Clarinex-D 12hr
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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.
Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Clarinex-D 12hr Information
Clarinex-D 12hr - User Reviews
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