This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Lidocaine (burn relief)

antiarrhythmic

Last updated: June 18, 2026

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Lidocaine is the brand name for burn relief, a antiarrhythmic. According to the FDA-approved label, for temporary relief of pain and itching associated with: sunburn minor burns minor cuts insect bites scrapes minor skin irritations. FAERS contains 47,405 submissions naming this drug from 1998 through 2026; the top three reactions cited are drug ineffective, pain, and fatigue.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Lidocaine. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Lidocaine. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 47,405 FAERS submissions that named Lidocaine. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Lidocaine. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Lidocaine. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

for temporary relief of pain and itching associated with: sunburn minor burns minor cuts insect bites scrapes minor skin irritations

Warnings

For external use only. Flammable: Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product do not get into eyes ask a doctor before using on children under 2 years of age Stop use and ask a doctor if condition gets worse symptoms last more than 7 days or clear up and occur again in a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA label effective date: 2025-11-06

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.