ADVERSE REACTIONS
In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:
Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.
Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.
Additional adverse experiences reported occasionally include:
Body as a Whole
fever, infection, sepsis
Cardiovascular System
congestive heart failure, hypertension, tachycardia, syncope
Digestive System
dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
Hemic and Lymphatic System
ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
Metabolic and Nutritional
weight changes
Nervous System
anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
Respiratory System
asthma, dyspnea
Skin and Appendages
alopecia, photosensitivity, sweating increased
Special Senses
blurred vision
Urogenital System
cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure
Other adverse reactions, which occur rarely are:
Body as a Whole
anaphylactic reactions, appetite changes, death
Cardiovascular System
arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
Digestive System
colitis, eructation, liver failure, pancreatitis
Hemic and Lymphatic System
agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Metabolic and Nutritional
hyperglycemia
Nervous System
convulsions, coma, hallucinations, meningitis
Respiratory System
respiratory depression, pneumonia
Skin and Appendages
angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
Special Senses
conjunctivitis, hearing impairment
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