{"id":"ketotifen","rwe":[{"pmid":"41898664","year":"2026","title":"Potential Role of Mast Cells in Intervertebral Disc Ageing, Herniation Resolution, and Degeneration: Evidence and Lessons Learned from Studies of Mast Cells in Other Connective Tissues.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41701442","year":"2026","title":"S1P2 Reduces Mast Cell Activation and Colonic Inflammation of L-Arginine-Induced Acute Pancreatitis.","finding":"","journal":"Digestive diseases and sciences","studyType":"Clinical Study"},{"pmid":"30000587","year":"2006","title":"Ketotifen.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"41619038","year":"2026","title":"Experimental and ALO-optimized machine learning interpretable models for pharmaceutical adsorption onto raw bentonite.","finding":"","journal":"Environmental geochemistry and health","studyType":"Clinical Study"},{"pmid":"41546591","year":"2026","title":"Sustained release effects of ketotifen nasal drops on nasal vascular permeability and duration in patients with post-exercise nasal symptoms.","finding":"","journal":"Pakistan journal of pharmaceutical sciences","studyType":"Clinical Study"}],"_fda":{"id":"948d4259-9d62-4bc7-9149-6961034364bf","set_id":"0fe119ad-cb44-4e90-a096-0ed0ba63dc31","openfda":{"unii":["HBD503WORO"],"route":["OPHTHALMIC"],"rxcui":["311237"],"spl_id":["948d4259-9d62-4bc7-9149-6961034364bf"],"brand_name":["KETOTIFEN FUMARATE"],"spl_set_id":["0fe119ad-cb44-4e90-a096-0ed0ba63dc31"],"package_ndc":["76385-106-17"],"product_ndc":["76385-106"],"generic_name":["KETOTIFEN FUMARATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["KETOTIFEN FUMARATE"],"manufacturer_name":["Unichem Pharmaceuticals (USA), Inc."],"application_number":["ANDA204059"],"is_original_packager":[true]},"purpose":[""],"version":"2","warnings":[""],"effective_time":"20251124","active_ingredient":[""],"inactive_ingredient":[""],"indications_and_usage":[""],"spl_unclassified_section":["Active ingredient Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%) Purpose Antihistamine Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander. Warnings For external use only Do not use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use Stop use and ask a doctor if you experience any of the following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor. Other information Only for use in the eye. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Inactive ingredients benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid. Questions? Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number. Made in India Distributed by: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816 USA Rev. 11/2025 KFO1236"],"dosage_and_administration":[""],"spl_product_data_elements":["KETOTIFEN FUMARATE KETOTIFEN FUMARATE KETOTIFEN FUMARATE KETOTIFEN GLYCERIN SODIUM HYDROXIDE HYDROCHLORIC ACID BENZALKONIUM CHLORIDE"],"keep_out_of_reach_of_children":[""],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76385-106-17 Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS 5 mL (0.17 FL OZ) Sterile ketotifenfumaratelabel","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76385-106-17 Now OTC Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS Eye Itch Relief Works in Minutes Original Prescription Strength for ages 3 years and older 20 day supply 5 mL (0.17 FL OZ) Sterile ketotifenfumaratecarton"]},"tags":[{"label":"Histamine-1 Receptor Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H1 receptor","category":"target"},{"label":"HRH1","category":"gene"},{"label":"HTR2A","category":"gene"},{"label":"CHRM5","category":"gene"},{"label":"R06AX17","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Solution","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Allergic conjunctivitis","category":"indication"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Antipruritics","category":"pharmacology"},{"label":"Dermatologic Agents","category":"pharmacology"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Antagonists","category":"pharmacology"},{"label":"Histamine H1 Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"TREATMENT FAILURE","source":"FDA FAERS","actionTaken":"2496 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"899 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"628 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"270 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"222 reports"},{"date":"","signal":"EYE PRURITUS","source":"FDA FAERS","actionTaken":"212 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"210 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"182 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"178 reports"},{"date":"","signal":"HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"171 reports"}],"commonSideEffects":[],"specialPopulations":{"Lactation":"There is no information regarding the presence or absence of ketotifen fumarate or its metabolites in human milk following use of ACUVUE(R) Theravision(TM) with Ketotifen, or on the breastfed infants and milk production. Ketotifen fumarate has been identified in breast milk in rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk.","Pregnancy":"There are no adequate and well-controlled studies of ACUVUE(R) Theravison(TM) with Ketotifen administration in pregnant women to inform drug-associated risk. ACUVUE(R) Theravison(TM) with Ketotifen is not absorbed systemically following ocular administration, and maternal use is not expected to result in fetal exposure to the drug. Oral administration of ketotifen fumarate to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data].","Geriatric use":"Clinical studies of etafilcon with ketotifen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.","Paediatric use":"The safety and efficacy of ACUVUE(R) Theravision(TM) with Ketotifen in pediatric patients below the age of 11 years has not been established."