Clarinex-D 12 Hour Side Effects
Please note - some side effects for Clarinex-D 12 Hour may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Clarinex-D 12 Hour - for the Consumer
Clarinex-D 12 Hour Sustained-Release Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clarinex-D 12 Hour Sustained-Release Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Clarinex-D 12 Hour Sustained-Release Tablets:Coughing; dizziness; drowsiness; dry mouth; excitability; fatigue; headache; loss of appetite; mild stomach upset; nausea; nervousness; sleeplessness; sore throat; thirst.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fast/irregular heartbeat; mental/mood changes; seizures; severe dizziness; uncontrolled shaking or tremor.
Clarinex-D 12 Hour Side Effects - for the Professional
Clarinex-D 12 Hour
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.
| 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.
TopSide Effects by Body System
Cardiovascular
Cardiovascular side effects have included tachycardia and palpitations.
Hypersensitivity
Hypersensitivity side effects have included rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis.
Nervous system
Nervous system side effects have included headache, insomnia, somnolence, dizziness, and hyperactivity.
Hepatic
Hepatic side effects have included elevated liver enzymes including bilirubin and very rarely hepatitis.
Gastrointestinal
Gastrointestinal side effects have included nausea and anorexia.
General
General side effects have included dry mouth, fatigue and pharyngitis.
TopMore resources:
Clarinex-D 12 Hour Sustained-Release Tablets
Clarinex-D 12 Hour - Includes detailed dosage instructions.
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