What the label lists and what reports show
Modafinil side effects
Modafinil's FDA label: “Most common adverse reactions (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.” FAERS holds 32,100 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,945 reports).
- Generic listed
- DEA Schedule IV
Check it at the source: the modafinil FDA label on DailyMed (effective October 16, 2025, Golden State Medical Supply, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of PROVIGIL?PROVIGIL may cause serious side effects. Stop taking PROVIGIL and call your doctor right away or get emergency help if you get any of the following: a serious rash or serious allergic reaction. ( See “What is the most important information I should know about PROVIGIL?”) mental (psychiatric) symptoms, including: depression feeling anxious hearing, seeing, feeling, or sensing things that are not really there (hallucinations) an extreme increase in activity and talking (mania) thoughts of suicide aggressive behavior other mental problems symptoms of a heart problem, including chest pain, abnormal heartbeat, and trouble breathing. […]
Source: FDA drug label, NDA020717 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective October 16, 2025 (SPL set 3b8d1c32-dac9-50e6-e063-6394a90aa5a5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.
Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials Adverse Reactions that occurred in > 1% of PROVIGIL-treated patients (either 200, 300, or 400 mg once daily) and greater incidence than placebo in…
| Reaction | PROVIGIL (%) (n = 934) | Placebo (%) (n = 567) |
|---|---|---|
| Headache | 34 | 23 |
| Nausea | 11 | 3 |
| Nervousness | 7 | 3 |
| Rhinitis | 7 | 6 |
| Back Pain | 6 | 5 |
| Diarrhea | 6 | 5 |
| Anxiety | 5 | 1 |
| Dizziness | 5 | 4 |
| Dyspepsia | 5 | 4 |
| Insomnia | 5 | 1 |
| Anorexia | 4 | 1 |
| Dry Mouth | 4 | 2 |
| Pharyngitis | 4 | 2 |
| Chest Pain | 3 | 1 |
| Hypertension | 3 | 1 |
| Abnormal Liver Function | 2 | 1 |
| Constipation | 2 | 1 |
| Depression | 2 | 1 |
| Palpitation | 2 | 1 |
| Paresthesia | 2 | 0 |
| Somnolence | 2 | 1 |
| Tachycardia | 2 | 1 |
| Vasodilatation | 2 | 0 |
| Abnormal Vision | 1 | 0 |
| Agitation | 1 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Serious Rash, including Stevens-Johnson Syndrome [see Warnings and Precautions ( 5.1 )] Angioedema and Anaphylaxis Reactions [see Warnings and Precautions ( 5.2 )] Multi-organ Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Persistent Sleepiness [see Warnings and Precautions ( 5.4 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.5 )] Effects on Ability to Drive and Use Machinery [see Warnings and Precautions ( 5.6 )] Cardiovascular Events [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. PROVIGIL has been evaluated for safety in over 3,500 patients, of whom more than 2,000 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.
Source: FDA drug label, NDA020717 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective October 16, 2025 (SPL set 3b8d1c32-dac9-50e6-e063-6394a90aa5a5), via openFDA; the full label on DailyMed
What do FAERS reports show?
32,100 reports list modafinil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,070 are coded as a death and 6,829 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (5,872, against a median of 1,338 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Modafinil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions