The following groups have been used for frequency of undesirable effects:
very common | (≥ 1/10) |
common | (≥ 1/100, < 1/10) |
uncommon | (≥ 1/1000, < 1/100) |
rare | (≥ 1/10 000, < 1/1000) |
very rare | (< 1/10 000) |
not known | (frequency cannot be estimated from the available data) |
Immune system disorders
Very rare: anaphylactic reaction
Metabolism and nutrition disorders
Very rare: decreased appetite
Psychiatric disorders
Very rare: restlessness, anxiety, confusion
Nervous system disorders
Rare: headache, dizziness, metallic taste
Very rare: syncope, nystagmus, drowsiness, tremor, convulsions
Not known: sleepiness, loss of coordination, hypoesthesia*, paraesthesia*
Eye disorders
Rare: conjunctivitis
Very rare: visual impairment, double vision
Cardiac disorders
Very rare: bradycardia
Vascular disorders
Rare: hypotonia
Very rare: hot flash
Respiratory, thoracic and mediastinal disorders
Rare: swelling of the nasal mucosa
Gastrointestinal disorders
Very rare: feeling sick, vomiting
Not known: nausea, diarrhoea
Skin and subcutaneous tissue disorders
Rare: angioedema, skin rash, pruritus, urticaria
General disorders and administration site conditions
Rare: fever
Not known: fatigue
*Localised,temporary sensory disorders predominantly affecting the head (e.g. face, scalp), the mouth region (e.g. lips and tongue) or the limbs (hands, fingers, feet).
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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.