Clarinex-D 12 Hour Side Effects

Please note - some side effects for Clarinex-D 12 Hour may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Clarinex-D 12 Hour - for the Consumer

Clarinex-D 12 Hour Sustained-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clarinex-D 12 Hour Sustained-Release Tablets:

Coughing; dizziness; drowsiness; dry mouth; excitability; fatigue; headache; loss of appetite; mild stomach upset; nausea; nervousness; sleeplessness; sore throat; thirst; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fast/irregular heartbeat; mental/mood changes (eg, anxiety, delusions, hallucinations); seizures; severe dizziness; shortness of breath; uncontrolled shaking or tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Clarinex-D 12 Hour Side Effects - for the Professional

Clarinex-D 12 Hour

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 (5.1)]
• Increased Intraocular pressure [see Warnings and Precautions (5.2)]
• Urinary retention in patients with prostatic hypertrophy [see Warnings and Precautions (5.2)]
• Hypersensitivity reactions [see Warnings and Precautions (5.4)].

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.

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 pruritis.

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), and elevated liver enzymes including bilirubin and very rarely, hepatitis.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included tachycardia and palpitations.

Hypersensitivity

Hypersensitivity side effects have included rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis.

Nervous system

Nervous system side effects have included headache, insomnia, somnolence, dizziness, and hyperactivity.

Hepatic

Hepatic side effects have included elevated liver enzymes including bilirubin and very rarely hepatitis.

Gastrointestinal

Gastrointestinal side effects have included nausea and anorexia.

General

General side effects have included dry mouth, fatigue and pharyngitis.

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