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]
- Increased intraocular pressure [see WARNINGS AND PRECAUTIONS]
- Urinary retention in patients with prostatic hypertrophy [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
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.
Table 1: Incidence of Adverse Reactions Reported by ≥ 2% of Subjects Receiving CLARINEX-D 12 HOUR Extended Release Tablets
|Adverse Reaction||CLARINEX-D 12 HOUR BID
|Desloratadine 5 mg QD
|Pseudoephedrine 120 mg BID
|General Disorders and Administration Site Conditions|
|Metabolism and Nutrition Disorders|
|Nervous System Disorders|
|Respiratory, Thoracic, and Mediastinal Disorders|
There were no relevant differences in adverse reactions for subgroups of patients as defined by gender, age, or race.
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 pruritus.
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), psychomotor
hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin and, very rarely, hepatitis.