Stadlofen 50 Adverse Reactions

Common (1/100 ≤ ADR < 1/10): Nervous system disorders: Headache, dizziness.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Hepatobiliary disorders: Transaminases increased.
Skin and subcutaneous tissue disorders: Rash.
Uncommon* (1/1,000 ≤ ADR < 1/100): Cardiac disorders: Myocardial infarction, cardiac failure, palpitations, chest pain.
Rare (1/10,000 ≤ ADR < 1/1,000): Immune system disorders: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Nervous system disorders: Somnolence, tiredness.
Respiratory, thoracic and mediastinal disorders: Asthma (including dyspnoea).
Gastrointestinal disorders: Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly).
Hepatobiliary disorders: Hepatitis, jaundice, liver disorder.
Skin and subcutaneous tissue disorders: Urticaria.
General disorders and administration site conditions: Oedema.
Very rare (ADR < 1/10,000): Blood and lymphatic system disorders: Thrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders: Angioneurotic oedema (including face oedema).
Psychiatric disorders: Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders: Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident.
Eye disorders: Visual disturbance, vision blurred, diplopia.
Ear and labyrinth disorders: Tinnitus, hearing impaired.
Vascular disorders: Hypertension, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders: Pneumonitis.
Gastrointestinal disorders: Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Hepatobiliary disorders: Fulminant hepatitis, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders: Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.
Renal and urinary disorders: Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
Reproductive system and breast disorders: Impotence.
Not known (cannot be estimated from the available data): Nervous system disorders: Confusion, hallucinations, disturbances of sensation, malaise.
Eye disorders: Optic neuritis.
Cardiac disorders: Kounis syndrome.
Gastrointestinal disorders: Ischaemic colitis.
* The frequency reflects data from long-term treatment with a high dose (150 mg/day).
Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment.