SAPHRIS: 89 Adverse Event Reports & Safety Profile
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89
Total FAERS Reports
3 (3.4%)
Deaths Reported
27
Hospitalizations
89
As Primary/Secondary Suspect
3
Life-Threatening
6
Disabilities
First Report: 1997 · Latest Report: 20140601
What Are the Most Common SAPHRIS Side Effects?
#1 Most Reported
Inappropriate schedule of drug administration
15 reports (16.9%)
#2 Most Reported
Weight increased
8 reports (9.0%)
#3 Most Reported
Underdose
8 reports (9.0%)
All SAPHRIS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Inappropriate schedule of drug administration | 15 | 16.9% | 0 | 8 |
| Underdose | 8 | 9.0% | 0 | 4 |
| Weight increased | 8 | 9.0% | 0 | 0 |
| Dizziness | 6 | 6.7% | 0 | 1 |
| Swollen tongue | 6 | 6.7% | 0 | 2 |
| Dyspnoea | 5 | 5.6% | 0 | 3 |
| Off label use | 5 | 5.6% | 0 | 2 |
Who Reports SAPHRIS Side Effects? Age & Gender Data
Average age: 42.0 years. Most reports from: US. View detailed demographics →
Is SAPHRIS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2011 | 6 | 0 | 4 |
| 2012 | 2 | 0 | 0 |
| 2013 | 25 | 0 | 10 |
| 2014 | 14 | 0 | 4 |
What Is SAPHRIS Used For?
| Indication | Reports |
|---|---|
| Bipolar disorder | 27 |
| Schizophrenia | 11 |
| Post-traumatic stress disorder | 5 |
| Psychotic disorder | 5 |
Official FDA Label for SAPHRIS
Official prescribing information from the FDA-approved drug label.