Nuvigil Side Effects

Generic name: armodafinil

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

Some side effects of Nuvigil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to armodafinil: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking armodafinil (the active ingredient contained in Nuvigil) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using armodafinil and call your doctor at once if you have a serious side effect such as:

• fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;

• the first sign of any type of skin rash, no matter how mild;

• bruising, severe tingling, numbness, pain, muscle weakness;

• easy bruising or bleeding;

• mouth sores, trouble swallowing;

• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• depression, confusion, hallucinations, aggression, unusual thoughts or behavior;

• chest pain, uneven heart beats.

Less serious side effects of armodafinil may include:

• headache, dizziness;

• feeling nervous or anxious;

• nausea, diarrhea, upset stomach;

• trouble sleeping (insomnia); or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to armodafinil: oral tablet

General

In general, armodafinil (the active ingredient contained in Nuvigil) has been well tolerated and most side effects have been mild to moderate in severity.

Cardiovascular

Cardiovascular side effects have included palpitations (2%) and tachycardia (1%).

Gastrointestinal

Gastrointestinal side effects have frequently included nausea (7%), diarrhea (4%), dry mouth (4%), dyspepsia (2%), and upper abdominal pain (2%). Constipation, vomiting, anorexia, decreased appetite, and loose stools have been reported in 1% of patients.

Nervous system

Nervous system side effects have included headache (17%), dizziness (5%), insomnia (5%), tremor (1%), migraine headache (1%), paresthesia (1%), and disturbance in attention (1%).

Other

Other side effects have included fatigue (2%), thirst (1%), influenza-like illness (1%), fever (1%), and pain (1%).

Psychiatric

Psychiatric side effects have included anxiety (4%), depression (2%), agitation (1%), nervousness (1%), and depressed mood (1%). Postmarketing adverse events associated with the use of modafinil have included aggression.

Genitourinary

Genitourinary side effects have included polyuria (1%).

Respiratory

Respiratory side effects have included dyspnea (1%).

Dermatologic

Dermatologic side effects have included rash (2%), contact dermatitis (1%), and hyperhydrosis (1%). Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults in association with the use of modafinil and armodafinil (the active ingredient contained in Nuvigil)

Hematologic

Hematologic side effects include a single case of mild pancytopenia that resolved following discontinuation of armodafinil (the active ingredient contained in Nuvigil)

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