Section 06 · Monograph

Lidocaine 5% patch

Reviewed Nov 2026FDA label

LidodermNa+ channel blocker (topical)

Indications

Relief of pain associated with post-herpetic neuralgia (PHN) — sole FDA-approved indicationFDA-labeled

Painful diabetic peripheral neuropathy (off-label)Off-label
Localized neuropathic pain of other etiologies (e.g. post-surgical/post-traumatic neuropathic pain, complex regional pain syndrome)Off-label
Low back pain and localized musculoskeletal painOff-label

Amide-type local anesthetic that blocks the generation and conduction of nerve impulses by decreasing sodium ion permeability/inhibiting voltage-gated sodium channels in the neuronal cell membrane
Applied topically, suppresses ectopic and spontaneous firing of damaged cutaneous nociceptors implicated in postherpetic neuralgia, without producing complete sensory block
Systemic absorption is minimal with correct use (roughly 3% of applied dose over 12 hours), limiting systemic toxicity risk compared with systemic lidocaine
The patch also provides a protective mechanical barrier over hypersensitive/allodynic skin

Apply up to 3 patches at one time, only to intact, unbroken skin, to cover the most painful area(s)
Wear time is up to 12 hours within a 24-hour period (12 hours on, 12 hours off); do not wear continuously for 24 hours
Patches may be cut into smaller sizes with scissors prior to removal of the release liner
Apply only once to the affected, intact skin; clothing may be worn over the patch
Avoid application of external heat sources over the patch, which can increase systemic lidocaine absorption

Discard used patches folded in half with the adhesive side inward, out of reach of children and pets

Known history of sensitivity to amide-type local anesthetics or to any other component of the patch

Caution when used concomitantly with Class I antiarrhythmic drugs (e.g. mexiletine, tocainide) since lidocaine is structurally related and toxic effects may be additive
If used with other lidocaine-containing products, total dose from all formulations must be considered to avoid cumulative systemic toxicity
No formal drug-drug interaction studies conducted given minimal systemic absorption

Application-site reactions: erythema, edema, burning, irritation, itching, papules, discoloration, bruising (most common, generally mild and transient)
Application-site vesicles, blisters, or dermatitis (less common)
Rare systemic effects with excessive dosing/absorption: dizziness, drowsiness, headache, nausea, confusion
Rare cardiovascular effects with significant systemic absorption: hypotension, bradycardia, arrhythmia
Risk of serious adverse effects, including seizures and cardiac arrest, if patches are ingested or grossly misused

Periodic assessment of application site for skin irritation, breakdown, or hypersensitivity reaction
Monitor for signs/symptoms of systemic lidocaine toxicity in patients using multiple patches, prolonged wear time, or with impaired skin barrier
Reassess ongoing need/efficacy periodically; ensure adherence to 12-hours-on/12-hours-off schedule and maximum of 3 patches
Educate patients/caregivers on safe storage and disposal given risk of pediatric or pet ingestion/toxicity

Animal reproduction studies have not demonstrated fetal risk, but there are no adequate and well-controlled studies in pregnant women
Because systemic absorption from the patch is minimal with correct use, systemic fetal exposure is expected to be low
Excreted in human breast milk in small amounts; systemic exposure from topical patch use is low, but caution is advised
Avoid application to the breast/nipple area in nursing mothers