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Clarinex-D 12hr

Last reviewed on RxList: 3/20/2017
Clarinex-D 12hr Side Effects Center

Last reviewed on RxList 3/14/2016

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. 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.

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.

Clarinex-D 12hr Consumer Information

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)

Clarinex-D 12hr Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

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)

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