Irbis Adverse Reactions

The frequency of adverse reactions listed as follows is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000) within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse reactions additionally reported from post marketing experience are also listed. These adverse reactions are derived from spontaneous reports.
Immune system disorders: Not known: hypersensitivity reactions such as angioedema, rash, urticaria.
Metabolism and nutrition disorders: Not known: hyperkalaemia.
Nervous system disorders: Common: dizziness, orthostatic dizziness*. Not known: vertigo, headache.
Ear and labyrinth disorder: Not known: tinnitus.
Cardiac disorders: Uncommon: tachycardia.
Vascular disorders: Common: orthostatic hypotension*. Uncommon: flushing.
Respiratory, thoracic and mediastinal disorders: Uncommon: cough.
Gastrointestinal disorders: Common: nausea/vomiting. Uncommon: diarrhoea, dyspepsia/heartburn. Not known: dysgeusia.
Hepatobiliary disorders: Uncommon: jaundice. Not known: hepatitis, abnormal liver function.
Skin and subcutaneous tissue disorders: Not known: leukocytoclastic vasculitis.
Musculoskeletal and connective tissue disorders: Common: musculoskeletal pain*. Not known: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase levels), muscle cramps.
Renal and urinary disorders: Not known: impaired renal function including cases of renal failure in patients at risk (see Precautions).
Reproductive system and breast disorders: Uncommon: sexual dysfunction.
General disorders and administration site conditions: Common: fatigue. Uncommon: chest pain.