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Voltaren (Diclofenac Sodium) - Summary



Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions] .
  • Voltaren® Gel is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications] .

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions(5.2)].


Voltaren® Gel (diclofenac sodium topical gel) is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzene–acetic acid derivative.

Voltaren® Gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

  • Voltaren® Gel has not been evaluated for use on the spine, hip, or shoulder.

See all Voltaren indications & dosage >>


Published Studies Related to Voltaren (Diclofenac)

Diclofenac with or without an antiemetic for acute migraine headaches in adults. [2013]
CONCLUSIONS: Oral diclofenac potassium 50 mg is an effective treatment

Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo. [2013]
medication... CONCLUSION: In a subgroup of patients with acute nonspecific LBP, spinal

Postoperative treatment with topical diclofenac versus topical dexamethasone after combined phacotrabeculectomy with mitomycin C. [2013]
(Voltaren Ophthalmic) after combined phacotrabeculectomy with mitomycin C... CONCLUSIONS: In this preliminary study, diclofenac sodium is at least as good as

Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee. [2012]
sodium in treatment of Indian patients with symptomatic osteoarthritis (OA) knee... CONCLUSION: Use of diacerein and diclofenac sodium together decreases pain and

Wound Infiltration with Bupivacaine and Intramuscular Diclofenac Reduces Postoperative Tramadol Consumption in Patients Undergoing Radical Retropubic Prostatectomy: A Prospective, Double-blind, Placebo-controlled, Randomized Study. [2011.12]
OBJECTIVES: To assess the impact of wound infiltration with bupivacaine and i.m. diclofenac administration on patient-controlled analgesia (PCA) tramadol consumptions and postoperative pain in patients who underwent radical retropubic prostatectomy (RRP) under general anesthesia. Previous studies have found only limited or no benefits of local anesthetics for postoperative opioid consumption and pain relief after RRP... CONCLUSIONS: This prospective, double-blind, placebo-controlled, randomized study demonstrated that wound infiltration with bupivacaine during surgical closure combined with i.m. diclofenac administration might decrease in 24 hours with PCA tramadol consumption in patients who underwent RRP under general anesthesia. Copyright (c) 2011 Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Voltaren (Diclofenac)

Pharmacokinetics, Bioavailability and Safety of PENNSAID� Gel [Completed]
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium [Completed]
This research study is being conducted to characterize the pharmacokinetic properties of a new topical medication (MFC51123) that contains two active ingredients (diclofenac and menthol) in two formulation packages. One formulation package is in the form of a gel in aluminum tube and the other one in the form of a gel in roll-on applicator bottle. Additionally, as a comparison, the pharmacokinetic properties of a marketed diclofenac gel and an oral diclofenac treatment will also be characterized. This topical diclofenac/menthol gel has being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains. The rationale for conducting the study is to prove that repeated topical treatment of the new diclofenac + menthol formulation in either of the two packages does not result in unsafe systemic exposure.

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain [Completed]
To demonstrate the therapeutic efficacy of a generic diclofenac epolamine patch against Flector patch in the treatment of pain in subjects with minor ankle sprain

Topical Diclofenac on Macular Thickness After Phacoemulsification [Active, not recruiting]
Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90. The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain [Recruiting]
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.

more trials >>

Reports of Suspected Voltaren (Diclofenac) Side Effects

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)more >>


Based on a total of 13 ratings/reviews, Voltaren has an overall score of 6.85. The effectiveness score is 8 and the side effect score is 7.85. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Voltaren review by 55 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   bursitis and tennis elbow
Dosage & duration:   100mg taken one daily for the period of 30 days
Other conditions:   rosacea on face
Other drugs taken:   none
Reported Results
Benefits:   I experienced almost immediate relief of both bursitis in my left thigh and tennis elbow in my right aarm. I also had a strained muscle in lower back area which I also experienced relief from. The bursitis had been bothering me for quite some time (8mths)and mainly at nighttime when I was lying down in bed. I found it difficult to get comfortable and often used a hot water bottle to soothe it.
Side effects:   Just after taking the pill (with food) I felt a bit dopey in the head which lasted for up to an hour, and sometimes a slight nausea (but not often).
Comments:   Take with a large glass of water (i must say I did not notice this instruction until now). Take 1 tablet daily (with food) when required to relieve pain and inflammation. Swallow whole. Do not crush or chew.


Voltaren review by 61 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   osteoarthritis
Dosage & duration:   50mg taken 2x each day for the period of 6 years
Other conditions:   none
Other drugs taken:   hormone replacement
Reported Results
Benefits:   Severe debilitating pain associated with inflammation and joint pain through out the body is alleviated, enabling more normal living. eg being able to do all housework tasks, gardening, running around and picking up grandchildren, enjoying social life plus taking part in daily fitness activities.
Side effects:   occaional stomach pains
Comments:   Always only take the medication with meals so as to minimize the likelihood of the stomach being affected.


Voltaren review by 52 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   Reactive Arthritis (leg joint swelling/stiffness)
Dosage & duration:   4x 50mg tablets taken 2 morning & 2 evening for the period of Approx 5 weeks
Other conditions:   Recent BCG wash after Polyps removed in baldder
Other drugs taken:   Sulfasalazine
Reported Results
Benefits:   Slight decrease in stiffness, and better degree of mobility of legs joints (ankles, knees and hips)
Side effects:   Small bowel perforation and lesion(wall thickened)
Comments:   Approx. 5 weeks into course of VOLTAREN at dosage of 4/day, felt pain in right side which increased to severe pain within 1/2 hour. Admitted as Emergency into hospital(Australia). CT scan showed air in abdomen. Open surgery: small bowel resection - for lesion(wall thickened) plus perforation.

See all Voltaren reviews / ratings >>

Page last updated: 2014-11-30

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