Evigrade
DrugsCosmetic ingredientsCalculatorsInteractionsEvigrade SkinEvigrade Meds ↗
ConditionsJournalMethodologyPro for practitioners
ESRU

Ketotifen

AEMPS

Antihistamine + mast cell stabilizer

ATC code: R06AX17

Updated · Methodology

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

C

Allergic rhinitis

Not recommended

Atopic rhinitis and atopic dermatitis in children and adults. Per ARIA 2023, not first-line – intranasal corticosteroids (mometasone, fluticasone) and 2nd-generation H1-blockers are more effective. 6–12 weeks for onset. Limited use by family tradition.

Sources

  1. AEMPS: Ficha técnica de Ketotifeno (2024)

ICD-10: J30.9 · ICD-11: CA08.0

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Blocks H1 receptors and stabilizes mast cell membranes, preventing inflammatory mediator release. Slow onset over 6–12 weeks. Mainly used for atopic asthma in children and atopic dermatitis. Rarely prescribed in EU and US due to more effective alternatives (inhaled corticosteroids, montelukast).

Safety

Contraindications

  • Hypersensitivity
  • Concurrent oral hypoglycemics at therapy start (thrombocytopenia risk)

Serious adverse effects

  • Thrombocytopenia
  • Allergic reactions

Common adverse effects

  • Drowsiness
  • Weight gain (1–3 kg)
  • Dry mouth

Pregnancy: can you take Ketotifen?

Use when indicated and no alternative available.

Breastfeeding: can you take Ketotifen?

Hale L3 · Probably compatible, limited data

Hale L3, limited data. Not first-line. Prefer loratadine, cetirizine.

Maternal half-life
21.0 h
Maternal peak time
2 h
Calculate RIDSafe feeding windowFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Onset 6–12 weeks – not for acute allergic reactions. Take in the evening due to sedation.
Label mentions1 mention

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Criticalantidiabéticos oralesclass named in the label
    «Pacientes en tratamiento con agentes antidiabéticos orales»

    AEMPS, section 4.3 · Open on CIMA

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Ketotifen used for?

Ketotifen is evaluated for the following indications with varying evidence strength: Allergic rhinitis (evidence tier C), Allergy during breastfeeding (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Ketotifen?

Common side effects of Ketotifen (≥ 1 in 100): Drowsiness, Weight gain (1–3 kg), Dry mouth. See the Safety section for uncommon and serious reactions.

Is Ketotifen safe during pregnancy?

Use when indicated and no alternative available.

Is Ketotifen compatible with breastfeeding?

Hale L3, limited data. Not first-line. Prefer loratadine, cetirizine.

Who should not take Ketotifen?

Ketotifen is contraindicated in: Hypersensitivity; Concurrent oral hypoglycemics at therapy start (thrombocytopenia risk). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Levocetirizine, Loratadine, Promethazine, Rupatadine, Cetirizine, Desloratadine, Diphenhydramine, Bilastine