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Clarinex-D 12hr

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Clarinex-D 12hr

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

SIDE EFFECTS: Dizziness, tiredness, dry mouth, sore throat, trouble sleeping, nausea, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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, confusion, nervousness, restlessness), problems urinating.

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 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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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. Patient Discussions FAQs

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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