Adverse reactions : תופעות לוואי

4.8. Undesirable effects

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 in table 1 are undesirable effects which generally occurred in more than 0.05% of the 6.417 patients treated in clinical phase II, III and IV trials.

The following convention is used for the classification of the frequency of an adverse drug reaction: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); rare (≥1/10.000, <1/1.000); Very rare (<1/10.000), not known (cannot be estimated from the available data)

Table 1: Adverse effects
System organ class            Frequency      Adverse reaction(s)
Infections and infestations   Rare           Pharyngitis
Blood and lymphatic           Rare           Anaemia, thrombocytopenia, leucopenia, prolonged system disorders                             bleeding time
Very rare      Ecchymosis. NSAIDs have been reported to cause potentially severe haematological disorders like neutropenia, agranulocytosis, aplastic anaemia, and haemolytic anaemia as class effects
Immune system disorders       Rare           Hypersensitivity including anaphylactoid reactions and anaphylaxis
Metabolism and nutrition      Uncommon       Anorexia, weight changes disorders
Psychiatric disorders         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 section 4.4)
Eye disorders                 Common         Conjunctivitis
Rare           Visual disturbances
Ear and labyrinth             Uncommon       Vertigo, tinnitus disorders
Cardiac disorders             Uncommon       Palpitations, tachycardia, oedema, cardiac failure (see section 4.4)
Vascular disorders            Uncommon       Flushing, oedema
Rare           Hypertension, hot flush, haemorrhage, haematoma
Respiratory, thoracic and     Uncommon       Rhinitis mediastinal disorders         Rare           Dyspnoea, cough, bronchospasm System organ class           Frequency        Adverse reaction(s)
Gastrointestinal disorders   Common           Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting Uncommon         Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, upper abdominal pain, 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        Uncommon         Rash, pruritus, hyperhidrosis, rash erythematous, tissue disorders                              urticaria, angioedema, alopecia Rare             Dermatitis, eczema, purpura
Very rare        Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis
Musculoskeletal and          Uncommon         Arthralgia connective tissue            Rare             Bone pain, muscle spasms, myalgia disorders
Renal and urinary            Rare             Nocturia, micturition disorders, increase in blood urea disorders                                     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 section 4.4). Nephrotoxicity in various forms including nephritis and nephrotic syndrome has been associated with NSAIDs as class effect
General disorders and        Uncommon         Malaise, face oedema administration site          Rare             Asthenia conditions


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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/