Arcoxia Side Effects

In clinical trials, ARCOXIA was evaluated for safety in 9295 individuals, including 5774 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for one year or longer).
The following drug-related adverse experiences were reported in clinical studies in patients with OA, RA, or chronic low back pain treated with etoricoxib 60 mg or 90 mg for up to 12 weeks. These common adverse experiences occurred in ≥1% and <10% of patients treated with ARCOXIA and at an incidence greater than placebo: asthenia/fatigue, dizziness, oedema/fluid retention, lower extremity edema, flu-like disease, hypertension, abdominal pain, flatulence, diarrhea, dyspepsia, heartburn, epigastric discomfort, nausea, headache, ALT increased, AST increased.
The adverse experience profile was similar in patients with OA or RA treated with ARCOXIA for one year or longer.
In the MEDAL Study, an endpoint driven CV outcomes trial involving 23,504 patients, the safety of ARCOXIA 60 or 90 mg daily was compared to diclofenac 150 mg daily in patients with OA or RA (mean duration of treatment was 20 months). In this large trial, only serious adverse events and discontinuations due to any adverse events were recorded. The rates of confirmed thrombotic cardiovascular serious adverse events were similar between ARCOXIA and diclofenac. The incidence of discontinuations for hypertension-related adverse events was less than 3% in each treatment group; however, ARCOXIA 60 and 90 mg demonstrated significantly higher rates of discontinuations for these events than diclofenac. The incidence of congestive heart failure adverse events (discontinuations and serious events) and the incidence of discontinuations due to edema occurred at similar rates on ARCOXIA 60 mg compared to diclofenac; however, the incidences for these events were higher for ARCOXIA 90 mg compared to diclofenac. The incidence of discontinuations due to atrial fibrillation was higher for etoricoxib compared to diclofenac.
The EDGE and EDGE II studies compared the GI tolerability of etoricoxib 90 mg daily (1.5 to 3 times the doses recommended for OA) and diclofenac 150 mg daily in 7111 patients with OA (EDGE Study; mean duration of treatment 9 months) and 4086 patients with RA (EDGE II; mean duration of treatment 19 months). In each of these studies, the adverse experience profile on ARCOXIA was generally similar to that reported in the phase IIb/III placebo-controlled clinical studies; however, hypertension and edema-related adverse experiences occurred at a higher rate on etoricoxib 90 mg than on diclofenac 150 mg daily. The rate of confirmed thrombotic cardiovascular serious adverse events occurring in the two treatment groups was similar.
In a combined analysis of phase IIb to V clinical studies of 4 weeks duration or longer (excluding the MEDAL Program Studies), there was no discernible difference in the rate of confirmed thrombotic cardiovascular serious adverse events between patients receiving etoricoxib ≥30 mg or non-naproxen NSAIDs. The rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
In a clinical study for ankylosing spondylitis, patients were treated with ARCOXIA 90 mg once daily for up to 1 year (N=126). In another clinical study for ankylosing spondylitis (N=857), patients were treated with ARCOXIA 60 mg or 90 mg once daily for up to 26 weeks. The adverse experience profile in these studies was generally similar to that reported in chronic studies in OA, RA and chronic low back pain.
In a clinical study for acute gouty arthritis, patients were treated with ARCOXIA 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 initial clinical studies for acute analgesia, patients were treated with ARCOXIA 120 mg once daily for one to seven days. The adverse experience profile in these studies was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
In the additional clinical studies for acute post-operative pain associated with dental and abdominal gynecological surgeries including 1222 patients treated with ARCOXIA (90 mg or 120 mg), the adverse experience profile was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
In the combined studies for acute post-operative dental pain, the incidence of post-dental extraction alveolitis (dry socket) reported in patients treated with ARCOXIA was similar to that of patients treated with active comparators.
The following adverse reactions occurred in less than 1% of patients and 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 for up to 12 weeks or have been reported in post-marketing experience: Blood and lymphatic system disorders: thrombocytopenia.
Infections and infestation: gastroenteritis, upper respiratory infection, urinary tract infection.
Immune system disorders: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock.
Metabolism and nutrition disorders: appetite increase or decrease, weight gain, hyperkalemia.
Psychiatric disorders: anxiety, depression, mental acuity decreased, confusion, hallucinations, restlessness.
Nervous system disorders: dysgeusia, insomnia, paresthaesia/hypaesthesia, somnolence, intracranial hemorrhage.
Eye disorders: blurred vision.
Ear and labyrinth disorders: tinnitus.
Cardiac disorders: congestive heart failure, non-specific ECG changes, myocardial infarction, palpitations, angina, arrhythmia.
Vascular disorders: flushing, cerebrovascular accident, hypertensive crisis, deep vein thrombosis.
Respiratory, thoracic and mediastinal disorders: cough, dyspnoea, epistaxis, bronchospasm, pulmonary embolism.
Gastrointestinal disorders: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcers, peptic ulcers including perforation and bleeding (mainly in elderly patients), vomiting, gastritis.
Hepatobiliary disorders: hepatitis, jaundice, hepatic failure.
Skin and subcutaneous tissue disorders: ecchymosis, facial oedema, pruritus, erythema, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, fixed drug eruption.
Musculoskeletal, connective tissue and bone disorders: muscular cramp/spasm, musculoskeletal pain/stiffness.
Renal and urinary disorders: proteinuria, renal insufficiency, including renal failure (See PRECAUTIONS).
General disorders and administration site conditions: chest pain.
Investigations: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.
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.