Adverse reactions : תופעות לוואי

4.8       Undesirable effects
Adverse reactions are ranked under the 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, <1/1000); very rare (<1/10,000); not known: cannot be estimated from available data.

The following undesirable effects include those reported with other 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.

CAT API 02JUN24                                                                      UK SmPC Feb2023 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 infraction, cardiac failure, palpitations, chest pain.
Not known                   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.
CAT API 02JUN24                                                                     UK SmPC Feb2023 * 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 doses (150mg daily) and in long term treatment (see sections 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use).


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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/