Lidocaine patch: adverse event reports filed with FDA

4,474

reports as suspect product

0% of all reports · about 356 a year

113

reports, 12 months to June 2026

133 in the 12 months before

4.3%

marked serious by the reporter

65.1% across the class

0.5%

record death among outcomes, as reported

21 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 patch reports recording the termmedian drug in amide local anesthetic

1. Product adhesion issue64%2,862
2. Product quality issuea problem with the product itself59.8%2,676
3. Off label useused for a purpose or in a way not on the label31.4%1,403
4. Drug ineffective for unapproved indication28.2%1,262
5. Drug ineffectivethe medicine did not work as expected11%493
6. Wrong technique in product usage processthe product was used in the wrong way7.4%330
7. No adverse eventno adverse event was reported6.7%300
8. Painpain, site not specified4%180
9. Expired product administeredthe product was used past its expiry date2.5%113
10. Product use in unapproved indicationused for a purpose not on the label2.3%105
11. Prescription drug used without a prescription2.1%93
12. Product availability issuethe product was not available1.9%84
13. Application site irritation1.7%74
14. Application site rash1.6%72
15. Application site pain1.5%65
16. Application site discomfort1.3%58
17. Application site erythemaredness where the product was applied1.3%56
18. Application site pruritusitching where the product was applied1.2%55
19. Product dose omission issuea dose was missed1.2%54
20. Incorrect product administration duration0.8%37
21. Inappropriate schedule of product administrationthe product was taken at the wrong times0.8%36
22. Drug effect decreasedthe medicine had less effect0.7%33
23. Incorrect drug administration duration0.7%33
24. Rashskin rash0.7%32
25. Incorrect dose administeredthe wrong dose was given0.7%30
26. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times0.6%28
27. Inability to afford medication0.6%27
28. Insurance issue0.6%26
29. Falla fall0.5%23
30. Hyperhidrosisexcessive sweating0.5%23

Top 30 of 202 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. 99.9% 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 4,474 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lidocaine patch 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 patch as a suspect or interacting product; reports listing it only as a concomitant medication (314) 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.