451 reports respectively.
Patients taking Modafinil should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Modafinil can interact with other medications, and patients should inform their healthcare providers of all drugs they are taking. Hypersensitivity reactions have been reported, and patients should discontinue use if they experience symptoms such as This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Modafinil received a safety concern score of 65/100 (elevated concern). This is based on a 57.9% serious event ratio across 31,622 classified reports. The score accounts for 65,856 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: 21,312, Male: 9,232, Unknown: 52. The most frequently reported age groups are age 55 (448 reports), age 53 (436 reports), age 52 (433 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,622 classified reports for MODAFINIL:
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.
Modafinil can interact with other medications, and patients should inform their healthcare providers of all drugs they are taking. Hypersensitivity reactions have been reported, and patients should discontinue use if they experience symptoms such as
If you are taking Modafinil, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, headache, fall. 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 all medications and supplements you are taking to avoid potential drug interactions. Report any unusual symptoms or side effects 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 Modafinil's safety profile, and updates will be issued as necessary. Healthcare providers should be vigilant in monitoring patients for serious adverse events and drug interactions.
The FDA has received approximately 65,856 adverse event reports associated with Modafinil. 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 Modafinil include Fatigue, Nausea, Drug Ineffective, Headache, Fall. By volume, the top reported reactions are: Fatigue (2,903 reports), Nausea (2,217 reports), Drug Ineffective (2,104 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Modafinil.
Out of 31,622 classified reports, 18,321 (57.9%) were classified as serious and 13,301 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 Modafinil break down by patient sex as follows: Female: 21,312, Male: 9,232, Unknown: 52. 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 Modafinil adverse events are: age 55: 448 reports, age 53: 436 reports, age 52: 433 reports, age 54: 414 reports, age 56: 412 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 Modafinil adverse event reports is Apotex Corp. 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 Modafinil include: Depression, Anxiety, Dizziness, Somnolence, Pain. 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 Modafinil 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.
Modafinil 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. Fatigue and nausea are the most frequently reported adverse events, with over 2,900 and 2,200 reports respectively.
Key safety signals identified in Modafinil's adverse event data include: Falls and depression are significant safety signals, particularly in older adults.. Suicidal ideation and death reports are concerning, especially given the high number of serious events.. Drug interactions and hypersensitivity reactions are key safety signals that require careful monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Modafinil can interact with other medications, and patients should inform their healthcare providers of all drugs they are taking. Hypersensitivity reactions have been reported, and patients should discontinue use if they experience symptoms such as Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Modafinil.
Inform your healthcare provider about all medications and supplements you are taking to avoid potential drug interactions. Report any unusual symptoms or side effects to your healthcare provider immediately.
Modafinil has 65,856 adverse event reports on file with the FDA. Serious adverse events, including falls, depression, and suicidal ideation, account for nearly 58% of all reports. The volume of reports for Modafinil reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Modafinil's safety profile, and updates will be issued as necessary. Healthcare providers should be vigilant in monitoring patients for serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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