Is Capsaicin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Capsaicin, including QUTENZA 179 mg Cutaneous Patch (179 mg, Cutaneous patch, SAR 1117.00).

Is Capsaicin approved by the US FDA?

Drugs@FDA lists 1 application product line for Capsaicin, including QUTENZA (Prescription).

Is Capsaicin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Capsaicin: Qutenza.

Are there safety signals or safety updates for Capsaicin?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2024-07-31).

Active substance

Capsaicin

SFDA 2
US FDA 1
EMA 1
US price lines 5
NHS prices 3
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
QUTENZA 179 mg Cutaneous Patch	179 mg	Cutaneous patch · Topical	1 Patch	SAR 1117.00	NCE · Prescription	GRUNENTHAL	Valid
QUTENZA 179 mg Cutaneous Patch	179 mg	Cutaneous patch · Topical	2 Patch	SAR 2234.00	NCE · Prescription	GRUNENTHAL	Valid

Indications — CHI Daman Drug Formulary

DIABETIC NEUROPATHY; LOW BACK PAIN; NEUROPATHIC PAIN; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
QUTENZA	8%	patch · topical	AVERITAS	Prescription	16 Nov 2009

EMA European Union — centrally authorised medicines

Qutenza Grunenthal GmbH · Authorised · authorised 15 May 2009 · ATC N01BX04

Therapeutic indication (EMA)

Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CAPSAICIN 0.025% CREAM	$0.08205	per GM	23 Sep 2026
US NADAC	CAPSAICIN 0.025% HEAT PATCH	$1.11695	per EA	23 Sep 2026
US NADAC	CAPSAICIN 0.075% CREAM	$0.07134	per GM	23 Sep 2026
US NADAC	CAPSAICIN 0.1% CREAM	$0.20681	per GM	23 Sep 2026
US NADAC	GNP CAPSAICIN 0.025% PATCH	$1.11695	per EA	23 Sep 2026
NHS Drug Tariff	Capsaicin 0.025% cream	£24.95	45 gram	1 Oct 2026
NHS Drug Tariff	Capsaicin 0.075% cream	£24.95	45 gram	1 Oct 2026
NHS Drug Tariff	Capsaicin 179mg cutaneous patches	£210.00	1 patch	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 31 Jul 2024 QUTENZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Nov 2012 PRAC signal: Severe burns
Action for MAH: update of the product information: No

All safety entries for capsaicin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.