Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
In 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 Aerius 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 %).

Paediatric population
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 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, depressed mood
Nervous system disorders                    Common              Headache Very rare           Dizziness, somnolence, insomnia,
psychomotor hyperactivity, seizures
Eye disorders                               Not Known           Eye dryness Cardiac disorders                            Very rare          Tachycardia, palpitations Not known           QT prolongation
Gastrointestinal disorders                   Common             Dry mouth 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              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.

A retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0 to 19 years of age when receiving desloratadine compared with periods not receiving desloratadine. Among children 0-4 years old, the adjusted absolute increase was 37.5 (95% Confidence Interval (CI) 10.5-64.5) per 100,000 person years (PY) with a background rate of new onset seizure of 80.3 per 100,000 PY. Among patients 5-19 years of age, the adjusted absolute increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a background rate of 36.4 per 100,000 PY.
(See section 4.4.)

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: https://sideeffects.health.gov.il