SINTROM: 55 Adverse Event Reports & Safety Profile
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55
Total FAERS Reports
8 (14.5%)
Deaths Reported
44
Hospitalizations
55
As Primary/Secondary Suspect
9
Life-Threatening
First Report: 199001 · Latest Report: 201406
What Are the Most Common SINTROM Side Effects?
#1 Most Reported
International normalised ratio increased
13 reports (23.6%)
#2 Most Reported
Drug interaction
13 reports (23.6%)
#3 Most Reported
Anaemia
9 reports (16.4%)
All SINTROM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug interaction | 13 | 23.6% | 1 | 11 |
| International normalised ratio increased | 13 | 23.6% | 1 | 10 |
| Anaemia | 9 | 16.4% | 0 | 9 |
| Cardiac failure | 8 | 14.6% | 1 | 8 |
| Hypotension | 7 | 12.7% | 0 | 7 |
| Fall | 6 | 10.9% | 1 | 6 |
| Haematoma | 6 | 10.9% | 0 | 4 |
| Therapeutic response increased | 6 | 10.9% | 0 | 6 |
| Bradycardia | 5 | 9.1% | 0 | 5 |
| Hyponatraemia | 5 | 9.1% | 0 | 5 |
| Overdose | 5 | 9.1% | 1 | 5 |
Who Reports SINTROM Side Effects? Age & Gender Data
Average age: 74.7 years. Most reports from: ES. View detailed demographics →
Is SINTROM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 1 |
| 2012 | 1 | 1 | 1 |
| 2013 | 31 | 3 | 26 |
| 2014 | 18 | 2 | 14 |
What Is SINTROM Used For?
| Indication | Reports |
|---|---|
| Atrial fibrillation | 21 |
| Product used for unknown indication | 5 |
Official FDA Label for SINTROM
Official prescribing information from the FDA-approved drug label.