The following adverse drug reactions have been identified or suspected in clinical trials and through post-marketing use. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Frequency categories are defined according to the following convention:
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), not known (cannot be estimated from the available data).
Cardiac disorders:
Rare: tachycardia
Gastrointestinal disorders:
Rare: nausea, abdominal discomfort
General disorders and administration site conditions:
Rare: induration at injection site
Immune system disorders:
Rare: hypersensitivity reactions
Infections and infestations:
Frequency unknown: sepsis
Investigations:
Rare: antibody test - positive for antibody formation
Nervous system disorders
Uncommon: pain
Rare: headache, dizziness
Reproductive system and breast disorders:
Frequency unknown: menorrhagia
Respiratory, thoracic and mediastinal disorders:
Rare: bronchospasm
Skin and subcutaneous disorders:
Uncommon: swelling, pruritis
Rare: urticaria, erythema, erythema of eyelid
Frequency unknown: rash
Vascular disorders:
Rare: flushing
Frequency unknown: thrombophlebitis
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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.