OpenClaim

Modafinil Side Effects

The most commonly reported side effects of modafinil include fatigue, nausea, and headache, based on 32,383 FDA adverse event reports from 2004 to 2025. 5.9% of reports found the drug to be ineffective.

Modafinil side effects

Percentages show how often each reaction appears relative to total reports for modafinil.

1
Fatigue7.8%2,538
2
Drug Ineffective5.9%1,913
3
Nausea5.7%1,843
4
Headache4.8%1,542
5
Fall4.8%1,540
6
Depression4.1%1,330
7
Anxiety3.9%1,259
8
Dizziness3.7%1,206
9
Somnolence3.7%1,186
10
Pain3.2%1,051
11
Feeling Abnormal3.1%1,002
12
Insomnia3.0%971
13
Condition Aggravated3.0%968
14
Weight Decreased2.9%943
15
Off Label Use2.7%871

These are voluntary reports and do not establish that modafinil caused these reactions.

Report severity

58.1%Serious18,822 reports
21.3%Hospitalizations6,887 reports
3.3%Fatal1,073 reports

Seriousness is determined by the reporter, not by OpenClaim.

Modafinil drug interactions

Other drugs that appear in adverse event reports alongside modafinil. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sodium-oxybate37.5%12,131
2
Dalfampridine6.7%2,185
3
Interferon5.3%1,726
4
Dimethyl4.1%1,328
5
Fingolimod3.2%1,044
6
Natalizumab2.8%913
7
Ocrelizumab2.3%738
8
Calcium-oxybate2.2%716
9
Magnesium-oxybate2.2%716
10
Potassium-oxybate2.2%716
11
Glatiramer-acetate1.6%506
12
Teriflunomide1.5%490
13
Armodafinil1.4%449
14
Methylphenidate1.3%415
15
Duloxetine-hydrochloride1.0%333

Taken alongside

1
Ergocalciferol22.4%7,241
2
Acetaminophen19.6%6,333
3
Gabapentin17.5%5,679
4
Levothyroxine-sodium13.9%4,514
5
Aspirin12.2%3,956
6
Baclofen12.1%3,929
7
Omeprazole12.1%3,916
8
Albuterol11.9%3,867
9
Ibuprofen11.2%3,641
10
Fluticasone11.2%3,623
11
Duloxetine-hydrochloride11.0%3,563
12
Bupropion10.9%3,539
13
Dextroamphetamine10.6%3,446
14
Clonazepam9.6%3,101
15
Amphetamine9.4%3,053

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports modafinil side effects

67.3% of modafinil adverse event reports involve female patients and 29.3% involve male patients. The largest age group is adult at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female67.3%
Male29.3%
Unknown3.4%

Age group

< 20.3%
2–110.4%
12–171.9%
18–6481.4%
65+16.1%

What is modafinil used for

Conditions and purposes for which patients were taking modafinil when the adverse event was reported.

Adrenal InsufficiencyAdverse Drug ReactionAdverse EventAffective DisorderAggressionAgitationAltered State Of ConsciousnessAmnesiaAntidepressant TherapyAnxietyAnxiety DisorderApathyApnoeaArthralgiaAsthenia

Showing 15 of 370 indications

Modafinil brand names and reporting trend

Modafinil is sold under the brand name Provigil.

Brand names

Provigil17,303

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking modafinil with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.