ADVERSE REACTIONS
In patients taking FELDENE or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:
- Cardiovascular System: Edema.
- Digestive System: Anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting.
- Hemic and Lymphatic System: Anemia, increased bleeding time.
- Nervous System: Dizziness, headache.
- Skin and Appendages: Pruritus, rash.
- Special Senses: Tinnitus.
- Urogenital System: Abnormal renal function.
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, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis.
- Hemic and Lymphatic System: Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, 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, bruising, desquamation, erythema, photosensitivity, sweat.
- Special Senses: Blurred vision.
- Urogenital System: Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, oliguria/polyuria, proteinuria, renal failure.
Other adverse reactions which occur rarely are:
- Body As a Whole: Anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness.
- Cardiovascular System: Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis.
- Digestive System: Eructation, liver failure, pancreatitis.
- Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia.
- Hypersensitivity: Positive ANA.
- Metabolic and Nutritional: Hyperglycemia, hypoglycemia.
- Nervous System: Akathisia, convulsions, coma, hallucinations, meningitis, mood alterations.
- Respiratory: Respiratory depression, pneumonia.
- Skin and Appendages: Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson syndrome, urticaria, vesiculobullous reaction.
- Special Senses: Conjunctivitis, hearing impairment, swollen eyes.
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