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Molecule

Capsaicin

Available on requestOrphanPain and anaesthesia
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Capsaicin is a prescription medicine indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. It is available as kits. MedsAcross supplies Capsaicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
M02AB01 Capsaicin · CapsaicinN01BX04 Capsaicin · Local anesthetic, subgroup N01BX
US FDA first approval
16 November 2009
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Dosage forms
Kit
Identifiers
UNII S07O44R1ZMRxCUI 1992CAS 404-86-4DrugBank DB06774Q273169

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. QUTENZA is a TRPV1 channel agonist indicated for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

Source: US FDA prescribing information

How it works

Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor (TRPV1), which is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration of capsaicin causes an initial enhanced stimulation of the TRPV1-expressing cutaneous nociceptors that may be associated with painful sensations. This is followed by pain relief thought to be mediated by a reduction in TRPV1-expressing nociceptive nerve endings. Over the course of several months, there may be a gradual re-emergence of painful neuropathy thought to be due to TRPV1 nerve fiber reinnervation of the treated area.

Source: US FDA prescribing information

Dosing overview

Only physicians or health care professionals are to administer QUTENZA. Administer QUTENZA in a well-ventilated treatment area. Wear nitrile (not latex) gloves when handling QUTENZA and when cleaning treatment areas. Use of a face mask and protective glasses is advisable for healthcare professionals. Do not use QUTENZA on broken skin. PHN: Apply up to four topical systems for 60 minutes. DPN: Apply up to four topical systems for 30 minutes on the feet. Repeat every 3 months or as warranted by the return of pain (not more frequently than every three months). See Dosage and Administration, Instructions for Use, for detailed instructions on QUTENZA administration.

Source: US FDA prescribing information

Warnings and precautions

Severe Irritation with Unintended Capsaicin Exposure: Capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin to the healthcare professional, patients, and others. Increase in Blood Pressure: Transient increases in blood pressure may occur with QUTENZA treatment. Monitor blood pressure during and following the treatment procedure. Sensory Function: Reductions in sensory function, which were generally minor and temporary, have been reported following administration of QUTENZA. Assess for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory loss occurs, treatment should be reconsidered. Severe Application Site Burns: Full-thickness (third-degree) and deep partial-thickness (second-degree) burns have been reported following administration of QUTENZA. Ensure that dosage and administration recommendations are followed.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed elsewhere in the labeling: Severe Irritation Due to Accidental Exposure of Eyes, Skin, Respiratory Tract, and Mucous Membranes Application-Associated Pain Increase in Blood Pressure Sensory Function Reduction Severe Application Site Burns ​ The most common adverse reactions (≥5% and greater than control) in all controlled clinical trials are application site erythema, application site pain, and application site pruritus.

Source: US FDA prescribing information

Interactions

No clinical drug interaction studies have been performed. Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples. Therefore, interactions with systemic medicinal products are unlikely.

Source: US FDA prescribing information

Storage

Storage Store carton between 20°C to 25°C (68°F to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Capsaicin, sorted by availability.

MedicineManufacturerRegisterAvailability
Qutenza kitAveritas PharmaUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 16 November 2009Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Capsaicin in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Capsaicin available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Capsaicin and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Capsaicin have?

The catalogue lists 1 brand names for Capsaicin, including Qutenza.

Is Capsaicin approved by the US FDA?

Yes. The US FDA first approved Capsaicin on 16 November 2009, according to Drugs@FDA.

Is Capsaicin authorised in the European Union?

Yes. Capsaicin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Capsaicin need cold chain shipping?

No listed presentation of Capsaicin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Capsaicin in?

Capsaicin is classified under ATC code M02AB01 (Capsaicin).

References

  1. Qutenza prescribing information (Averitas Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 7 July 2026
  2. Qutenza: European public assessment report (EPAR). European Medicines Agency. Retrieved 5 May 2026

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