STRATTERA: 143 Adverse Event Reports & Safety Profile
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143
Total FAERS Reports
6 (4.2%)
Deaths Reported
51
Hospitalizations
143
As Primary/Secondary Suspect
8
Life-Threatening
8
Disabilities
First Report: 2005 · Latest Report: 20140521
What Are the Most Common STRATTERA Side Effects?
#1 Most Reported
Depression
20 reports (14.0%)
#2 Most Reported
Suicidal ideation
17 reports (11.9%)
#3 Most Reported
Somnolence
15 reports (10.5%)
All STRATTERA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Depression | 20 | 14.0% | 0 | 16 |
| Suicidal ideation | 17 | 11.9% | 0 | 3 |
| Agitation | 15 | 10.5% | 0 | 13 |
| Somnolence | 15 | 10.5% | 0 | 11 |
| Fatigue | 14 | 9.8% | 0 | 2 |
| Anxiety | 11 | 7.7% | 0 | 6 |
| Major depression | 11 | 7.7% | 0 | 11 |
| Sedation | 11 | 7.7% | 0 | 11 |
| Attention deficit/hyperactivity disorder | 10 | 7.0% | 0 | 10 |
| Bipolar i disorder | 10 | 7.0% | 0 | 10 |
| Merycism | 10 | 7.0% | 0 | 10 |
| Nausea | 10 | 7.0% | 0 | 4 |
| Dizziness | 7 | 4.9% | 1 | 2 |
| Drug ineffective | 7 | 4.9% | 0 | 3 |
| Self injurious behaviour | 7 | 4.9% | 0 | 4 |
| Self-injurious ideation | 7 | 4.9% | 0 | 1 |
| Weight increased | 7 | 4.9% | 1 | 3 |
| Aggression | 6 | 4.2% | 0 | 2 |
| Crying | 6 | 4.2% | 0 | 0 |
| Depressed mood | 6 | 4.2% | 0 | 0 |
Who Reports STRATTERA Side Effects? Age & Gender Data
Average age: 23.6 years. Most reports from: GB. View detailed demographics →
Is STRATTERA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 3 | 0 | 3 |
| 2008 | 1 | 1 | 0 |
| 2009 | 2 | 0 | 1 |
| 2010 | 2 | 0 | 1 |
| 2011 | 2 | 0 | 1 |
| 2012 | 3 | 0 | 1 |
| 2013 | 44 | 1 | 24 |
| 2014 | 37 | 0 | 9 |
What Is STRATTERA Used For?
| Indication | Reports |
|---|---|
| Attention deficit/hyperactivity disorder | 104 |
| Product used for unknown indication | 30 |
STRATTERA vs Alternatives: Which Is Safer?
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Official FDA Label for STRATTERA
Official prescribing information from the FDA-approved drug label.