Voltaren/Voltaren SR Adverse Reactions

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), including isolated reports.
The following undesirable effects include those reported with Voltaren and/or other pharmaceutical forms of diclofenac during either short-term or long-term use.
Blood and lymphatic system disorders: Very rare: Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.
Immune system disorders: Rare: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare: Angioedema (including facial oedema).
Psychiatric disorders: Very rare: Disorientation, depression, insomnia, nightmares, irritability, psychotic disorder.
Nervous system disorders: Common: Headache, dizziness/light-headedness.
Rare: Somnolence.
Very rare: Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances/dysgeusia, cerebrovascular accident.
Eye disorders: Very rare: Visual disturbances, vision blurred/visual impairment, diplopia.
Ear and labyrinth disorders: Common: Vertigo.
Very rare: Tinnitus, hearing impaired.
Respiratory, thoracic and mediastinal disorders: Rare: Asthma (including dyspnoea).
Very rare: Pneumonitis.
Gastrointestinal disorders: Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia/decreased appetite.
Rare: Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer (with or without bleeding, gastrointestinal stenosis or perforation, which may lead to peritonitis).
Very rare: Colitis (including haemorrhagic colitis, ischaemic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.
Hepatobiliary disorders: Common: Transaminases increased.
Rare: Hepatitis, jaundice, liver disorder/hepatic dysfunction.
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/alopecia, photosensitivity reaction, purpura, allergic purpura/Henoch-Schönlein purpura, pruritus.
Renal and urinary disorders: Very rare: Acute kidney injury (acute renal failure), haematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions: Rare: Oedema.
Voltaren EC tablet/suppository: Cardiac disorders: Very rare: Palpitations, chest pain, cardiac failure, myocardial infarction.
Vascular disorders: Very rare: Hypertension, vasculitis.
Voltaren SR-FC tablet: Cardiac disorders: Uncommon*: Myocardial infarction, heart failure, palpitations, chest pain.
Not known: Kounis syndrome.
Vascular disorders: Common: Hypertension.
Very rare: Vasculitis.
Gastrointestinal disorders: Voltaren prolonged-release coated tablets may provoke chronic inflammatory conditions with pseudomembranes and strictures in the lower intestines (small and large intestines).
Skin and subcutaneous tissue disorders: Not known: Drug rash with eosinophilia and systemic symptoms (DRESS).
Renal and urinary disorders: Common: Fluid retention, oedema.
* The frequency reflects data from long-term treatment with a high dose (150 mg/day).
Meta-analyses of controlled clinical studies and pharmacoepidemiological data point towards an increased risk of arterial thromboembolic events (for example, myocardial infarction or stroke) associated with the use of diclofenac, particularly at a high dose (150 mg daily) and during long-term treatment (see Warnings and Precautions).
Description of selected adverse effects: Visual effects: Visual disturbances such as visual impairment, blurred vision and diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances is the inhibition of prostaglandin synthesis and other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. If such symptoms occur during diclofenac treatment, an ophthalmological examination may be considered to exclude other causes.
Reporting of suspected adverse effects: Reporting suspected adverse effects after authorisation of the medicinal product is very important. It allows continued monitoring of the risk-benefit ratio of the medicinal product. Healthcare professionals are asked to report any suspected new or serious adverse effects.
Voltaren suppository: Gastrointestinal disorders: Rare: Proctitis.
Very rare: Haemorrhoids aggravated.
General disorders and administration site conditions: Common: Application site irritation.