Ketotifen 1mg tablets
Requires a prescription from a doctor or prescriber
Ketotifen is a benzocycloheptathiophene derivative[A231204] with potent antihistaminic and mast cell stabilizing properties.
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Ketotifen
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Ketotifen
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
2 branded products available
MHRA licensed products
View all licensed products for Ketotifen on the MHRA register
Zaditen 1mg tablets
Zaditen 1mg tablets
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
2 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
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Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 7 · Randomised trials: 9 · 1981–2026
Showing the 50 most relevant studies, sorted by most relevant.
Xinyan Dou, Wei Zhang
International journal of ophthalmology, 2023
Zhao X, Sun H, Li W
2024
AimThis network meta-analysis was to analyze and rank the efficacy and safety of different systemic drugs in the treatment of uremic pruritus (UP) among hemodialysis patients.MethodPubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to 10 July 2023 for randomized controlled trials (RCTs) investigating different drugs in the treatment of UP among hemodialysis patients. Drugs including cromolyn sodium, dexchlorpheniramine, difelikefalin, gabapentin, hydroxyzine, ketotifen, melatonin, montelukast, nalbuphine, nalfurafine, nemolizumab, nicotinamide, pregabalin, sertraline, thalidomide, and placebo were assessed. Outcome measures, including pruritus relief, response, and adverse events, were analyzed. Network plots, forest plots, league tables, and the surface under the cumulative ranking (SUCRA) probabilities were depicted for each outcome.ResultsThe network meta-analysis retrieved 22 RCTs. Gabapentin (69.74%) had the highest likelihood to be the most effective drug for pruritus relief in UP patients receiving hemodialysis, followed by cromolyn sodium and hydroxyzine. Thalidomide (60.69%) and gabapentin (58.99%) were associated with significantly more drug responses for treating UP among patients receiving hemodialysis. Patients who were treated with gabapentin (40.01%) were likely to have risks of adverse events and dizziness. Lower risks of adverse events, nausea, and diarrhea were found in patients who received cromolyn sodium and lower risks of somnolence.ConclusionThis study suggests considering gabapentin treatment when facing a patient suffering from UP. This study provides a reference for the selection of drug therapy for UP patients receiving hemodialysis.
Abstract licence: CC BY
Li S, Zhong S
2023
Cruz ACL, Cassiano DP, Bleixuvehl de Brito M, et al.
2025
Wahby SS, Mostafa TM, El-Din MAA, et al.
2026
- Colorectal Neoplasms
- Peripheral Nervous System Diseases
- Ketotifen
S. Grant, K. Goa, A. Fitton, et al.
Drugs, 1990
Tamira K. Klooker, Breg Braak, Karin E. Koopman, et al.
Gut, 2010
- Cell Count
- Elasticity
- Histamine H1 Antagonists
J. Dias, P. B. Lima, D. Cassiano, et al.
Journal of the European Academy of Dermatology and Venereology, 2021
A. Avunduk, Y. Tekelioğlu, Adem Turk, et al.
Clinical therapeutics, 2005
Barry L. Gruber, Lee D. Kaufman
Arthritis & Rheumatism, 1991
- Drug Evaluation
- Intradermal Tests
- Ketotifen
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
3-5 hours
Mechanism
The precise mechanism(s) through which ketotifen exerts its therapeutic effects are unclear.
Food interactions
1 warning
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3 hours
Half-life
3-5 hours
[A231214]…
Protein binding
75%
[L32283]
Metabolism
50%
Elimination
60%
[A231214]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Ketotifen was first developed in Switzerland in 1970 by Sandoz Pharmaceuticals and was initially marketed for the treatment of anaphylaxis.[A231204] In the US, it is now used in an over-the-counter ophthalmic formulation for the treatment of itchy eyes associated with allergies,[L32278] and in Canada a prescription-only oral formulation is available and indicated as an add-on therapy for children with atopic asthma.[L32283] In addition, oral ketotifen is used in Mexico and across Europe for the treatment of various allergic symptoms and disorders,[A231204] including urticaria, mastocytosis, and food allergy.
[L32283]
It is also available as an over-the-counter ophthalmic solution which is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.
[L32278]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 74 interactions
[A231209]
Symptoms of ketotifen overdosage may include significant sedation, confusion, disorientation, tachycardia, hypotension, convulsions, hyperexcitability (particularly in children), and/or reversible coma.
[L32283]
If ingestion is recent, consider the use of gastric lavage or activated charcoal.
[L32283]
Other treatments should be supportive and administered as necessary based on symptoms.
Physostigmine may be useful to mitigate anticholinergic effects, and short-acting barbiturates or benzodiazepines may be used if the patient presents with excitation or convulsions.
[L32283]
Other in vivo observations thought to contribute to ketotifen's efficacy in asthma include the inhibition of various PAF-mediated processes (e.g. airway hyperreactivity, eosinophil and platelet accumulation in the airways), prevention of leukotriene-induced bronchoconstriction, and suppression of eosinophil priming.[L32283]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L32283]
[A231214]
[L32283]
[L32283]
Nor-ketotifen appears to be equally as active as its parent drug,[L32283] though the clinical relevance of this is unclear given the relatively small proportion in which nor-ketotifen is found in the plasma.
Formation of the N-glucuronide metabolite is carried out by several UGT enzymes, including UGT1A3, UGT1A4, and UGT2B10.
[A32560]
[A231214]
Proteins and enzymes this drug interacts with in the body
PMID:33828102 PMID:8280179
Through the H1 receptor, histamine mediates the contraction of smooth muscles and increases capillary permeability due to contraction of terminal venules. Also mediates neurotransmission in the central nervous system and thereby regulates circadian rhythms, emotional and locomotor activities as well as cognitive functions (By similarity)
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC S01GX08
ATC R06AX17
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Ketotifen
Additional database identifiers
Drugs Product Database (DPD)
11175
Drugs Product Database (DPD)
1944
ChemSpider
3695
BindingDB
94597
ZINC
ZINC000000004351
HUGO Gene Nomenclature Committee (HGNC)
HGNC:5182
GenAtlas
HRH1
GeneCards
HRH1
GenBank Gene Database
Z34897
GenBank Protein Database
510296
Guide to Pharmacology
262
UniProt Accession
HRH1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8891
GeneCards
PGD
GenBank Gene Database
U30255
GenBank Protein Database
984325
UniProt Accession
6PGD_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12535
GeneCards
UGT1A3
GenBank Gene Database
M84127
GenBank Protein Database
340135
UniProt Accession
UD13_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12536
GeneCards
UGT1A4
GenBank Gene Database
M57951
GenBank Protein Database
184475
UniProt Accession
UD14_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:12544
GeneCards
UGT2B10
UniProt Accession
UDB10_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
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Structured knowledge from the free knowledge base
Linked open data from Wikidata (Q2458673), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.