Gastrointestinal, dermatological and CNS adverse reactions are the most common seen. The most severe adverse reactions observed were gastric ul cer and gastrointestinal bleeding while the most severe dermatological reactions observed were erythema multiforme (Stevens-Johnson Syndrome and Lyell Syndrome). Fatalities have occurred on occasion, particularly in the elderly.
Adverse reactions reported in clinical trials and spontaneous reports are summarized as follows.
epigastric or abdominal di scomfort, pressure, heaviness, or distention (6%); nausea (2%); anorexia (1%); diarrhea, vomiting, flat ulence, constipation or eructation (1%); gastric and duodenal ulcerations and bleeding (0.2%); hyperacidity, stomatitis, coated tongue; peptic ulcer with perforation; lower gut disorders (e.g. nonspecific he morrhagic colitis and exacerbation of ulcerative colitis).
hypersensitivity reactions (e.g. bronchos pasm anaphylactic/anaphylactoid systemic reactions including hypotension).
dizziness (5%); headache (3%); malaise, insomnia, drowsiness, impaired concentration, impaired vision, tiredness (1%); irritability, sweating; vertigo, disturbances of sensation, tinnitus, convulsions.
rash (2%); pruritus (1.5%); skin eruption, eczema, urticaria, erythema (less than 0.5%). In isolated cases: Photosensitivity reactions: loss of hair, erythema multiforme and variants (Stevens-Johnson Syndrome, Lyell Syndrome).
palpitation (2.5%): angina, arrhythmias (2.0%); exacerbation of cardiac failure.
disturbances of vision (blurred vision, diplopia).
some patients manifested anemia secondary to gastrointestinal bleeding, leukopenia, thrombocytopenia, aplastic anemia, agranulocytosis, hemolytic anemia.
Edema and Water Retention (2.5%):
facial edema (2%); general edema, (0.5%); peripheral edema, renal failure, nephrotic syndrome; urinary abnormalities (e.g. hematuria), interstitial nephritis.
liver function disorders including hepatitis with or without jaundice, in isolated cases fulminant.
asthma in patient sensitive to ASA.
Uncommon*: Myocardial infarction, cardiac failure, palpitations, chest pain.
*The frequency reflects data from long-term treatment with high dose (150mg/day).
Description of selected adverse drug reaction: Arteriothrombotic events:
Meta-analysis and pharmacoepidemiological data point towards a small increased risk of arteriothrombotic events (for example myocardial infarction) associated with the use of diclofenac, particularly at a high dose (150 mg daily) and during long-term treatment.