Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal


Classification: B

Drug products: Ketotifen STADA, Zaditen, Zaditen Defiante, Zaditen Novartis, Zaditen®, Zalerg, Zasten

ATC code: R06AX17, S01GX08

Substances: ketotifen, ketotifen fumarate


There are no published controlled studies on differences between the sexes regarding efficacy, safety and pharmacokinetics of ketotifen.

Additional information

The prevalence of self-reported allergic rhinoconjunctivitis symptoms was in a Swedish population study (n=10,670) similar in men and women [1]. Ketotifen is topically used in allergic conjunctivitis. Systemic exposure of ketotifen in topical administration can be expected to be very low or absent based on a study where plasma levels were not detectable when given the ophtalmic route [2].

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding pharmacokinetics and dosing of ketotifen have been found.


No studies with a clinically relevant sex analysis regarding effects of ketotifen have been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of ketotifen have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2022-09-13

Date of litterature search: 2022-08-04


  1. Olsson P, Berglind N, Bellander T, Stjärne P. Prevalence of self-reported allergic and non-allergic rhinitis symptoms in Stockholm: relation to age, gender, olfactory sense and smoking. Acta Otolaryngol. 2003;123(1):75-80. PubMed
  2. Zaditen (ketotifen). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2020-10-08, cited 2022-08-04]
  3. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.] länk

Authors: Paulina Flis

Reviewed by: Diana Rydberg, Carl-Olav Stiller, Pauline Raaschou

Approved by: Karin Schenck-Gustafsson