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Voltaren (Diclofenac) - Side Effect Reports to FDA

 
 



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

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 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 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 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 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 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 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 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 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



Possible Voltaren side effects in 64 year old female

Reported by a physician from United States on 2012-08-15

Patient: 64 year old female

Reactions: Thrombosis, Off Label Use, Cellulitis, Pain, Underdose, Fluid Retention, Venous Recanalisation

Drug(s) suspected as cause:
Voltaren

Other drugs received by patient: Insulin; Lasix; Synthroid; Medrol; Morphine; Toprol-XL; Flexeril; Nuvigil; Oxycodone

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