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Nuvigil Side Effects

Generic name: armodafinil

Medically reviewed by Drugs.com. Last updated on Jun 15, 2023.

Note: This document contains side effect information about armodafinil. Some dosage forms listed on this page may not apply to the brand name Nuvigil.

Applies to armodafinil: oral tablet.

Serious side effects of Nuvigil

Along with its needed effects, armodafinil (the active ingredient contained in Nuvigil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking armodafinil:

Less common

Get emergency help immediately if any of the following symptoms of overdose occur while taking armodafinil:

Symptoms of overdose

Other side effects of Nuvigil

Some side effects of armodafinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

For Healthcare Professionals

Applies to armodafinil: oral tablet.

General

The following reactions occurred more frequently with the 250 mg/day dose compared to the 150 mg/day dose: headache, rash, depression, dry mouth, insomnia, nausea.[Ref]

Dermatologic

Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of armodafinil (the active ingredient contained in Nuvigil) or modafinil (the racemic mixture of S- and R-enantiomers). Rare cases of serious or life-threatening rash, including SJS and TEN, have been reported in adults and children in worldwide post-marketing experience with

modafinil and armodafinil.[Ref]

Common (1% to 10%): Rash, contact dermatitis, hyperhidrosis

Frequency not reported: Serious skin reactions including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN)

Postmarketing reports: Skin and mouth sores, blistering, ulceration, Drug Reaction with Eosinophilia and System Symptoms

(DRESS)/Multiorgan Hypersensitivity[Ref]

Immunologic

Common (1% to 10%): Seasonal allergy

Frequency not reported: Angioedema, anaphylaxis[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression, agitation, depressed mood, disturbance in attention, nervousness

Frequency not reported: Irritability, suicidal ideation

Postmarketing reports: Mania, delusions, hallucinations, aggression[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, increased heart rate, increased blood pressure[Ref]

Hypersensitivity

Frequency not reported: Angioedema, hypersensitivity (rash, dysphagia, and bronchospasm)

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, dry mouth, dyspepsia, upper abdominal pain, constipation, vomiting, loose stools

Postmarketing reports: Mouth sores (including mouth blistering and ulceration)[Ref]

Genitourinary

Common (1% to 10%): Polyuria[Ref]

Hematologic

Frequency not reported: Pancytopenia[Ref]

Hepatic

Common (1% to 10%): Increased gamma-glutamyltransferase, increased alkaline phosphatase

Rare (less than 0.1%): Elevated AST and/or ALT[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite,

Frequency not reported: Decreased serum uric acid[Ref]

Nervous system

Very common (10% or more): Headache (17%)

Common (1% to 10%): Dizziness, paresthesia, tremor, migraine[Ref]

Other

Common (1% to 10%): Fatigue, influenza-like illness, pain, pyrexia, thirst[Ref]

Respiratory

Common (1% to 10%): Dyspnea[Ref]

References

1. Product Information. Nuvigil (armodafinil). Cephalon Inc. 2007.

2. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.