Clear-Atadine Children's Side Effects
Generic Name: loratadine
Note: This page contains information about the side effects of loratadine. Some of the dosage forms included on this document may not apply to the brand name Clear-Atadine Children's.
Not all side effects for Clear-Atadine Children's may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to loratadine: oral fixed-combination tablets, oral orally disintegrating tablets, oral solution, oral tablets
Side effects include:
Children 2–5 years of age receiving oral solution: Diarrhea, epistaxis, pharyngitis, flu-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, rash.
Children 6–12 years of age receiving oral solution: Nervousness, wheezing, fatigue, hyperkinesia, abdominal pain, conjunctivitis, dysphonia, upper respiratory tract infection.
Adults and children ≥12 years of age receiving conventional or orally disintegrating tablets: Headache, somnolence, fatigue, dry mouth.
Fixed combination loratadine (the active ingredient contained in Clear-Atadine Children's) pseudoephedrine sulfate preparations: Insomnia, dry mouth, headache, somnolence, nervousness, dizziness, fatigue.
For Healthcare Professionals
Applies to loratadine: oral capsule, oral syrup, oral tablet, oral tablet chewable, oral tablet disintegrating
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.
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 side effects have included rare reports of nausea and dry mouth.
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 side effects have included a case report of a fixed drug eruption.
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