Fexofenadine/Pseudoephedrine Side Effects

Please note - some side effects for Fexofenadine/Pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Fexofenadine/Pseudoephedrine - for the consumer

Fexofenadine/Pseudoephedrine Extended-Release Tablets (12 Hour)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fexofenadine/Pseudoephedrine Extended-Release Tablets (12 Hour):

Dizziness; dry mouth; headache; nausea; nervousness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficult urination; fast/irregular heartbeat; hallucinations; mental or mood changes; seizures; shaking or tremor.

Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour):

Dizziness; dry mouth; headache; nausea; nervousness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficult urination; fast/irregular heartbeat; hallucinations; mental or mood changes; seizures; involuntary shaking or tremor.

By body system

Gastrointestinal side effects

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 side effects

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 side effects

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 side effects

Hypersensitivity reactions have included fixed drug eruptions.

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

Respiratory side effects

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

Musculoskeletal side effects

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

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