Clarinex Side Effects

Generic Name: desloratadine

Please note - some side effects for Clarinex 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 - for the Consumer

Clarinex

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:

Dizziness; drowsiness; dry mouth; menstrual pain; muscle pain; nausea; sore throat; tiredness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Clarinex:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); dark urine; fast or irregular heartbeat; pale stools; seizures; yellowing of the skin or eyes.

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 Reditabs Orally Disintegrating 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 Reditabs Orally Disintegrating Tablets:

Dizziness; drowsiness; dry mouth; menstrual pain; muscle pain; nausea; sore throat; tiredness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur when using Clarinex Reditabs Orally Disintegrating Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); dark urine; fast or irregular heartbeat; pale stools; seizures; yellowing of the skin or eyes.

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 24 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 24 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.

Seek medical attention right away if any of these SEVERE side effects occur when using Clarinex-D 24 Hour Sustained-Release Tablets:

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 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.

Seek medical attention right away if any of these SEVERE side effects occur when using Clarinex-D 12 Hour Sustained-Release Tablets:

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 Syrup

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 Syrup:

Cough; diarrhea; dizziness; drowsiness; increased or decreased appetite; nausea; nosebleed; sore throat; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Clarinex Syrup:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); dark urine; ear pain or discharge; fast or irregular heartbeat; fever, chills, or sore throat; mental or mood changes; pale stools; seizures; severe or persistent cough; severe or persistent nosebleed; yellowing of the skin or eyes.

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.

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Clarinex Side Effects - for the Professional

Clarinex

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

• Hypersensitivity reactions. [See Warnings and Precautions (5.1).]

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.

Adults and Adolescents

Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2,834 patients ages 12 years or older received Clarinex Tablets at doses of 2.5 mg to 20 mg daily, of whom 1,655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between Clarinex and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Clarinex group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Clarinex Tablets (5 mg once daily), and that were more common with Clarinex Tablets than placebo, are listed in Table 1.

Table 1 Incidence of Adverse Events Reported by ≥2% of Adult and Adolescent Allergic Rhinitis Patients Receiving Clarinex Tablets

Adverse Event	Clarinex Tablets 5 mg (n=1,655)	Placebo   (n=1,652)
Infections and Infestations
Pharyngitis	4.1%	2.0%
Nervous System Disorders
Somnolence	2.1%	1.8%
Gastrointestinal Disorders
Dry Mouth	3.0%	1.9%
Musculoskeletal and Connective Tissue Disorders
Myalgia	2.1%	1.8%
Reproductive System and Breast Disorders
Dysmenorrhea	2.1%	1.6%
General Disorders and Administration Site Conditions
Fatigue	2.1%	1.2%

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Clarinex and placebo-treated patients.

There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.

Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Clarinex Tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Clarinex Tablets and that were more common with Clarinex than placebo were (rates for Clarinex and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).

Pediatrics

Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Clarinex Oral Solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.

In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.

In subjects 2 to 5 years of age, adverse events reported for Clarinex and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).

In subjects 12 months to 23 months of age, adverse events reported for the Clarinex product and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).

In subjects 6 months to 11 months of age, adverse events reported for Clarinex and placebo in at least 2 percent of subjects receiving Clarinex Oral Solution and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).

There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving Clarinex Oral Solution in the clinical trials discontinued treatment because of an adverse event.

Post-Marketing Experience

Because adverse 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. The following spontaneous adverse events have been reported during the marketing of desloratadine: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects of spontaneous nature reported during the marketing of desloratadine have included tachycardia and palpitations.

Hypersensitivity

Hypersensitivity side effects of spontaneous nature reported during the marketing of desloratadine have included rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis.

Hepatic

Hepatic side effects have included elevated liver enzymes and bilirubin. Very rarely, hepatitis has been observed in clinical practice.

Gastrointestinal

Gastrointestinal side effects have included dry mouth, dry throat, nausea, and pharyngitis.

Nervous system

Nervous system side effects have included somnolence and dizziness. Psychomotor hyperactivity and seizures have been observed in clinical practice.

An increase in the incidence of somnolence has been reported in clinical trials (n=1838) at doses of 10 mg/day and 20 mg/day (5.2% and 7.6%, respectively), compared to placebo (2.3%).

General

General side effects have included myalgia and influenza-like symptoms.

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