Propofol: adverse event reports filed with FDA

19,118

reports as suspect product

0.1% of all reports · about 850 a year

1,463

reports, 12 months to June 2026

1,573 in the 12 months before

95.1%

marked serious by the reporter

94.2% across the class

13%

record death among outcomes, as reported

2,486 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 Propofol reports recording the termmedian drug in general anesthetic

1. Hypotensionlow blood pressure9%1,712
2. Drug ineffectivethe medicine did not work as expected8.4%1,614
3. Anaphylactic shocka severe allergic reaction with collapse7.1%1,355
4. Anaphylactic reactiona severe, sudden allergic reaction5.4%1,036
5. Cardiac arrestthe heart stopped5.2%990
6. Off label useused for a purpose or in a way not on the label4.7%901
7. Drug interactionan interaction between medicines4.5%851
8. Bradycardiaslow heart rate3.2%618
9. Propofol infusion syndrome3.1%601
10. Tachycardiafast heart rate3%570
11. Rhabdomyolysismuscle breakdown2.9%548
12. Pyrexiafever2.6%492
13. Toxicity to various agentspoisoning or toxic effect of one or more substances2.5%474
14. Oxygen saturation decreased2.4%461
15. Bronchospasmtightening of the airways2.1%406
16. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.1%394
17. Rashskin rash2%381
18. Maternal exposure during pregnancythe mother took the medicine during pregnancy2%379
19. Metabolic acidosistoo much acid in the body fluids2%373
20. Condition aggravatedthe condition being treated got worse1.9%367
21. Product use in unapproved indicationused for a purpose not on the label1.8%352
22. Vomitingbeing sick1.8%352
23. Hypoxialow oxygen1.7%325
24. Dyspnoeashortness of breath1.7%323
25. Status epilepticus1.7%318
26. Nauseafeeling sick1.6%311
27. Overdosea dose above the recommended amount1.6%305
28. Circulatory collapsecollapse of the circulation1.6%304
29. Respiratory depressionslow or shallow breathing1.5%294
30. Agitationrestlessness1.5%293

Top 30 of 1,718 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 general anesthetic 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 31,985 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. 29.3% 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 19,118 reports.

Drugs most often listed in the same reports

Other products listed in reports where Propofol 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 general anesthetic 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 Propofol as a suspect or interacting product; reports listing it only as a concomitant medication (14,757) 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.