Short answer: In pooled placebo-controlled trials of 150 mg and 250 mg, the most common Nuvigil side effects were headache (17% vs 9% on placebo), nausea (7% vs 3%), dizziness (5% vs 2%) and trouble sleeping (5% vs 1%). Headache, rash, depression, dry mouth, insomnia and nausea rose with dose. Nuvigil has no boxed warning; serious skin reactions, including Stevens-Johnson syndrome, are its first listed risk.
What Nuvigil is approved for: Nuvigil is approved to improve wakefulness in adults with excessive sleepiness from obstructive sleep apnea (OSA), narcolepsy or shift work disorder (section 1). In OSA it treats the sleepiness, not the blocked airway. It has not been studied in children and is not approved for them (section 5.1).
Source
NUVIGIL (armodafinil) tablets, for oral use, C-IV, prescribing information and Medication Guide. Cephalon (Teva Pharmaceuticals). DailyMed, version published May 7, 2025. DailyMed setid d878aed0-ddbf-8fa1-abf7-d3e480260845
No. The current Nuvigil 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 Nuvigil.
| Adverse reaction | NUVIGIL (%) N=645 | Placebo (%) N=445 |
|---|---|---|
| Headache | 17 | 9 |
| Nausea | 7 | 3 |
| Dizziness | 5 | 2 |
| Insomnia | 5 | 1 |
| Anxiety | 4 | 1 |
| Diarrhea | 4 | 2 |
| Dry Mouth | 4 | 1 |
| Depression | 2 | 0 |
| Dyspepsia | 2 | 0 |
| Fatigue | 2 | 1 |
| Palpitations | 2 | 1 |
| Rash | 2 | 0 |
| Upper Abdominal Pain | 2 | 1 |
Reactions in more than 1% of people on Nuvigil and more often than on placebo. Rows at 2% or more are shown; the full table also lists 23 reactions at 1% vs 0% (such as agitation, migraine, tremor, fever and increased heart rate).
| Adverse reaction | NUVIGIL 250 mg (%) N=198 | NUVIGIL 150 mg (%) N=447 | NUVIGIL Combined (%) N=645 | Placebo (%) N=445 |
|---|---|---|---|---|
| Headache | 23 | 14 | 17 | 9 |
| Nausea | 9 | 6 | 7 | 3 |
| Insomnia | 6 | 4 | 5 | 1 |
| Dry Mouth | 7 | 2 | 4 | <1 |
| Rash | 4 | 1 | 2 | <1 |
| Depression | 3 | 1 | 2 | <1 |
7% of people on Nuvigil (44 of 645) stopped because of a side effect vs 4% on placebo (16 of 445); the most frequent reason was headache (1%).
Anxiety, agitation, nervousness and irritability led to stopping in 1.2% on Nuvigil vs 0.3% on placebo, and depression in 0.6% vs 0.2%. Cases of suicidal thoughts were seen in trials.
Average blood pressure rose 1.2 to 4.3 mmHg vs placebo, and pulse 0.9 to 3.5 beats per minute. New or more blood pressure medicine was needed by 2.9% vs 1.8%.
Mean GGT and alkaline phosphatase were higher on Nuvigil but not placebo, with few values outside normal. One case of mild pancytopenia resolved after stopping.
Reported after approval: mouth sores, including blistering and ulceration.
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 skin reactions, including Stevens-Johnson syndrome. Serious rash needing hospital care has been reported with armodafinil and modafinil, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Onset was 1 day to 2 months after starting, sometimes later. Nuvigil is stopped at the first sign of rash, skin or mouth sores, blistering or ulceration unless clearly not drug-related.
DRESS and multi-organ allergic reactions. DRESS can start with fever, swollen lymph nodes or facial swelling, even before a rash, and can affect the liver, kidneys, blood, heart or muscles. One fatal case was reported 3 weeks after starting Nuvigil. Nuvigil is stopped if it is suspected.
Angioedema and anaphylaxis. Angioedema and allergic reactions with rash, trouble swallowing and wheezing were seen with Nuvigil. Signs such as swelling of the face, lips, tongue or throat or hoarseness mean stopping and reporting right away.
Persistent sleepiness. Wakefulness may not return to normal. People are reassessed often 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, at daily doses from 50 to 450 mg. Caution is used with a history of psychosis, depression or mania.
Heart events. Nuvigil is not recommended with left ventricular hypertrophy or with mitral valve prolapse syndrome on earlier stimulants. Heart rate and blood pressure may be watched more closely, with caution in known heart disease.
Controlled substance. Armodafinil is a Schedule IV controlled substance, and the Medication Guide says it can be abused or lead to dependence.
Birth control. Hormonal birth control may work less well during Nuvigil use and for one month after stopping, so a barrier or non-hormonal method is advised.
From the Medication Guide that comes with Nuvigil:
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.