Veletri: adverse event reports filed with FDA

8,723

reports as suspect product

0% of all reports · about 554 a year

153

reports, 12 months to June 2026

139 in the 12 months before

88.7%

marked serious by the reporter

58.2% across the class

22.6%

record death among outcomes, as reported

1,970 reports · not verified by FDA

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 Veletri reports recording the termmedian drug in prostacycline vasodilator

1. Dyspnoeashortness of breath25.1%2,187
2. Headachehead pain21.1%1,843
3. Diarrhoealoose or frequent stools20.6%1,793
4. Nauseafeeling sick18.4%1,603
5. Pain in jaw18.2%1,590
6. Deaththe patient died; cause not stated by this term12.5%1,093
7. Flushingsudden reddening or warmth of the skin11.5%1,000
8. Fatiguetiredness10.2%891
9. Pulmonary arterial hypertension10%876
10. Vomitingbeing sick10%868
11. Dyspnoea exertional9.7%847
12. Fluid retentionthe body holding extra fluid8.5%743
13. Pneumonialung infection8%701
14. Malaisegeneral feeling of being unwell8%700
15. Pain in extremitypain in an arm or leg8%698
16. Dizzinesslight-headedness or unsteadiness7.6%661
17. Condition aggravatedthe condition being treated got worse7%611
18. Hypotensionlow blood pressure7%608
19. Chest painchest pain6.9%598
20. Weight decreasedweight loss6.5%566
21. Painpain, site not specified6.2%544
22. Catheter site erythema6.1%531
23. Catheter management5.9%513
24. Hospitalisationadmission to hospital5.8%504
25. Device related infectionan infection related to the device5.7%498
26. Palpitationsawareness of the heartbeat5.5%484
27. Rashskin rash5.4%475
28. Astheniaweakness or lack of energy5.3%463
29. Pyrexiafever5.1%449
30. Decreased appetitereduced appetite5.1%448

Top 30 of 1,372 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 90.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 8,723 reports.

Drugs most often listed in the same reports

Other products listed in reports where Veletri 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

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

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.

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 Veletri as a suspect or interacting product; reports listing it only as a concomitant medication (2,130) 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.