Pharmacologic class (EPC) · 8 drug pages

Prostacycline vasodilator: adverse event reports filed with FDA

119,150 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

119,150
reports across the class: 0.6% of all reports; 11,216
reports, 12 months to June 2026: 10,526 in the 12 months before; 58.2%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Prostacycline vasodilator is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 119,150 adverse event reports received by FDA, 0.6% of the database, from April 2004 to June 2026.

11,216 reports arrived in the 12 months to June 2026, close to the 10,526 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 58.2% of the class's reports are marked serious, 12.3% record death among the outcomes and 41.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are dyspnoea (18.1%), headache (15.8%) and diarrhoea (12.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
RemodulinTreprostinil	brand	47,657	2,928	61%	Dyspnoea
TyvasoTreprostinil	brand	28,206	1,249	53.8%	Dyspnoea
OrenitramTreprostinil	brand	16,692	1,291	45.1%	Headache
Tyvaso DPITreprostinil	brand	9,216	2,660	38.6%	Cough
VeletriEpoprostenol	brand	8,723	153	88.7%	Dyspnoea
Treprostinil	generic	5,689	1,146	76%	Dyspnoea
YutrepiaTreprostinil	brand	1,665	1,660	42.8%	Cough
Epoprostenol	generic	1,302	129	92%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Dyspnoeashortness of breath18.1%21,528
Headachehead pain15.8%18,799
Diarrhoealoose or frequent stools12.9%15,340
Nauseafeeling sick11.7%13,936
Coughcough9.9%11,829
Fatiguetiredness8.3%9,912
Dizzinesslight-headedness or unsteadiness8.1%9,656
Deaththe patient died; cause not stated by this term7.2%8,591
Vomitingbeing sick5.9%6,973
Hypotensionlow blood pressure5.1%6,082
Infusion site pain4.9%5,894
Malaisegeneral feeling of being unwell4.9%5,804
Pain in extremitypain in an arm or leg4.6%5,495
Pneumonialung infection4.4%5,222
Pain in jaw4.3%5,141
Oxygen saturation decreased4.3%5,140
Fluid retentionthe body holding extra fluid4.2%5,051
Dyspnoea exertional4.2%5,017
Painpain, site not specified4.2%4,952
Flushingsudden reddening or warmth of the skin4.1%4,879
Chest painchest pain4%4,813
Pulmonary arterial hypertension3.9%4,609
Astheniaweakness or lack of energy3.9%4,591
Off label useused for a purpose or in a way not on the label3.7%4,353
Weight decreasedweight loss3.6%4,273

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death12.3%14,708

Life-threatening1.7%2,047

Hospitalisation (initial or prolonged)41.8%49,862

Disability0.3%302

Congenital anomaly0%38

Other serious26.2%31,192

Not serious41.8%49,860

Patient age

Under 20.4%453

2 to 111.1%1,268

12 to 170.8%1,008

18 to 4411%13,162

45 to 6423%27,361

65 to 7413.9%16,606

75 and over9.2%10,934

Age not given40.6%48,358

Who reported

Physician6.9%8,206

Pharmacist3.8%4,566

Other health professional23.5%27,956

Lawyer0%2

Consumer or non-health professional60.6%72,180

Not given5.2%6,240

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Prostacycline vasodilator reports

Which drugs are in the Prostacycline vasodilator class on this site?

Remodulin, Tyvaso, Orenitram, Tyvaso DPI, Veletri and Treprostinil and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

119,150 reports through June 2026, 11,216 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

dyspnoea (18.1%), headache (15.8%), diarrhoea (12.9%), nausea (11.7%) and cough (9.9%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.