Safrosyn S Adverse Reactions

Gastrointestinal disorders: Heartburn, nausea, vomiting, constipation, diarrhoea, flatulence, dyspepsia, abdominal discomfort and epigastric distress. More serious reactions which may occur are inflammation bleeding, which is sometimes fatal, particularly in older people, ulceration, perforation, and obstruction of the upper and lower gastrointestinal tract, melaena, haematemesis, stomatitis, exacerbation of ulcerative colitis and Crohn's disease, oesophagitis, gastritis and pancreatitis.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs in patients with, or without, a history of previous hypersensitivity reactions to 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).
Metabolic and nutrition disorders: Hyperkalaemia.
Psychiatric disorders: Insomnia, dream abnormalities, depression, confusion and hallucinations.
Nervous system disorders: Convulsions, dizziness, headache, lightheadedness, drowsiness, paraesthesia, retrobulbar optic neuritis, inability to concentrate and cognitive dysfunction have been reported. Aseptic meningitis with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.
Eye disorders: Visual disturbances, corneal opacity, papillitis and papilloedema.
Ear and labyrinth disorders: Tinnitus, hearing disturbances, including impairment and vertigo.
Cardiac disorders: Oedema, palpitations, hypertension, cardiac failure and congestive heart failure have been reported. The use of coxibs and some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke).
Vascular disorders: Hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, asthma, eosinophilic pneumonitis and pulmonary oedema.
Renal and urinary disorders: Nephropathy and nephrotoxicity in various forms, including but not limited to glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, raised serum creatinine, renal disease, renal papillary necrosis and renal failure.
Hepatobiliary disorders: Abnormal liver function tests, fatal hepatitis and jaundice.
Blood and lymphatic system disorders: Granulocytopenia, thrombocytopenia, neutropenia, agranulocytosis, eosinophilia, leucopenia, aplastic anaemia and haemolytic anaemia.
Skin and subcutaneous tissue disorders: Skin eruption, skin rashes including fixed drug eruption, itching (pruritus), urticaria, ecchymoses, purpura, sweating. Alopecia, erythema multiforme, bullous reactions, Stevens-Johnson syndrome, erythema nodosum, lichen planus, pustular reaction, SLE, epidermal necrolysis, very rarely toxic epidermal necrolysis, photosensitivity reactions (including cases in which skin resembles porphyria cutanea tarda "pseudoporphyria") or epidermolysis bullosa-like reactions which may occur rarely, and angioneurotic oedema.
If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Musculoskeletal and connective tissue disorders: Myalgia and muscle weakness.
Reproductive system and breast disorders: Female infertility.
General disorders and administration site conditions: Oedema, thirst, pyrexia, fatigue and malaise.
Investigations: Abnormal liver function tests, raised serum creatinine.