PROVIGIL: 48 Adverse Event Reports & Safety Profile
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48
Total FAERS Reports
2 (4.2%)
Deaths Reported
9
Hospitalizations
48
As Primary/Secondary Suspect
First Report: 2005 · Latest Report: 20140615
What Are the Most Common PROVIGIL Side Effects?
#1 Most Reported
Off label use
9 reports (18.8%)
#2 Most Reported
Drug ineffective
8 reports (16.7%)
#3 Most Reported
Somnolence
7 reports (14.6%)
All PROVIGIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 9 | 18.8% | 1 | 3 |
| Drug ineffective | 8 | 16.7% | 0 | 0 |
| Somnolence | 7 | 14.6% | 0 | 1 |
| Fatigue | 6 | 12.5% | 0 | 0 |
| Insomnia | 6 | 12.5% | 0 | 2 |
| Headache | 5 | 10.4% | 0 | 0 |
| Nausea | 5 | 10.4% | 0 | 0 |
| Pain | 5 | 10.4% | 0 | 0 |
Who Reports PROVIGIL Side Effects? Age & Gender Data
Average age: 46.2 years. Most reports from: US. View detailed demographics →
Is PROVIGIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 4 | 1 | 2 |
| 2013 | 10 | 0 | 4 |
| 2014 | 7 | 0 | 1 |
What Is PROVIGIL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 11 |
| Narcolepsy | 7 |
| Fatigue | 5 |
Official FDA Label for PROVIGIL
Official prescribing information from the FDA-approved drug label.