Voltaren Gel - 10 Things You Should Know

Understanding How to Safely Use Voltaren Gel

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Voltaren Gel (diclofenac) was the first prescription topical treatment for osteoarthritis approved by the FDA. Voltaren Gel, a nonsteroidal anti-inflammatory medication in topical form, is mostly used on knees and hands. Here are 10 important facts you should know about Voltaren Gel regarding safe use and effectiveness.

1 - Voltaren Gel may effectively relieve pain and it has a favorable safety profile.

The systemic absorption of Voltaren Gel, which is one percent diclofenac sodium in topical gel formulation, is 94 percent less than oral diclofenac.

Consequently, the risk of serious gastrointestinal and cardiovascular side effects associated with oral NSAIDs is considerably less with the topical formulation.

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

The FDA approval was based on several studies, including two randomized, double-blind, placebo-controlled efficacy studies and a 12-month safety study.

3 - Voltaren Gel significantly reduced pain levels.

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

4 - Adverse reactions can occur with Voltaren Gel.

The most common adverse reactions reported in clinical trials were application site reactions in seven percent of study participants treated with Voltaren Gel.

The prescribing information for Voltaren Gel provides warnings and precautions for serious adverse reactions as well. Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. The elderly, people with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors, should be cautious when using Voltaren Gel.

Hypertension can occur with NSAID treatment making it important to monitor blood pressure. Fluid retention and edema may also occur. If an anaphylactoid reaction occurs, use should be discontinued immediately. NSAIDs can cause serious skin adverse events, too, including exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis which can be fatal.

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

As with all NSAIDs, there may be an increased risk of serious or possibly fatal cardiovascular events, heart attack, or stroke with the use of Voltaren Gel. Despite the fact that the risk is less than with oral NSAIDS, you should be aware of the risk.

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 which may include bleeding, ulcers, and perforation of the stomach and intestines. These adverse events could possibly be fatal. Again, despite the fact that the risk is less than with oral NSAIDS, there still is a risk.

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

Voltaren Gel should not be used by people with known hypersensitivity to diclofenac.

It also should not be used by people who developed asthma, urticaria, or allergic reactions after taking aspirin or NSAIDs. Voltaren Gel should also not be used to treat perioperative pain by people who had coronary artery bypass surgery.

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. Just as topical NSAID cream should not be used with oral NSAIDs, two different oral NSAIDs should not be taken together.

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

If you are using cosmetics or sunscreen, do not use Voltaren Gel at the same time. The combinations have not been tested and, if topical agents are combined, there is the potential to change how Voltaren Gel is tolerated and absorbed.

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

After you have just learned how Voltaren Gel should not be used and who should not use it, you may be wondering who should use it. People who have experienced gastrointestinal side effects from oral NSAIDs are clearly the ones who will benefit most from Voltaren Gel. If you think that you may be a candidate for Voltaren Gel, discuss it with your doctor to determine if it is appropriate for you.

Label Revised in 2009

In 2009, the FDA updated the label for Voltaren Gel to include information about possible hepatic effects. It now reads, "In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulfillment hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation. Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms."

A Word From Verywell

The more treatment options there are for people with arthritis, the better. The availability of a topical formulation of Voltaren is important for people who cannot tolerate oral NSAIDs for one reason or another. Be aware that both oral and topical NSAIDs carry the same risks.

Never use more than the prescribed amount. The total dose of Voltaren Gel should not exceed 32 grams per day, over all affected joints. Voltaren Gel should be measured onto the dosing card which is enclosed—measure to the appropriate 2 gram or 4 gram mark. For lower extremities: Apply the gel (4 grams) to the affected area 4 times daily. Do not apply more than 16 grams daily to any one affected joint of the lower extremities. For upper extremities: Apply the gel (2 grams) to the affected area 4 times daily. Do not apply more than 8 gram daily to any one affected joint of the upper extremities. 


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

Voltaren Gel. Prescribing Information. FDA. Revised July 2009.

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