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=KETOTIFEN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:49:45.991824+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ketotifen","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:49:53.316892+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:49:51.810818+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:41:39.538564+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=KETOTIFEN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:49:52.270581+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:49:44.878034+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:49:44.878061+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":"2026-04-20T00:41:48.663676+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:49:53.316828+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1633/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:49:52.973887+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA204059","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:49:44.878072+00:00"}},"allNames":"zaditor","offLabel":[],"synonyms":["HC 20-511","ketotifen","ketotifen fumarate"],"timeline":[{"date":"1999-07-02","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"2006-10-19","type":"positive","source":"FDA Orange Book","milestone":"Zaditor approved — EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"2007-07-26","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"},{"date":"2022-02-25","type":"positive","source":"FDA Orange Book","milestone":"Acuvue Theravision With Ketotifen approved — EQ 19MCG BASE"}],"approvals":[{"date":"1999-07-02","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Zaditor","ecosystem":[{"indication":"Allergic conjunctivitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alcaftadine","slug":"alcaftadine","company":"Allergan"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null}],"mechanism":{"target":"Histamine H1 receptor","novelty":"Follow-on","targets":[{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"},{"gene":"HTR2A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2A","protein":"5-hydroxytryptamine receptor 2A"},{"gene":"CHRM5","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M5","protein":"Muscarinic acetylcholine receptor M5"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"HTR2C","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2C","protein":"5-hydroxytryptamine receptor 2C"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"ADRA2B","source":"DrugCentral","target":"Alpha-2B adrenergic receptor","protein":"Alpha-2B adrenergic receptor"},{"gene":"DRD1","source":"DrugCentral","target":"D(1A) dopamine receptor","protein":"D(1A) dopamine receptor"}],"moaClass":"Histamine H1 Receptor Antagonists","modality":"Small Molecule","drugClass":"Histamine-1 Receptor Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Ketotifen acts as a competitive antagonist at the histamine H1 receptor, inhibiting the binding of histamine and subsequent downstream signaling pathways that lead to allergic responses."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Ketotifen","title":"Ketotifen","extract":"Ketotifen is an antihistamine medication and a mast cell stabilizer used to treat allergic conditions such as conjunctivitis, asthma, and hives. Ketotifen is available in ophthalmic and oral forms: the ophthalmic form relieves eye itchiness and irritation associated with seasonal allergies, while the oral form helps prevent systemic conditions such as asthma attacks and allergic reactions. In addition to treating allergies, ketotifen has shown efficacy in managing systemic mast cell diseases such as mastocytosis and mast cell activation syndrome (MCAS), which involve abnormal accumulation or activation of mast cells throughout the body. Ketotifen is also used for other allergic-type conditions like atopic dermatitis (eczema) and food allergies.","wiki_history":"== History ==\nKetotifen was patented in 1970 and came into medical use in 1976. Ketotifen was developed and patented by Sandoz Pharmaceuticals (a part of Novartis), a Swiss company.\n\nKetotifen was approved for medical use in Canada in December 1990. A contact lens with ketotifen was approved for medical use in the United States in 2022.","wiki_society_and_culture":"== Society and culture ==\nthumb|right|A generic formulation of ketotifen marketed under the Ketotifen Sopharma brand name\n\n=== Economics ===\nKetotifen is available as a generic drug. In October 2006, the FDA approved the switch of Zaditor from prescription to over-the-counter (OTC) status, and it became available OTC in January 2007. Outside the United States, oral ketotifen is available as a generic in countries where it is approved, including Canada, EU member states, and the United Kingdom. In the United States, ketotifen fumarate ophthalmic solution is marketed under brand name Zaditor, which is owned by Alcon Inc., a Swiss-American pharmaceutical company."},"commercial":{"launchDate":"1999","_launchSource":"DrugCentral (FDA 1999-07-02, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1530","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=KETOTIFEN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=KETOTIFEN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Ketotifen","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T12:13:16.503227","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:49:54.544964+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"cyproheptadine","drugSlug":"cyproheptadine","fdaApproval":"1961-10-17","genericCount":31,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"antazoline","drugSlug":"antazoline","fdaApproval":"1990-04-30","relationship":"same-class"},{"drugName":"triprolidine","drugSlug":"triprolidine","fdaApproval":"1983-05-17","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"azatadine","drugSlug":"azatadine","fdaApproval":"1977-03-29","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"astemizole","drugSlug":"astemizole","fdaApproval":"1988-12-31","relationship":"same-class"},{"drugName":"terfenadine","drugSlug":"terfenadine","fdaApproval":"","relationship":"same-class"},{"drugName":"loratadine","drugSlug":"loratadine","fdaApproval":"1993-04-12","genericCount":29,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"acrivastine","drugSlug":"acrivastine","fdaApproval":"1994-03-25","relationship":"same-class"},{"drugName":"azelastine","drugSlug":"azelastine","fdaApproval":"1996-11-01","patentExpiry":"Jun 4, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"epinastine","drugSlug":"epinastine","fdaApproval":"2003-10-16","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"fexofenadine","drugSlug":"fexofenadine","fdaApproval":"1996-07-25","patentExpiry":"Aug 2, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"desloratadine","drugSlug":"desloratadine","fdaApproval":"2001-12-21","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"ketotifen","indications":{"approved":[{"name":"Allergic conjunctivitis","source":"DrugCentral","snomedId":473460002,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Bausch And Lomb","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book 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