Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, 

<1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.
The following undesirable effects include those reported with either short-term or long-term use.
Table 1
Blood and lymphatic system disorders
Very rare                 Thrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders
Rare                      Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare                 Angioneurotic oedema (including face oedema).
Psychiatric disorders
Very rare                 Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders
Common                    Headache, dizziness.
Rare                      Somnolence, tiredness.
Very rare                 Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances,
cerebrovascular accident.
Unknown                   Confusion, hallucinations, disturbances of sensation, malaise.
Eye disorders
Very rare                 Visual disturbance, vision blurred, diplopia.
Unknown                   Optic neuritis.
Ear and labyrinth disorders
Common                    Vertigo.
Very rare                 Tinnitus, hearing impaired.
Cardiac disorders
Uncommon*                 Myocardial infarction, cardiac failure, palpitations, chest pain.
Unknown                   Kounis syndrome
Vascular disorders
Very rare                 Hypertension, hypotension, vasculitis.
Respiratory, thoracic and mediastinal disorders
Rare                      Asthma (including dyspnoea).
Very rare                 Pneumonitis.
Gastrointestinal disorders
Common                    Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Rare                      Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly).
Very rare                 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.
Unknown                   Ischaemic colitis
Hepatobiliary disorders

Common                   Transaminases increased.
Rare                     Hepatitis, jaundice, liver disorder.
Very rare                Fulminant hepatitis, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders
Common                   Rash.
Rare                     Urticaria.
Very rare                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
Very rare                Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
Reproductive system and breast disorders
Very rare                Impotence
General disorders and administration site conditions
Rare                     Oedema
*The frequency reflects data from long-term treatment with a high dose (150mg/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 (see sections 4.3 and 4.4).

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