The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Cardiovascular and cerebrovascular:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Aceclofenac is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (for example myocardial infarction or stroke). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac.
Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment.
Other adverse reactions reported less commonly include: Renal:
Neurological and special senses:
Optic neuritis, reports of aseptic meningitis (especially in patients with existing auto immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, confusion, hallucinations, malaise and drowsiness.
Agranulocytosis, aplastic anaemia.
Bullous reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis (very rare). Photosensitivity.
If serious adverse reactions occur, Aceclofenac should be withdrawn.
The following is a list of adverse reactions reported during clinical studies and after authorization, grouped by System-Organ Class and estimated frequencies. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Blood and lymphatic system disorders:
Very rare: Bone Marrow depression, granulocytopenia, thrombocytopenia, neutropenia, haemolytic anaemia.
Immune system disorders:
Rare: Anaphylactic reaction (including shock), hypersensitivity.
Metabolism and nutrition disorders:
Very rare: Hyperkalemia.
Very rare: Depression, abnormal dreams, insomnia.
Nervous system disorders:
Very rare: Paraesthesia, tremor, somnolence, headache, dysgeusia (abnormal taste).
Rare: Visual disturbance.
Ear and labyrinth disorders:
Very rare: Vertigo, tinnitus.
Rare: Cardiac failure.
Very rare: Palpitations.
Very rare: Flushing, hot flush, vasculitis.
Respiratory, thoracic and mediastinal disorders:
Very rare: Bronchospasm, stridor.
Common: Dyspepsia, abdominal pain, nausea, diarrhea.
Uncommon: Flatulence, gastritis, constipation, vomiting, mouth ulceration.
Rare: Melaena, Gastrointestinal haemorrhage, gastrointestinal ulceration.
Very rare: Stomatitis, intestinal perforation, exacerbation of Crohn's disease and colitis ulcerative, haematemesis, pancreatitis.
Common: Hepatic enzyme increased.
Very rare: Hepatic injury (including hepatitis), jaundice, blood alkaline phosphatase increased.
Skin and subcutaneous tissue disorders:
Uncommon: Pruritus rash, dermatitis, urticaria.
Very rare: Purpura, severe mucocutaneous skin reaction (including Stevens Johnson Syndrome) and toxic epidermal necrolysis.
Renal and urinary disorders:
Uncommon: Blood urea increased, blood creatinine increased.
Very rare: Renal failure nephrotic syndrome.
General disorders and administration site conditions:
Very rare: Oedema, fatigue, cramps in legs.
Very rare: Weight increase.