Summary of the safety profile: In clinical trials, Etoricoxib was evaluated for safety in 9,295 individuals, including 6,757 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately 600 patients with OA or RA were treated for one year or longer).
In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with Etoricoxib for one year or longer.
In a clinical study for acute gouty arthritis, patients were treated with Etoricoxib 120 mg once daily for eight days. The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
In a cardiovascular safety outcomes programme of pooled data from three active comparator-controlled trials, 17,412 patients with OA or RA were treated with Etoricoxib (60 mg or 90 mg) for a mean duration of approximately 18 months. The safety data and details from this programme are presented.
In clinical studies for acute postoperative dental pain following surgery including 614 patients treated with Etoricoxib (90 mg or 120 mg), the adverse experience profile in these studies was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
Tabulated list of adverse reactions: The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with Etoricoxib 30 mg, 60 mg or 90 mg up to the recommended dose for up to 12 weeks; in the MEDAL Programme studies for up to 3½ years; in short term acute pain studies for up to 7 days; or in post-marketing experience.
Infections and infestations: Common: Alveolar; Uncommon: gastroenteritis, upper respiratory infection, urinary tract infection.
Blood and lymphatic system disorders: Uncommon: Anaemia (primarily associated with gastro-intestinal bleeding), leukopenia, thrombocytopenia.
Immune system disorders: Uncommon: hypersensitivity; Rare: including angioedema, anaphylactic/anaphylactic reactions including shock.
Metabolism and nutrition disorders: Common: oedema/fluid retention; Uncommon: appetite increase or decrease, weight gain.
Psychiatric disorders: Uncommon: anxiety, depression, mental acuity decreased, hallucinations; Rare: confusion, restlessness.
Nervous system disorders: Common: dizziness, headache; Uncommon: dysgeusia, insomnia, paraesthesia/hypaesthesia, somnolence.
Eye disorders: Uncommon: blurred vision, conjunctivitis.
Ear and labyrinth disorders: Uncommon: tinnitus, vertigo.
Cardiac disorders: Common: palpitations; Uncommon: Atrial fibrillation, congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction*.
Vascular disorders: Common: hypertension; Uncommon: flushing, cerebrovascular accident*, hypertensive crisis, transient ischemic attack.
Respiratory, thoracic and mediastinal disorders: Common: bronchospasm; Uncommon: cough, dyspnoea, epistaxis.
Gastrointestinal disorders: Very Common: Abdominal pain; Common: Constipation, flatulence, heartburn, diarrhoea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer; Uncommon: Abdominal distention, bowel movement pattern change, dry mouth, gastro duodenal ulcer, irritable bowel syndrome, pancreatitis.
Hepatobiliary disorders: Common: ALT increased, AST increased; Rare: hepatitis, jaundice.
Skin and subcutaneous tissue disorders: Common: ecchymosis; Uncommon: facial oedema, pruritus, erythema, rash; Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption.
Musculoskeletal and connective tissue disorders: Uncommon: muscular cramp/spasm, musculoskeletal pain/stiffness.
Renal and urinary disorders: Uncommon: proteinuria, serum creatinine increased, renal failure/renal insufficiency.
General disorders and administration site conditions: Common: asthenia/fatigue, flu-like disease; Uncommon: chest pain.
Investigations: Uncommon: blood urea nitrogen increased, creatine phosphokinase increased, hyperkalaemia, uric acid increased; Rare: blood sodium decreased.
The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for Etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome; hepatotoxicity including hepatic failure.
Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitor have associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke. The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data.