THROMBOMODULIN ALFA: 72 Adverse Event Reports & Safety Profile
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72
Total FAERS Reports
37 (51.4%)
Deaths Reported
22
Hospitalizations
72
As Primary/Secondary Suspect
17
Life-Threatening
3
Disabilities
First Report: 20130404 · Latest Report: 20221122
What Are the Most Common THROMBOMODULIN ALFA Side Effects?
#1 Most Reported
Drug ineffective
15 reports (20.8%)
#2 Most Reported
Thrombotic microangiopathy
11 reports (15.3%)
#3 Most Reported
Off label use
11 reports (15.3%)
All THROMBOMODULIN ALFA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 15 | 20.8% | 7 | 7 |
| Off label use | 11 | 15.3% | 6 | 3 |
| Thrombotic microangiopathy | 11 | 15.3% | 1 | 3 |
| Disseminated intravascular coagulation | 9 | 12.5% | 4 | 5 |
| Blood alkaline phosphatase increased | 7 | 9.7% | 0 | 0 |
| Blood creatinine increased | 7 | 9.7% | 0 | 0 |
| Blood urea increased | 7 | 9.7% | 0 | 0 |
| Cardiac failure acute | 7 | 9.7% | 0 | 0 |
| Gamma-glutamyltransferase increased | 7 | 9.7% | 0 | 0 |
| Weight increased | 7 | 9.7% | 0 | 0 |
| Diarrhoea | 6 | 8.3% | 0 | 3 |
| Sepsis | 6 | 8.3% | 2 | 3 |
| Hypotension | 5 | 6.9% | 3 | 3 |
| Respiratory failure | 5 | 6.9% | 5 | 3 |
| Venoocclusive liver disease | 5 | 6.9% | 5 | 1 |
Who Reports THROMBOMODULIN ALFA Side Effects? Age & Gender Data
Gender: 41.7% female, 58.3% male. Average age: 56.4 years. Most reports from: JP. View detailed demographics →
Is THROMBOMODULIN ALFA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 10 | 1 | 3 |
| 2014 | 1 | 0 | 0 |
| 2015 | 4 | 4 | 2 |
| 2016 | 3 | 3 | 1 |
| 2017 | 2 | 1 | 1 |
| 2018 | 5 | 0 | 2 |
| 2019 | 3 | 3 | 0 |
| 2020 | 4 | 1 | 2 |
| 2021 | 3 | 1 | 0 |
| 2022 | 3 | 2 | 1 |
What Is THROMBOMODULIN ALFA Used For?
| Indication | Reports |
|---|---|
| Disseminated intravascular coagulation | 23 |
| Product used for unknown indication | 12 |
| Acute promyelocytic leukaemia | 5 |
| Thrombotic microangiopathy | 5 |
| Venoocclusive liver disease | 5 |
Official FDA Label for THROMBOMODULIN ALFA
Official prescribing information from the FDA-approved drug label.