Desloratadine Sandoz Adverse Reactions

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 desloratadine 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.
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. 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).
Metabolism and nutrition disorders: Not known: Increased appetite.
Psychiatric disorders: Very rare: Hallucinations.
Not known: Abnormal behaviour, aggression.
Nervous system disorders: Common: Headache.
Very rare: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures.
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 disorders: Not known: Photosensitivity.
Musculoskeletal and connective tissue disorders: Very rare: Myalgia.
General disorders and administration site conditions: Common: Fatigue.
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 Precautions).