Rupafin Adverse Reactions

Tablet: Rupatadine (Rupafin) 10 mg has been administered to over 2025 patients in clinical studies, 120 of whom received Rupatadine for at least 1 year.
The most common adverse reactions in controlled clinical studies were somnolence (9.5%), headache (6.9%) and fatigue (3.2%).
The majority of adverse reactions observed in clinical trials was mild to moderate in severity and usually did not require cessation of therapy. The frequencies are summarized according to this scheme: Common (≥ 1/100 to < 1/10) and Uncommon (≥ 1/1000 to < 1/100).
Investigations: Uncommon: Blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, abnormal liver function test and weight increased.
Nervous system disorders: Common: Somnolence, headache and dizziness. Uncommon: Disturbance in attention.
Respiratory, thoracic and mediastinal disorders: Uncommon: Epistaxis, nasal dryness, pharyngitis, cough, dry throat, pharyngolaryngeal pain and rhinitis.
Gastrointestinal disorders: Common: Dry mouth. Uncommon: Nausea, upper abdominal pain, diarrhea, dyspepsia, vomiting and constipation.
Skin and subcutaneous tissue disorders: Uncommon: Rash.
Musculoskeletal and connective tissue disorders: Uncommon: Back pain, arthralgia and myalgia.
Metabolism and nutrition disorders: Uncommon: Increased appetite.
General disorders and administration site conditions: Common: Fatigue and asthenia. Uncommon: Thirst, malaise and pyrexia.
Psychiatric disorders: Uncommon: Irritability.
Oral solution: Clinical trials with rupatadine oral solution in children aged 2-11 years included 626 patients. From these, 147 patients were treated with rupatadine 2.5 mg, 159 patients were treated with rupatadine 5 mg, 249 received placebo and 71 received desloratadine.
The frequencies of adverse reactions are assigned as follows: Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100).
The frequencies of adverse reactions reported in patients treated with rupatadine oral solution during clinical trials were as follows: See table.

Click on icon to see table/diagram/image

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system