This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Voltaren (Diclofenac) 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 (810)
Death (66)
Life Threatening Events (78)
Disability (31)
Reports by Reaction Type
Off Label Use (117),
Drug Administered AT Inappropriate Site (100),
Therapeutic Response Unexpected (78),
Wrong Technique in Drug Usage Process (67),
Pain (45),
Renal Failure Acute (45),
Nausea (45),
Malaise (43),
Erythema (41),
Dyspnoea (40),
Abdominal Pain Upper (38),
Pyrexia (37)
Below are a few examples of reports where side effects / adverse reactions may be related to Voltaren (Diclofenac). For a complete list or a specific selection of reports, please use the links above.
Possible Voltaren side effects in 22 year old male
Reported by a consumer/non-health professional from China on 2012-08-27
Patient: 22 year old male
Reactions: Cardiac Discomfort, Chest Pain, Cardiovascular Disorder, Cardiomyopathy
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in female
Reported by a physician from Colombia on 2012-08-27
Patient: female
Reactions: Sudden Visual Loss
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Voltaren
Other drugs received by patient: Antidol
Possible Voltaren side effects in
Reported by a consumer/non-health professional from Sweden on 2012-08-27
Patient:
Reactions: Gallbladder Disorder, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from Sweden on 2012-08-27
Patient: female
Reactions: Insomnia, Gastrointestinal Disorder, Rash, Liver Disorder
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in 78 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 78 year old male
Reactions: Drug Administered AT Inappropriate Site, Wrong Technique in Drug Usage Process, Cataract, Application Site Pain, Off Label Use, Impaired Driving Ability, Eyelid Function Disorder, Vision Blurred, Blindness Unilateral, Application Site Irritation, Accidental Exposure
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Voltaren
Dosage: on and off
Administration route: Topical
Indication: Myalgia
Start date: 2010-11-01
Voltaren
Dosage: unk, once
Possible Voltaren side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27
Patient: 66 year old male, weighing 125.0 kg (275.0 pounds)
Reactions: Renal Failure Acute
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: 1-2* 600 mg, qd
Administration route: Oral
Indication: Arthralgia
Start date: 2011-10-25
End date: 2011-11-02
Ibuprofen
Dosage: 1-2*800 mg, qd
Administration route: Oral
Start date: 2011-11-03
End date: 2011-12-08
Pantoprazole Sodium
Dosage: 20 mg, qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-11-19
End date: 2011-12-05
Pantoprazole Sodium
Dosage: 40 mg, qd
Administration route: Oral
Start date: 2011-12-06
End date: 2011-12-08
Valoron N Retard, Pfizer
Dosage: 1 df, bid
Administration route: Oral
Start date: 2011-11-18
End date: 2011-12-08
Valoron N Retard, Pfizer
Dosage: 1 df, qd
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-11-18
End date: 2011-11-18
Voltaren
Dosage: nearly 2 tablets weekly per os
Administration route: Oral
Indication: Arthralgia
Start date: 2011-10-25
End date: 2011-11-16
Possible Voltaren side effects in female
Reported by a physician from Italy on 2012-08-27
Patient: female
Reactions: Vomiting, Intentional Overdose, Unresponsive To Stimuli, Abnormal Behaviour, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lanoxin
Dosage: 6 vials
Start date: 2012-07-12
Voltaren
Dosage: 60 df, unk
Administration route: Oral
Start date: 2012-07-12
End date: 2012-07-12
Zoloft
Dosage: 120 df, unk
Administration route: Oral
Start date: 2012-07-12
End date: 2012-07-12
Zolpidem
Dosage: 60 df, unk
Administration route: Oral
Start date: 2012-07-12
End date: 2012-07-12
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-08-27
Patient: female
Reactions: Sudden Hearing Loss, Tinnitus, Deafness Neurosensory, Deafness, Headache, Pyrexia, Abdominal Pain Upper, Malaise, Visual Impairment, Hearing Impaired, Vision Blurred, Inflammation
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Strocain
Dosage: unk ukn, unk
Administration route: Oral
Indication: Peptic Ulcer
Start date: 2012-07-16
Voltaren
Dosage: unk ukn, unk
Administration route: Oral
Indication: Influenza Like Illness
Zoledronoc Acid
