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
Infection and Infestations

Unknown              Injection site necrosis.

Blood and lymphatic system disorders
Thrombocytopenia, leucopoenia, anaemia (including haemolytic and aplastic Very rare
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.

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
Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial Very rare
nephritis, renal papillary necrosis.

Reproductive system and breast disorders

Very rare                     Impotence.
General disorders and administration site conditions
Common
Injection site reaction, injection site pain, injection site induration.
Rare                          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