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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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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FELDENE
Below is a sample of reports where side effects / adverse reactions may be related to Feldene. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Feldene side effects / adverse reactions in 41 year old male
Reported by a individual with unspecified qualification from United States on 2007-03-12
Patient: 41 year old male
Reactions: Blood Pressure Increased, Medication Error, Chest Pain, Wrong Drug Administered, Drug Dispensing Error
Suspect drug(s):
Feldene
Dosage: capsule
Felodipine
Dosage: tablet, extended release
Possible Feldene side effects / adverse reactions in 15 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2007-03-16
Patient: 15 year old male weighing 57.0 kg (125.4 pounds)
Reactions: Duodenal Ulcer Perforation, Peritonitis
Adverse event resulted in: life threatening event
Suspect drug(s):
Feldene
Administration route: Oral
Indication: Abdominal Pain
Start date: 2007-02-07
End date: 2007-02-14
Domperidone
Indication: Abdominal Pain
Start date: 2007-02-07
End date: 2007-02-14
Spasfon
Dosage: text:3 df
Administration route: Oral
Indication: Abdominal Pain
Start date: 2007-02-07
End date: 2007-02-14
Possible Feldene side effects / adverse reactions in 62 year old female
Reported by a physician from Spain on 2007-04-02
Patient: 62 year old female
Reactions: Diarrhoea, Oesophageal Disorder, Gastrointestinal Disorder, Deafness, Toxic Epidermal Necrolysis, Tracheal Ulcer, Blindness
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Feldene
Administration route: Oral
Indication: Arthralgia
Start date: 2005-06-19
End date: 2005-06-24
Feldene
Indication: Inflammation
Feldene
Indication: Osteoarthritis
Other drugs received by patient: Xicil; Acetaminophen; Omeprazole
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Drug label data at the top of this Page last updated: 2007-03-05
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