Clear-Atadine Children's Side Effects

Generic name: loratadine

Note: This document contains side effect information about loratadine. Some of the dosage forms listed on this page may not apply to the brand name Clear-Atadine Children's.

Some side effects of Clear-Atadine Children's 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: oral capsule, oral syrup, oral tablet, oral tablet chewable, oral tablet disintegrating

Get emergency medical help if you have any of these signs of an allergic reaction while taking loratadine (the active ingredient contained in Clear-Atadine Children's) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fast or uneven heart rate;

• feeling like you might pass out;

• jaundice (yellowing of your skin or eyes); or

• seizures (convulsions).

Less serious side effects of loratadine may include:

• headache;

• nervousness;

• feeling tired or drowsy;

• stomach pain, diarrhea;

• dry mouth, sore throat hoarseness;

• eye redness, blurred vision;

• nosebleed; or

• skin rash.

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: oral capsule, oral syrup, oral tablet, oral tablet chewable, oral tablet disintegrating

Nervous system

Nervous system side effects have included headache in approximately 7% of treated patients. Usually, loratadine (the active ingredient contained in Clear-Atadine Children's) has not been shown to cause significant drowsiness, sedation, or impair psychomotor skills.

One study of second generation antihistamines reported cetirizine was 3.5 times more likely and acrivastine 2.8 times more likely to result in sedation than loratadine. There was no significant difference in incidence of sedation between loratadine and fexofenadine.

Cardiovascular

One study reported prolongation of the QT interval when larger than recommended (20 mg per day) doses of loratadine (the active ingredient contained in Clear-Atadine Children's) were administered with nefazodone (300 mg every 12 hours).

Cardiovascular side effects have included hypertension, hypotension, palpitation, supraventricular tachyarrhythmias, syncope and tachycardia.

Gastrointestinal

Gastrointestinal side effects have included rare reports of nausea and dry mouth.

Hepatic

Hepatic side effects have included rare reports of jaundice, hepatitis, and hepatic necrosis.

Two cases of necroinflammatory liver injury have been reported in patients taking loratadine. One case presented within 2 weeks of starting loratadine therapy and the other occurred 14 months after the start of therapy. Liver transplantation was necessary in one patient.

Dermatologic

Dermatologic side effects have included a case report of a fixed drug eruption.

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