{"id":"capsaicin","rwe":[{"pmid":"41898686","year":"2026","title":"Gastroprotective Action of Adiponectin Against Gastric Mucosal Injury Induced by Ischemia and Reperfusion-Involvement of Nitric Oxide, Sensory Afferent Nerves, and Anti-Inflammatory Mediators.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41884973","year":"2026","title":"Bidirectional Roles of TRPV1 in a Latent Sensitization Model of Myofascial Low Back Pain.","finding":"","journal":"European journal of pain (London, England)","studyType":"Clinical Study"},{"pmid":"41884965","year":"2026","title":"Local therapeutic strategies for neurocutaneous dysesthesia: from capsaicin to cannabinoids.","finding":"","journal":"The Journal of dermatological treatment","studyType":"Clinical Study"},{"pmid":"41880378","year":"2026","title":"Inhibition of transient receptor potential vanilloid 1 (TRPV1) by a novel selective antagonist for anti-nociceptive effect on inflammatory pain without hyperthermia.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"41876799","year":"2026","title":"Light flickering with 40 Hz causes analgesia via activation of a retina-amygdala pathway and the local release of adenosine.","finding":"","journal":"Purinergic signalling","studyType":"Clinical Study"}],"_fda":{"id":"4dd9a4a8-6316-41d9-b9cc-75b31e9a0fb7","set_id":"0090ca38-6433-45c4-9453-edf2788c14c6","openfda":{"upc":["0350488106061"],"unii":["S07O44R1ZM"],"route":["TOPICAL"],"rxcui":["646333"],"spl_id":["4dd9a4a8-6316-41d9-b9cc-75b31e9a0fb7"],"brand_name":["Capsaicin 0.1 Percent"],"spl_set_id":["0090ca38-6433-45c4-9453-edf2788c14c6"],"package_ndc":["50488-1060-6"],"product_ndc":["50488-1060"],"generic_name":["CAPSAICIN"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CAPSAICIN"],"manufacturer_name":["Alexso, Inc"],"application_number":["M017"],"is_original_packager":[true]},"purpose":["Purpose External analgesic"],"version":"3","stop_use":["Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs"],"warnings":["Warnings For external use only Read all warnings and directions before use. Test first on small area of skin. Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use Stop use and as k a doctor if • Condition worsens or does not improve after regular use • Severe burning persists or blistering occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"do_not_use":["Do not use • On wounds or damaged skin • If you are allergic to capsicum or chili peppers"],"when_using":["Whe n us ing this product • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. • Avoid contact with the eyes, lips, nose and mucous membranes • Do not tightly wrap or bandage the treated area • Do not apply heat to the treated area immediately before or after use"],"effective_time":"20241206","active_ingredient":["Active ingredient Capsaicin 0.1%"],"inactive_ingredient":["Inactive ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine"],"storage_and_handling":["Other information Store at room temperature 15°-30°C (59°-86°F)"],"indications_and_usage":["Uses Temporarily relieves minor aches and pains of muscles and joints due to: • simple backache • arthritis • strains • sprains"],"spl_unclassified_section":["CAPSAICIN – Capsaicin 0.1 % Cream Alexso, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Capsaicin 0.1 % Cream Drug Facts"],"dosage_and_administration":["Directions Adults and children 18 years of age and older: Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily. Children under 18 years : Ask a doctor"],"spl_product_data_elements":["Capsaicin 0.1 Percent Capsaicin CAPSAICIN CAPSAICIN STEARIC ACID TROLAMINE CHONDROITIN SULFATE (BOVINE) POLYACRYLAMIDE (10000 MW) SODIUM POLYACRYLATE (2500000 MW) WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CETOSTEARYL ALCOHOL ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERIN GLYCERYL MONOSTEARATE C13-14 ISOPARAFFIN ISOSTEARYL PALMITATE LAURETH-7 DIMETHYL SULFONE PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Capsaicin 0.1 % C ream NDC 50488-1060-6 6 0 grams Alexso, Inc PRINCIPAL DISPLAY PANEL Capsaicin 0.1% Cream NDC 50488-1060-6 60 grams Alexso, Inc"]},"tags":[{"label":"capsaicin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Transient receptor potential cation channel subfamily V member 1","category":"target"},{"label":"TRPV1","category":"gene"},{"label":"KDM1A","category":"gene"},{"label":"CYP1A2","category":"gene"},{"label":"M02AB01","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cloth","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Arthritic Pain","category":"indication"},{"label":"Backache","category":"indication"},{"label":"Neuralgia","category":"indication"},{"label":"Postherpetic neuralgia","category":"indication"},{"label":"Sprains and 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skin","Diabetes mellitus","Disease of liver","Disorder of cardiovascular system","Disorder of skin","Factor II deficiency","Gastritis","Gastroesophageal reflux disease","Gastrointestinal hemorrhage","Gastrointestinal ulcer","Heart block","Hemophilia","Hepatic failure","Hypertensive disorder","Kidney disease"],"specialPopulations":{"Pregnancy":"If pregnant or breast feeding, ask health professional before use."