Slideshows Images Quizzes

Provigil

Last reviewed on RxList: 5/8/2018
Provigil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/8/2018

Provigil (modafinil) is a stimulant prescribed to increase wakefulness in patients with excessive sleepiness related to narcolepsy, shiftwork sleep disorder, and obstructive sleep apnea/hypopnea syndrome. Common side effects of Provigil are:

Tell your doctor if you experience serious side effects of Provigil including:

  • fever,
  • easy bruising or bleeding,
  • hallucinations,
  • depression,
  • chest pain,
  • fast/pounding/irregular heartbeat, or
  • mental/mood changes (such as confusion, depression, hallucinations, rare thoughts of suicide).

Provigil dosage is 200 or 400 mg daily. Provigil drug interactions include cyclosporine (Sandimmune), theophylline (Theo-24), hormonal contraceptives (for example, Micronor), warfarin (Coumadin), diazepam (Valium), propranolol (Inderal), imipramine (Tofranil), desipramine (Norpramin), phenytoin (Dilantin), carbamazepine (Tegretol), rifampin (Rifadin), Ketoconazole (Nizoral) and itraconazole (Sporanox). Provigil has not been adequately studied in pregnant women and it is unknown if it is excreted in breast milk. Consult your doctor before breastfeeding.

Our Provigil Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Provigil Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using modafinil and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • easy bruising or bleeding;
  • white patches or sores inside your mouth or on your lips;
  • hallucinations, unusual thoughts or behavior;
  • depression, anxiety, aggression; or
  • chest pain, uneven heart beats.

Less serious side effects may include:

  • headache, dizziness;
  • feeling nervous or agitated;
  • nausea, diarrhea;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Provigil (Modafinil)

Provigil Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

PROVIGIL has been evaluated for safety in over 3,500 patients, of whom more than 2,000 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.

Most Common Adverse Reactions

In placebo-controlled clinical trials, the most common adverse reactions ( ≥ 5%) associated with the use of PROVIGIL more frequently than placebo-treated patients were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse reaction profile was similar across these studies.

Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in PROVIGIL-treated patients than in placebo-treated patients in the placebo-controlled clinical trials.

Table 1: Adverse Reactions in Pooled Placebo-Controlled Trials* in Narcolepsy, OSA, and SWD

  PROVIGIL (%)
(n = 934)
Placebo (%)
(n = 567)
Headache 34 23
Nausea 11 3
Nervousness 7 3
Rhinitis 7 6
Back Pain 6 5
Diarrhea 6 5
Anxiety 5 1
Dizziness 5 4
Dyspepsia 5 4
Insomnia 5 1
Anorexia 4 1
Dry Mouth 4 2
Pharyngitis 4 2
Chest Pain 3 1
Hypertension 3 1
Abnormal Liver Function 2 1
Constipation 2 1
Depression 2 1
Palpitation 2 1
Paresthesia 2 0
Somnolence 2 1
Tachycardia 2 1
Vasodilatation 2 0
Abnormal Vision 1 0
Agitation 1 0
Asthma 1 0
Chills 1 0
Confusion 1 0
Dyskinesia 1 0
Edema 1 0
Emotional Lability 1 0
Eosinophilia 1 0
Epistaxis 1 0
Flatulence 1 0
Hyperkinesia 1 0
Hypertonia 1 0
Mouth Ulceration 1 0
Sweating 1 0
Taste Perversion 1 0
Thirst 1 0
Tremor 1 0
Urine Abnormality 1 0
Vertigo 1 0
* Adverse Reactions that occurred in ≥ 1% of PROVIGIL-treated patients (either 200, 300, or 400 mg once daily) and greater incidence than placebo

Dose-Dependent Adverse Reactions

In the placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of PROVIGIL and placebo, the following adverse reactions were dose related: headache and anxiety.

Adverse Reactions Resulting in Discontinuation of Treatment

In placebo-controlled clinical trials, 74 of the 934 patients (8%) who received PROVIGIL discontinued due to an adverse reaction compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for PROVIGIL than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain, and nervousness (each < 1%).

Laboratory Abnormalities

Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of PROVIGIL, but not placebo. Few patients, however, had GGT or AP elevations outside of the normal range. Shifts to higher, but not clinically significantly abnormal, GGT and AP values appeared to increase with time in the population treated with PROVIGIL in the placebo-controlled clinical trials. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of PROVIGIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic: agranulocytosis

Psychiatric disorders: psychomotor hyperactivity

Read the entire FDA prescribing information for Provigil (Modafinil)

Related Resources for Provigil

Read the Provigil User Reviews »

© Provigil Patient Information is supplied by Cerner Multum, Inc. and Provigil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

CONTINUE SCROLLING FOR RELATED ARTICLE

Health Solutions From Our Sponsors