Loratadine Adverse Reactions
- drowsiness
- fatigue
- headache
- restlessness
- sinus tachycardia
- wheezing
- xerostomia
Loratadine Adverse Reactions
Drowsiness and/or sedation is a frequent adverse reaction to most H1-blockers, however, H1-blockers vary in their ability to produce drowsiness, and this side effect does not correlate with peripheral antihistamine potency. Somnolence was reported in 8% of patients taking loratadine vs. 6% taking placebo. Fatigue is also experienced in about 4% of patients taking loratadine. Patients should be warned about undertaking hazardous tasks while taking loratadine, although the risk of sedation is relatively low. Anticholinergic side effects are minimal with loratadine compared to most other H-blockers; however, some patients experience xerostomia (3%). Headache (12%) is the most common adverse reaction experienced by patients taking loratadine.
In children >= 6 years old, adverse events were similar to those reported in adult populations and similar to placebo; the rate of discontinuation due to side effects was < 1%. Side effects occurring in >= 2% of those aged 6 - 12 years included nervousness (restlessness), wheezing, fatigue, hyperkinesia, abdominal pain, conjunctivitis, dysphonia, malaise, and respiratory tract infection. In children 2 - 5 years, the following adverse events were reported in 2 - 3% taking loratadine and more frequently than with placebo: diarrhea, epistaxis, pharyngitis, influenza-like symptoms, fatigue, stomatitis, tooth disorder (unspecified), earache, viral infection, and rash (unspecified).
Drowsiness, headache, and sinus tachycardia have occurred when the maximum recommended dose of loratadine has been exceeded (doses of 40 - 180 mg). In a human study in which doses 4 times the clinical dose were administered for up to 90 days, loratadine did not cause clinically significant changes on the QT interval. The manufacturer reports that in a single, rising-dose study in which doses up to 160 mg (16 times the clinical dose) were studied, loratadine did not cause any clinically significant changes on the QTc interval.
Specific information regarding non-causally associated, less common side effects and post-marketing adverse reactions may be found in the manufacturers’ current prescribing information for loratadine.
[ Last revised: 1/12/2004 12:21:00 PM ]
References
. Levander S, Hagermark O, Stahle M. Peripheral antihistamine and central sedative effects of three H1-receptor antagonists. Eur J Clin Pharmacol 1985;28:523 - 9.
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