What the label lists and what reports show
Armodafinil side effects
Armodafinil's FDA label: “Most common adverse reactions (≥5%): headache, nausea, dizziness, and insomnia.” FAERS holds 20,967 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 (1,508 reports).
- Generic listed
- DEA Schedule IV
Check it at the source: the armodafinil FDA label on DailyMed (effective September 2, 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 the possible side effects of NUVIGIL?NUVIGIL may cause serious side effects. Stop taking NUVIGIL 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 NUVIGIL?”) mental (psychiatric) symptoms, including: depression hearing, seeing, feeling, or sensing things that are not really there (hallucinations) thoughts of suicide other mental problems feeling anxious an extreme increase in activity and talking (mania) aggressive behavior symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing. The most common side effects of NUVIGIL include: headache dizziness nausea trouble sleeping These are not all the possible side effects of NUVIGIL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, NDA021875 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective September 2, 2025 (SPL set 3dd49302-f757-d945-e063-6294a90afcba), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5%): headache, nausea, dizziness, and insomnia.
Table 1: Adverse Reactions in Pooled Placebo-Controlled Clinical Trials* in OSA, Narcolepsy, and SWD with NUVIGIL (150 mg and 250 mg)
| 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 |
| Agitation | 1 | 0 |
| Anorexia | 1 | 0 |
| Constipation | 1 | 0 |
| Contact Dermatitis | 1 | 0 |
| Decreased Appetite | 1 | 0 |
| Depressed Mood | 1 | 0 |
| Disturbance In Attention | 1 | 0 |
| Dyspnea | 1 | 0 |
| Hyperhydrosis | 1 | 0 |
| Increased Gamma-Glutamyltransferase | 1 | 0 |
| Increased Heart Rate | 1 | 0 |
| Influenza-Like Illness | 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 below and elsewhere in the labeling: Serious Dermatologic Reactions [see Warnings and Precautions ( 5.1 )] Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.2 )] Angioedema and Anaphylaxis 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, dizziness, and insomnia. ( 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. NUVIGIL has been evaluated for safety in over 1,100 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy. …
Source: FDA drug label, NDA021875 (Nuvo Pharms), as published by Golden State Medical Supply, Inc., effective September 2, 2025 (SPL set 3dd49302-f757-d945-e063-6294a90afcba), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,967 reports list armodafinil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 325 are coded as a death and 2,534 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 (5,261, against a median of 681 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?
- Armodafinil: 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