Desloratadine Side Effects

Brand Names: Clarinex, Clarinex Reditabs

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

Desloratadine

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 Desloratadine:

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 Desloratadine:

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.

Desloratadine 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 Desloratadine 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 Desloratadine 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.

Desloratadine/Pseudoephedrine 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 Desloratadine/Pseudoephedrine 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 Desloratadine/Pseudoephedrine 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.

Desloratadine 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 Desloratadine 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 Desloratadine 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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Desloratadine Side Effects - for the Professional

Desloratadine

Adults and Adolescents

Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2,834 patients ages 12 years or older received Desloratadine 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 Desloratadine and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Desloratadine 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 Desloratadine tablets (5 mg once-daily), and that were more common with Desloratadine tablets than placebo, are listed in Table 5.

Table 5 Incidence of Adverse Events Reported by 2% or More of Adult and Adolescent Allergic Rhinitis Patients in Placebo-Controlled, Multiple-Dose Clinical Trials with the Tablet Formulation of Desloratadine.

Adverse Experience	Desloratadine Tablets 5 mg (n=1,655)	Placebo (n=1,652)
Pharyngitis	4.1%	2%
Dry Mouth	3%	1.9%
Myalgia	2.1%	1.8%
Fatigue	2.1%	1.2%
Somnolence	2.1%	1.8%
Dysmenorrhea	2.1%	1.6%

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Desloratadine 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 Desloratadine tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Desloratadine tablets and that were more common with Desloratadine than placebo were (rates for Desloratadine 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%).

Observed During Clinical Practice: 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. Top

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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