Reproduction system and breast disorders erectile dysfunction Not known Respiratory, thoracic and mediastinal disorders dyspnoea Uncommon respiratory depression Not known Skin and subcutaneous tissue disorders hyperhidrosis, pruritus, rash Common Vascular disorders hot flush Common increase in blood pressure, decrease in blood pressure Uncommon The following additional adverse events are known for oxycodone: Due to its pharmacological properties, oxycodone may cause respiratory depression, miosis, bronchial spasm, and spasms of non-striated muscles as well as suppress the cough reflex. Ear and labyrinth disorders Uncommon tinnitus Eye disorders miosis Uncommon Gastrointestinal disorders gastritis, hiccup Common colic, dysphagia, gastrointestinal disorder, ileus, stomatitis Uncommon dental caries Not known General disorders and administration site conditions fever Common facial flushing, lymphadenopathy, neck pain, oedema, drug tolerance Uncommon drug withdrawal syndrome neonatal Not known Hepatobiliary disorders biliary Uncommon cholestasis Not known Immune system disorders allergic reaction, anaphylactoid reaction Uncommon anaphylactic reaction Not known Metabolism and nutrition disorders dehydration, hyponatraemia Uncommon Rare: increased appetite Musculoskeletal and connective tissue disorders involuntary muscle contractions, muscular rigidity Uncommon
Reproduction system and breast disorders Not known erectile dysfunction Respiratory, thoracic and mediastinal disorders Uncommon dyspnoea Not known respiratory depression Skin and subcutaneous tissue disorders Common hyperhidrosis, pruritus, rash Vascular disorders Common hot flush Uncommon increase in blood pressure, decrease in blood pressure The following additional adverse events are known for oxycodone: Due to its pharmacological properties, oxycodone may cause respiratory depression, miosis, bronchial spasm, and spasms of non-striated muscles as well as suppress the cough reflex. Ear and labyrinth disorders Uncommon tinnitus Eye disorders Uncommon miosis Gastrointestinal disorders Common gastritis, hiccup Uncommon colic, dysphagia, gastrointestinal disorder, ileus, stomatitis Not known dental caries General disorders and administration site conditions Common fever Uncommon facial flushing, lymphadenopathy, neck pain, oedema, drug tolerance Not known drug withdrawal syndrome neonatal Hepatobiliary disorders Uncommon biliary Not known cholestasis Immune system disorders Uncommon allergic reaction, anaphylactoid reaction Not known anaphylactic reaction Metabolism and nutrition disorders Uncommon dehydration, hyponatraemia Rare: increased appetite Musculoskeletal and connective tissue disorders Uncommon involuntary muscle contractions, muscular rigidity
auspar-oxycodone-170607-pi.docx