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 tablets 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.
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 DICLOFENAC
Below is a sample of reports where side effects / adverse reactions may be related to Diclofenac. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Diclofenac side effects / adverse reactions in 89 year old male
Reported by a individual with unspecified qualification from United Kingdom on 2007-04-03
Patient: 89 year old male
Reactions: Oedema Peripheral, Dermatomyositis
Adverse event resulted in: hospitalization
Suspect drug(s):
Diclofenac
Dosage: oral
Administration route: Oral
Indication: Back Pain
Start date: 2006-11-22
End date: 2006-11-23
Paracetamol W/codeine Phosphate
Dosage: oral
Administration route: Oral
Start date: 2006-11-22
End date: 2006-11-23
Possible Diclofenac side effects / adverse reactions in 20 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2007-04-06
Patient: 20 year old male
Reactions: Stevens-Johnson Syndrome
Adverse event resulted in: hospitalization
Suspect drug(s):
Ibuprofen
Dosage: 400 mg prn po
Administration route: Oral
Indication: Headache
Start date: 2007-02-01
End date: 2007-02-10
Diclofenac
Dosage: 150 mg qday po
Administration route: Oral
Indication: Headache
Start date: 2007-02-10
End date: 2007-02-12
Other drugs received by patient: Chloramphenicol; Amoxicillin + Clavulanate Potassium
Possible Diclofenac side effects / adverse reactions in 83 year old female
Reported by a health professional (non-physician/pharmacist) from Norway on 2007-04-11
Patient: 83 year old female
Reactions: Blood Calcium Decreased, Haemoglobin Decreased, Gastrointestinal Haemorrhage, Drug Interaction, Duodenal Ulcer, Oesophageal Ulcer, Blood Sodium Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Fosamax
End date: 2007-01-01
Aspirin and Magnesium Oxide
Administration route: Oral
End date: 2007-01-01
Diclofenac
Administration route: Oral
Indication: Pain
End date: 2007-01-01
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