Adverse reactions have been ranked under headings of frequency using 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).
Infections and infestations: Uncommon: Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis.
Rare: Sepsis including fatal outcome.
Blood and the lymphatic system disorders: Uncommon: Anaemia.
Rare: Eosinophilia, thrombocytopenia.
Immune system disorders: Rare: Anaphylactic reaction, hypersensitivity.
Metabolism and nutrition disorders: Uncommon: Hyperkalaemia.
Rare: Hypoglycaemia (in diabetic patients).
Psychiatric disorders: Uncommon: Depression, insomnia.
Rare: Anxiety.
Nervous system disorders: Uncommon: Syncope.
Rare: Somnolence.
Eye disorders: Rare: Visual disturbance.
Ear and labyrinth disorders: Uncommon: Vertigo.
Cardiac disorders: Uncommon: Bradycardia.
Rare: Tachycardia.
Vascular disorders: Uncommon: Hypotension, orthostatic hypotension.
Respiratory thoracic and mediastinal disorders: Uncommon: Dyspnoea, cough.
Very rare: Interstitial lung disease.
Gastrointestinal disorders: Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting.
Rare: Stomach discomfort, dry mouth, dysgeusia.
Hepato-biliary disorders: Rare: Hepatic function abnormal/liver disorder.
Skin and subcutaneous tissue disorders: Uncommon: Hyperhidrosis, pruritus, rash.
Rare: Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption.
Musculoskeletal and connective tissue disorders: Uncommon: Myalgia, back pain (e.g. sciatica), muscle spasms.
Rare: Arthralgia, pain in extremity, tendon pain (tendonitis like symptoms).
Renal and urinary disorders: Uncommon: Renal impairment including acute renal failure.
General disorders and administration site conditions: Uncommon: Chest pain, asthenia (weakness).
Rare: Influenza-like illness.
Investigations: Uncommon: Blood creatinine increased.
Rare: Blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased, haemoglobin decreased.