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Clarinex-D 12hr

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Clarinex-D 12hr

Clarinex-D 12hr

SIDE EFFECTS

The clinical trials with CLARINEX-D®12 HOUR Extended Release Tablets included 1248 patients, of which 414 patients received CLARINEX-D®12 HOUR Extended Release Tablets twice daily for up to 2 weeks. The percentage of patients receiving CLARINEX-D®12 HOUR Extended Release Tablets, and who discontinued from the clinical trials because of an adverse event was 3.6%. Adverse events that were reported by ≥ 2% of patients receiving CLARINEX-D®12 HOUR Extended Release Tablets, regardless of relationship to study drugs, are shown in Table 3.

Table 3: Incidence of Adverse Events Reported by ≥ 2% of Patients Receiving CLARINEX-D® 12 HOUR (desloratadine and pseudoephedrine sulfate) Extended Release Tablets

Adverse Reaction CLARINEX-D®
12 HOUR BID
(N = 414)
Desloratadine
5 mg QD
(N = 412)
Pseudoephedrine
120 mg BID
(N = 422)
Insomnia 10% 3% 13%
Headache 8% 8% 9%
Mouth Dry 8% 2% 8%
Fatigue 4% 2% 2%
Somnolence 3% 4% 2%
Pharyngitis 3% 3% 3%
Dizziness 3% 2% 2%
Infection, viral 2% 2% 2%
Nausea 2% 1% 3%
Anorexia 2% 0% 2%

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

Observed During Clinical Practice: The following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: headache, somnolence, dizziness, tachycardia, palpitations and rarely hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), and elevated liver enzymes including bilirubin and very rarely, hepatitis.

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with CLARINEX® or CLARINEX-D®12 HOUR Extended Release Tablets.

Read the Clarinex-D 12hr (desloratadine and pseudoephedrine sulfate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Read the Clarinex-D 12hr Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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Clarinex-D 12hr - User Reviews

Clarinex-D 12hr User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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