PLAQUENIL: 79 Adverse Event Reports & Safety Profile
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79
Total FAERS Reports
4 (5.1%)
Deaths Reported
17
Hospitalizations
79
As Primary/Secondary Suspect
4
Life-Threatening
2
Disabilities
First Report: 2001 · Latest Report: 20140614
What Are the Most Common PLAQUENIL Side Effects?
#1 Most Reported
Drug hypersensitivity
13 reports (16.5%)
#2 Most Reported
Fatigue
11 reports (13.9%)
#3 Most Reported
Pain
7 reports (8.9%)
All PLAQUENIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 13 | 16.5% | 0 | 1 |
| Fatigue | 11 | 13.9% | 0 | 1 |
| Drug ineffective | 7 | 8.9% | 0 | 3 |
| Pain | 7 | 8.9% | 0 | 2 |
| Musculoskeletal stiffness | 6 | 7.6% | 0 | 1 |
| Nausea | 6 | 7.6% | 0 | 2 |
| Pruritus | 6 | 7.6% | 1 | 4 |
| Arthralgia | 5 | 6.3% | 0 | 1 |
| Headache | 5 | 6.3% | 0 | 1 |
| Weight increased | 5 | 6.3% | 0 | 1 |
Who Reports PLAQUENIL Side Effects? Age & Gender Data
Average age: 56.4 years. Most reports from: US. View detailed demographics →
Is PLAQUENIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 1 |
| 2003 | 1 | 0 | 0 |
| 2007 | 1 | 1 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 1 | 1 | 1 |
| 2010 | 3 | 0 | 1 |
| 2012 | 10 | 0 | 1 |
| 2013 | 23 | 0 | 5 |
| 2014 | 7 | 1 | 4 |
What Is PLAQUENIL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 20 |
| Rheumatoid arthritis | 13 |
Official FDA Label for PLAQUENIL
Official prescribing information from the FDA-approved drug label.