Modafinil Side Effects

Brand Names: Provigil

Please note - some side effects for Modafinil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Modafinil - for the consumer

Modafinil

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 Modafinil:

Back pain; diarrhea; dizziness; headache; nausea; nervousness; stomach upset; stuffy nose; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thinking; chest pain; confusion; dark urine; fever, chills, or sore throat; irregular heartbeat; mental or mood changes (eg, anxiety, depression, exaggerated sense of well-being, hallucinations); mouth sores; red, swollen, blistered, or peeling skin; shortness of breath; suicidal thoughts or actions; unusual bruising or bleeding; unusual weakness; yellowing of the skin or eyes.

By body system

General side effects

General side effects including headache (50% vs 40% in placebo), chest pain (2%), neck pain (2%), chills (2%), rigid neck (1%), and fever/chills (1%) have been reported.

Dermatologic side effects

Some cases of rash were serious or life-threatening requiring hospitalization and discontinuation of treatment. Some cases have occurred after prolonged treatment (e.g., 3 months), while others have been reported within 1 to 5 weeks of initiation of treatment. Although benign rashes may also occur, modafinil should be discontinued at the first sign of rash unless the rash is definitely not drug-related.

Dermatologic side effects including rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms have been reported. In addition, herpes simplex (1%) and dry skin (1%) have been reported.

Hypersensitivity side effects

Multi-organ hypersensitivity reactions have occurred in close temporal association to the initiation of modafinil, including at least one fatality in postmarketing experience. Multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. Patients typically present with fever and rash associated with other organ system involvement. Myocarditis, hepatitis, liver function test abnormalities, hematological abnormalities (e.g., eosinophilia, leukopenia, thrombocytopenia), pruritus, and asthenia may also occur. If multi-organ hypersensitivity is suspected at any time, modafinil should be discontinued.

Hypersensitivity reactions including rare cases of angioedema have been observed in patients treated with the racemic mixture of modafinil. Although no such cases were observed in modafinil clinical trials, angioedema has been reported in postmarketing experience. Patients should be advised to immediately discontinue therapy and promptly report any signs or symptoms suggesting angioedema or anaphylaxis to their physician (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).

Multi-organ hypersensitivity reactions have occurred in close temporal association to the initiation of modafinil, including at least one fatality in postmarketing experience.

Psychiatric side effects

Psychiatric side effects, some resulting in hospitalization, have been reported. These include mania, delusions, hallucinations, and suicidal ideation. Many, but not all, patients had a prior psychiatric history. Caution should be exercised when modafinil is given to patients with a history of psychosis, depression, or mania. Clinicians should consider discontinuation if psychiatric symptoms develop in association with modafinil therapy.

Cardiovascular side effects

Cardiovascular side effects including hypotension (2%), hypertension (2%), vasodilation (1%), arrhythmia (1%), and syncope (1%) have been reported. One case of modafinil-induced premature ventricular contractions ((PVCs), ventricular ectopic beats) has been reported and confirmed by rechallenge. Following discontinuation of modafinil, PVCs continued for 14 to 20 days before finally subsiding.

Gastrointestinal side effects

Gastrointestinal side effects including nausea (13%), diarrhea (8%), dry mouth (5%), anorexia (5%), abnormal liver function (3% vs 2% placebo), vomiting (2%), mouth ulcer (1%), gingivitis (1%), thirst (1%), and hypersalivation have been reported.

Respiratory side effects

Respiratory side effects including rhinitis (11% vs 8% placebo), pharyngitis (6%), lung disorder (4%), dyspnea (2%), asthma (1%), and epistaxis (1%) have been reported.

Nervous system side effects

Nervous system side effects including nervousness (8% vs 6% placebo), dizziness (5% vs 4% placebo), depression (4% vs 3% placebo), anxiety (4%), cataplexy (3% vs 2% placebo), insomnia (3%), paresthesia (3%), dyskinesia (2%), hypertonia (2%), confusion (1%), amnesia (1%), emotional lability (1%), ataxia (1%), and tremor (1%) have been reported.

Hematologic side effects

Hematologic side effects including eosinophilia (2%) have been reported.

Ocular side effects

Ocular side effects including amblyopia (2%), and abnormal vision (2%) have been reported.

Metabolic side effects

Metabolic side effects including hyperglycemia (1%) and albuminuria (1%) have been reported.

Musculoskeletal side effects

Musculoskeletal side effects including joint disorder (1%) have been reported.

Genitourinary side effects

Genitourinary side effects including abnormal urine (1%), urinary retention (1%), and abnormal ejaculation (1%) have been reported.

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