Dosage: 5 mg per 100 ml (100 cc)
Indication: Osteoporosis Postmenopausal
Start date: 2012-07-16
End date: 2012-07-16
Other drugs received by patient: Tapal; Cinnarizine; Xanax; Famotidine
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-26
Patient: female
Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Swelling, DRY Mouth, Feeling Hot, Insomnia, Salmonellosis, Gait Disturbance, Blister
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Naproxen
Dosage: 2 df, unk
Indication: Inflammation
Start date: 2012-07-01
End date: 2012-07-14
Voltaren
Dosage: applied no more than 6 times
Administration route: Topical
Indication: Inflammation
Start date: 2012-07-14
End date: 2012-07-17
Other drugs received by patient: Omeprazole
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-24
Patient: female
Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Feeling Hot, DRY Mouth, Insomnia, Swelling, Salmonellosis, Gait Disturbance, Blister
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Naproxen
Dosage: 1 df, unk
Administration route: Oral
Indication: Inflammation
Start date: 2012-07-01
End date: 2012-07-14
Naproxen
Indication: Pain
Voltaren
Indication: Pain
Voltaren
Dosage: bid
Administration route: Topical
Indication: Inflammation
Start date: 2012-07-14
End date: 2012-07-17
Other drugs received by patient: Omeprazole
Possible Voltaren side effects in 76 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 76 year old male
Reactions: Gout, Renal Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Voltaren
Other drugs received by patient: Triamcinolone Acetonide
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Renal Disorder, Drug Ineffective, Staphylococcal Infection
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in 52 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24
Patient: 52 year old male
Reactions: Suicide Attempt, Gastrointestinal Sounds Abnormal, Alcohol Poisoning
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Doxepin
Administration route: Oral
Start date: 2012-08-11
Tramadol HCL
Administration route: Oral
Voltaren
Administration route: Oral
Possible Voltaren side effects in female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-24
Patient: female
Reactions: Duodenal Ulcer, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Dosage: 300 mg
Administration route: Oral
Indication: Platelet Aggregation Inhibition
Start date: 2002-08-01
End date: 2012-08-09
Nimesulide Hexal
Dosage: 100 mg
Administration route: Oral
Indication: Back Pain
Start date: 2012-07-25
End date: 2012-07-31
Voltaren
Dosage: 100 mg, unk
Administration route: Oral
Indication: Back Pain
Start date: 2012-08-01
End date: 2012-08-09
Other drugs received by patient: Bisoprolol Fumarate; Ramipril; Escitalopram
Possible Voltaren side effects in 22 year old male
Reported by a consumer/non-health professional from China on 2012-08-24
Patient: 22 year old male
Reactions: Cardiac Discomfort, Chest Pain, Cardiovascular Disorder, Cardiomyopathy
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in 37 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 37 year old female
Reactions: Drug Administered AT Inappropriate Site, Emphysema, Off Label Use, Wrong Technique in Drug Usage Process, Bronchitis Chronic, Therapeutic Response Unexpected, Expired Drug Administered, Chronic Obstructive Pulmonary Disease
Drug(s) suspected as cause:
Voltaren
Other drugs received by patient: Anxiolytics; Carisoprodol; Analgesics,other
Possible Voltaren side effects in 46 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-08-23
Patient: 46 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Drug Ineffective, Incorrect Dose Administered, Joint Stiffness, Weight Increased, Oedema Peripheral, Vision Blurred, Gait Disturbance, Back Disorder, Neuralgia, Influenza Like Illness
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Lyrica
Dosage: 200 mg, 3x/day
Administration route: Oral
Indication: Neuralgia
Start date: 2012-06-01
Voltaren
Dosage: 50 mg, daily
Indication: Back Pain
Start date: 2012-01-01
Possible Voltaren side effects in 84 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 84 year old female
Reactions: Anxiety, Blood Pressure Increased, Underdose, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 66 year old female
