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Voltaren Gel - What You Need to Know

Information for the Safe Use of Voltaren Gel


Updated May 16, 2014

Man wearing knee brace, cropped
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Voltaren Gel is the first prescription topical treatment for osteoarthritis that has been approved by the Food and Drug Administration. Voltaren Gel, a nonsteroidal anti-inflammatory medication in topical form, will mostly be used on knees and hands. Here are 10 important facts for the safe use of Voltaren Gel.

1 - Voltaren Gel delivers effective pain relief and has a favorable safety profile.

The systemic absorption of Voltaren Gel (1% diclofenac sodium in topical gel formulation) is 94% less than oral diclofenac (generic for Voltaren).

2 - The effectiveness and safety of Voltaren Gel was studied in more than 900 patients with knee or hand osteoarthritis.

The FDA approval was based on several studies, including two randomized, double-blind, placebo-controlled efficacy (such as to test effectiveness) studies and a 12-month safety study.

3 - Voltaren Gel significantly reduced pain levels.

After 6 weeks of treatment in an efficacy study of patients with hand osteoarthritis, pain levels were reduced by 46%. In a 12-week study of patients with knee osteoarthritis, Voltaren Gel reduced pain levels by 51%.

4 - Adverse reactions can occur with Voltaren Gel.

The most common adverse reactions reported in Voltaren Gel clinical trials were application site reactions in 7% of patients treated with the gel.

5 - Since Voltaren Gel is an NSAID, it carries the same risks.

As with all NSAIDs, there may be increased risk of serious or possibly fatal cardiovascular events, heart attack, or stroke with use of Voltaren Gel.

6 - The usual gastrointestinal side effects associated with NSAIDs also apply to Voltaren Gel.

NSAID use can cause an increased risk of serious gastrointestinal events including bleeding, ulcers, and perforation of the stomach and intestines, which may be fatal. Because there is decreased absorption of Voltaren Gel, it is presumed the risk of gastrointestinal side effects are lower than for oral NSAIDs, even though the side effects are still possible.

7 - Certain patients with known medical problems should not use Voltaren Gel.

Voltaren Gel should not be used by patients with known hypersensitivity to diclofenac. It also should not be used by patients who developed asthma, urticaria, or allergic reactions after taking aspirin or NSAIDs. Voltaren Gel should also not be used by patients who had coronary artery bypass surgery in order to treat peri-operative pain.

8 - You should avoid using Voltaren Gel along with other NSAIDs.

Voltaren Gel should not be used together with oral NSAIDs or aspirin because of an increased risk of adverse events. The risk of side effects increases with the increased absorption of the active ingredients in NSAIDs.

9 - Voltaren Gel should also not be used in combination with other topical agents.

If you are using cosmetics or sunscreen, don't use Voltaren Gel too. The combinations have not been tested and there is potential to change how Voltaren Gel is tolerated and absorbed.

10 - Voltaren Gel will mostly benefit patients who cannot take oral NSAIDs.

After reading all about who shouldn't use Voltaren Gel, you might be wondering who should use it. Patients who suffer gastrointestinal side effects from oral NSAIDs are clearly the ones who will benefit most from this topical product. Discuss it with your doctor and see if it's for you.

Learn more about Oral Voltaren (diclofenac) - What You Need to Know.

UPDATE (2009) - Warnings Added to Voltaren Gel


Voltaren Gel Receives US Regulatory Approval. Novartis. October 22, 2007.

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