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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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; fatigue; headache; indigestion; muscle pain; nausea; painful menstruation; sore throat; throat inflammation; tiredness.

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

Clarinex-D 24 Hour 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 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.

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; seizures; severe dizziness; uncontrolled shaking or tremor.

Clarinex Reditab 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 Reditab Disintegrating Tablets:

Dizziness; drowsiness; dry mouth; fatigue; headache; indigestion; muscle pain; nausea; painful menstruation; sore throat; throat inflammation; tiredness.

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

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:

Dizziness; drowsiness; dry mouth; fatigue; headache; indigestion; muscle pain; nausea; painful menstruation; sore throat; throat inflammation; tiredness.

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

For the professional

Clarinex

Adults and Adolescents

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 (5.0 mg once-daily), and that were more common with Clarinex Tablet than placebo, are listed in Table 5.

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.

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 Syrup 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 Syrup 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 Syrup 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 Syrup 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 Syrup in the clinical trials discontinued treatment because of an adverse event.

Observed During Clinical Practice

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

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