Fexofenadine: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Fexofenadine. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Headache10.6%
Coughing3.8%
Upper respiratory tract infection3.2%
Accidental injury2.9%
Back pain2.8%
Myalgia2.6%
Viral infection (cold, flu)2.5%
Fever2.4%
Pain2.4%
Otitis media2.4%
Nasopharyngitis2.4%
Dizziness2.1%
Pain in extremity2.1%
Nausea1.6%
Dysmenorrhea1.5%
Drowsiness1.3%
Dyspepsia1.3%
Fatigue1.3%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

INDICATIONS AND USAGE Seasonal Allergic RhinitisFexofenadine Hydrochloride Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. Chronic Idiopathic UrticariaFexofenadine Hydrochloride Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.

Source: FDA labeling via NIH DailyMed (set 9738127d…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.