Drug Information for DICLOFENAC POTASSIUM TABLETS50 mg (Mylan Pharmaceuticals Inc.): ADVERSE REACTIONS

  • In 718 patients treated for shorter periods, i.e., 2 weeks or less, with diclofenac potassium tablets, adverse reactions were reported one-half to one-tenth as frequently as by patients treated for longer periods. In a 6-month, double-blind trial comparing diclofenac potassium tablets (N = 196) versus diclofenac sodium delayed-release tablets (N = 197) versus ibuprofen (N = 197), adverse reactions were similar in nature and frequency.

    In patients taking diclofenac potassium or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 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.

  • Drug Information Provided by National Library of Medicine (NLM).