TREPROSTINIL DIOLAMINE: 250 Adverse Event Reports & Safety Profile
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250
Total FAERS Reports
40 (16.0%)
Deaths Reported
136
Hospitalizations
250
As Primary/Secondary Suspect
11
Life-Threatening
3
Disabilities
Dec 20, 2013
FDA Approved
Prescription
Status
FDA Application: 203496 ·
Patent Expires: Jul 30, 2026 · First Report: 20061206 · Latest Report: 20250101
What Are the Most Common TREPROSTINIL DIOLAMINE Side Effects?
#1 Most Reported
Headache
86 reports (34.4%)
#2 Most Reported
Diarrhoea
68 reports (27.2%)
#3 Most Reported
Dyspnoea
59 reports (23.6%)
All TREPROSTINIL DIOLAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 86 | 34.4% | 8 | 44 |
| Diarrhoea | 68 | 27.2% | 9 | 25 |
| Dyspnoea | 59 | 23.6% | 12 | 37 |
| Nausea | 58 | 23.2% | 6 | 26 |
| Dizziness | 34 | 13.6% | 4 | 20 |
| Flushing | 28 | 11.2% | 3 | 11 |
| Vomiting | 28 | 11.2% | 2 | 12 |
| Hypotension | 26 | 10.4% | 3 | 18 |
| Dyspnoea exertional | 25 | 10.0% | 2 | 13 |
| Malaise | 25 | 10.0% | 3 | 16 |
| Pain in extremity | 25 | 10.0% | 2 | 7 |
| Fatigue | 24 | 9.6% | 5 | 9 |
| Pain in jaw | 22 | 8.8% | 2 | 10 |
| Decreased appetite | 19 | 7.6% | 4 | 12 |
| Pulmonary arterial hypertension | 18 | 7.2% | 7 | 15 |
| Abdominal discomfort | 17 | 6.8% | 2 | 6 |
| Chest pain | 17 | 6.8% | 1 | 12 |
| Condition aggravated | 17 | 6.8% | 4 | 15 |
| Death | 16 | 6.4% | 16 | 7 |
| Pain | 16 | 6.4% | 0 | 7 |
Who Reports TREPROSTINIL DIOLAMINE Side Effects? Age & Gender Data
Gender: 79.2% female, 20.8% male. Average age: 55.7 years. Most reports from: US. View detailed demographics →
Is TREPROSTINIL DIOLAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 2 | 0 | 2 |
| 2007 | 2 | 2 | 2 |
| 2008 | 9 | 3 | 7 |
| 2009 | 6 | 4 | 4 |
| 2010 | 7 | 2 | 5 |
| 2011 | 11 | 3 | 7 |
| 2012 | 3 | 0 | 3 |
| 2013 | 4 | 1 | 3 |
| 2014 | 12 | 4 | 6 |
| 2015 | 34 | 3 | 20 |
| 2016 | 33 | 3 | 20 |
| 2017 | 6 | 2 | 4 |
| 2018 | 32 | 5 | 13 |
| 2019 | 7 | 2 | 4 |
| 2020 | 6 | 0 | 0 |
| 2021 | 5 | 2 | 4 |
| 2022 | 4 | 0 | 3 |
| 2023 | 1 | 0 | 1 |
| 2024 | 4 | 1 | 2 |
| 2025 | 1 | 0 | 1 |
What Is TREPROSTINIL DIOLAMINE Used For?
| Indication | Reports |
|---|---|
| Pulmonary arterial hypertension | 159 |
| Product used for unknown indication | 68 |
| Pulmonary hypertension | 17 |
TREPROSTINIL DIOLAMINE vs Alternatives: Which Is Safer?
TREPROSTINIL DIOLAMINE vs TRETINOIN
TREPROSTINIL DIOLAMINE vs TRIAMCINOLONE
TREPROSTINIL DIOLAMINE vs TRIAMCINOLONE ACETONIDE
TREPROSTINIL DIOLAMINE vs TRIAMCINOLONE HEXACETONIDE
TREPROSTINIL DIOLAMINE vs TRIAMTERENE
TREPROSTINIL DIOLAMINE vs TRIATEC
TREPROSTINIL DIOLAMINE vs TRIAZOLAM
TREPROSTINIL DIOLAMINE vs TRICHLORMETHIAZIDE
TREPROSTINIL DIOLAMINE vs TRICLOSAN
TREPROSTINIL DIOLAMINE vs TRIENTINE
Official FDA Label for TREPROSTINIL DIOLAMINE
Official prescribing information from the FDA-approved drug label.