Common or very common: Ecchymosis; fatigue; influenza-like symptoms; palpitation.
Uncommon: Anxiety; appetite change; arthralgia; atrial fibrillation; chest pain; cough; dry mouth; dyspnoea; electrolyte disturbance; epistaxis; flushing; mental acuity impaired; mouth ulcer; myalgia; paraesthesia; taste disturbance; transient ischaemic attack; weight change.
Rare: Alveolitis; aseptic meningitis (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible); hepatic damage; interstitial fibrosis associated with NSAIDs can lead to renal failure; pancreatitis; papillary necrosis associated with NSAIDs can lead to renal failure; pulmonary eosinophilia; Stevens-Johnson syndrome; toxic epidermal necrolysis; visual disturbances.
Very rare: Confusion; hallucinations.
Frequency not known: Angioedema; blood disorders; bronchospasm; colitis (induction of or exacerbation of); Crohn's disease (induction of or exacerbation of); depression; diarrhoea; dizziness; drowsiness; fluid retention (rarely precipitating congestive heart failure); gastro-intestinal bleeding; gastro-intestinal discomfort; gastro-intestinal disturbances; gastro-intestinal ulceration; haematuria; headache; hearing disturbances; hypersensitivity reactions; insomnia; nausea; nervousness; photosensitivity; raised blood pressure; rashes; renal failure (especially in patients with pre-existing renal impairment); tinnitus; vertigo.
Side-effects, further information: NSAIDs and cardiovascular events: All NSAID use (including cyclo-oxygenase-2 selective inhibitors) can, to varying degrees, be associated with a small increased risk of thrombotic events (e.g. myocardial infarction and stroke) independent of baseline cardiovascular risk factors or duration of NSAID use; however, the greatest risk may be in those receiving high doses long term.
Cyclo-oxygenase-2 selective inhibitors, diclofenac (150 mg daily) and ibuprofen (2.4 g daily) are associated with an increased risk of thrombotic events. Although there are limited data regarding the thrombotic effects of Aceclofenac, treatment advice has been updated in line with diclofenac, based on aceclofenac's structural similarity to diclofenac and its metabolism to diclofenac. The increased risk for diclofenac is similar to that of licensed doses of etoricoxib. Naproxen (1 g daily) is associated with a lower thrombotic risk and low doses of ibuprofen (1.2 g daily or less) have not been associated with an increased risk of myocardial infarction.
The lowest effective dose of NSAID should be prescribed for the shortest period of time to control symptoms and the need for long-term treatment should be reviewed periodically.
NSAIDs and gastro-intestinal events: All NSAIDs are associated with serious gastro-intestinal toxicity; the risk is higher in the elderly. Evidence on the relative safety of non-selective NSAIDs indicates differences in the risks of serious upper gastro-intestinal side effects - piroxicam, ketoprofen, and ketorolac trometamol are associated with the highest risk; indomethacin, diclofenac, and naproxen are associated with intermediate risk, and ibuprofen with the lowest risk (although high doses of ibuprofen have been associated with intermediate risk). Selective inhibitors of cyclooxygenase-2 are associated with a lower risk of serious upper gastro-intestinal side-effects than non-selective NSAIDs.
Recommendations are that NSAIDs associated with a low risk e.g. ibuprofen are generally preferred, to start at the lowest recommended dose and not to use more than one oral NSAID at a time.
The combination of a NSAID and low-dose aspirin can increase the risk of gastro-intestinal side-effects; this combination should be used only if absolutely necessary and the patient should be monitored closely.
While it is preferable to avoid NSAIDs in patients with active or previous gastro-intestinal ulceration or bleeding, and to withdraw them if gastro-intestinal lesions develop, nevertheless patients with serious rheumatic diseases (e.g. rheumatoid arthritis) are usually dependent on NSAIDs for effective relief of pain and stiffness.
Patients at risk of gastro-intestinal ulceration (including the elderly), who need NSAID treatment should receive gastro protective treatment.
Systemic as well as local effects of NSAIDs contribute to gastro-intestinal damage, taking oral formulations with milk or food, or using enteric-coated formulations, or changing the route of administration may only partially reduce symptoms such as dyspepsia.
NSAIDs and alcohol: Alcohol increases the risk of gastro-intestinal haemorrhage associated with NSAIDs. Specialist sources recommend that concurrent use need not be avoided with moderate alcohol intake, but greater caution is warranted in those who drink more than the recommended daily limits. Some cases of acute kidney injury have been attributed to use of NSAIDs and acute excessive alcohol consumption.