Antihistamine + mast cell stabilizer
ATC code: R06AX17 (Ketotifen)
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).
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
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.
Not recommended
Ketotifen while breastfeeding – limited data. Hale L3. Sedating, theoretical infant drowsiness risk. Prefer loratadine and cetirizine with better safety profile and faster onset.
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Use when indicated and no alternative available.
Hale L3, limited data. Not first-line. Prefer loratadine, cetirizine.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
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.
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.
FDA category C. Use when indicated and no alternative available.
Hale L3, limited data. Not first-line. Prefer loratadine, cetirizine.
Ketotifen is contraindicated in: Hypersensitivity; Concurrent oral hypoglycemics at therapy start (thrombocytopenia risk). Full list in the Safety section.