Adverse reactions : תופעות לוואי

4.8   Undesirable effects

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 diarrhoea (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 urticaria, undesirable effects with Aerius 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 (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

System Organ Class                           Frequency             Adverse reactions seen with Aerius Metabolism and nutrition                     Not known             Increased appetite disorders
Psychiatric disorders                         Very rare            Hallucinations Not known             Abnormal behaviour, aggression
Nervous system disorders                    Common                 Headache Common (children less       Insomnia than 2 years)
Very rare              Dizziness, somnolence, insomnia,
psychomotor hyperactivity, seizures
Cardiac disorders                           Very rare              Tachycardia, palpitations Not known               QT prolongation
Gastrointestinal disorders                  Common                 Dry mouth Common (children less       Diarrhoea than 2 years)
Very rare              Abdominal pain, nausea, vomiting,
dyspepsia, diarrhoea
Hepatobiliary disorders                       Very rare            Elevations of liver enzymes, increased bilirubin, hepatitis
Not known             Jaundice
Skin and subcutaneous tissue                 Not known             Photosensitivity disorders
Musculoskeletal and                           Very rare            Myalgia connective tissue disorders
General disorders and                       Common                 Fatigue administration site conditions         Common (children less       Fever than 2 years)
Very rare              Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea,
pruritus, rash, and urticaria)
Not known            Asthenia
Investigations                                Not known            Weight increased 
Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an unknown frequency included QT prolongation, arrhythmia, bradycardia, abnormal behaviour, and aggression.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@m oh.gov.il )