Drugs › Prostacycline vasodilator
Brand name · Treprostinil
Remodulin: adverse event reports filed with FDA
47,657 reports list it as a suspect or interacting product, 2004–2026. Class: Prostacycline vasodilator.
- 47,657
- reports as suspect product
- 0.2% of all reports · about 2,142 a year
- 2,928
- reports, 12 months to June 2026
- 3,358 in the 12 months before
- 61%
- marked serious by the reporter
- 58.2% across the class
- 13.6%
- record death among outcomes, as reported
- 6,491 reports · not verified by FDA
47,657 adverse event reports received by FDA list the brand name Remodulin (treprostinil) as a suspect or interacting product, from April 2004 to June 2026. A further 9,702 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 2,928 reports listed it, down 13% from 3,358 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 2,142 reports a year and 0.2% of the 20,646,523 reports in the database, and 40% of the reports for the prostacycline vasodilator class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are dyspnoea (14.4%), infusion site pain (11%) and headache (10.7%). A report can list several reactions, so shares add to more than 100%; 2,060 different terms appear across these reports. Dyspnoea is recorded in 14.4% of these reports, a smaller share than in the median prostacycline vasodilator drug (20.4%).
61% of the reports are marked serious by the reporter (58.2% across the class); 13.6% record death among the outcomes and 45.5% record hospitalisation, as reported. 56.4% of the reports came from consumers, and the largest patient age group is 45 to 64 (25.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Remodulin reports recording the termmedian drug in prostacycline vasodilator
- Dyspnoeashortness of breath14.4%6,854
- Infusion site pain11%5,247
- Headachehead pain10.7%5,081
- Diarrhoealoose or frequent stools10.4%4,940
- Nauseafeeling sick9.6%4,568
- Deaththe patient died; cause not stated by this term8.2%3,898
- Infusion site erythema6.3%3,020
- Fatiguetiredness5.8%2,774
- Dizzinesslight-headedness or unsteadiness5.5%2,602
- Vomitingbeing sick5.2%2,465
- Pain in extremitypain in an arm or leg4.7%2,233
- Malaisegeneral feeling of being unwell4.2%1,978
- Pulmonary arterial hypertension4.1%1,958
- Hypotensionlow blood pressure4%1,884
- Painpain, site not specified3.9%1,877
- Dermatitis contact3.8%1,826
- Pneumonialung infection3.7%1,760
- Infusion site swelling3.6%1,729
- Fluid retentionthe body holding extra fluid3.6%1,723
- Device dislocationthe device moved out of position3.5%1,665
- Pain in jaw3.3%1,580
- Weight decreasedweight loss3.1%1,498
- Chest painchest pain3%1,427
- Infusion site infection2.9%1,395
- Infusion site haemorrhage2.8%1,315
- Astheniaweakness or lack of energy2.7%1,296
- Oxygen saturation decreased2.7%1,291
- Drug dose omissiona dose was missed2.7%1,274
- Oedema peripheralswelling of the legs, ankles or hands2.6%1,262
- Device issuea problem with the device2.6%1,252
Top 30 of 2,060 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the prostacycline vasodilator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 119,150 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 94.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pulmonary arterial hypertension | 30,784 | 64.6% |
| Pulmonary hypertension | 4,311 | 9% |
| Cor pulmonale chronic | 1,113 | 2.3% |
| Heritable pulmonary arterial hypertension | 41 | 0.1% |
| Portopulmonary hypertension | 36 | 0.1% |
| Primary pulmonary hypertension | 32 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 47,657 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Remodulin reports |
|---|---|---|
| Opsumit | 9,033 | 19% |
| Adcirca | 7,374 | 15.5% |
| Letairis | 6,072 | 12.7% |
| Oxygen | 5,094 | 10.7% |
| Ambrisentan | 4,817 | 10.1% |
| Tadalafil | 4,734 | 9.9% |
| Revatio | 4,503 | 9.4% |
| Adempas | 4,115 | 8.6% |
| Sildenafil | 3,910 | 8.2% |
| Gabapentin | 3,135 | 6.6% |
Other products listed in reports where Remodulin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Remodulin | Prostacycline vasodilator | All reports |
|---|---|---|---|
| Reports as suspect product | 47,657 | 119,150 | 20,646,523 |
| Share of that pool | — | 40% | 0.2% |
| Reports, latest 12 months | 2,928 | — | 1,332,454 |
| Marked serious | 61% | 58.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 136 | 123 | 91 |
| Hospitalisation recorded, per 1,000 reports | 455 | 418 | 213 |
| Consumer-filed share | 56.4% | 60.6% | 45.8% |
| Top term, share of reports | Dyspnoea 14.4% | median 20.4% | 2.7% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the prostacycline vasodilator class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Tyvaso | brand | 28,206 | 1,249 | 53.8% |
| Orenitram | brand | 16,692 | 1,291 | 45.1% |
| Tyvaso DPI | brand | 9,216 | 2,660 | 38.6% |
| Veletri | brand | 8,723 | 153 | 88.7% |
| Treprostinil | generic | 5,689 | 1,146 | 76% |
| Yutrepia | brand | 1,665 | 1,660 | 42.8% |
| Epoprostenol | generic | 1,302 | 129 | 92% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Remodulin reports
How many adverse event reports has FDA received for Remodulin?
47,657 reports list Remodulin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 2,928 of them arrived in the latest 12 months. Another 9,702 list it only as a concomitant medication.
What reactions are recorded in Remodulin reports?
dyspnoea (14.4%), infusion site pain (11%), headache (10.7%), diarrhoea (10.4%) and nausea (9.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Remodulin was responsible.
How serious are the reports?
61% are marked serious by the reporter. Among the outcomes recorded, 13.6% of reports include death and 45.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (56.4%), other health professional (23.3%) and not given (8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Remodulin rising?
2,928 reports in the 12 months to June 2026, down 13% from 3,358 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Remodulin was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Remodulin?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Remodulin as a suspect or interacting product; reports listing it only as a concomitant medication (9,702) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.