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 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
Hypersensitivity, anaphylactic and anaphylactoid reactions (including Rare hypotension and shock).
Very rare                     Angioneurotic oedema (including face oedema).
Psychiatric disorders
Disorientation, depression, insomnia, nightmare, irritability, psychotic Very rare disorder.
Nervous system disorders

Common                        Headache, dizziness.
Rare                          Somnolence, tiredness.
Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic Very rare 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.
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                          Application site irritation, oedema
* 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 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.