ADVERSE REACTIONS
In patients taking Voltaren® -XR (diclofenac sodium extended-release 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 SUSPECTED VOLTAREN-XR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Voltaren-XR. The information is not vetted and should not be considered as verified clinical evidence.
Possible Voltaren-XR side effects / adverse reactions in 95 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-31
Patient: 95 year old male weighing 52.0 kg (114.4 pounds)
Reactions: Gastrointestinal Haemorrhage, Respiratory Disorder, Lymphadenopathy, Hyperkalaemia, Bronchopneumonia, Hypoglycaemia, Pyrexia, Haemangioma of Liver, Erythrophagocytosis, White Blood Cell Count Increased, Restlessness, Prostate Cancer, Hypotension, Urine Output Decreased, Benign Prostatic Hyperplasia, Hepatic Steatosis, Arteriosclerosis Coronary Artery, Abscess Bacterial, Spermatogenesis Abnormal, Hyperuricaemia, Haematemesis, Gastrointestinal Ulcer, Ventricular Hypertrophy, Gastric Mucosal Lesion, Renal Arteriosclerosis, Adrenal Insufficiency, Myocardial Infarction, Emphysema, Colon Cancer, Blood Urea Increased, Vomiting, Hyponatraemia, Condition Aggravated, Cardiac Aneurysm, Tumour Lysis Syndrome, Renal Impairment, Adenocarcinoma, Chronic Myelomonocytic Leukaemia, Lung Infiltration
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Voltaren-XR
Other drugs received by patient: Sennoside; Valsartan; Magnesium Oxide; Oxycodone HCL
Possible Voltaren-XR side effects / adverse reactions in 59 year old male
Reported by a consumer/non-health professional from United States on 2011-12-19
Patient: 59 year old male
Reactions: Blood Pressure Increased, Drug Ineffective, Stress
Suspect drug(s):
Voltaren
Dosage: 25 mg
Indication: Pain
Diflucan
Diclofenac Sodium
Indocin
Voltaren-XR
Dosage: 75 mg
Indication: Bursitis
Voltaren
Dosage: 50 mg,
Possible Voltaren-XR side effects / adverse reactions in 59 year old male
Reported by a consumer/non-health professional from United States on 2011-12-19
Patient: 59 year old male
Reactions: Blood Pressure Increased, Drug Ineffective, Stress
Suspect drug(s):
Diflucan
Voltaren-XR
Dosage: 75 mg
Indication: Bursitis
Voltaren
Dosage: 25 mg
Indication: Pain
Voltaren
Dosage: 50 mg,
Indocin
Diclofenac Sodium D.r. Tablets USP
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