Summary of the safety profileIn clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with Neoclarityn were reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse reactions reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse event was headache; this occurred in 5.9 % of patients treated with desloratadine and 6.9 % of patients receiving placebo.
Tabulated list of adverse reactionsOther undesirable effects reported very rarely during the post-marketing period are listed in the following table. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000).
|System Organ Class||Frequency||Adverse reactions seen with Neoclarityn|
|Psychiatric disorders||Very rare
|Nervous system disorders||Very rare
||Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
|Cardiac disorders||Very rare
|Gastrointestinal disorders||Very rare
||Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea
|Hepatobiliary disorders||Very rare
||Elevations of liver enzymes, increased bilirubin, hepatitis
|Musculoskeletal and connective tissue disorders||Very rare
|General disorders||Very rare
||Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria)
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website www.mhra.gov.uk/yellowcard.