August 1, 2015
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Provigil

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Provigil




Provigil Side Effects Center

Pharmacy Editor: Eni Williams, Pharm.D., Ph.D.

Last reviewed on RxList 4/24/2015

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 headache, dizziness, upper respiratory tract infection, nausea, diarrhea, nervousness, anxiety, agitation, dry mouth, and trouble sleeping (insomnia). Tell your doctor if you experience serious side effects of Provigil including fever, easy bruising or bleeding, hallucinations, depression, or chest pain.

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Provigil in Detail - Patient Information: Side Effects

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)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Provigil Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, nervousness, dizziness, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood changes (such as agitation, confusion, depression, hallucinations, rare thoughts of suicide).

Get medical help right away if you have any very serious side effects, including: chest pain.

A very serious allergic reaction to this drug is rare. However, stop taking modafinil and get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, skin blisters/peeling, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, mouth sores, weakness, easy bruising/bleeding, symptoms of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Provigil (Modafinil)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Provigil FDA Prescribing Information: Side Effects
(Adverse Reactions)

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)

Provigil - User Reviews

Provigil User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Provigil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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