The most commonly observed adverse events of NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration of NSAIDs. Less frequently, gastritis has been observed.Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions. The most frequent adverse effects of lornoxicam include nausea, dyspepsia, indigestion, abdominal pain, vomiting, and diarrhoea. These symptoms have generally occurred in less than 10% of patients in available studies. Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).Exceptionally, occurrence of serious cutaneous and soft tissues infectious complications during varicella.Listed below are undesirable effects, which generally occurred in more than 0.05% of the 6.,17 patients treated in clinical phase II, III and IV trials. 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), not known (cannot be estimated from the available data).
Infections and infestations
Blood and lymphatic system disorders
Rare: Anaemia, thrombocytopenia, leukopenia, prolonged bleeding timeVery rare: Ecchymosis. NSAIDs have been reported to cause potentially severe hematological disorders like neutropenia, agranulocytosis, aplastic anaemia, and hemolytic anaemia as class effects.
Immune system disorders
Rare: Hypersensitivity , anaphylactoid reaction and anaphylaxis.
Metabolism and nutrition disorders
Uncommon: Anorexia, weight changes.
Uncommon: Insomnia, depression.Rare: Confusion, nervousness, agitation.
Nervous system disorders
Common: Mild and transient headache, dizziness.Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine.Very rare: Aseptic meningitis in patients with SLE and mixed connective tissue disorder (see 4.4).
Uncommon: Conjunctivitis.Rare: Visual disturbances.
Ear and labyrinth disorders
Uncommon: Vertigo, tinnitus.
Uncommon: Palpitations, tachycardia, oedema, cardiac failure.
Uncommon: Flushing, oedema.Rare: Hypertension, hot flush, haemorrhage, haematoma.
Respiratory, thoracic and mediastinal disorders
Uncommon: Rhinitis.Rare: Dyspnoea, cough, bronchospasm.
Common: Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting. Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration.Rare: Melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer, gastrointestinal haemorrhage.Hepatobiliary disorders Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).Very rare: Hepatotoxicity resulting in e.g. hepatic failure, hepatitis, jaundice and cholestasis.
Skin and subcutaneous tissue disorders
Uncommon: Rash, pruritus, hyperhidrosis, rash erythematous, urticaria and angioedema, alopecia.Rare: Dermatitis and eczema, purpura.Very rare: Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders
Uncommon: Arthralgia. Rare: Bone pain, muscle spasms, myalgia.
Renal and urinary disorders
Rare: Nocturia, micturition disorders, increase in blood urea nitrogen and creatinine levels.Very rare: Lornoxicam may precipitate acute renal failure in patients with pre-existing renal impairment, who are dependent on renal prostaglandins for maintenance of renal blood flow (see 4.4). Nephrotoxicity in various forms including nephritis and nephrotic syndrome has been associated with NSAIDs as class effect.
General disorders and administration site conditions
Uncommon: Malaise, face oedema.Rare: Asthenia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.