Clarinex-D 12hr
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Clarinex-D 12hr
Clarinex-D 12hr Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Clarinex-D 12 Hour (desloratadine and pseudoephedrine sulfate) Extended Release Tablets are used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold. Desloratadine is an antihistamine, and pseudoephedrine is a decongestant. Common side effects include dry mouth, headache, trouble sleeping, tiredness, throat discomfort, nausea, dizziness, stomach upset, or loss of appetite.
The recommended dose of Clarinex-D12 Hour Extended Release Tablets for adults and children 12 years and older is one tablet twice a day, administered approximately 12 hours apart and with or without a meal. Clarinex-D 12 Hour may interact with medicines to treat high blood pressure, diuretics (water pills), medications to treat irritable bowel syndrome, bladder or urinary medications, aspirin or salicylates, beta-blockers, or antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Clarinex-D 12 Hour should be used only when prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding. Our Clarinex-D 12 Hour (desloratadine and pseudoephedrine sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Clarinex-D 12hr in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- fast, pounding, or uneven heartbeat;
- confusion, hallucinations, unusual thoughts or behavior;
- severe dizziness, anxiety, restless feeling, or nervousness;
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);
- easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
- urinating less than usual or not at all.
Less serious side effects may include:
- dry mouth;
- nausea, stomach pain, constipation;
- mild loss of appetite, stomach upset;
- warmth, redness, or tingly feeling under your skin;
- sleep problems (insomnia);
- feeling restless or excited (especially in children);
- skin rash or itching;
- dizziness, drowsiness; or
- problems with memory or concentration.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Clarinex-D 12hr (Desloratadine and Pseudoephedrine Sulfate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Clarinex-D 12hr Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, shaking (tremor), mental/mood changes (such as anxiety, nervousness, restlessness).
Get medical help right away if you have any very serious side effects, including: seizures.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Clarinex-D 12hr (Desloratadine and Pseudoephedrine Sulfate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Clarinex-D 12hr FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 entire FDA prescribing information for Clarinex-D 12hr (Desloratadine and Pseudoephedrine Sulfate) »
Additional Clarinex-D 12hr Information
Clarinex-D 12hr - User Reviews
Clarinex-D 12hr User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Clarinex-D 12hr sorted by most helpful.
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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