Second-generation antihistamine
ATC code: R06AX26 (Fexofenadine)
An active metabolite of terfenadine. A selective peripheral H1-antagonist without significant anticholinergic activity. P-glycoprotein keeps it out of the brain – sedation is near zero. Not CYP-metabolized; mostly excreted unchanged via bile and urine, so CYP-mediated interactions are minimal.
First line
First-line for seasonal and perennial allergic rhinitis under ARIA 2020. Adult dose 120 mg once daily for rhinitis; children 6–11 years take 30 mg twice daily. Efficacy and tolerability match cetirizine and loratadine; near-zero sedation makes it convenient for working patients and drivers.
Sources
First line
First-line for chronic spontaneous urticaria at 180 mg once daily. Per 2022, up-titration to 720 mg/day is acceptable before adding 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
Fexofenadine is a second-generation antihistamine. It is prescribed for seasonal and perennial allergic rhinitis and urticaria ( 2024). Fexofenadine is taken at the first signs of a cold and for immunity, expecting a systemic anti-allergic effect. The Cochrane review by De Sutter 2015 did not confirm significant benefit of antihistamines in the common cold. If fexofenadine was prescribed for a cold without confirmed allergic rhinitis, consider seeking a second opinion.
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FDA category C. Pregnancy data are limited. Loratadine or cetirizine with more data are preferred in pregnancy.
Compatible. Hale L2. RID 0.7%. Active metabolite of terfenadine without cardiotoxicity. Non-sedating.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Fexofenadine is evaluated for the following indications with varying evidence strength: Chronic urticaria (evidence tier A), Allergic rhinitis (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 Fexofenadine (≥ 1 in 100): Headache, Drowsiness (1–2%, placebo-level), Nausea. See the Safety section for uncommon and serious reactions.
FDA category C. FDA category C. Pregnancy data are limited. Loratadine or cetirizine with more data are preferred in pregnancy.
Compatible. Hale L2. RID 0.7%. Active metabolite of terfenadine without cardiotoxicity. Non-sedating.
Fexofenadine is contraindicated in: Fexofenadine hypersensitivity; Age under 6 months (liquid forms). Full list in the Safety section.