FRAGMIN: 45 Adverse Event Reports & Safety Profile
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45
Total FAERS Reports
12 (26.7%)
Deaths Reported
25
Hospitalizations
45
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
First Report: 20110820 · Latest Report: 20140510
What Are the Most Common FRAGMIN Side Effects?
#1 Most Reported
Drug interaction
7 reports (15.6%)
#2 Most Reported
Hypoxic-ischaemic encephalopathy
5 reports (11.1%)
#3 Most Reported
Eosinophilic pneumonia
5 reports (11.1%)
All FRAGMIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug interaction | 7 | 15.6% | 0 | 7 |
| Allergic hepatitis | 5 | 11.1% | 5 | 1 |
| Alveolitis | 5 | 11.1% | 5 | 1 |
| Bone marrow eosinophilic leukocyte count increased | 5 | 11.1% | 5 | 1 |
| Brain oedema | 5 | 11.1% | 5 | 1 |
| Cardiac arrest | 5 | 11.1% | 5 | 1 |
| Drug reaction with eosinophilia and systemic symptoms | 5 | 11.1% | 5 | 1 |
| Eosinophilic myocarditis | 5 | 11.1% | 5 | 1 |
| Eosinophilic pneumonia | 5 | 11.1% | 5 | 1 |
| Hypoxic-ischaemic encephalopathy | 5 | 11.1% | 5 | 1 |
Who Reports FRAGMIN Side Effects? Age & Gender Data
Average age: 58.0 years. Most reports from: CH. View detailed demographics →
Is FRAGMIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 2 | 2 | 2 |
| 2012 | 1 | 0 | 0 |
| 2013 | 17 | 7 | 7 |
| 2014 | 14 | 2 | 9 |
What Is FRAGMIN Used For?
| Indication | Reports |
|---|---|
| Deep vein thrombosis | 8 |
| Thrombosis prophylaxis | 7 |
| Prophylaxis | 6 |
| Product used for unknown indication | 5 |
Official FDA Label for FRAGMIN
Official prescribing information from the FDA-approved drug label.