Ketotifen
GET
/api/v1/drug/ketotifenMechanism of action
Sourced from openFDAMechanism-of-action class: Histamine H1 Receptor Antagonists.
Histamine H1 Receptor
Approval history
Sourced from openFDA- Dec 1, 2006NDANDA021996Bausch And Lomb
- Jul 26, 2007ANDAANDA077958Sentiss
- Sep 2, 2008ANDAANDA077200Alcon Pharms Ltd
- Jun 1, 2020ANDAANDA204059Unichem
FAERS reports
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
6,414 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Treatment Failure2,49639%
- 2Drug Ineffective90614%
- 3Eye Irritation6319.8%
- 4Eye Pain2714.2%
- 5Ocular Hyperaemia2233.5%
- 6Eye Pruritus2133.3%
- 7Pruritus2133.3%
- 8Fatigue1892.9%
- 9Headache1892.9%
- 10Hypersensitivity1712.7%
- 11Nausea1702.7%
- 12Dyspnoea1682.6%
- 13Diarrhoea1522.4%
- 14Pain1512.4%
- 15Vision Blurred1432.2%
Literature
Recent PubMed references pinned to Ketotifen as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Ketotifen for Preventing Oxaliplatin-Induced Neuropathy in Stage III Colorectal Cancer: a Randomized Controlled Trial.Journal of gastrointestinal cancer · 2026 · Wahby SS, Mostafa TM, El-Din MAA, et al.PMID 42096115DOI 10.1007/s12029-026-01456-4
- Immunomodulatory and Anti-Inflammatory Effects of Ketotifen Versus Vitamin E in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized Pilot Study.Drug design, development and therapy · 2026 · Aldossary KM, Talkhan H, Abdulelah FM, et al.PMID 42039690DOI 10.2147/DDDT.S593561
- Sustained release effects of ketotifen nasal drops on nasal vascular permeability and duration in patients with post-exercise nasal symptoms.Pakistan journal of pharmaceutical sciences · 2026 · Du J, Wu H, Wang S, et al.PMID 41546591DOI 10.36721/PJPS.2026.39.2.REG.15173.1
- Smart Nanoplatform with Self-Stimulation Strategy for Dynamic Regulation and In Situ Visual Imaging of Histamine Activities in Allergic Rhinitis.ACS nano · 2026 · Shen Q, Fu C, Cao M, et al.PMID 41499188DOI 10.1021/acsnano.5c11975
- Enhancing nanomedicine efficacy in KPC pancreatic tumors through ketotifen-mediated tumor microenvironment remodeling.Journal of controlled release : official journal of the Controlled Release Society · 2026 · Charalambous A, Mpekris F, Voutouri C, et al.PMID 41391724DOI 10.1016/j.jconrel.2025.114541
- Exosome-mediated modulation of bortezomib cytotoxicity in multiple myeloma cells: involvement of redox balance and cell cycle arrest through ketotifen treatment.Medical oncology (Northwood, London, England) · 2025 · Nourafshan N, Sarab GA, Mesbahzadeh B, et al.PMID 41283937DOI 10.1007/s12032-025-03147-9
- Ketotifen reacidifies secretory lysosomes and normalises ageing phenotypes in mast cells.Biochemical and biophysical research communications · 2025 · Barrella L, Ramírez-Ponce MP, Vázquez-Román V, et al.PMID 41175648DOI 10.1016/j.bbrc.2025.152887
- Prevention of morphine dependence with a combination of ketotifen and l-carnitine in mice: a new potential therapeutic approach.Behavioural pharmacology · 2025 · Habibi Asl B, Fallahi S, Bohlouli S, et al.PMID 40905352DOI 10.1097/FBP.0000000000000849
Clinical trials
The 10 most recently updated of 40 ClinicalTrials.gov registrations naming Ketotifen as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Mast Cell Treatment in Post-tick Bite Illness (PTBI)Not yet recruiting · Phase 2 · Interventional · 50 enrolled · University of North Carolina, Chapel HillNCT07526558updated 2026-04-13
- Topical Ketotifen 0.25% for Secondary VestibulodyniaRecruiting · Phase 2 · Interventional · 54 enrolled · Center for Vulvovaginal DisordersNCT07257029updated 2026-03-18
- Ketotifen in Non-Alcoholic Fatty Liver Disease PatientsCompleted · Phase 4 · Interventional · 60 enrolled · Tanta UniversityNCT05616442updated 2026-02-06
- Ketotifen for Children With Functional Dyspepsia in Association With Duodenal EosinophiliaRecruiting · Phase 3 · Interventional · 40 enrolled · Craig A. Friesen, MDNCT02484248updated 2026-01-09
- A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic DermatitisCompleted · Phase 3 · Interventional · 303 enrolled · Tanabe Pharma CorporationNCT01840605updated 2026-01-08
- PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2Completed · Phase 3 · Interventional · 395 enrolled · University of CalgaryNCT03582176updated 2025-12-04
- A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal EctasiaRecruiting · Observational · 168 enrolled · Massachusetts General HospitalNCT02118922updated 2025-11-06
- Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic SolutionCompleted · Phase 3 · Interventional · 512 enrolled · Bausch & Lomb IncorporatedNCT05815758updated 2025-07-10
- Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic ConjunctivitisCompleted · Phase 3 · Interventional · 229 enrolled · Bausch & Lomb IncorporatedNCT05591755updated 2025-07-01
- The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral NeuropathyRecruiting · Phase 3 · Interventional · 64 enrolled · Tanta UniversityNCT05624138updated 2025-05-11
Frequently asked questions
- How does Ketotifen work?
- Mechanism-of-action class: Histamine H1 Receptor Antagonists.
- What class of drug is Ketotifen?
- Ketotifen is classified as Other antiallergics, Other antihistamines for systemic use, Histamine-1 Receptor Inhibitor, Histamine H1 Receptor Antagonists, Decreased Histamine Activity.
- What are the brand names for Ketotifen?
- Ketotifen is marketed under brand names including Alaway, Claritin Eye, Wal-Zyr Itchy Eye, Zaditor.
Note. Data for
ketotifen is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.