Lidocaine adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Lidocaine
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Amide local anesthetic
Also reported as: Lidocaine /00033402/, Lidocaine Gel, Lidocaine Injection

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 13,993 adverse event reports that name Lidocaine. In these reports the drug is a suspect or interacting product.

In the same period, 37,952 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,469 reports in the 12 months to June 2026 and 1,593 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Lidocaine is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 414 reports that name Lidocaine.
In January to March 2026, FDA received 366.
In April to June 2025, FDA received 462.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 1,070 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 13,908 of the 13,993 reports (99.4%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 1,070 terms.

Reaction terms in the reports that name Lidocaine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 13,993 reports
Drug ineffectivethe medicine did not work as expected	2,126	15.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	1,022	7.3%
Off label useused for a purpose or in a way not on the label	963	6.9%
Hypotensionlow blood pressure	701	5%
Cardiac arrestthe heart stopped	609	4.4%
Local anaesthetic systemic toxicity	603	4.3%
Product adhesion issue	516	3.7%
Anaphylactic reactiona severe, sudden allergic reaction	471	3.4%
Dyspnoeashortness of breath	463	3.3%
Nauseafeeling sick	454	3.2%
Product use in unapproved indicationused for a purpose not on the label	450	3.2%
Overdosea dose above the recommended amount	417	3%
Painpain, site not specified	414	3%
Dizzinesslight-headedness or unsteadiness	406	2.9%
Drug ineffective for unapproved indication	393	2.8%
Anaphylactic shocka severe allergic reaction with collapse	383	2.7%
Product quality issuea problem with the product itself	348	2.5%
Drug interactionan interaction between medicines	346	2.5%
Bradycardiaslow heart rate	340	2.4%
Vomitingbeing sick	335	2.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	315	2.3%
Seizurea fit or convulsion	315	2.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	307	2.2%
Loss of consciousnesspassing out	300	2.1%
Headachehead pain	288	2.1%
Tachycardiafast heart rate	282	2%
Rashskin rash	279	2%
Somnolencedrowsiness	275	2%
Hypertensionhigh blood pressure	274	2%
Condition aggravatedthe condition being treated got worse	270	1.9%
Fatiguetiredness	245	1.8%
Generalised tonic-clonic seizure	239	1.7%
Confusional stateconfusion	235	1.7%
Methaemoglobinaemia	233	1.7%
Drug abusemisuse of a medicine	223	1.6%
Deaththe patient died; cause not stated by this term	221	1.6%
Exposure during pregnancythe medicine was taken during pregnancy	215	1.5%
Malaisegeneral feeling of being unwell	209	1.5%
Pruritusitching	201	1.4%
Intentional product misusedeliberate use not as intended	189	1.4%
Erythemaskin redness	187	1.3%
Pyrexiafever	186	1.3%
Unresponsive to stimuli	186	1.3%
Drug intolerancethe medicine was not tolerated	182	1.3%
Anxiety	181	1.3%
Hypersensitivityan allergic-type reaction	180	1.3%
Therapy non-responderthe treatment did not work	179	1.3%
Hypoaesthesianumbness	178	1.3%
Treatment failurethe treatment did not work	177	1.3%
Status epilepticus	170	1.2%

Download all 1,070 terms of Lidocaine (CSV)

The counts add to more than 13,993 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Lidocaine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Lidocaine (this page)	Generic name	13,993
Lidocaine hydrochloride	Generic name	3,047

Sum of the separately reported names: 17,040. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Lidocaine, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	99	81	31	16	22	9	0	22	18
2005	94	84	10	18	28	12	0	35	10
2006	107	102	13	15	40	8	0	58	5
2007	130	123	28	20	35	7	0	54	7
2008	165	148	18	23	47	10	0	83	17
2009	154	144	24	26	51	6	0	76	10
2010	176	151	21	25	55	3	0	89	25
2011	363	332	36	66	84	16	3	199	31
2012	224	209	24	36	56	5	0	137	15
2013	261	216	40	26	63	9	0	118	45
2014	288	256	33	36	86	19	0	153	32
2015	418	341	90	35	96	8	2	201	77
2016	407	264	34	36	95	17	0	179	143
2017	599	386	52	113	130	5	0	291	213
2018	821	587	109	113	175	11	0	440	234
2019	879	673	84	124	275	13	1	446	206
2020	1,003	791	112	171	359	22	0	512	212
2021	1,163	931	75	219	449	13	4	646	232
2022	1,125	900	96	156	465	19	0	648	225
2023	1,461	1,192	216	299	575	41	2	836	269
2024	1,507	1,170	153	284	591	34	2	784	337
2025	1,649	1,356	145	371	681	53	16	1,020	293
2026	900	762	199	194	367	55	24	547	138

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Lidocaine, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Lidocaine, by the year in which FDA received them
Year	Reports
2004	92
2005	94
2006	106
2007	132
2008	159
2009	156
2010	177
2011	361
2012	262
2013	251
2014	291
2015	448
2016	406
2017	625
2018	870
2019	907
2020	1,055
2021	1,208
2022	1,160
2023	1,472
2024	1,513
2025	1,468
2026	780

Reports that name Lidocaine, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Lidocaine
Age	Reports	Share
Under 2	236	1.7%
2 to 11	242	1.7%
12 to 17	301	2.2%
18 to 44	3,440	24.6%
45 to 64	2,972	21.2%
65 to 74	1,490	10.6%
75 and over	1,168	8.3%
Age not given	4,144	29.6%

Sex of the patient in the reports that name Lidocaine
Sex	Reports	Share
Female	6,872	49.1%
Male	4,813	34.4%
Unknown or not given	2,308	16.5%

Type of reporter in the reports that name Lidocaine
Reporter	Reports	Share
Physician	3,764	26.9%
Pharmacist	826	5.9%
Other health professional	6,187	44.2%
Lawyer	32	0.2%
Consumer or non-health professional	2,636	18.8%
Not given	548	3.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 52.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lidocaine record
Indication as recorded (MedDRA)	Reports	Share
Local anaesthesia	1,285	9.2%
Anaesthesia	944	6.7%
Pain	576	4.1%
Ventricular tachycardia	421	3%
General anaesthesia	272	1.9%
Back pain	259	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 13,993 reports.

Drugs in the same reports

Other drugs that the reports of Lidocaine name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	1,119
Bupivacaine	751
Dexamethasone	745
Epinephrine	1,046
Fentanyl	1,601
Gabapentin	1,040
Ketamine	849
Midazolam	670
Morphine	619
Propofol	1,627

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Lidocaine hydrochloride same ingredient
Icy Hot same class
Lidocaine hcl same class
Exparel same class
Carbocaine same class
Lidocaine hydrochloride and epinephrine bitartrate same class
Libtayo next in the A to Z list
Librium next in the A to Z list
Lialda next in the A to Z list
Lidocaine Hydrochloride 2% with Epinephrine 1 100 000 Injection next in the A to Z list
Lexotan next in the A to Z list
Lexomil next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for LidocaineThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Lidocaine: adverse event reports that FDA received. https://reportedreactions.com/drug/lidocaine/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Lidocaine as a suspect or interacting product. The 37,952 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Lidocaine was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Lidocaine?

No. It is a count of what people reported to FDA: 13,993 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (44.2%), physician (26.9%) and consumer or non-health professional (18.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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