Ajalorin

Ajalorin Adverse Reactions

desloratadine

Manufacturer:

AJ Research & Pharma

Distributor:

AJ Research & Pharma
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: Paediatric population: In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years. The overall incidence of adverse events in children 2 through 11 years of age was similar for the desloratadine and the placebo groups. In infants and toddlers aged 6 to 23 months, the most frequent adverse reactions reported in excess of placebo were diarrhea (3.7 %), fever (2.3 %) and insomnia (2.3 %). In an additional study, no adverse events were seen in subjects between 6 and 11 years of age following a single 2.5 mg dose of desloratadine oral solution.
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.
Adults and adolescents: At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticarial, undesirable effects with desloratadine were reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Tabulated list of adverse reactions: The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported 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 (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) not known (cannot be estimated from the available data). (See table.)

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Paediatric population: Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, abnormal behavior (including anger, aggression and agitation) and bradycardia.
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