},"seriousAdverseEvents":[{"effect":"Deep partial-thickness (second-degree) burns","drugRate":"","severity":"serious"},{"effect":"Full-thickness (third-degree) burns","drugRate":"","severity":"serious"},{"effect":"Scarring","drugRate":"","severity":"serious"},{"effect":"Accidental exposure with eye pain","drugRate":"","severity":"serious"},{"effect":"Accidental exposure with cough","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Averitas","patents":[{"applNo":"N022395","source":"FDA Orange Book","status":"Active","expires":"Dec 15, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9226903","drugSubstance":false},{"applNo":"N022395","source":"FDA Orange Book","status":"Active","expires":"Mar 26, 2030","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8821920","drugSubstance":false}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0957/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$35","description":"CAPSAICIN 0.025% CREAM","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CAPSAICIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:11:44.284031+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange 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warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:11:41.729458+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:11:58.255954+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Vanilloid receptor opener","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:11:57.343993+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL294199/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:11:57.246630+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M017","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:11:41.729461+00:00"}},"allNames":"qutenza","offLabel":[],"synonyms":["capsaicin","capsaicine","qutenza","NGX-4010","NGX 4010"],"timeline":[{"date":"2009-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ACORDA to Averitas"},{"date":"2009-11-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Acorda)"}],"aiSummary":"Qutenza is a capsaicin-based small molecule that targets the transient receptor potential cation channel subfamily V member 1. It is FDA-approved for treating various types of pain, including arthritic pain, backache, neuralgia, postherpetic neuralgia, and sprains and strains. Qutenza is owned by Averitas, a company that acquired the rights from ACORDA, the original developer. The commercial status of Qutenza is patented, with no generic manufacturers available. Key safety considerations include potential skin irritation and allergic reactions.","brandName":"Qutenza","ecosystem":[{"indication":"Arthritic Pain","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"camphor","slug":"camphor","company":""},{"name":"levomenthol","slug":"levomenthol","company":""},{"name":"methyl salicylate","slug":"methyl-salicylate","company":"Hisamitsu Pharm Co"}],"globalPrevalence":null},{"indication":"Backache","otherDrugs":[{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"camphor","slug":"camphor","company":""}],"globalPrevalence":null},{"indication":"Neuralgia","otherDrugs":[{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"}],"globalPrevalence":28000000},{"indication":"Postherpetic neuralgia","otherDrugs":[{"name":"gabapentin","slug":"gabapentin","company":"Pfizer Pharms"},{"name":"gabapentin enacarbil","slug":"gabapentin-enacarbil","company":"Xenoport Inc"},{"name":"lidocaine","slug":"lidocaine","company":"Fresenius Kabi Usa"},{"name":"pregabalin","slug":"pregabalin","company":"Pf Prism Cv"}],"globalPrevalence":28000000},{"indication":"Sprains and Strains","otherDrugs":[{"name":"camphor","slug":"camphor","company":""},{"name":"diclofenac","slug":"diclofenac","company":""},{"name":"levomenthol","slug":"levomenthol","company":""},{"name":"methyl salicylate","slug":"methyl-salicylate","company":"Hisamitsu Pharm Co"}],"globalPrevalence":null}],"mechanism":{"target":"Transient receptor potential cation channel subfamily V member 1","novelty":"Follow-on","targets":[{"gene":"TRPV1","source":"DrugCentral","target":"Transient receptor potential cation channel subfamily V member 1","protein":"Transient receptor potential cation channel subfamily V member 1"},{"gene":"KDM1A","source":"DrugCentral","target":"Lysine-specific histone demethylase 1A","protein":"Lysine-specific histone demethylase 1A"},{"gene":"CYP1A2","source":"DrugCentral","target":"Cytochrome P450 1A2","protein":"Cytochrome P450 1A2"},{"gene":"PTGS1","source":"DrugCentral","target":"Prostaglandin G/H synthase 1","protein":"Prostaglandin G/H synthase 1"},{"gene":"KCNA1","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily A member 1","protein":"Potassium voltage-gated channel subfamily A member 1"},{"gene":"YARS","source":"DrugCentral","target":"Tyrosine--tRNA ligase, cytoplasmic","protein":"Tyrosine--tRNA ligase, cytoplasmic"},{"gene":"ALOX5","source":"DrugCentral","target":"Arachidonate 5-lipoxygenase","protein":"Arachidonate 5-lipoxygenase"}],"modality":"Small Molecule","drugClass":"capsaicin","explanation":"","oneSentence":"","technicalDetail":"Qutenza binds to the transient receptor potential cation channel subfamily V member 1 (TRPV1) receptor, a ligand-gated ion channel that plays a key role in the transmission of pain signals. Activation of TRPV1 leads to an influx of cations, including calcium, which triggers the release of neurotransmitters that transmit pain signals to the brain."},"commercial":{"launchDate":"2009","_launchSource":"DrugCentral (FDA 2009-11-16, ACORDA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3064","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CAPSAICIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CAPSAICIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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aches and muscle pains associated with arthritis"},{"name":"Backache","source":"DrugCentral","snomedId":161891005,"regulator":"FDA","eligibility":"simple backache"},{"name":"Neuralgia","source":"DrugCentral","snomedId":16269008,"regulator":"FDA","eligibility":"not specified","usPrevalence":null,"globalPrevalence":28000000,"prevalenceMethod":"curated","prevalenceSource":"BMJ Open, 2016 (PMID:27324708)"},{"name":"Postherpetic neuralgia","source":"DrugCentral","snomedId":2177002,"regulator":"FDA","eligibility":"not specified","usPrevalence":null,"globalPrevalence":28000000,"prevalenceMethod":"curated","prevalenceSource":"BMJ Open, 2016 (PMID:27324708)"},{"name":"Sprains and Strains","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"strains, muscle soreness and stiffness"}],"offLabel":[{"name":"Cannabis hyperemesis syndrome co-occurrent and due to cannabis 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