Zyrtec-D 12 Hour Side Effects

Generic name: cetirizine / pseudoephedrine

Note: This document contains side effect information about cetirizine / pseudoephedrine. Some of the dosage forms listed on this page may not apply to the brand name Zyrtec-D 12 Hour.

Some side effects of Zyrtec-D 12 Hour 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 cetirizine / pseudoephedrine: oral tablet extended release

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

Stop using cetirizine and pseudoephedrine and call your doctor at once if you have:

• fast, pounding, or uneven heartbeat;

• weakness, tremors (uncontrolled shaking)

• severe restless feeling, hyperactivity, extreme feeling of fear or confusion;

• problems with vision;

• little or no urinating; or

• high blood pressure (severe headache, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats).

Common side effects may include:

• dizziness, drowsiness, tired feeling;

• sleep problems (insomnia);

• dry mouth, nausea, stomach pain, constipation; or

• trouble concentrating.

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 cetirizine / pseudoephedrine: oral tablet extended release

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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