In clinical trials of desloratadine, 246 patients aged from 6 months to 11 years old received the oral solution. In children aged 2 to 11 years with the use of desloratadine, the incidence of side effects was the same as with placebo. In infants and young children (6 to 23 months), the following undesirable effects were observed with desloratadine, which were slightly higher than with placebo: diarrhea (3.7%), fever (2.3% ),insomnia (2.3%). In the additional study, no adverse events were observed in patients aged 6 to 1 1 years with desloratadine administered at a dose of 2.5 mg as an oral solution.
In clinical studies, with desloratadine taken by adults and adolescents, according to indications, including allergic rhinitis and chronic idiopathic urticaria, adverse reactions were reported in 3% of patients, which exceeded the same value in the placebo group. More often than others the following undesirable reactions are noted, their frequency exceeded in the placebo group: increased fatigue (1.2%), dryness of the oral mucosa (0.8%), headache (0,6%).
In clinical studies involving 578 adolescents from 12 to 17 years, the most common reported headache. It occurred in 5.9% of patients receiving desloratadine and in 6.9% of patients taking placebo.
The incidence of undesirable reactions revealed during the clinical study of desloratadine, which exceeded the frequency of occurrence of similar values in the placebo group, as well as other undesirable reactions reported during the post-detection period, are listed below.
The incidence of adverse events was classified as follows: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10,000 , <1/1000), very rarely (<1/10000, including individual cases), the frequency is unknown (can not be estimated from the available data).
Disorders of the psyche: very rarely - hallucinations.
From the nervous system: often - headache, insomnia (for children younger than 2 years); very rarely - dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.
From the heart: very rarely - tachycardia, palpitation; frequency unknown - interval elongation QT.
From the gastrointestinal tract: often - dryness of the oral mucosa, diarrhea (for children younger than 2 years); very rarely - abdominal pain, nausea, vomiting, indigestion, diarrhea.
From the liver and bile ducts: very rarely - increased activity of liver enzymes, increased concentrations of bilirubin, hepatitis; frequency is unknown - jaundice.
From the skin and subcutaneous tissues: frequency unknown - photosensitivity.
From the osteomuscular system and connective tissue: very rarely - myalgia.
General disorders and disorders at the site of administration: often - increased fatigue, increased body temperature (for children under 2 years); very rarely - hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash, urticaria); frequency unknown - asthenia.
Postpayment period
Childhood: frequency unknown - interval elongation QT, arrhythmia, bradycardia.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.