Fentanyl citrate: adverse event reports filed with FDA

15,039

reports as suspect product

0.1% of all reports · about 669 a year

270

reports, 12 months to June 2026

295 in the 12 months before

88%

marked serious by the reporter

91.7% across the class

37.1%

record death among outcomes, as reported

5,578 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 Fentanyl citrate reports recording the termmedian drug in opioid agonist

1. Dependence26.1%3,926
2. Overdosea dose above the recommended amount16.1%2,415
3. Deaththe patient died; cause not stated by this term13.2%1,978
4. Drug abusemisuse of a medicine11.6%1,741
5. Toxicity to various agentspoisoning or toxic effect of one or more substances9.2%1,378
6. Ill-defined disordera condition that was not clearly described8.5%1,271
7. Cardiac arrestthe heart stopped5.6%848
8. Respiratory arrestbreathing stopped4.8%723
9. Drug hypersensitivityan allergic-type reaction to a medicine4.1%612
10. Drug ineffectivethe medicine did not work as expected3.8%569
11. Wrong technique in drug usage processthe medicine was used in the wrong way3.2%483
12. Accidental overdosean accidental overdose3%454
13. Painpain, site not specified2.9%435
14. Nauseafeeling sick2.7%401
15. Drug dependencedependence on a medicine2.5%370
16. Off label useused for a purpose or in a way not on the label2.3%353
17. Drug interactionan interaction between medicines2.2%338
18. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.2%333
19. Withdrawal syndrome2.2%324
20. Drug withdrawal syndrome neonatal2.1%316
21. Completed suicidedeath by suicide2%304
22. Hypotensionlow blood pressure2%299
23. Depressionlow mood1.9%288
24. Incorrect route of product administrationthe product was given by the wrong route1.7%260
25. Product quality issuea problem with the product itself1.7%259
26. Vomitingbeing sick1.7%249
27. Somnolencedrowsiness1.6%235
28. Cardio-respiratory arrestthe heart and breathing stopped1.5%224
29. Respiratory depressionslow or shallow breathing1.5%220
30. Malaisegeneral feeling of being unwell1.5%219

Top 30 of 1,163 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. 82.8% 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 15,039 reports.

Drugs most often listed in the same reports

Other products listed in reports where Fentanyl citrate 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 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 Fentanyl citrate as a suspect or interacting product; reports listing it only as a concomitant medication (2,789) 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.