Second-generation antihistamine
ATC code: R06AX29 (Bilastine)
A second-generation selective peripheral H1-antagonist. Minimal blood-brain barrier penetration and negligible central H1 binding result in almost no sedation. Not metabolized hepatically; 95% is excreted unchanged via the kidneys and gut, so it lacks meaningful CYP-mediated interactions. Developed by Spain's Faes Farma; brand Bilaxten in Spain.
First line
First-line for seasonal and perennial allergic rhinitis per ARIA 2020 and 2022, on par with other second-generation antihistamines (desloratadine, levocetirizine, fexofenadine, ). Dose 20 mg once daily on empty stomach. Bilastine has the lowest sedative potential in the class (Wang 2016 psychomotor studies showed no cognitive impairment); EASA permits its use by commercial airline pilots.
First line
First-line for chronic spontaneous urticaria under /GA²LEN/EDF/ 2022 at standard 20 mg. With insufficient response, up-titration to 80 mg/day is acceptable (off-label, EAACI consensus). When symptoms persist at quadruple-dose, add omalizumab.
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
Bilastine is a second-generation antihistamine. It is prescribed for seasonal and perennial allergic rhinitis and urticaria ( 2024, AEMPS Ficha Técnica). Bilastine is taken for colds and for immunity with the expectation that the antihistamine effect will relieve runny nose and congestion in respiratory infections. The Cochrane review by De Sutter 2015 (16 RCTs) in people with common colds did not confirm benefit of antihistamines as monotherapy. Second-generation antihistamines (bilastine, cetirizine, loratadine, and others) cause virtually no drowsiness – a marketing advantage – but also no cold-relieving effect. If bilastine was prescribed for a cold without confirmed allergic rhinitis, consider seeking a second opinion.
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Pregnancy data are limited. Per EMA: use only when clearly necessary. For pregnancy, antihistamines with more data are preferred – loratadine or cetirizine.
Compatible. Hale L3 (limited data). RID 0.4%. Does not cross BBB, minimal sedation. Per ARIA 2023, recommended for allergic rhinitis in adults, including nursing mothers.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Bilastine is evaluated for the following indications with varying evidence strength: Allergic rhinitis (evidence tier A), Chronic urticaria (evidence tier A), Immune support and respiratory infection care (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Bilastine (≥ 1 in 100): Headache, Drowsiness (~3%, placebo-level), Dry mouth. See the Safety section for uncommon and serious reactions.
FDA category C. Pregnancy data are limited. Per EMA: use only when clearly necessary. For pregnancy, antihistamines with more data are preferred – loratadine or cetirizine.
Compatible. Hale L3 (limited data). RID 0.4%. Does not cross BBB, minimal sedation. Per ARIA 2023, recommended for allergic rhinitis in adults, including nursing mothers.
Bilastine is contraindicated in: Bilastine hypersensitivity; Age under 6. Full list in the Safety section.