Alavert D-12 Hour Allergy and Sinus Side Effects

Generic name: loratadine / pseudoephedrine

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

Some side effects of Alavert D-12 Hour Allergy and Sinus 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 loratadine / pseudoephedrine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking loratadine / 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;

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats, 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 loratadine / pseudoephedrine may include:

• blurred vision;

• dry mouth;

• nausea, stomach pain, constipation;

• mild loss of appetite, stomach upset;

• warmth, redness, or tingly feeling under your skin;

• sleep problems (insomnia);

• restless or excitability (especially in children);

• skin rash or itching;

• dizziness, drowsiness;

• problems with memory or concentration; or

• mild 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 loratadine / pseudoephedrine: oral tablet extended release

Nervous system

Nervous system side effects of loratadine have included headaches in approximately 7% of treated patients. Loratadine has not been shown to cause significant drowsiness, sedation, or impair psychomotor skills.

Nervous system side effects of pseudoephedrine have included nervous system stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache, somnolence, and dizziness have also occurred in patients receiving pseudoephedrine.

Cardiovascular

Cardiovascular side effects of loratadine have included at least one report of syncopal episodes, premature ventricular complexes, and a prolonged QT interval.

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.

Adverse effects which have been reported during therapy with loratadine and pseudoephedrine included dizziness, syncopal episodes, palpitations, ventricular arrhythmias including torsades de pointes, cardiac arrest, and cardiac death.

Gastrointestinal

Gastrointestinal side effects have included anorexia and gastric irritation in approximately 5% of patients treated with pseudoephedrine. Dry mouth, nose, or throat have occurred in up to 15% of patients. Gastrointestinal effects of loratadine have been rare and included nausea and dry mouth. A few cases of mechanical upper gastrointestinal tract obstruction have been reported with Claritin-D 24 Hour tablets (brand of loratadine-pseudoephedrine), primarily in patients who have difficulty swallowing tablets or in whom there is upper gastrointestinal tract narrowing or abnormal esophageal peristalsis. Ischemic colitis has been reported.

Hypersensitivity

Hypersensitivity side effects of pseudoephedrine have included reports of fixed drug eruptions.

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