Cetirizine/Pseudoephedrine Side Effects

Please note - some side effects for Cetirizine/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 Cetirizine/Pseudoephedrine - for the Consumer

Cetirizine/Pseudoephedrine

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 Cetirizine/Pseudoephedrine:

Dizziness; drowsiness; dry mouth; fatigue; headache; nausea; nervousness; sore throat; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; mental or mood changes; persistent tiredness; seizures; sleeplessness; uncontrolled shaking or tremor; unusually fast/irregular heart rhythm; weakness; yellowing of the eyes or skin.

Side Effects by Body System

Dermatologic

Dermatologic side effects have included maculopapular and urticarial eruptions.

Gastrointestinal

Gastrointestinal side effects of cetirizine have included dry mouth (5.7%) and nausea or vomiting (2.2%). Pharyngitis, dyspepsia, and increased appetite have occasionally been reported.

Gastrointestinal adverse effects of pseudoephedrine have included anorexia and gastric irritation (5%). Dry mouth, nose, or throat have occurred in up to 15% of patients.

Hepatic

Hepatic side effects have included rare liver function test abnormalities which resolved spontaneously following discontinuation of cetirizine therapy.

Nervous system

Cetirizine appears to be more sedating than terfenadine, astemizole, and loratadine.

Nervous system side effects of cetirizine administration have included headache (16%), fatigue (5.6%), and somnolence (5% to 20%). Somnolence tends to be dose-related and generally occurs more frequently with doses higher than 10 mg per day. Other nervous system side effects include dizziness (1.8%), insomnia (1.5%), and nervousness (1.1%). Post marketing reports have included aggression reaction and convulsions.

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.

Respiratory

Respiratory side effects have included wheezing, coughing, bronchitis, sinusitis, and asthma.

Hypersensitivity

Hypersensitivity reactions have included fixed drug eruptions with pseudoephedrine use.

Cardiovascular

Cardiovascular side effects have included tachycardia. Some patients have developed hypertension and/or arrhythmias.

General

General side effects have included epistaxis (1.1%) and accidental injury (1.1%).

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