Clarinex-D 24hr
- Generic Name: desloratadine and pseudoephedrine sulfate
- Brand Name: Clarinex-D 24hr
Clarinex-D 24hr (Desloratadine and Pseudoephedrine Sulfate) side effects drug center
Clarinex-D 24hr Side Effects Center
Clarinex-D 24 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 24 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-D 24 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 24 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 24 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.
Clarinex-D 24hr Consumer Information
Get 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.
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:
- 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 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)
&Copy; 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.