Ultiva: adverse event reports filed with FDA

613

reports as suspect product

0% of all reports · about 27 a year

20

reports, 12 months to June 2026

11 in the 12 months before

94.3%

marked serious by the reporter

91.7% across the class

11.1%

record death among outcomes, as reported

68 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 Ultiva reports recording the termmedian drug in opioid agonist

1. Anaphylactic shocka severe allergic reaction with collapse19.6%120
2. Hypotensionlow blood pressure7.3%45
3. Bronchospasmtightening of the airways5.5%34
4. Tachycardiafast heart rate5.2%32
5. Anaphylactic reactiona severe, sudden allergic reaction5.1%31
6. Rashskin rash5.1%31
7. Blood pressure decreaseda low blood pressure reading4.9%30
8. Cardiac arrestthe heart stopped4.7%29
9. Renal failure acute3.8%23
10. Circulatory collapsecollapse of the circulation3.4%21
11. Erythemaskin redness2.9%18
12. Toxic epidermal necrolysisa severe skin reaction with peeling2.9%18
13. Drug interactionan interaction between medicines2.8%17
14. Haematuriablood in the urine2.8%17
15. Bradycardiaslow heart rate2.6%16
16. Coma2.4%15
17. Drug ineffectivethe medicine did not work as expected2.4%15
18. Cardio-respiratory arrestthe heart and breathing stopped2.3%14
19. Hypoxialow oxygen2.3%14
20. Lymphopenia2.3%14
21. Oliguria2.3%14
22. Generalised erythema2.1%13
23. Optic neuritis1.8%11
24. Painpain, site not specified1.6%10
25. Respiratory depressionslow or shallow breathing1.6%10
26. Cerebral haemorrhage1.5%9
27. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement1.5%9
28. Sinus tachycardia1.5%9
29. Tongue oedemaa swollen tongue1.5%9
30. Dyspnoeashortness of breath1.3%8

Top 30 of 278 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 42 drugs in the opioid agonist 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 965,051 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. 7.3% 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 613 reports.

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 opioid agonist 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 Ultiva as a suspect or interacting product; reports listing it only as a concomitant medication (548) 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.