Demerol: adverse event reports filed with FDA

5,360

reports as suspect product

0% of all reports · about 239 a year

285

reports, 12 months to June 2026

314 in the 12 months before

49.4%

marked serious by the reporter

91.7% across the class

5.1%

record death among outcomes, as reported

272 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 Demerol reports recording the termmedian drug in opioid agonist

1. Drug hypersensitivityan allergic-type reaction to a medicine57.7%3,091
2. Drug ineffectivethe medicine did not work as expected19.8%1,061
3. Nauseafeeling sick16.1%863
4. Hyperhidrosisexcessive sweating14.7%787
5. Off label useused for a purpose or in a way not on the label14.1%755
6. Painpain, site not specified13.8%740
7. Drug intolerancethe medicine was not tolerated13.4%716
8. Rashskin rash12%643
9. Hypertensionhigh blood pressure10.2%548
10. Upper respiratory tract infectiona cold or similar infection9.5%509
11. Joint swellinga swollen joint9.3%501
12. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease9.3%500
13. Overdosea dose above the recommended amount9.3%497
14. Vomitingbeing sick9.1%490
15. Infusion related reactiona reaction during or soon after an infusion9%483
16. Hypersensitivityan allergic-type reaction9%480
17. Psoriasispsoriasis, a skin condition8.5%457
18. Treatment failurethe treatment did not work8.5%454
19. Exposure during pregnancythe medicine was taken during pregnancy8.2%442
20. Pyrexiafever8.2%441
21. Thrombocytopenialow platelets7.9%424
22. Sedationdrowsiness from a medicine7.9%422
23. Nightmarenightmares7.8%420
24. Headachehead pain7.5%403
25. Infectionan infection, type not specified7%375
26. Product use issuea problem in how the product was used6.4%343
27. Immunodeficiency6.4%342
28. Product use in unapproved indicationused for a purpose not on the label6.4%342
29. Hepatic enzyme increasedraised liver enzymes6.4%341
30. Food allergy6.3%340

Top 30 of 631 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. 68.8% 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 5,360 reports.

Drugs most often listed in the same reports

Other products listed in reports where Demerol 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 Demerol as a suspect or interacting product; reports listing it only as a concomitant medication (2,667) 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.