Clinical trials The most common undesirable effects observed during clinical trials with AKIS are gastrointestinal in nature or injection site reactions which are generally mild and transitory. Clinical trial data suggest that the use of diclofenac injectable solution is associated with injection site reactions, such as: pain and haematoma.
The frequency of injection site adverse events was significantly lower at the 25 and 50 mg dose than at the 75 mg dose. After administering diclofenac the following have also been reported: nausea, vomiting, diarrhoea and constipation.
The undesirable effects are presented below according to MedDRA System Organ Class classification (SOC) and frequency of observation, in accordance with the following convention: very common (≥1/10); common (≥1/100 - <1/10); uncommon (≥1/1000 - <1/100); rare (≥1/10000 - <1/1000); very rare (<1/10000), not known (cannot be estimated from the data available).
Body system Frequency Adverse Drug Reaction Infection and infestations Not known Injection site necrosis Nervous system disorders Uncommon Dizziness Headache Gastrointestinal disorders Common Uncommon Not known Nausea Diarrhoea Vomiting Constipation Gastritis Ischaemic colitis Hepatobiliary disorders Uncommon Hepatic enzymes increase Skin and subcutaneous tissue disorders Uncommon Pruritus General disorders and administration site conditions Very common Injection site reactions The most appropriate MedDRA term is listed to describe a certain reaction.
Synonyms or related conditions are not listed, but should be taken into consideration as well. Class 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, leukopenia, anaemia (including haemolytic and aplastic anaemia), Agranulocytosis.
Immune system disorders Rare Very rare Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Angioneurotic oedema (including face oedema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous system disorders Common Rare Very rare Headache, dizziness. Somnolence. Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident. Eye disorders Very rare Visual disturbance, vision blurred, diplopia.
Ear and labyrinth disorders Common Very rare Vertigo. Tinnitus, hearing impaired. Cardiac disorders Very rare Palpitations, chest pain, cardiac failure, myocardial infarction. Vascular disorders Very rare Hypertension, vasculitis. Respiratory, thoracic and mediastinal disorders Rare Very rare Asthma (including dyspnoea).
Pneumonitis. Gastrointestinal disorders Common Rare Very rare Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Gastritis, gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastrointestinal ulcer (with or without bleeding or perforation).
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.
Hepatobiliary disorders Common Rare Very rare Transaminases increased. Hepatitis, jaundice, liver disorder. Fulminant hepatitis, hepatic necrosis, hepatic failure. Skin and subcutaneous tissue disorders Common Rare Very rare Rash. Urticaria.
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. General disorders and administration site conditions Common Rare Injection site reaction, injection site pain, injection site induration Oedema Injection site necrosis.
Infections and infestations Very rare Injection site abscess. 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. uk/yellowcard.