Summary

Commonly reported side effects of fexofenadine include: headache. Other side effects include: otitis media. Continue reading for a comprehensive list of adverse effects.

Applies to fexofenadine: oral capsules and tablets, oral fixed-combination tablets.

Side effects include:

Children 6–11 years of age receiving conventional tablets: Headache, upper respiratory tract infection, coughing, accidental injury, fever, pain, otitis media.

Adults and children ≥12 years of age receiving conventional capsules or tablets: Viral infection (e.g., cold, flu), nausea, dysmenorrhea, sinusitis, dizziness, drowsiness, dyspepsia, fatigue, headache, upper respiratory tract infection, back pain.

Fixed-combination fexofenadine hydrochloride (60 mg)/pseudoephedrine hydrochloride (120 mg): Headache, insomnia, nausea, dry mouth, dyspepsia, throat irritation, dizziness, agitation, back pain, palpitation, nervousness, anxiety, upper respiratory tract infection, abdominal pain.

For Healthcare Professionals

Applies to fexofenadine: oral capsule, oral suspension, oral tablet, oral tablet disintegrating.

General

The most commonly reported side effects included headache, drowsiness, dizziness, and nausea.^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (up to 12%)

Common (1% to 10%): Nausea, diarrhea, stomach discomfort^[Ref]

Nervous system

Very common (10% or more): Headache (up to 10.3%)

Common (1% to 10%): Drowsiness, dizziness, somnolence^[Ref]

Other

Common (1% to 10%): Otitis media, pyrexia, fatigue, extremity pain^[Ref]

Respiratory

Common (1% to 10%): Cough, upper respiratory tract infection, rhinorrhea

Frequency not reported: Dyspnea^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain^[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea^[Ref]

Psychiatric

Frequency not reported: Insomnia, nervousness, nightmares, sleep disorders or paroniria/excessive dreaming^[Ref]

Cardiovascular

Frequency not reported: Palpitations, tachycardia, chest tightness^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions, angioedema, systemic anaphylaxis^[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, flushing^[Ref]