Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity reactions.
[ See Warnings and Precautions (5.1) .] • The most common adverse reactions (reported in ≥2% of adult and adolescent patients with allergic rhinitis and greater than placebo) were pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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, 2834 patients ages 12 years or older received Desloratadine Tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 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
Table 1 Incidence of Adverse Events Reported by ≥2% of Adult and Adolescent Allergic Rhinitis Patients Receiving Desloratadine Tablets Adverse Event Desloratadine Tablets 5 mg (n=1655) Placebo (n=1652) 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 Desloratadine and placebo-treated patients.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported.
In such cases, stop Desloratadine Tablets at once and consider alternative treatments.
( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine.
If such a reaction occurs, therapy with Desloratadine Tablets should be stopped and alternative treatment should be considered.
[ See Adverse Reactions (6.2) .]
Like all medications, Desloratadine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: