Lidocaine hydrochloride: adverse event reports filed with FDA

3,047

reports as suspect product

0% of all reports · about 136 a year

314

reports, 12 months to June 2026

540 in the 12 months before

80.7%

marked serious by the reporter

65.1% across the class

11.4%

record death among outcomes, as reported

347 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 Lidocaine hydrochloride reports recording the termmedian drug in amide local anesthetic

1. Drug ineffectivethe medicine did not work as expected13.1%399
2. Off label useused for a purpose or in a way not on the label8.8%268
3. Toxicity to various agentspoisoning or toxic effect of one or more substances5.6%170
4. Cardiac arrestthe heart stopped5.5%168
5. Product use in unapproved indicationused for a purpose not on the label4%123
6. Local anaesthetic systemic toxicity4%122
7. Hypotensionlow blood pressure3.9%118
8. Nauseafeeling sick3.6%111
9. Anaphylactic shocka severe allergic reaction with collapse3.5%106
10. Dizzinesslight-headedness or unsteadiness3.3%100
11. Drug interactionan interaction between medicines3.3%100
12. Fatiguetiredness3.3%100
13. Dyspnoeashortness of breath3.2%96
14. Drug hypersensitivityan allergic-type reaction to a medicine2.9%88
15. Bradycardiaslow heart rate2.6%80
16. Painpain, site not specified2.6%79
17. Overdosea dose above the recommended amount2.3%71
18. Seizurea fit or convulsion2.3%71
19. Headachehead pain2.2%66
20. Anaphylactic reactiona severe, sudden allergic reaction2.1%65
21. Hypertensionhigh blood pressure2%62
22. Drug ineffective for unapproved indication1.8%56
23. Weight increasedweight gain1.8%56
24. Generalised tonic-clonic seizure1.7%51
25. Poor quality sleep1.6%50
26. Hypersensitivityan allergic-type reaction1.6%49
27. Condition aggravatedthe condition being treated got worse1.6%48
28. Erythemaskin redness1.6%48
29. Vomitingbeing sick1.5%47
30. Insomniadifficulty sleeping1.5%45

Top 30 of 720 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. 48% 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 3,047 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lidocaine hydrochloride 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 Lidocaine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (3,761) 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.