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Armodafinil Side Effects

Brand Names: Nuvigil

Please note - some side effects for Armodafinil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Armodafinil - for the Consumer

Armodafinil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Armodafinil:

Diarrhea; dizziness; dry mouth; headache; nausea; stomach pain or upset; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Armodafinil:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters on the inside of the eyes, nose, or mouth; chest pain; dark urine; fast or irregular heartbeat; fever, chills, or sore throat; increased urination; mental or mood changes (eg, aggression, agitation, anxiety, depression, exaggerated sense of well-being, hallucinations, irritability, nervousness); red, swollen, blistered, or peeling skin; shortness of breath; suicidal thoughts or actions; swelling of the legs; unusual bruising or bleeding; vomiting; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Side Effects by Body System - for Healthcare Professionals

General

In general, armodafinil 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.

Hematologic

Hematologic side effects include a single case of mild pancytopenia that resolved following discontinuation of armodafinil.

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