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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NUVIGIL: 223 Adverse Event Reports & Safety Profile

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223
Total FAERS Reports
1 (0.4%)
Deaths Reported
13
Hospitalizations
223
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities

First Report: 2004 · Latest Report: 20140620

What Are the Most Common NUVIGIL Side Effects?

#1 Most Reported
Off label use
38 reports (17.0%)
#2 Most Reported
Drug ineffective
31 reports (13.9%)
#3 Most Reported
Headache
25 reports (11.2%)

All NUVIGIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 38 17.0% 0 1
Drug ineffective 31 13.9% 0 0
Headache 25 11.2% 0 2
Somnolence 23 10.3% 0 0
Fatigue 19 8.5% 0 1
Nausea 17 7.6% 0 2
Insomnia 15 6.7% 0 1
Alopecia 14 6.3% 0 0
Drug effect decreased 10 4.5% 0 0
Rash 10 4.5% 0 1
Pain 9 4.0% 0 2
Anxiety 8 3.6% 0 0
Asthenia 8 3.6% 0 1
Adverse event 6 2.7% 0 0
Depression 6 2.7% 0 1
Fall 6 2.7% 0 2
Incorrect dose administered 6 2.7% 0 0
Sleep disorder 6 2.7% 0 0
Abdominal discomfort 5 2.2% 0 1
Arthralgia 5 2.2% 0 2

Who Reports NUVIGIL Side Effects? Age & Gender Data

Average age: 47.5 years. Most reports from: US. View detailed demographics →

Is NUVIGIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2009 2 0 1
2010 2 0 0
2011 3 0 2
2012 1 0 0
2013 24 0 2
2014 64 0 5

View full timeline →

What Is NUVIGIL Used For?

IndicationReports
Narcolepsy 37
Sleep apnoea syndrome 28
Fatigue 23
Product used for unknown indication 20
Somnolence 20
Attention deficit/hyperactivity disorder 7
Hypersomnia 7
Insomnia 6
Circadian rhythm sleep disorder 5
Multiple sclerosis 5

NUVIGIL vs Alternatives: Which Is Safer?

NUVIGIL vs NYSTATIN NUVIGIL vs NYSTATIN\TRIAMCINOLONE ACETONIDE NUVIGIL vs OBETICHOLIC ACID NUVIGIL vs OBINUTUZUMAB NUVIGIL vs OCELLA NUVIGIL vs OCRELIZUMAB NUVIGIL vs OCRIPLASMIN NUVIGIL vs OCTINOXATE\OCTISALATE\ZINC NUVIGIL vs OCTINOXATE\OCTOCRYLENE NUVIGIL vs OCTREOTIDE

Official FDA Label for NUVIGIL

Official prescribing information from the FDA-approved drug label.