Pharmacologic class (EPC) · 13 drug pages

Amide local anesthetic: adverse event reports filed with FDA

41,804 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

41,804
reports across the class: 0.2% of all reports; 3,153
reports, 12 months to June 2026: 3,523 in the 12 months before; 65.1%
marked serious by the reporter: 57.4% across all reports; 13
drugs with a page: brand and generic names counted separately

Amide local anesthetic is a pharmacologic class (an FDA Established Pharmacologic Class) with 13 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 41,804 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

3,153 reports arrived in the 12 months to June 2026, down 11% from 3,523 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 65.1% of the class's reports are marked serious, 7.7% record death among the outcomes and 25% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (16.2%), off label use (9.1%) and product adhesion issue (8.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Lidocaine	generic	13,993	1,469	80%	Drug ineffective
Bupivacaine	generic	5,447	310	83.3%	Off label use
Lidocaine patch	generic	4,474	113	4.3%	Product adhesion issue
Lidocaine hydrochloride	generic	3,047	314	80.7%	Drug ineffective
ExparelBupivacaine	brand	2,157	217	42.4%	Off label use
MarcaineBupivacaine hydrochloride	brand	2,089	50	44.1%	Drug ineffective
Xylocaine (lidocaine hcl )	generic	2,015	109	89.9%	Anaphylactic shock
Bupivacaine hcl	generic	1,870	0	45.3%	Drug ineffective
Lidocaine hcl	generic	1,854	0	49.5%	Drug hypersensitivity
Bupivacaine hydrochloride	generic	1,797	251	62.3%	Drug ineffective
Ropivacaine hydrochloride	generic	1,388	300	94.2%	Vomiting
LidodermLidocaine patch 5%	brand	967	7	45%	Drug ineffective for unapproved indication
NaropinRopivacaine hydrochloride	brand	706	13	79.7%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected16.2%6,761
Off label useused for a purpose or in a way not on the label9.1%3,790
Product adhesion issue8.1%3,389
Product quality issuea problem with the product itself7.7%3,229
Painpain, site not specified4.6%1,918
Drug ineffective for unapproved indication4.4%1,856
Hypotensionlow blood pressure4%1,692
Drug hypersensitivityan allergic-type reaction to a medicine3.7%1,557
Dyspnoeashortness of breath3.7%1,533
Toxicity to various agentspoisoning or toxic effect of one or more substances3.6%1,523
Vomitingbeing sick3.1%1,314
Cardiac arrestthe heart stopped2.9%1,217
Nauseafeeling sick2.5%1,066
Local anaesthetic systemic toxicity2.5%1,037
Dizzinesslight-headedness or unsteadiness2.3%948
Maternal exposure during pregnancythe mother took the medicine during pregnancy2.3%943
Hypoaesthesianumbness2.2%900
Product use in unapproved indicationused for a purpose not on the label2%837
Anaphylactic shocka severe allergic reaction with collapse1.9%804
Overdosea dose above the recommended amount1.9%802
Pneumonialung infection1.9%801
Bradycardiaslow heart rate1.8%769
Anaphylactic reactiona severe, sudden allergic reaction1.8%767
Headachehead pain1.7%709
No adverse eventno adverse event was reported1.7%708

Solid bar: share of all class reports. Hollow bar: the median share across the 13 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death7.7%3,202

Life-threatening11.6%4,850

Hospitalisation (initial or prolonged)25%10,461

Disability3.4%1,426

Congenital anomaly0.3%132

Other serious44.2%18,473

Not serious34.9%14,578

Patient age

Under 21.1%468

2 to 111.1%439

12 to 171.3%561

18 to 4419.2%8,027

45 to 6419.5%8,144

65 to 7411.2%4,689

75 and over7.8%3,257

Age not given38.8%16,219

Who reported

Physician25.3%10,590

Pharmacist8.3%3,469

Other health professional34.1%14,256

Lawyer0.7%311

Consumer or non-health professional27%11,299

Not given4.5%1,879

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Amide local anesthetic reports

Which drugs are in the Amide local anesthetic class on this site?

Lidocaine, Bupivacaine, Lidocaine patch, Lidocaine hydrochloride, Exparel and Marcaine and 7 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

41,804 reports through June 2026, 3,153 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (16.2%), off label use (9.1%), product adhesion issue (8.1%), product quality issue (7.7%) and pain (4.6%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.