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Voltaren Gel

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Voltaren® Gel
(diclofenac sodium) Topical Gel

For topical use only

WARNING

CARDIOVASCULAR AND GASTROINTESTINAL RISK

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 (diclofenac sodium 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].

DRUG DESCRIPTION

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. The chemical name is 2-[ (2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2. It has the following structural formula:

Voltaren® Gel (diclofenac sodium) Structural Formula Illustration

Voltaren® Gel (diclofenac sodium gel) also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.

What are the possible side effects of diclofenac topical (Flector Patch, Solaraze, Voltaren Topical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness,...

Read All Potential Side Effects and See Pictures of Voltaren Gel »

What are the precautions when taking diclofenac sodium gel (Voltaren Gel)?

Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist...

Read All Potential Precautions of Voltaren Gel »

Last reviewed on RxList: 10/15/2009
This monograph has been modified to include the generic and brand name in many instances.

Voltaren Gel - User Reviews

Voltaren Gel User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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