Fexofenadine / pseudoephedrine Side Effects

Some side effects of 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.

For the Consumer

Applies to fexofenadine / pseudoephedrine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking fexofenadine / pseudoephedrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;

• confusion, hallucinations, unusual thoughts or behavior;

• severe dizziness, anxiety, restless feeling, or nervousness;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• urinating less than usual or not at all.

Less serious side effects of fexofenadine / pseudoephedrine may include:

• dry mouth;

• nausea, stomach pain, constipation;

• mild loss of appetite, stomach upset;

• sleep problems (insomnia);

• feeling restless or excited (especially in children);

• skin rash or itching;

• dizziness, drowsiness;

• problems with memory or concentration; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fexofenadine / pseudoephedrine: 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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