ADVERSE REACTIONS
In patients taking Voltaren® (diclofenac sodium enteric-coated tablets), 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 VOLTAREN
Below is a sample of reports where side effects / adverse reactions may be related to Voltaren. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Voltaren side effects / adverse reactions in female
Reported by a health professional (non-physician/pharmacist) from Australia on 2007-01-09
Patient: female weighing 118.0 kg (259.6 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Nexium
Administration route: Oral
Indication: Oesophageal Disorder
Micardis
Administration route: Oral
Indication: Essential Hypertension
Voltaren
Indication: Osteoarthritis
End date: 2006-08-11
Allopurinol Sodium
Administration route: Oral
Indication: Gout
Profloxin
Administration route: Oral
Start date: 2006-08-07
End date: 2006-08-11
Gentamicin Sulfate
Start date: 2006-08-07
End date: 2006-08-10
Possible Voltaren side effects / adverse reactions in 77 year old male
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2007-01-10
Patient: 77 year old male
Reactions: Abdominal Pain, Tachycardia, Gastritis Erosive, Peripheral Vascular Disorder, Duodenal Ulcer, General Physical Health Deterioration, Helicobacter Infection, Pallor, Gastric Haemorrhage, Feeling Cold, Haemoglobin Decreased, Melaena, Blood Pressure Decreased, Normochromic Normocytic Anaemia
Adverse event resulted in: hospitalization
Suspect drug(s):
Voltaren
Other drugs received by patient: Glucophage; Amaryl
Possible Voltaren side effects / adverse reactions in 62 year old female
Reported by a consumer/non-health professional from Brazil on 2007-01-12
Patient: 62 year old female weighing 64.0 kg (140.8 pounds)
Reactions: Hot Flush, Urinary Tract Infection, Blister
Adverse event resulted in: hospitalization
Suspect drug(s):
Voltaren
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