Provigil Side Effects

Generic Name: modafinil

Note: This page contains side effects data for the generic drug modafinil. It is possible that some of the dosage forms included below may not apply to the brand name Provigil.

It is possible that some side effects of Provigil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to modafinil: oral tablet

As well as its needed effects, modafinil (the active ingredient contained in Provigil) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking modafinil, check with your doctor immediately:

Less common
  • Black, tarry stools
  • blurred vision or other vision changes
  • chest pain
  • chills or fever
  • clumsiness or unsteadiness
  • confusion
  • dizziness or fainting
  • increased thirst and urination
  • mental depression
  • problems with memory
  • rapidly changing moods
  • shortness of breath
  • sore throat
  • trembling or shaking
  • trouble in urinating
  • uncontrolled movements of the face, mouth, or tongue
  • unusual bleeding or bruising
  • unusual tiredness or weakness

If any of the following symptoms of overdose occur while taking modafinil, get emergency help immediately:

Symptoms of overdose
  • Agitation or excitement
  • fast or pounding heartbeat
  • increased blood pressure
  • trouble with sleeping

Some modafinil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Anxiety
  • headache
  • nausea
  • nervousness
Less common
  • Back pain
  • belching
  • decrease in appetite
  • diarrhea
  • difficulty having a bowel movement
  • dryness of the mouth
  • dryness of the skin
  • feeling of constant movement of self or surroundings
  • flushing or redness of the skin
  • heartburn
  • indigestion
  • muscle stiffness
  • sores, ulcers, or white spots on the lips or in the mouth
  • sour stomach
  • stomach discomfort upset or pain
  • stuffy or runny nose
  • swelling
  • tingling, burning, or prickling sensations in the skin
  • vomiting

For Healthcare Professionals

Applies to modafinil: oral tablet

General

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.[Ref]

Dermatologic

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 (the active ingredient contained in Provigil) should be discontinued at the first sign of rash unless the rash is definitely not drug-related.[Ref]

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.[Ref]

Hypersensitivity

Multi-organ hypersensitivity reactions have occurred in close temporal association to the initiation of modafinil (the active ingredient contained in Provigil) 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

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 (the active ingredient contained in Provigil) 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. Postmarketing adverse events associated with the use of modafinil have included aggression.[Ref]

Cardiovascular

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 (the active ingredient contained in Provigil) PVCs continued for 14 to 20 days before finally subsiding.[Ref]

Gastrointestinal

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.[Ref]

Respiratory

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

Nervous system

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.[Ref]

Hematologic

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

Ocular

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

Metabolic

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

Musculoskeletal

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

Genitourinary

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

References

1. "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.

2. Vorspan F, Warot D, Consoli A, Cohen D, Mazet P "Mania in a boy treated with modafinil for narcolepsy." Am J Psychiatry 162 (2005): 813-4

3. Narendran R, Young CM, Valenti AM, Nickolova MK, Pristach CA "Is psychosis exacerbated by modafinil?" Arch Gen Psychiatry 59 (2002): 292-3

4. Oskooilar N "A case of premature ventricular contractions with modafinil." Am J Psychiatry 162 (2005): 1983-4

5. Heitmann J, Cassel W, Grote L, et al. "Does short-term treatment with modafinil affect blood pressure in patients with obstructive sleep apnea?" Clin Pharmacol Ther 65 (1999): 328-35

6. "Multum Information Services, Inc. Expert Review Panel"

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