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Diclofenac (Diclofenac Potassium) - Summary


Cardiovascular Risk

  • •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).
  • •Diclofenac sodium extended-release tablets, USP are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
  •   Gastrointestinal Risk
  • •NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, 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).


Diclofenac sodium extended-release tablets, USP are a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of diclofenac sodium extended-release, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Diclofenac sodium extended-release tablets are indicated:

  • •For relief of the signs and symptoms of osteoarthritis
  • •For relief of the signs and symptoms of rheumatoid arthritis

See all Diclofenac indications & dosage >>


Published Studies Related to 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 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 Diclofenac Side Effects

Renal Failure Acute (27)Vomiting (25)Nausea (22)Multi-Organ Failure (18)Abdominal Pain (14)Blood Bilirubin Increased (12)Somnolence (12)Abdominal Pain Upper (12)Melaena (12)Anaemia (12)more >>


Based on a total of 10 ratings/reviews, Diclofenac has an overall score of 7.20. The effectiveness score is 8 and the side effect score is 8.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Diclofenac review by care giver of 43 year old male patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   muscular pain - arm
Dosage & duration:   75 mg taken one tablet twice daily for the period of 30 days
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   Patient complained of muscular pain in arm, thought to be broken. Visit to physician proved otherwise. Arm imobilised and patent put on diclofenac. Thus far,no further complaint of pain, over past month increased mobility, and muscular strength.
Side effects:   Only side effect is slight drowsiness. Excepting this no other side effect has been displayed.
Comments:   Patient takes treatment one tablet bu mouth twice daily. Instructed to take with food. Warned to not take prescribes drugs containing aspirin, ibuprofent or naproxen without physicians cosent.


Diclofenac review by 48 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   illiotibital tibital syndrom
Dosage & duration:   50 mg taken twice per day for the period of 2 months
Other conditions:   attention deficiet disorder
Other drugs taken:   adderall
Reported Results
Benefits:   I had swelling and pain in my knee from itbs and in my ankle from tendenitis and it took down the swelling
Side effects:   I had gas after about 6 hours of taking it
Comments:   one tablet twice per day with food took one month to see if worked then another to continue and then as needed. marathon runner and needed it for repeat injury


Diclofenac review by 41 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   Knee pain/inflamation
Dosage & duration:   75 mg taken twice daily for the period of 8 days
Other conditions:   n/a
Other drugs taken:   n/a
Reported Results
Benefits:   Seemed to reduce some every-day pain and inflamation, although I still experienced increased pain and inflamation after physical therapy or increased activity.
Side effects:   I became very depressed. It began as crankiness and then crying and then not wanting to leave my room or continue my PT.
Comments:   After realizing that I was more than just a little upset about my condition, I began to ask questions about the depression. My pharmacist and I decided I should discontinue and contact my doctor.

See all Diclofenac reviews / ratings >>

Page last updated: 2014-11-30

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