Bupivacaine: adverse event reports filed with FDA

5,447

reports as suspect product

0% of all reports · about 242 a year

310

reports, 12 months to June 2026

312 in the 12 months before

83.3%

marked serious by the reporter

65.1% across the class

6.4%

record death among outcomes, as reported

350 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 Bupivacaine reports recording the termmedian drug in amide local anesthetic

1. Off label useused for a purpose or in a way not on the label10.3%563
2. Painpain, site not specified9.1%497
3. Hypotensionlow blood pressure7.4%402
4. Drug ineffectivethe medicine did not work as expected6.8%372
5. Maternal exposure during pregnancythe mother took the medicine during pregnancy6.3%341
6. Exposure during pregnancythe medicine was taken during pregnancy5.7%313
7. Nauseafeeling sick4.3%234
8. Hypoaesthesianumbness4.3%233
9. Maternal exposure during delivery4.2%230
10. Drug withdrawal syndromesymptoms on stopping a medicine4.1%224
11. Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.1%221
12. Premature babya baby born early3.5%189
13. Muscular weaknessmuscle weakness3.2%175
14. Overdosea dose above the recommended amount3.1%168
15. Bradycardiaslow heart rate2.9%159
16. Vomitingbeing sick2.9%156
17. Somnolencedrowsiness2.8%150
18. Dizzinesslight-headedness or unsteadiness2.6%143
19. Anaesthetic complication2.5%135
20. Dyspnoeashortness of breath2.5%134
21. Astheniaweakness or lack of energy2.4%132
22. Cardiac arrestthe heart stopped2.4%129
23. Condition aggravatedthe condition being treated got worse2.3%128
24. Back painback pain2.3%125
25. Loss of consciousnesspassing out2.2%122
26. Toxicity to various agentspoisoning or toxic effect of one or more substances2.2%119
27. Local anaesthetic systemic toxicity2.1%116
28. Falla fall2.1%113
29. Headachehead pain2.1%112
30. Paraesthesiatingling or pins and needles1.9%103

Top 30 of 1,044 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 13 drugs in the amide local 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 41,804 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. 58% 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 5,447 reports.

Drugs most often listed in the same reports

Other products listed in reports where Bupivacaine 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 amide local 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 Bupivacaine as a suspect or interacting product; reports listing it only as a concomitant medication (2,266) 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.