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How Safe Are Topical NSAIDs Like Voltaren Gel?

FDA's warning on doctor-prescribed topical NSAIDs like Voltaren Gel is scary. Are gels as dangerous as oral NSAIDs like ibuprofen or naproxen?

When the FDA allowed drug companies to sell NSAIDs over the counter we were concerned. That’s because drugs like ibuprofen (Advil, Motrin IB, etc) and naproxen (Aleve) came with some pretty serious side effects including stomach irritation and bleeding ulcers. Given that tens of millions of Americans use such drugs every day, the potential problem worried us. When the FDA gave the green light to topical NSAIDs like Voltaren Gel (diclofenac), we thought it was probably a good idea. It seemed to suggest that people could get localized relief for arthritic fingers, knees, shoulders and hips without as many systemic side effects. Were we wrong?

Oral NSAIDS Come With Other Worrisome Side effects:

Americans are in a lot of pain! Medscape provides physicians and other healthcare professionals up-to-date medical news and information. It offered this overview of “Nonsteroidal Anti-inflammatory Drutg (NSAID) Toxicity” on Sept. 15, 2023:

“More than 70 million prescriptions for NSAIDs are written each year in the United States. With over-the-counter use included, more than 30 billion doses of NSAIDs are consumed annually in the United States alone.”

According to my calculations, that represents 90 NSAID pills for every person in the United States, including infants and some older people who should never take an NSAID. Clearly a lot of people are taking NSAIDs every single day.

We now know that oral NSAIDs like celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) ibuprofen (Motrin), indomethacin (Indocin), naproxen (Naprosyn), meloxicam (Mobic) and piroxicam (Feldene) can cause heart attacks and strokes. In addition, there are data to suggest that when you swallow NSAIDs you increase your risk of developing hypertension, irregular heart rhythms (atrial fibrillation or A-fib), dizziness, blood clots, fluid retention, heart failure, ringing in the ears, liver or kidney damage.

If someone suffers a heart attack or stroke and then dies after taking an NSAID, it is extremely unlikely that the medical examiner will attribute the cardiovascular “accident” to the medication. Most health professionals will chalk up the demise, whether in a fit middle-aged person or a vulnerable senior citizen, to underlying vascular disease or just bad luck. An NSAID will rarely be considered as a contributing factor.

Are Topical NSAIDs Like Voltaren Gel Safer?

Many other countries permitted the sale of topical NSAIDs like Voltaren Gel over the counter long before the FDA gave this formulation a green light. This reader would like to know if such products are safer than oral medicines:

Q. Please clarify whether Voltaren Gel used topically on my knee or spine carries the same risk as NSAID pills. I use a fingertip-size portion on a knee and a fingernail-size portion on one irritated vertebra as needed.

A rheumatologist prescribed it. Neither he nor my other doctor seems to know about NSAID risks with Voltaren Gel.

A. The Cochrane Database of Systematic Reviews is a collaborative effort by international experts to analyze the benefits and risks of many medications and medical procedures. On June 15, 2015 it reviewed 61 studies of topical NSAIDs like Voltaren Gel and concluded that these products provided:

“…good levels of pain relief in acute conditions such as sprains, strains and overuse injuries, probably similar to that provided by oral NSAIDs. Gel formulations of diclofenac (as Emugel®), ibuprofen, and ketoprofen, and some diclofenac patches, provided the best effects. Adverse events were usually minimal.”

Short-Term Use of Topical NSAIDs like Voltaren Gel:

That review was for “acute musculoskeletal pain.” In other words, for relatively short-term pain and inflammation. It was reassuring to learn that using NSAIDs like Voltaren Gel for a few days to treat a sprain or strain did not appear to cause a lot of serious side effects.

Long-Term Use of Topical NSAIDs:

Less than a year later some of the same authors published a new review of “Topical NSAIDs for Chronic Musculoskeletal Pain” (Cochrane Database of Systematic Reviews, April 22, 2016). Here was their “Bottom Line“:

“Topical diclofenac and topical ketoprofen can provide good levels of pain relief in osteoarthritis, but only for about 10% more people than get this result with topical placebo. There is no evidence for other chronic painful conditions.”

That was hardly a ringing endorsement! A 10% improvement over placebo is not very impressive in my opinion.

What about “systemic” side effects?

The authors reported that:

“Events were wide ranging, including headache, diarrhoea, drowsiness, and dyspepsia [heartburn], and were usually described as mild. In most studies the incidence was below or around 10%…”

That being said, the authors went on to state:

“We judged the quality of this evidence for systemic adverse events as very low…”

In other words, the researchers did not do a very good job collecting and recording NSAID side effects. Perhaps even more alarming, the authors “judged the quality of this evidence for serious adverse events as very low.” Despite questions about the quality of the evidence, the Cochrane reviewers concluded:

“Adverse events are minimal with topical nonsteroidal anti‐inflammatory drugs (NSAIDs).”

