Fexofenadine

Regulatory sources consulted

• AEMPS CIMA: https://cima.aemps.es/cima/dochtml/ft/79726/FT_79726.html
• CredibleMeds.org
• AEMPS CIMA · nº registro 79726 ↗
• RxNorm rxcui 87636 ↗

Approved indications

• Relief of symptoms associated with seasonal allergic rhinitis in adults and adolescents 12 years of age and older.
• Relief of uncomplicated cutaneous manifestations of chronic idiopathic urticaria in adults and adolescents 12 years of age and older (180 mg dose).

Contraindications

Clinical warnings

• Should be administered with caution in elderly patients and in patients with renal or hepatic impairment due to limited data. — AEMPS CIMA

Drug interactions

• ModerateKetoconazoleJ02AB02

  Mechanism: Inhibition of P-glycoprotein (P-gp) and/or organic anion transporting polypeptides (OATP), resulting in a 2-3 fold increase in fexofenadine plasma levels.

  Recommendation: Use with caution. No clinically significant increase in adverse effects or QT interval has been observed with concomitant use.

  AEMPS CIMA

• ModerateFruit juice (grapefruit, orange, apple)

  Mechanism: Inhibition of organic anion transporting polypeptides (OATP) in the gut, reducing the absorption and bioavailability of fexofenadine.

  Recommendation: Take fexofenadine with water. Avoid co-administration with fruit juices, separating intake by at least 4 hours.

  AEMPS CIMAPMID:12042722

Adverse events

Pregnancy and lactation

FDA category: C

Pregnancy: Should not be used unless clearly necessary. Lactation: Not recommended.