Short answer: In pooled placebo-controlled trials, the most common Provigil side effects were headache (34% vs 23% on placebo), nausea (11% vs 3%), nervousness (7% vs 3%), stuffy nose, back pain, diarrhea, anxiety (5% vs 1%), dizziness, upset stomach and trouble sleeping (5% vs 1%). Headache and anxiety rose with dose. Provigil has no boxed warning; serious rash, including Stevens-Johnson syndrome, is its first listed risk.
What Provigil is approved for: Provigil is approved to improve wakefulness in adults with excessive sleepiness from narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (section 1). In OSA it treats the sleepiness, not the blocked airway, and CPAP is continued where it is the treatment of choice. It is not approved for children for any use (section 8.4).
Source
PROVIGIL (modafinil) tablets, for oral use, C-IV, prescribing information and Medication Guide. Cephalon (Teva Pharmaceuticals). DailyMed, version published March 21, 2025. DailyMed setid e16c26ad-7bc2-d155-3a5d-da83ad6492c8
No. The current Provigil label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Provigil.
| Adverse 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 |
Rows at 2% or more on Provigil are shown; the full table also lists 20 reactions at 1% vs 0% (such as agitation, confusion, tremor, sweating and vertigo). Rhinitis means a stuffy or runny nose; dyspepsia means upset stomach; anorexia means loss of appetite.
In trials comparing 200, 300 and 400 mg/day with placebo, headache and anxiety were dose related.
8% of people on Provigil stopped because of a side effect vs 3% on placebo, most often headache (2%), then nausea, anxiety, dizziness, trouble sleeping, chest pain and nervousness (each under 1%).
New or higher blood pressure medicine was needed by 2.4% on Provigil vs 0.7% on placebo, and 3.4% vs 1.1% in the sleep apnea studies.
In children (not an approved use), rash leading to stopping occurred in about 0.8% (13 of 1,585), including one possible Stevens-Johnson case, vs none of 380 on placebo; median time to rash was 13 days.
Mean GGT and alkaline phosphatase levels were higher on Provigil but not on placebo; few people had values outside the normal range.
Reported after approval: agranulocytosis (a severe drop in white blood cells) and psychomotor hyperactivity.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Serious rash, including Stevens-Johnson syndrome. Serious rashes needing hospital care have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS. Nearly all occurred 1 to 5 weeks after starting, but some came later. No factor predicts them, so Provigil is stopped at the first sign of rash unless it is clearly not drug-related.
Angioedema and anaphylaxis. Angioedema has been reported after approval. Swelling of the face, eyes, lips, tongue or throat, trouble swallowing or breathing, or hoarseness means stopping and reporting it to the doctor right away.
Multi-organ allergic reactions. Reactions affecting several organs, including at least one death, have occurred a median of 13 days after starting. They often begin with fever and rash, and can involve the heart, liver or blood. Provigil is stopped if one is suspected.
Persistent sleepiness. Wakefulness may not return to normal. People are reassessed often for sleepiness and, if needed, told to avoid driving or other dangerous activities.
Psychiatric symptoms. Mania, delusions, hallucinations, suicidal thoughts and aggression have been reported, some needing hospital care. Caution is used with a history of psychosis, depression or mania, and stopping is considered if symptoms develop.
Heart events. Chest pain, palpitations, shortness of breath and ECG changes occurred in people with mitral valve prolapse or left ventricular hypertrophy. Provigil is not recommended in those groups, and blood pressure and heart rate may be watched more closely.
Controlled substance. Modafinil is a Schedule IV controlled substance. It produced euphoric and stimulant-like effects in a study of people experienced with drugs of abuse, and people are watched for misuse (section 9.2).
Birth control. Hormonal birth control may work less well during Provigil use and for one month after stopping, so other or added methods are recommended.
From the Medication Guide that comes with Provigil:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.