MALARONE: 33 Adverse Event Reports & Safety Profile
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33
Total FAERS Reports
0
Deaths Reported
12
Hospitalizations
33
As Primary/Secondary Suspect
2
Disabilities
First Report: 20090702 · Latest Report: 20140317
What Are the Most Common MALARONE Side Effects?
#1 Most Reported
Headache
7 reports (21.2%)
#2 Most Reported
Mouth ulceration
5 reports (15.2%)
#3 Most Reported
Fatigue
4 reports (12.1%)
All MALARONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 7 | 21.2% | 0 | 5 |
| Mouth ulceration | 5 | 15.2% | 0 | 2 |
Who Reports MALARONE Side Effects? Age & Gender Data
Average age: 46.8 years. Most reports from: FR. View detailed demographics →
Is MALARONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 1 |
| 2013 | 9 | 0 | 2 |
| 2014 | 14 | 0 | 7 |
What Is MALARONE Used For?
| Indication | Reports |
|---|---|
| Malaria prophylaxis | 20 |
| Prophylaxis | 5 |
Official FDA Label for MALARONE
Official prescribing information from the FDA-approved drug label.