This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Voltaren-XR (Diclofenac Extended Release) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (19)
Death (2)
Reports by Reaction Type
Rectal Perforation (3),
Blood Pressure Increased (3),
Vomiting (3),
Muscular Weakness (3),
Thrombosis (2),
Drug Ineffective (2),
Diverticulitis (2),
Therapeutic Response Unexpected (2),
Overdose (2),
Fatigue (2),
Dizziness (2),
Chest Discomfort (2)
Possible Voltaren-XR side effects in
Reported by a physician from Japan on 2012-08-15
Patient:
Reactions: Renal Disorder, Rash
Drug(s) suspected as cause:
Rebetol
Dosage: 600 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-07-04
Telavic
Dosage: 2250 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-07-04
End date: 2012-07-06
PEG-Intron
Dosage: 100mcg
Indication: Hepatitis C
Start date: 2012-07-04
Telavic
Dosage: unk
Voltaren-XR
Dosage: 37.5 mg, qd
Administration route: Oral
Indication: Adverse Event
Start date: 2012-07-04
Other drugs received by patient: Metformin Hydrochloride; Novorapid
Possible Voltaren-XR side effects in 76 year old male
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: 76 year old male
Reactions: LIP Swelling, Rash Generalised, Prostate Cancer, Carotid Artery Occlusion, Tongue Neoplasm Malignant Stage Unspecified
Drug(s) suspected as cause:
Voltaren-XR
Possible Voltaren-XR side effects in 41 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-03
Patient: 41 year old male
Reactions: Rectal Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Prednisolone
Possible Voltaren-XR side effects in 41 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-30
Patient: 41 year old male
Reactions: Rectal Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Prednisolone
Possible Voltaren-XR side effects in 41 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27
Patient: 41 year old male
Reactions: Rectal Perforation
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Prednisolone
Possible Voltaren-XR side effects in 61 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-25
Patient: 61 year old male
Reactions: Gastrointestinal Perforation, Death, Interstitial Lung Disease, Diverticulum Intestinal
Adverse event resulted in: death
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Oxycontin; Gabapentin; Oxycodone Hydrochloride
Possible Voltaren-XR side effects in
Reported by a pharmacist from Japan on 2012-07-24
Patient:
Reactions: Platelet Count Decreased
Drug(s) suspected as cause:
Voltaren-XR
Possible Voltaren-XR side effects in 24 year old male
Reported by a consumer/non-health professional from Brazil on 2012-06-26
Patient: 24 year old male
Reactions: Vomiting, Syncope, Malaise, Overdose, Angina Pectoris, Dizziness, Salivary Hypersecretion, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Voltaren-XR
Possible Voltaren-XR side effects in female
Reported by a physician from Japan on 2012-06-14
Patient: female, weighing 34.0 kg (74.8 pounds)
Reactions: Large Intestine Perforation, Large Intestinal Ulcer, Infectious Peritonitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Start date: 2009-12-24
End date: 2009-12-24
Omeprazole
Administration route: Oral
Indication: Prophylaxis
Voltaren
Voltaren-XR
Dosage: dose form: sustained release capsule
Administration route: Oral
Prednisolone
Dosage: dose form: peroral agent
Administration route: Oral
Indication: Rheumatoid Arthritis
Voltaren
Dosage: voltaren:lotion(diclofenac sodium)
Indication: Product Used FOR Unknown Indication
Start date: 2008-12-04
End date: 2010-09-07
Voltaren-XR
Dosage: dose form: sustained release capsule
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-07-06
End date: 2010-09-07
Actemra
Start date: 2009-09-30
End date: 2009-09-30
Actemra
Start date: 2010-02-16
End date: 2010-09-28
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-08-26
End date: 2009-08-26
Actemra
Start date: 2009-10-28
End date: 2009-10-28
Actemra
Start date: 2009-11-25
End date: 2009-11-25
Actemra
Start date: 2010-01-20
End date: 2010-01-20
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Lipitor; Cotrim; Allopurinol; Basen; Polaramine; Olmesartan Medoxomil; Actonel; Vitamin B12; Cytotec
Possible Voltaren-XR side effects in 24 year old male
Reported by a consumer/non-health professional from Brazil on 2012-05-30
Patient: 24 year old male
Reactions: Malaise, Overdose, Vomiting, Syncope, Angina Pectoris, Dizziness, Salivary Hypersecretion, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Voltaren-XR
Possible Voltaren-XR side effects in 44 year old male
Reported by a consumer/non-health professional from Turkey on 2012-02-24
Patient: 44 year old male
Reactions: Blood Pressure Increased, Panic Attack, Dyskinesia, Muscular Weakness, Heart Rate Irregular, Blood Pressure Fluctuation, Erythema
Drug(s) suspected as cause:
Voltaren-XR
Administration route: Oral
Indication: Pain
Start date: 2012-02-18
Voltaren-XR
Indication: Inflammation
Other drugs received by patient: Caffeine W / Codeine Phosphate / Paracetamol
Possible Voltaren-XR side effects in 68 year old male
Reported by a consumer/non-health professional from China on 2012-02-21
Patient: 68 year old male
Reactions: Thrombosis, Chest Discomfort, Fatigue, Dyspnoea, Cardiac Failure, Muscular Weakness
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Tarceva
Possible Voltaren-XR side effects in 68 year old male
Reported by a consumer/non-health professional from China on 2012-02-17
Patient: 68 year old male
Reactions: Thrombosis, Chest Discomfort, Dyspnoea, Fatigue, Cardiac Failure, Muscular Weakness
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Tarceva
Possible Voltaren-XR side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-01-06
Patient: 58 year old female
Reactions: Off Label Use, Diverticulitis, Therapeutic Response Unexpected, Underdose
Drug(s) suspected as cause:
Diclofenac Sodium
Dosage: unk, unk
Administration route: Oral
Indication: Osteoarthritis
Voltaren-XR
Dosage: 75 mg, unk
Administration route: Oral
Indication: Osteoarthritis
Voltaren
Dosage: about an inch, qd
Administration route: Topical
Indication: Osteoarthritis
Possible Voltaren-XR side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-01-05
Patient: 58 year old female
Reactions: Off Label Use, Diverticulitis, Therapeutic Response Unexpected, Underdose
Drug(s) suspected as cause:
Voltaren-XR
Dosage: 75 mg, unk
Administration route: Oral
Indication: Osteoarthritis
Diclofenac Sodium
Dosage: unk, unk
Administration route: Oral
Indication: Osteoarthritis
Voltaren
Dosage: about an inch, qd
Administration route: Topical
Indication: Osteoarthritis
Possible Voltaren-XR side effects 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
Drug(s) suspected as cause:
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 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
Drug(s) suspected as cause:
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
Possible Voltaren-XR side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2011-12-06
Patient: male
Reactions: RIB Fracture
Drug(s) suspected as cause:
Voltaren-XR
Possible Voltaren-XR side effects 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
Drug(s) suspected as cause:
Voltaren-XR
Other drugs received by patient: Sennoside; Valsartan; Magnesium Oxide; Oxycodone HCL
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