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Clarinex - Side Effects & Drug Interactions

[Desloratadine]

ADVERSE REACTIONS

In multiple-dose placebo-controlled trials, 2,834 patients received CLARINEX Tablets at doses of 2.5 mg to 20 mg daily, of whom 1,655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between CLARINEX and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the CLARINEX group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of CLARINEX Tablets (5.0 mg once-daily), and that were more common with CLARINEX Tablet than placebo, are listed in Table 5.

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The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in CLARINEX and placebo-treated patients.

There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.

Chronic Idiopathic Urticaria:

In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients received CLARINEX Tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received CLARINEX Tablets and that were more common with CLARINEX than placebo were (rates for CLARINEX and placebo, respectively):

headache (14%, 13%),

nausea (5%, 2%),

fatigue (5%, 1%),

dizziness (4%, 3%),

pharyngitis (3%, 2%),

dyspepsia (3%, 1%),

myalgia (3%, 1%).

The following spontaneous adverse events have been reported during the marketing of desloratadine: tachy-cardia, palpitations and rarely hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), and elevated liver enzymes including bilirubin.

Drug Interactions

In two controlled crossover clinical pharmacology studies in healthy male (n= 12 in each study) and female (n= 12 in each study) volunteers, desloratadine 7.5 mg (1.5 times the daily dose) once daily was coadministered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for 10 days.