FOCALIN: 37 Adverse Event Reports & Safety Profile
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37
Total FAERS Reports
0
Deaths Reported
8
Hospitalizations
37
As Primary/Secondary Suspect
First Report: 20110516 · Latest Report: 20140522
What Are the Most Common FOCALIN Side Effects?
#1 Most Reported
Product substitution issue
9 reports (24.3%)
#2 Most Reported
Palpitations
4 reports (10.8%)
#3 Most Reported
Insomnia
4 reports (10.8%)
All FOCALIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product substitution issue | 9 | 24.3% | 0 | 2 |
Who Reports FOCALIN Side Effects? Age & Gender Data
Average age: 12.4 years. Most reports from: US. View detailed demographics →
Is FOCALIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2013 | 7 | 0 | 1 |
| 2014 | 15 | 0 | 4 |
What Is FOCALIN Used For?
| Indication | Reports |
|---|---|
| Attention deficit/hyperactivity disorder | 26 |
Official FDA Label for FOCALIN
Official prescribing information from the FDA-approved drug label.