Summary of the safety profile The most common adverse reaction for this medicine is nausea. The most serious reactions occur uncommonly to rarely, and include cardiovascular events such as myocardial infarction and severe hypotension, as well as hypersensitivity events such as anaphylaxis, angioedema, and severe skin reactions.
1), deep surgical infections, and sternal wound healing complications. Tabulated list of adverse reactions The following adverse reactions were reported for patients who received parecoxib (N=5,402) in 28 placebo-controlled clinical trials.
Reports from post-marketing experience have been listed as “frequency not known” because the respective frequencies cannot be estimated from the available data. Within each frequency grouping, adverse reactions are listed using MedDRA terminology and presented in order of decreasing seriousness.
Adverse Drug Reaction Frequency Very Common ( ≥1/10) Common ( ≥1/100 to <1/10) Uncommon ( ≥1/1000 to <1/100) Rare ( ≥1/10,000 to <1/1000) Not known Infections and infestations Pharyngitis, alveolar osteitis (dry socket) Abnormal sternal serous wound drainage, wound infection Blood and lymphatic system disorders Anaemia postoperative Thrombocytopenia Immune system disorders Anaphylactoid reaction Metabolism and nutrition disorders Hypokalaemia Hyperglycaemia, anorexia Adverse Drug Reaction Frequency Very Common ( ≥1/10) Common ( ≥1/100 to <1/10) Uncommon ( ≥1/1000 to <1/100) Rare ( ≥1/10,000 to <1/1000) Not known Psychiatric disorders Agitation, insomnia Nervous system disorders Hypoaesthesia, dizziness Cerebrovascular disorder Ear and labyrinth disorders Ear pain Cardiac disorders Myocardial infarction, bradycardia Circulatory collapse, congestive heart failure, tachycardia Vascular disorders Hypertension, hypotension Hypertension (aggravated), orthostatic hypotension Respiratory, thoracic and mediastinal disorders Respiratory insufficiency Pulmonary embolism Dyspnoea Gastrointestinal disorders Nausea Abdominal pain, vomiting, constipation, dyspepsia, flatulence Gastroduodenal ulceration, gastrooesophageal reflux disease, dry mouth, gastrointestinal sounds abnormal Pancreatitis, oesophagitis, oedema mouth (perioral swelling) Skin and subcutaneous tissue disorders Pruritus, hyperhidrosis Ecchymosis, rash, urticaria Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis Musculoskeletal and connective tissue disorders Back pain Arthralgia Renal and urinary disorders Oliguria Renal failure acute Renal failure, General disorders and administration site conditions Oedema peripheral Asthenia, injection site pain, injection site reaction Hypersensitivity reactions including anaphylaxis and angioedema Adverse Drug Reaction Frequency Very Common ( ≥1/10) Common ( ≥1/100 to <1/10) Uncommon ( ≥1/1000 to <1/100) Rare ( ≥1/10,000 to <1/1000) Not known Investigations Blood creatinine increased Blood CPK increased, blood LDH increased, SGOT increased, SGPT increased, BUN increased.
4). In addition, the following rare, serious adverse reactions have been reported in association with the use of NSAIDs and cannot be ruled out for this medicine: bronchospasm and hepatitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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