ADVERSE REACTIONS
In 718 patients treated for shorter periods, i.e., 2 weeks or less, with Cataflam® (diclofenac potassium immediate-release 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 Cataflam (N=196) versus Voltaren® (diclofenac sodium delayed-release tablets) (N=197) versus ibuprofen (N=197), adverse reactions were similar in nature and frequency.
In patients taking Cataflam 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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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CATAFLAM
Below is a sample of reports where side effects / adverse reactions may be related to Cataflam. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Cataflam side effects / adverse reactions in 42 year old female
Reported by a consumer/non-health professional from Venezuela on 2007-02-05
Patient: 42 year old female
Reactions: Neuroma, Musculoskeletal Discomfort, Musculoskeletal Chest Pain, Abdominal Discomfort, Hepatomegaly, Upper Respiratory Tract Infection, Neurectomy, Abdominal Distension, Depression
Adverse event resulted in: hospitalization
Suspect drug(s):
Zelmac / HTF 919a
Dosage: 6 mg, bid
Administration route: Oral
Indication: Irritable Bowel Syndrome
Start date: 2001-01-01
Dolomax
End date: 2007-01-09
Cataflam
Dosage: 100 mg, qd
Administration route: Oral
End date: 2007-01-09
Possible Cataflam side effects / adverse reactions in 64 year old female
Reported by a consumer/non-health professional from United States on 2007-03-02
Patient: 64 year old female weighing 90.7 kg (199.6 pounds)
Reactions: Pain, Muscle Injury, Groin Pain, Muscle Spasms
Suspect drug(s):
Cataflam
Possible Cataflam side effects / adverse reactions in 66 year old female
Reported by a consumer/non-health professional from Brazil on 2007-04-02
Patient: 66 year old female weighing 77.0 kg (169.4 pounds)
Reactions: Chondropathy
Suspect drug(s):
Voltaren
Dosage: 50 mg/day
Indication: Pain
Cataflam
Indication: Pain
Other drugs received by patient: Gluporiomin; Anador; Lisador
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