Reactions: Chondropathy, Drug Ineffective, Drug Ineffective FOR Unapproved Indication, Arthritis
Drug(s) suspected as cause:
Voltaren
Other drugs received by patient: Naproxen (Aleve)
Possible Voltaren side effects in
Reported by a pharmacist from Japan on 2012-08-21
Patient:
Reactions: Urinary Retention
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-21
Patient: female
Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Swelling, DRY Mouth, Feeling Hot, Insomnia, Salmonellosis, Gait Disturbance, Blister
Drug(s) suspected as cause:
Naproxen Sodium
Dosage: unk
Indication: Inflammation
Start date: 2012-07-01
End date: 2012-07-14
Voltaren
Dosage: unk
Administration route: Topical
Indication: Inflammation
Start date: 2012-07-14
End date: 2012-07-17
Other drugs received by patient: Omeprazole
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-08-20
Patient: female
Reactions: Sudden Hearing Loss, Tinnitus, Deafness Neurosensory, Deafness, Pyrexia, Headache, Abdominal Pain Upper, Malaise, Visual Impairment, Hearing Impaired, Vision Blurred, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Strocain
Dosage: unk ukn, unk
Administration route: Oral
Indication: Peptic Ulcer
Start date: 2012-07-16
Voltaren
Dosage: unk ukn, unk
Administration route: Oral
Indication: Influenza Like Illness
Zoledronoc Acid
Dosage: 5 mg per 100 ml (100 cc)
Indication: Osteoporosis Postmenopausal
Start date: 2012-07-16
End date: 2012-07-16
Other drugs received by patient: Cinnarizine; Xanax; Famotidine; Tapal
Possible Voltaren side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-16
Patient: male
Reactions: Dysuria, Renal Ischaemia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cocaine
Dosage: 1 g, unk
Start date: 2012-07-17
Voltaren
Dosage: 75 mg, bid
Administration route: Oral
Indication: Back Pain
Start date: 2012-07-18
Other drugs received by patient: Acetaminophen; Calciparine; Esomeprazole; Naproxen; Amlodipine Besylate; Sodium Bicarbonate
Possible Voltaren side effects in 82 year old male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 82 year old male
Reactions: Lung Neoplasm Malignant
Adverse event resulted in: death
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in 82 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 82 year old female
Reactions: Drug Administered AT Inappropriate Site, Wrong Technique in Drug Usage Process, Therapeutic Response Unexpected, Animal Bite, Rash Pruritic
Drug(s) suspected as cause:
Clindamycin
Dosage: 300 mg
Voltaren
Dosage: a little on hand applied
Administration route: Topical
Indication: Pain
Possible Voltaren side effects in 76 year old male
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 76 year old male
Reactions: Gout, Adverse Drug Reaction
Adverse event resulted in: death
Drug(s) suspected as cause:
Steroids NOS
Dosage: unk, unk
Indication: Gout
Voltaren
Dosage: unk, couple times a day as needed
Administration route: Topical
Indication: Arthritis
Start date: 2011-01-01
Other drugs received by patient: Triamcinolone Acetonide
Possible Voltaren side effects in 70 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-16
Patient: 70 year old female
Reactions: Osteoarthritis, Spinal Fracture, Pain, Raynaud's Phenomenon, Bone Disorder, Hypertension
Drug(s) suspected as cause:
Voltaren
Other drugs received by patient: Episol; Dipyrone TAB; Valium
Possible Voltaren side effects in 82 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 82 year old female
Reactions: Drug Administered AT Inappropriate Site, Wrong Technique in Drug Usage Process, Therapeutic Response Unexpected, Animal Bite, Rash Pruritic
Drug(s) suspected as cause:
Clindamycin
Dosage: 300 mg
Voltaren
Dosage: a little on hand applied
Administration route: Topical
Indication: Pain
Possible Voltaren side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female
Reactions: Drug Administered AT Inappropriate Site, Diarrhoea, Cystitis, Kidney Infection
Drug(s) suspected as cause:
Voltaren
Possible Voltaren side effects in 84 year old female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 84 year old female
Reactions: Anxiety, Blood Pressure Increased, Underdose, Gait Disturbance
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Voltaren
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