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Clarinex-D 24hr

Last reviewed on RxList: 5/5/2014
Clarinex-D 24hr Side Effects Center

Last reviewed on RxList 2/5/2016

Clarinex-D 24 Hour (desloratadine, pseudoephedrine sulfate) Extended Release Tablets is an antihistamine and 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. Clarinex-D 24 Hour is available over-the-counter. Side effects of Clarinex-D 24 Hour include dry mouth, nausea, stomach pain or upset, constipation, loss of appetite, flushing (warmth, redness, or tingly feeling under your skin), sleep problems (insomnia), restlessness or excitement (especially in children), skin rash or itching, dizziness, drowsiness, and problems with memory or concentration.

The recommended dosage of Clarinex-D 24 Hour is one tablet taken once daily with or without a meal. Clarinex-D 24 Hour may interact with medications to treat high blood pressure, diuretics, medication to treat irritable bowel syndrome, bladder or urinary medications, aspirin, backache medication, Pepto-Bismol, beta-blockers, and antidepressants. Tell your doctor all medications you are taking. Avoid drinking alcohol while taking this medication. Do not give Clarinex-D 24 Hour to a child younger than 2 years old and always ask a doctor before giving a cough or cold medicine to a child. Only use Clarinex-D 24 Hour while pregnant if clearly needed. If you are breastfeeding do not take Clarinex-D 24 Hour.

Our Clarinex-D 24 Hour (desloratadine/pseudoephedrine sulfate) Extended Release Tablets 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 24hr 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 24hr (Desloratadine and Pseudoephedrine Sulfate)

Clarinex-D 24hr 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 24 HOUR Extended Release Tablets that included 2852 patients, of which 708 patients received CLARINEX-D 24 HOUR Extended Release Tablets daily for up to 15 days. The majority of patients were between 18 and < 65 years of age with a mean age of 34.3 years and were predominantly women (63%). Patient ethnicity was 79 % Caucasian, 10% Black, 8 % Hispanic and 3% Asian/other ethnicity. The percentage of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets, and who discontinued from the clinical trials because of an adverse event was 3.4%. Adverse reactions that were reported by ≥ 2% of subjects receiving CLARINEX-D 24 HOUR Extended Release Tablets are shown in Table 1.

Table 1: Incidence of Adverse Reactions Reported by ≥ 2% of Subjects Receiving CLARINEX-D 24 HOUR Extended Release Tablets

Adverse Reaction CLARINEX-D 24 HOUR
(N=708)
Desloratadine 5 mg
(N=712)
Pseudoephedrine 240 mg
(N=719)
Gastrointestinal Disorders
Mouth Dry 8% 2% 11%
Nausea 2% 1% 3%
Anorexia 2% 0% 2%
General Disorders and Administration Site Conditions
Fatigue 3% 3% 2%
Nervous System Disorders
Headache 6% 5% 7%
Somnolence 3% 2% 3%
Dizziness 2% 1% 2%
Psychomotor hyperactivity 2% 0% 2%
Psychiatric Disorders
Insomnia 5% 1% 8%
Nervousness 2% 1% 1%
Respiratory, Thoracic and Mediastinal Disorders
Pharyngitis 3% 2% 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 24 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 24 HOUR Extended Release Tablets include palpitations, pruritus and urticaria.

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, tachycardia, and rarely hypersensitivity reactions (such as rash, edema, dyspnea, and anaphylaxis), 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 24hr (Desloratadine and Pseudoephedrine Sulfate)

Related Resources for Clarinex-D 24hr

Read the Clarinex-D 24hr User Reviews »

© Clarinex-D 24hr Patient Information is supplied by Cerner Multum, Inc. and Clarinex-D 24hr Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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