Medical Editor: John P. Cunha, DO, FACOEP
What Is Clarinex-D 12hr?
Clarinex-D 12 Hour (desloratadine and pseudoephedrine sulfate) Extended Release Tablets is a combination of an antihistamine and a decongestant 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.
What Are Side Effects of Clarinex-D 12hr?
Common side effects of Clarinex-D 12 Hour include:
- dry mouth,
- headache,
- trouble sleeping (insomnia),
- tiredness,
- throat discomfort,
- nausea,
- dizziness,
- stomach upset or pain,
- loss of appetite,
- constipation,
- flushing (warmth, redness, or tingly feeling under your skin),
- restlessness or excitability (especially in children),
- skin rash or itching,
- drowsiness, or
- problems with memory or concentration
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Clarinex-D 12hr
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.
What Drugs, Substances, or Supplements Interact with Clarinex-D 12hr?
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.
Clarinex-D 12hr During Pregnancy or Breastfeeding
During pregnancy, Clarinex-D 12 Hour should be used only when prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
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.
SLIDESHOW
Could I Be Allergic? Discover Your Allergy Triggers See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- tremors;
- severe weakness;
- irregular heartbeats;
- a seizure; or
- a severe skin reaction--fever, skin redness, small pimples.
Common side effects may include:
- drowsiness, dizziness;
- headache
- nausea, loss of appetite;
- sleep problems (insomnia); or
- dry mouth, sore throat.
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.
QUESTION
Allergies can best be described as: See AnswerSIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Cardiovascular and Central Nervous System effects [see WARNINGS AND PRECAUTIONS]
- Increased intraocular pressure [see WARNINGS AND PRECAUTIONS]
- Urinary retention in patients with prostatic hypertrophy [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data described below are from 2 clinical trials with CLARINEX-D 12 HOUR Extended Release Tablets that included 1248 patients with seasonal allergic rhinitis, of which 414 patients received CLARINEX-D 12 HOUR Extended Release Tablets twice daily for up to 2 weeks. The majority of patients were between 18 and < 65 years of age with a mean age of 35.8 years and were predominantly women (64%). Patient ethnicity was 82% Caucasian, 9% Black, 6% Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 12 HOUR Extended Release Tablets and who discontinued from the clinical trials because of an adverse event was 3.6%. Adverse reactions that were reported by ≥ 2% of subjects receiving CLARINEX-D 12 HOUR Extended Release Tablets are shown in Table 1.
Table 1: Incidence of Adverse Reactions Reported by
≥ 2% of Subjects Receiving CLARINEX-D 12 HOUR Extended Release Tablets
| Adverse Reaction | CLARINEX-D 12 HOUR BID (N=414) |
Desloratadine 5 mg QD (N=412) |
Pseudoephedrine 120 mg BID (N=422) |
| Gastrointestinal Disorders | |||
| Mouth Dry | 8% | 2% | 8% |
| Nausea | 2% | 1% | 3% |
| General Disorders and Administration Site Conditions | |||
| Fatigue | 4% | 2% | 2% |
| Metabolism and Nutrition Disorders | |||
| Anorexia | 2% | 0% | 2% |
| Nervous System Disorders | |||
| Headache | 8% | 8% | 9% |
| Somnolence | 3% | 4% | 2% |
| Dizziness | 3% | 2% | 2% |
| Psychiatric Disorders | |||
| Insomnia | 10% | 3% | 13% |
| Respiratory, Thoracic, and Mediastinal Disorders | |||
| Pharyngitis | 3% | 3% | 3% |
There were no relevant differences in adverse reactions for subgroups of patients as defined by gender, age, or race.
Post-Marketing Experience
In addition to the adverse reactions reported during clinical trials and listed above, adverse events have been identified during post approval use of CLARINEX-D 12 HOUR Extended Release Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse events identified from post-marketing surveillance on the use of CLARINEX-D 12 HOUR Extended Release Tablets include tachycardia, palpitations, dyspnea, rash and pruritus.
In addition to these events, the following spontaneous adverse events have been reported during the marketing of desloratadine as a single ingredient product: headache, somnolence, dizziness and rarely hypersensitivity reactions (such as urticaria, edema and anaphylaxis), psychomotor
hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin and, very rarely, hepatitis.
Read the entire FDA prescribing information for Clarinex-D 12hr (Desloratadine and Pseudoephedrine Sulfate)
© Clarinex-D 12hr Patient Information is supplied by Cerner Multum, Inc. and Clarinex-D 12hr Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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