In another analysis published in May, 2017, the Cochrane reviewers again reported “very low-quality evidence,” but added that “Serious adverse events were rare.”

These analyses found very few systemic adverse events like digestive tract irritation or cardiovascular complications. Nevertheless, some people are extremely susceptible to NSAID side effects. A few readers have reported stomach pain or abdominal cramps associated with Topical NSAIDs like Voltaren Gel. Others have experienced more serious side effects, like this reader:

Blood Pressure Elevation with Voltaren Gel:

Q. My experience with Voltaren Gel was not good. At the time, my blood pressure was normally around 120/65. I take it most mornings now that I’m older and have some health issues.

Within a day or two of starting Voltaren, my blood pressure was about 155. I was a little concerned, so I took my blood pressure during the day, and it kept rising. When it reached 180, I went to the emergency room. It registered 190 at that time. I don’t know what the lower numbers were.

At the ER, they put me in a bed and after several hours my blood pressure began to come down. They released me when it came down to 145. Later I read that Voltaren can cause high blood pressure, so I never used it again.

A. One of the mysteries that we cannot answer is why some people react badly to topical diclofenac (Voltaren Gel) while others get pain relief with no complications. The official prescribing information for Voltaren Gel states that:

“Hypertension can occur with NSAID treatment. Blood pressure should be monitored closely during treatment with Voltaren® Gel.”

This suggests that some people absorb enough of this non-steroidal anti-inflammatory drug (NSAID) through the skin to experience a systemic side effect as you did. Others have complained of digestive tract upset. The prescribing information warns that NSAIDs, including Voltaren Gel, can cause bleeding, ulceration and perforation of the stomach or intestines.

To learn more about managing joint pain without NSAIDs, you may want to read our eGuide to Alternatives for Arthritis. This online resource may be found under the Health eGuides tab. Prefer a printed book to an eGuide? Here is a link to our 104-page handy printed booklet.

NSAID Side Effects:

It took a long time for the FDA to allow topical NSAIDs to be sold without a prescription. Whether this was because the drug companies were slow to apply for approval or because the FDA was not enthusiastic about topical NSAIDs remains unclear. We have always been puzzled why the FDA allows oral NSAIDs sold OTC to avoid a lot of scary warnings about side effect such as:

Oral NSAID Side Effects:

• Heartburn, indigestion, abdominal pain, nausea, vomiting, constipation, diarrhea
• Headache, dizziness, drowsiness, disorientation
• 
Skin rash, sensitivity to sunlight, itching (potentially serious, so notify the MD!)
• Fluid retention, edema, high blood pressure
• Heart failure, heart attack, stroke
• 
Ringing in ears, hearing changes
• Visual disturbances
• Ulcers, bleeding ulcers, perforated ulcers
• Liver damage, kidney damage
• Blood disorders, anemia
• Worsening asthma symptoms
• NEW: Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)

Warnings on Topical Voltaren Gel:

The FDA required a black box warning for doctor-prescribed Voltaren Gel that is similar to the warning with oral diclofenac:

“Non steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction [heart attack] and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

“NSAIDs can cause an increased risk of serious gastrointestinal (GI) 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.”

Reader Comments:

Whitley in North Carolina:

“I started applying Voltaren Gel in 2007. I use it on my knees when I have an active period ahead. I get 5-6 hours of excellent pain relief from Voltaren Gel. Two doctors have told me that some NSAID will reach your blood but not in large enough amounts to worry about.

“I recently injured a rotator cuff and Voltaren Gel works very well on the shoulder. After 9 years I’ve had zero negative reactions.

“As to reading side effects on bottle – lawyers have made those lists so long my eyes glaze over. I read the main problems to look out for. Voltaren Gel works for me.”

E.B.M. also had good results:

“I have been buying Voltaren Gel in Germany and Mexico (Cozumel) and St. Maarten while traveling. It costs usually $10-15 overseas for a large tube and it has worked great for me and my friend who has rheumatoid arthritis and sometimes muscle spasms.

“I don’t use a lot since it is very easily spread (a thin gel) and my blood pressure is normal. I would not be without it.”

Ann in Ottawa offers a word of caution:

“I have had chronic pain for years and have been on a lot of different meds (both prescription and over the counter). They didn’t bother my stomach. I started using Voltaren Gel and now I am having a burning and gnawing pain in my stomach under my breast bone.”

Marilyn reacted to the topical gel; something that others also report:

“My doctor prescribed Voltaren Gel since pain meds upset my stomach. It didn’t upset my stomach, but on the fourth day of applying it, I broke out in a rash all over my arms and legs. I had to stop using it.”

If you would like to read more about how other people have responded to topical NSAIDs like Voltaren Gel, here is a link to another article:

“Serious Side Effects of Voltaren Gel Are Scary?”

Other Options for Pain Relief:

We discuss topical NSAIDs and a variety of other treatments for painful, inflamed joints in our Guide to Alternatives for Arthritis. Many nondrug options carry fewer side effects than NSAIDs.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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