Fexofenadine and pseudoephedrine Side Effects

Please note - some side effects for Fexofenadine and pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral tablet, extended release

Gastrointestinal

Gastrointestinal side effects have included nausea (7.4 %), dry mouth (2.8%), dyspepsia (2.8 %), throat irritation (2.3%), and abdominal pain (1.4 %).

Cardiovascular

Cardiovascular side effects have included palpitations (1.9%).

Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.

One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (simulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.

Nervous system

Nervous system side effects have included headache (13 %), insomnia (12.6%), dizziness (1.9%), agitation (1.9%), nervousness (1.4%), and anxiety (1.4%).

Hypersensitivity

In rare cases, rash urticaria, pruritus, angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

Hypersensitivity reactions have included fixed drug eruptions.

Respiratory

Respiratory side effects have included upper respiratory infections (1.4%).

Musculoskeletal

Musculoskeletal side effects have included back pain (1.9%).

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