Drug class · FAERS comparison

Amide Local Anesthetic side effects compared: 13 drugs, 312,569 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14

How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

Drug	FAERS reports	Serious	Death outcome	Boxed warning	Top labeled signals	Unlabeled (unassessed)
Lidocaine	59,879	74%	6,089	–	Local anaesthetic systemic toxicity; Infusion site urticaria	Infusion site erythema; Infusion site swelling
Lidocaine	57,952	66%	5,192	–	Local anaesthetic systemic toxicity; Infusion site urticaria	Insurance issue; Infusion site swelling
Lidocaine 4%	54,146	67%	5,056	–	–	–
Burn Relief (Lidocaine)	48,628	73%	4,963	–	–	–
Lidicaine (Lidocaine)	48,627	73%	4,963	–	Local anaesthetic systemic toxicity; Infusion site urticaria	Infusion site swelling; Infusion site erythema
Bupivacaine (Exparel)	9,290	75%	578	–	Chondrolysis; Procedural hypotension; Bradycardia foetal	Local anaesthetic systemic toxicity; Implant site extravasation
Lidocaine Patch 5% (Lidoderm)	7,715	65%	750	–	Application site rash	Chronic kidney disease; Neck pain
Bupivacaine (Exparel)	7,136	56%	416	–	Musculoskeletal pain; Joint injury; Bradycardia	Joint range of motion decreased; Osteoarthritis
Lidocaine	6,579	69%	564	–	Cardiac arrest; Bradycardia	Anaphylactic shock; Dermatitis contact
Lidocaine Patch	4,778	9%	46	–	Application site irritation; Application site rash; Application site pain	Inability to afford medication; Insurance issue
Lidocaine 4% Maximum Strength 24 Hr (Lidocaine Patch)	4,778	9%	46	–	–	–
Lidocaine	2,562	54%	209	–	Drug hypersensitivity; Cardiac arrest; Anaphylactic reaction	Toxicity to various agents; Burning sensation
Lidocaine 5%	499	70%	39	–	–	–

Class-wide signals (flagged in at least 7 of 13 members)

No term is flagged in at least half the members.

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Implant site extravasation	Bupivacaine	64	198.8	Not in label — unassessed
Body tinea	Lidocaine	60	41.6	Not in label — unassessed
Infusion site induration	Lidocaine	145	39.7	Not in label — unassessed
Infusion site inflammation	Lidocaine	64	36.6	Not in label — unassessed
Infusion site infection	Lidocaine	176	29.4	Not in label — unassessed
Joint injury	Bupivacaine	204	28.3	Labeled (related wording)
Infusion site reaction	Lidocaine	193	24.8	Not in label — unassessed
Helicobacter infection	Bupivacaine	84	24.4	Not in label — unassessed
Intervertebral disc degeneration	Lidocaine Patch 5%	70	20.6	Not in label — unassessed
Mastoiditis	Lidocaine	52	19.7	Not in label — unassessed
Multiple allergies	Lidocaine	403	19.5	Not in label — unassessed
Hypercholesterolaemia	Bupivacaine	61	18.8	Not in label — unassessed
Application site discomfort	Lidocaine 4%	78	17.5	No label text to screen
Drug hypersensitivity	Lidocaine	412	17.4	Labeled (related wording)
Hyperthermia malignant	Lidocaine 4%	55	14.9	No label text to screen
Musculoskeletal pain	Bupivacaine	267	14.9	Labeled adverse reaction
Musculoskeletal discomfort	Bupivacaine	85	14.6	Labeled (related wording)
Activities of daily living impaired	Bupivacaine	88	12.9	Not in label — unassessed
End stage renal disease	Lidocaine Patch 5%	84	12.4	Not in label — unassessed
Musculoskeletal disorder	Bupivacaine	75	11.5	Labeled (related wording)
Impaired quality of life	Lidocaine	51	11.3	Not in label — unassessed
Chronic kidney disease	Lidocaine Patch 5%	292	10.4	Not in label — unassessed
Pain in jaw	Lidocaine	90	10.1	Likely indication confounding
Intervertebral disc protrusion	Lidocaine Patch 5%	78	9.7	Not in label — unassessed
Rib fracture	Lidocaine Patch 5%	60	8.0	Not in label — unassessed

Common questions

Which amide local anesthetic has the most FDA adverse event reports?

Lidocaine has the most FAERS co-reports in this class (59,879), followed by Lidocaine (57,952). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across amide local anesthetic drugs?

No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.