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 61 year old female
Reported by a physician from Costa Rica on 2009-04-09
Patient: 61 year old female
Reactions: Basal Cell Carcinoma
Suspect drug(s):
Cataflam
Dosage: 50 mg, unk
Administration route: Oral
Indication: Skin Ulcer
Start date: 2007-01-01
Cataflam
Indication: Arthropod Sting
Cataflam
Indication: Analgesia
Other drugs received by patient: Irbesartan; Levotiroxina; Lovastatin
Possible Cataflam side effects / adverse reactions in 53 year old male
Reported by a consumer/non-health professional from Brazil on 2009-05-08
Patient: 53 year old male
Reactions: Drug Interaction, Blood Pressure Fluctuation
Suspect drug(s):
Cataflam
Chlorthalidone
Dosage: 50 mg 1 tab/day
Administration route: Oral
Indication: Hypertension
Exforge
Dosage: 160/5 mg 1 tab/day
Administration route: Oral
Indication: Hypertension
Exforge
Dosage: 320/5 mg 1 tab/day
Administration route: Oral
Ranitidine
Possible Cataflam side effects / adverse reactions in 7 year old male
Reported by a consumer/non-health professional from Brazil on 2009-05-08
Patient: 7 year old male
Reactions: Pruritus Generalised, Pharyngeal Oedema, Hypersensitivity, Dyspnoea, Rash Erythematous, Neck Mass
Adverse event resulted in: life threatening event
Suspect drug(s):
Cataflam
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