Last update May 10, 2021

Ketotifen Fumarate

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

1st-generation-antihistamine and piperidine-type drug with a minimal sedative effect.
Indicated on prophylaxis of asthma, rhinitis (oral administration) and conjunctivitis (administrated as eye drops).

At latest update relevant published data on excretion into breast milk were not found.

Pharmacokinetic data (large volume of distribution and moderately high molecular weight) make it unlikely that significant amounts of milk would pass through breastmilk.

Plasma levels following ophthalmic administration are undetectable (AEMPS 2011).
It is a medicine authorized for use in infants from 6 months of age on.

It does not influence prolactin levels (Dolecek 1984).

Expert authors consider antihistamines compatible with breastfeeding (So 2010).

Until more published data on this drug related to breastfeeding is available, a safer and known alternative should be preferred during the neonatal period and in case of prematurity.
Ophthalmic administration is safe while breastfeeding.


  • Loratadine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Nedocromil Sodium ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Sodium Cromoglicate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Ketotifen Fumarate in other languages or writings:


Ketotifen Fumarate belongs to these groups or families:


Main tradenames from several countries containing Ketotifen Fumarate in its composition:


Variable Value Unit
Oral Bioavail. 50 %
Molecular weight 426 daltons
Protein Binding 75 %
VD 56 l/Kg
Tmax 2 - 4 hours
12 (7 - 27) hours


  1. AEMPS. Ketotifeno oral Ficha técnica. 2015 Full text (in our servers)
  2. AEMPS. Ketotifeno colirio Ficha técnica. 2011 Full text (in our servers)
  3. Novartis. Ketotifen (Zaditen). Drug Summary. 2011 Full text (in our servers)
  4. So M, Bozzo P, Inoue M, Einarson A. Safety of antihistamines during pregnancy and lactation. Can Fam Physician. 2010 May;56(5):427-9. Abstract Full text (link to original source) Full text (in our servers)
  5. del Cuvillo A, Mullol J, Bartra J, Dávila I, Jáuregui I, Montoro J, Sastre J, Valero AL. Comparative pharmacology of the H1 antihistamines. J Investig Allergol Clin Immunol. 2006;16 Suppl 1:3-12. Review. No abstract available. Abstract Full text (link to original source) Full text (in our servers)
  6. Grahnén A, Lönnebo A, Beck O, Eckernäs SA, Dahlström B, Lindström B. Pharmacokinetics of ketotifen after oral administration to healthy male subjects. Biopharm Drug Dispos. 1992 Abstract
  7. Dolecek R, Janstová V, Halatová A. Growth hormone plasma levels in children treated for 6 months with ketotifen. Pharmatherapeutica. 1984 Abstract

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