Section 06 · Monograph

Capsaicin 8%

Reviewed Nov 2026FDA label

QutenzaTRPV1 agonist (topical)

Indications

Management of neuropathic pain associated with postherpetic neuralgia (PHN) in adultsFDA-labeled
Management of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adultsFDA-labeled

Highly selective agonist for the transient receptor potential vanilloid 1 (TRPV1) receptor, a ligand-gated cation channel expressed on nociceptive nerve fibers in the skin
Initial TRPV1 activation produces excitation of nociceptors (causing the burning/application pain), followed by a prolonged period of nociceptor defunctionalization/desensitization
Sustained TRPV1 activation causes calcium influx leading to reversible depletion of neurotransmitters (e.g. substance P) and local, reversible loss of epidermal nociceptor nerve fiber terminals
Nerve fiber density gradually recovers via reinnervation, correlating with gradual return of pain, hence re-treatment at approximately 3-month intervals
Systemic absorption is minimal because capsaicin is highly lipophilic and remains localized to the skin

For use only by, or under the supervision of, a physician or healthcare professional in a monitored office/clinical setting — not for home use
Up to four 179 mg (8%) capsaicin patches applied to the most painful skin areas for 60 minutes (PHN) or 30 minutes (diabetic peripheral neuropathy of the feet)
Pretreat the application area with a topical local anesthetic prior to application to reduce procedural application pain
Treatment may be repeated every 3 months, or as warranted by return of pain, based on individual response
Application must be performed with nitrile gloves (not latex); face mask and protective eyewear recommended for the treating clinician
Do not apply to the face, scalp above the hairline, or near mucous membranes; do not apply to broken or irritated skin
Cleansing gel must be applied to the treatment area after patch removal

No formal clinical drug interaction studies have been performed
In vitro data indicate capsaicin does not significantly inhibit or induce major cytochrome P450 enzymes
Caution advised with concomitant use of other topical products on the same skin area

Application-site erythema (very common, ~63%)
Application-site pain, burning, and stinging (very common, ~42%), often requiring pretreatment/post-treatment analgesia
Application-site pruritus and papules
Transient increases in blood pressure during/after application, of particular concern in patients with unstable cardiovascular disease
Postmarketing reports of second-degree burns, and rarely permanent scarring/skin discoloration
Transient reduction in sensation (hypoesthesia) at the application site

Monitor blood pressure before, during, and after application, especially in patients with cardiovascular disease
Monitor application site during and immediately after treatment for excessive erythema, blistering, or burn-like injury
Assess procedural pain and provide adequate analgesia during application and removal
Reassess neuropathic pain severity and function periodically to determine need for repeat treatment
Ensure proper personal protective equipment use by clinical staff

Animal reproduction studies showed no evidence of impaired fertility or harm to the fetus at systemic exposures well exceeding human dose, but no adequate well-controlled human studies exist; systemic absorption in humans is minimal
Not known whether capsaicin is excreted in human breast milk; low levels detected in the milk of lactating rats
Given minimal systemic absorption, risk to nursing infant is expected to be low, but caution is advised