Provigil Side Effects

Generic name: modafinil

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Note: This document provides detailed information about Provigil Side Effects associated with modafinil. Some dosage forms listed on this page may not apply specifically to the brand name Provigil.

Applies to modafinil: oral tablet.

Common side effects of Provigil

Some side effects of modafinil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• anxiety
• headache
• nausea
• nervousness

Less common side effects

• 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

Serious side effects of Provigil

Along with its needed effects, modafinil (the active ingredient contained in Provigil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking modafinil:

Less common side effects

• 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking modafinil:

Symptoms of overdose

• agitation or excitement
• fast or pounding heartbeat
• increased blood pressure
• trouble with sleeping

For healthcare professionals

Applies to modafinil: oral tablet.

General adverse events

The most common adverse reactions occurring in 5% of patients or greater included headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, palpitation, tachycardia, vasodilation
• Uncommon (0.1% to 1%): Extrasystoles, arrhythmia, bradycardia, hypotension, abnormal ECG
• Frequency not reported: Hypotension
• Postmarketing reports: Ischemic heart disease

Dermatologic

• Uncommon (0.1% to 1%): Rash, acne, pruritus
• Postmarketing reports: Serious or life threatening rash, including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and system symptoms (DRESS), hyperhidrosis, urticaria (hives), angioedema, eczema

Endocrine

• Uncommon (0.1% to 1%): Diabetes mellitus

Gastrointestinal

• Very common (10% or more): Nausea (up to 11%)
• Common (1% to 10%): Diarrhea, dry mouth, dyspepsia, constipation, flatulence, mouth ulceration, abdominal pain
• Uncommon (0.1% to 1%): Reflux, vomiting, dysphagia, glossitis
• Frequency not reported: Periodontal abscess

Genitourinary

• Common (1% to 10%): Urine abnormality, hematuria, pyuria
• Uncommon (0.1% to 1%): Urinary frequency
• Frequency not reported: Urinary tract infection
• Postmarketing reports: Foul urine odor

Hematologic

• Common (1% to 10%): Eosinophilia
• Uncommon (0.1% to 1%): Leukopenia
• Frequency not reported: Ecchymosis
• Postmarketing reports: Agranulocytosis

Hepatic

• Common (1% to 10%): Abnormal liver function
• Frequency not reported: Elevated liver enzymes

Hypersensitivity

• Frequency not reported: Allergic reaction
• Postmarketing reports: Multi-organ system hypersensitivity reactions, anaphylaxis

Metabolic

• Uncommon (0.1% to 1%): Hypercholesterolemia, hyperglycemia
• Frequency not reported: Increased gamma glutamyltransferase, increased alkaline phosphatase

Musculoskeletal

• Common (1% to 10%): Back pain, hypertonia, neck rigidity
• Uncommon (0.1% to 1%): Myasthenia, twitch, neck pain, myalgia, leg cramps, arthralgia
• Frequency not reported: Arthritis
• Postmarketing reports: Muscle weakness

Nervous system

• Very common (10% or more): Headache (up to 34%)
• Common (1% to 10%): Dizziness, paresthesia, somnolence, confusion, dyskinesia, hyperkinesia, tremor, vertigo, taste perversion
• Uncommon (0.1% to 1%): Incoordination, movement disorder, speech disorder
• Frequency not reported: Migraine, cataplexy, pro-facial dyskinesias
• Postmarketing reports: Dyskinesias including tardive dyskinesia, convulsions

Ocular

• Common (1% to 10%): Abnormal vision, amblyopia, eye pain, blurred vision
• Uncommon (0.1% to 1%): Dry eye
• Frequency not reported: Conjunctivitis

Other

• Common (1% to 10%): Anorexia, chest pain, fever, viral infection, thirst, edema, chills, flu syndrome, herpes simplex, infection, pain
• Frequency not reported: Hypothermia, increased appetite, weight loss, weight gain, ear pain, dysmenorrhea
• Postmarketing reports: Tolerance, lack of efficacy, aggravated condition, malaise, fatigue

Psychiatric

• Common (1% to 10%): Nervousness, anxiety, insomnia, depression, agitation, emotional lability
• Uncommon (0.1% to 1%): Sleep disorder, decreased libido, hostility, depersonalization, personality disorder, abnormal dreams, aggression, suicidal ideation, psychomotor hyperactivity
• Rare (0.01% to 0.1%): Hallucinations, mania, psychosis
• Frequency not reported: Asthenia
• Postmarketing reports: Irritability, confusion, suicide attempt, aggravated depression, delusions, thinking abnormally

Respiratory

• Common (1% to 10%): Rhinitis, pharyngitis, asthma, epistaxis, lung disorder
• Uncommon (0.1% to 1%): Dyspnea, increased cough
• Frequency not reported: Sinusitis, bronchitis

Frequently asked questions

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Further information

Provigil side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer