REMODULIN: 696 Adverse Event Reports & Safety Profile
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696
Total FAERS Reports
144 (20.7%)
Deaths Reported
500
Hospitalizations
696
As Primary/Secondary Suspect
9
Life-Threatening
1
Disabilities
First Report: 201009 · Latest Report: 20230822
What Are the Most Common REMODULIN Side Effects?
#1 Most Reported
Death
95 reports (13.6%)
#2 Most Reported
Dyspnoea
79 reports (11.4%)
#3 Most Reported
Device related infection
64 reports (9.2%)
All REMODULIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 95 | 13.7% | 93 | 8 |
| Dyspnoea | 79 | 11.4% | 4 | 71 |
| Device related infection | 64 | 9.2% | 1 | 63 |
| Drug dose omission | 42 | 6.0% | 1 | 37 |
| Nausea | 32 | 4.6% | 0 | 25 |
| Headache | 30 | 4.3% | 0 | 18 |
| Diarrhoea | 28 | 4.0% | 1 | 19 |
| Pulmonary arterial hypertension | 28 | 4.0% | 10 | 20 |
| Vomiting | 28 | 4.0% | 1 | 24 |
| Fluid retention | 27 | 3.9% | 1 | 23 |
| Pneumonia | 27 | 3.9% | 1 | 25 |
| Hypotension | 24 | 3.5% | 3 | 20 |
| Fall | 23 | 3.3% | 2 | 16 |
| Infusion site pain | 21 | 3.0% | 0 | 10 |
| Dizziness | 20 | 2.9% | 0 | 15 |
| Sepsis | 20 | 2.9% | 5 | 19 |
| Fluid overload | 19 | 2.7% | 4 | 17 |
| Device dislocation | 17 | 2.4% | 0 | 14 |
| Malaise | 17 | 2.4% | 2 | 12 |
| Pyrexia | 17 | 2.4% | 0 | 15 |
Who Reports REMODULIN Side Effects? Age & Gender Data
Gender: 66.7% female, 33.3% male. Average age: 52.6 years. Most reports from: US. View detailed demographics →
Is REMODULIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 1 |
| 2011 | 4 | 0 | 4 |
| 2012 | 3 | 0 | 3 |
| 2013 | 131 | 17 | 116 |
| 2014 | 376 | 94 | 272 |
| 2023 | 2 | 0 | 2 |
What Is REMODULIN Used For?
| Indication | Reports |
|---|---|
| Pulmonary arterial hypertension | 372 |
| Cor pulmonale chronic | 220 |
| Product used for unknown indication | 56 |
| Pulmonary hypertension | 11 |
REMODULIN vs Alternatives: Which Is Safer?
REMODULIN vs REPAGLINIDE
REMODULIN vs REPOTRECTINIB
REMODULIN vs REQUIP
REMODULIN vs RESLIZUMAB
REMODULIN vs RESMETIROM
REMODULIN vs RESTASIS
REMODULIN vs RETINOL
REMODULIN vs REVATIO
REMODULIN vs REVEFENACIN
REMODULIN vs REVLIMID
Official FDA Label for REMODULIN
Official prescribing information from the FDA-approved drug label.