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Capsaicin

AEMPS

Selective TRPV1 agonist, topical analgesic for neuropathic pain

ATC code: N01BX04

Brand names: Qutenza, Capzasin, Zostrix

Updated · Methodology

Indications

A

Postherpetic neuralgia

Second line

Capsaicin 8% patch (Qutenza) is an authorised option for postherpetic neuralgia when first-line therapy (gabapentin, pregabalin, amitriptyline) is insufficient. A single 60-minute application reduces pain by about 30% for 8–12 weeks. CG173 and SED (Sociedad Española del Dolor) recommend the patch in localised neuropathic pain and when oral medication is poorly tolerated. The patch is applied by a clinician or trained nurse under local skin anaesthesia.

Sources

  1. AEMPS: Ficha técnica de Capsaicina (Qutenza) (2023)
  2. EMA: Qutenza – EPAR (2024)
  3. NICE: Neuropathic pain in adults: pharmacological management in non-specialist settings (2020)

ICD-10: B02.2 · ICD-11: 1E91.5

B

Diabetic polyneuropathy

Second line

Capsaicin 8% patch was -approved in 2020 for painful diabetic peripheral polyneuropathy of the feet. CG173 and redGDPS position the patch as second-line after gabapentinoids and duloxetine in patients with localised pain that does not extend above the knee. AEMPS authorised this indication in 2023. Low-dose 0.025–0.075% creams are not included in current recommendations for diabetic neuropathy – evidence quality is low.

Sources

  1. AEMPS: Ficha técnica de Capsaicina (Qutenza) (2023)
  2. EMA: Qutenza – EPAR (2024)
  3. NICE: Neuropathic pain in adults: pharmacological management in non-specialist settings (2020)

ICD-10: G63.2 · ICD-11: 8C03.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

C

Osteoarthritis

Not recommended

Low-dose capsaicin 0.025–0.075% creams for knee and hand osteoarthritis is an option with limited evidence. Cochrane (Derry 2017): the effect is small, clinically marginal and evidence quality is low. and SER osteoarthritis guidelines do not list capsaicin as first line; they recommend topical NSAIDs, paracetamol and, for knee osteoarthritis, duloxetine or intra-articular corticosteroids. Use can be discussed when topical NSAIDs are not tolerated, but the effect is limited and burning often leads patients to discontinue.

Sources

  1. Cochrane: Topical capsaicin (low concentration) for chronic neuropathic pain in adults (2017)

ICD-10: M19 · ICD-11: FA0Z

F

Warming creams for back and joint pain

Not recommended

Capsaicin is a selective TRPV1 agonist with proven efficacy only in neuropathic pain as the high-dose 8% patch (Qutenza). Low-dose warming creams with capsaicin (Espol, Nicoflex, several OTC combinations) are marketed for «back pain, osteochondrosis, muscle pain, bruises». Cochrane (Derry 2017) on topical capsaicin for chronic pain: evidence quality is low and the effect is clinically insignificant. AAOS, and SER do not include such creams in first-line recommendations for acute musculoskeletal pain. If a capsaicin cream was prescribed for acute back pain, osteochondrosis or a bruise, consider seeking a second opinion.

Sources

  1. Cochrane: Topical capsaicin (low concentration) for chronic neuropathic pain in adults (2017)
  2. NICE: Neuropathic pain in adults: pharmacological management in non-specialist settings (2020)

ICD-10: M54.5 · ICD-11: ME84.2Z

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Highly selective agonist of the TRPV1 receptor on cutaneous C and Aδ nociceptive fibres. After application it first depolarises fibres and causes burning; with prolonged exposure (8% patch for 60 minutes) it induces functional defunctionalisation and reversible degeneration of epidermal nerve endings for months. Analgesia after a single 8% patch (Qutenza) lasts up to 3 months. Low concentrations (0.025–0.075% creams) produce only a brief local effect and relieve itch. Systemic absorption through skin is clinically negligible when used correctly.

Safety

Contraindications

  • Hypersensitivity to capsaicin or excipients
  • Broken skin, eczema or weeping wounds at the application site
  • Children under 18 years for the 8% patch

Serious adverse effects

  • Severe pain and spasm during 8% patch application requiring local anaesthesia
  • Chemical burn on contact with eyes or mucous membranes
  • Hypertensive crisis in patients with uncontrolled hypertension

Common adverse effects

  • Intense burning and pain at the application site (especially during the first 30 minutes of the 8% patch)
  • Erythema and oedema
  • Itching
  • Transient blood pressure rise during patch application

Pregnancy: can you take Capsaicin?

EMA summary of product characteristics (section 4.6): there are no or limited data on capsaicin in pregnant women. Systemic exposure to capsaicin after a Qutenza 179 mg patch is low and transient in humans, so the patch is unlikely to increase the risk of developmental abnormalities, but it is prescribed with caution in pregnant women. For the 0.075% cream (AEMPS summary of product characteristics for Capsicin 0.75 mg/g, section 4.6), safety in pregnancy has not been established because there is no experience of use, but the small amounts absorbed through the skin are considered unlikely to cause harm. According to this summary of product characteristics, if the doctor considers it appropriate, the cream may be used during pregnancy.

Breastfeeding: can you take Capsaicin?

Hale L2. Systemic absorption with correct use is minimal; do not apply to the breast or nipple before feeding. The 8% patch is not used during lactation – no formal safety data exist.

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Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Capsaicin used for?

Capsaicin is evaluated for the following indications with varying evidence strength: Postherpetic neuralgia (evidence tier A), Diabetic polyneuropathy (evidence tier B), Osteoarthritis (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Capsaicin?

Common side effects of Capsaicin (≥ 1 in 100): Intense burning and pain at the application site (especially during the first 30 minutes of the 8% patch), Erythema and oedema, Itching, Transient blood pressure rise during patch application. See the Safety section for uncommon and serious reactions.

Is Capsaicin safe during pregnancy?

EMA summary of product characteristics (section 4.6): there are no or limited data on capsaicin in pregnant women. Systemic exposure to capsaicin after a Qutenza 179 mg patch is low and transient in humans, so the patch is unlikely to increase the risk of developmental abnormalities, but it is prescribed with caution in pregnant women. For the 0.075% cream (AEMPS summary of product characteristics for Capsicin 0.75 mg/g, section 4.6), safety in pregnancy has not been established because there is no experience of use, but the small amounts absorbed through the skin are considered unlikely to cause harm. According to this summary of product characteristics, if the doctor considers it appropriate, the cream may be used during pregnancy.

Is Capsaicin compatible with breastfeeding?

Hale L2. Systemic absorption with correct use is minimal; do not apply to the breast or nipple before feeding. The 8% patch is not used during lactation – no formal safety data exist.

Who should not take Capsaicin?

Capsaicin is contraindicated in: Hypersensitivity to capsaicin or excipients; Broken skin, eczema or weeping wounds at the application site; Children under 18 years for the 8% patch. Full list in the Safety section.

Official sources

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