What the label lists and what reports show
Lidocaine side effects
Lidocaine's FDA label: “The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus …” FAERS holds 71,853 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (4,194 reports).
- Generic listed
- In shortage
Check it at the source: the lidocaine FDA label on DailyMed (effective May 13, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of BONDLIDO?BONDLIDO may cause serious side effects, including: Lidocaine overdose can happen if you apply more than the prescribed number of BONDLIDO, apply BONDLIDO for longer than 12 hours, have liver problems, use BONDLIDO on skin that is not intact, or if you apply external heat sources directly on BONDLIDO. This can result in increased levels of lidocaine in your blood. See " How should I use BONDLIDO ? " for information on how to use BONDLIDO. A serious blood problem called methemoglobinemia. Methemoglobinemia is a serious blood problem where too much methemoglobin is produced in the blood. Methemoglobinemia can happen with the use of local anesthetics and may not let enough oxygen reach the organs and tissues in your body. […]
Source: FDA drug label (BONDLIDO), MEDRx USA, Inc., effective October 6, 2025 (SPL set 17e69028-d2c2-4080-8090-cb0cab570196), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Lidocaine Hydrochloride label published by Hospira, Inc. of November 20, 2024; the label quoted above does not print one.
| Reaction | ≤60 mg | >60 to 90 mg | >90 to 120 mg | >120 mg |
|---|---|---|---|---|
| <65 years of age | 0.4% | 0.4% | 0.9% | 4.6% |
| ≥65 years of age | 1.2% | 2.8% | 2.2% | 7.7% |
| <65 years of age | 2.1% | 4.6% | 7.8% | 15.4% |
| ≥65 years of age | 4.7% | 3.7% | 2.8% | 25.0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedSystemic Adverse experiences following the administration of lidocaine HCl are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine HCl is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. …
Source: FDA drug label, Fresenius Kabi USA, LLC, effective May 13, 2024 (SPL set d5e0d06f-ba1e-44d4-aa89-39d6c146dc23), via openFDA; the full label on DailyMed
What do FAERS reports show?
71,853 reports list lidocaine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,533 are coded as a death and 23,748 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lidocaine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions