Adverse drug reactions from clinical trials and/or spontaneous or literature cases are listed by MedDRA system organ class.
Within each system organ class, the adverse drug reactions ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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).
The following undesirable effects include those reported with Almiral tablets and/or other pharmaceutical forms of diclofenac, with either short-term or long-term use.
Blood and Lymphatic System Disorders:
Very Rare: Thrombocytopenia, leukopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis.
Immune System Disorders:
Rare: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock). Very Rare: Angioedema (including face edema).
Very Rare: Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.
Nervous System Disorders:
Common: Headache, dizziness. Rare: Somnolence. Very Rare: Paresthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, dysgeusia, cerebrovascular accident.
Very Rare: Visual impairment, blurred vision, diplopia.
Ear and Labyrinth Disorders:
Common: Vertigo. Very Rare: Tinnitus, impaired hearing.
Uncommon*: Myocardial infarction, cardiac failure, palpitations, chest pain.
Very Rare: Hypertension, vasculitis.
Respiratory, Thoracic and Mediastinal Disorders:
Rare: Asthma (including dyspnoea). Very Rare: Pneumonitis.
Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, decreased
appetite. Rare: Gastritis, gastrointestinal hemorrhage, hematemesis, hemorrhagic diarrhea, melena, gastrointestinal ulcer (with or without bleeding or perforation). Very Rare: Colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, intestinal diaphragm disease, pancreatitis.
Common: Increased transaminases. Rare: Hepatitis, jaundice, liver disorder. Very Rare: Fulminant hepatitis, hepatic necrosis, hepatic failure.
Skin and Subcutaneous Tissue Disorders:
Common: Rash. Rare: Urticaria. Very Rare: Dermatitis bullous, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reaction, purpura, Henoch-Schonlein purpura, pruritus.
Renal and Urinary Disorders:
Very Rare: Acute renal failure, hematuria, proteinuria, nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis.
General Disorders and Administration Site Conditions:
*The frequency reflects data from long-term treatment with a high dose (150 mg/day).
Description of Selected Adverse Reactions: Arteriothrombotic Events:
Meta-analysis and pharmacoepidemiological data point towards a small increased risk of arteriothrombotic events (eg, myocardial infarction) associated with the use of diclofenac, particularly at a high dose (150 mg daily) and during long-term treatment (see Precautions).