Provigilmodafinil
According to the FDA label: Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
31,874 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Provigil in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Fatigue 2,925 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 2,233 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 2,123 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Headache 1,854 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Fall 1,777 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Depression 1,605 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Anxiety 1,493 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Somnolence 1,403 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,395 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Pain 1,284 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Insomnia 1,142 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 1,130 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Feeling Abnormal 1,112 reports
A general report that the person did not feel like themselves, without a more specific description.
Full definition in the glossary →Weight Decreased 1,102 reports
Asthenia 1,071 reports
Physical weakness or lack of strength.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 21,445 |
| Male | 9,307 |
| Unknown | 52 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 423 |
| 18-34 | 2,679 |
| 35-49 | 5,047 |
| 50-64 | 5,790 |
| 65-74 | 1,899 |
| 75+ | 760 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Provigil. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 13,759 |
| Non-Serious | 13,370 |
| Hospitalization | 6,782 |
| Death | 1,064 |
| Disability | 683 |
| Life-Threatening | 455 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Provigil. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 333 |
| 2005 | 475 |
| 2006 | 441 |
| 2007 | 570 |
| 2008 | 787 |
| 2009 | 704 |
| 2010 | 781 |
| 2011 | 975 |
| 2012 | 1,010 |
| 2013 | 801 |
| 2014 | 1,045 |
| 2015 | 2,420 |
| 2016 | 5,872 |
| 2017 | 2,523 |
| 2018 | 2,558 |
| 2019 | 2,338 |
| 2020 | 1,879 |
| 2021 | 1,267 |
| 2022 | 1,338 |
| 2023 | 1,328 |
| 2024 | 1,269 |
| 2025 | 951 |
| 2026 (partial) | 209 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Provigil
In FDA adverse event reports that mention Provigil, these medications appeared most often in the same report.
- Oxybate (11,326 reports)
- Ergocalciferol (6,595 reports)
- Gabapentin (5,806 reports)
- Baclofen (3,907 reports)
- Omeprazole (3,671 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026