Summary of the safety profile In clinical trials, etoricoxib was evaluated for safety in 7152 individuals, including 4614 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.
1. 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.
4) Uncommon General disorders and administration site conditions asthenia/fatigue, flu-like disease Common chest pain Uncommon Investigations blood urea nitrogen increased, creatine phosphokinase increased, hyperkalaemia, Uncommon uric acid increased blood sodium decreased Rare *Frequency Category: Defined for each Adverse Experience Term by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).
‡ This adverse reaction was identified through post-marketing surveillance. Its reported frequency has been estimated based upon the highest frequency observed across clinical trial data pooled by indication and approved dose. †The frequency category of “Rare” was defined per the Summary of Product Characteristics (SmPC) guidance (rev.
2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of subjects treated with etoricoxib in the analysis of the Phase III data pooled by dose and indication (n=15,470).
ß Hypersensitivity includes the terms "allergy", "drug allergy", "drug hypersensitivity", "hypersensitivity", "hypersensitivity NOS", "hypersensitivity reaction" and "nonspecific allergy". §Based on analyses of long-term placebo and active controlled clinical trials, selective COX-2 inhibitors have been 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 (uncommon). 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.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the […]