The People's Perspective on Medicine

How Safe Are Topical NSAIDs Like Voltaren Gel?

If you read the FDA's warning on topical NSAIDs like Voltaren Gel you will be very scared. 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.

That was long before we learned that oral NSAIDs like celecoxib (Celebrex), diclofenac (Cataflam, Voltaren) naproxen (Naprosyn) and meloxicam (Mobic) could also cause heart attacks and strokes. In addition, there are now 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.

Are Topical NSAIDs Safer?

Many other countries permit the sale of topical NSAIDs like Voltaren Gel over the counter. 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. A review of 61 studies of topical NSAID pain relievers like Voltaren Gel concluded that these products provide “good levels of pain relief in acute conditions such as sprains, strains and overuse injuries, probably similar to that provided by oral NSAIDs” (Cochrane Database of Systematic Reviews, June 15, 2015).

This analysis 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 Voltaren Gel use.

NSAID Side Effects:

For reasons that puzzle us, the FDA has seemed behind the rest of the world when it comes to topical NSAIDs. It took a long time for the agency to allow topical NSAIDs to be sold by 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. The FDA does not require oral NSAIDs sold OTC to carry 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:

There is a black box warning for Voltaren Gel that is similar to the warning with oral diclofenac:

“Non steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular 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.”

FDA vs the Cochrane Collaboration:

We tend to trust the independent Cochrane analysis more than the FDA’s standard NSAID labeling. That’s because the Cochrane authors constantly review the latest research and include it in their assessment. The FDA often moves slowly to update its labeling. Here is the June 11, 2015 Cochrane conclusion about topical NSAIds for acute musculoskeletal pain in adults:

“Topical NSAIDs 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.”

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.”

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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I was prescribed Voltaren gel for arthritis in my feet. Didn’t expect much, but got pain relief within minutes. Unfortunately, my co-pay was $42.00, which kind of pissed me off. I researched Voltaren, and saw it was available over the counter in Canada, so I had a friend get me several tubes at a time. I’ve been on SSD for a decade, but Voltaren has allowed me to work part-time. It works so well, for me anyway, that there’s no reason for it not to be OTC, except that pharmaceutical companies like the money.

Started using Voltaren Gel nine months ago. Fantastic for pain relief. However, just recovered from aortic valve transplant then went into sustained ventricular tachycardia with a zombie pulse! Suffer with back injuries, arthritis, and fibromyalgia. Have to have some relief. But will be try not to use as often as I use to. Basically can’t do much of anything anymore. I am a 67 year old female

I have been using voltaren for a year now with no adverse affects. As I can’t buy it otc in the us and am almost out, I was wondering if I can use the ibuprofen gels and rub them over my back with the same affect as voltaren. I could mix with a cream if a capsule is too strong. Anyone try this.?

Recently I injured my shoulder. Due my occupation I have to be in shape and be able to do some physical tests.

To recover faster from the injury, I started taking Ibuprofen or Alive together with Voltaren gel.

So in a few days I noticed that sometimes I have inexplicable chest pain and difficulties with breathing. It never lasts more that a minute or two, but worries me a lot.
Maybe it happens because of the combination of pills and gel, but it was my doctor’s recommendation in a first place.

I have been doing the same thing for a year in order to play golf with no adverse reaction. I Take an Aleve and rub voltaren on my lower back.

I am really happy this information has been published to draw double attention to the leaflet information. I received Voltaren pills at hospital after my Cesarean (alongside other painkillers). All worked fine and I felt no side-effects at that time. Then I had some Voltaren pills at home preserved from that period (they were before the expiry date) and I decided to use them for a headache.

I can’t remember if it worked for a headache, but I remember well that I developed a slight chest pain. I got scared, I scrutinised the leaflet and found the warning. I was really shocked… especially cause they gave it to me at hospital. I was fine, thank God, but I will never get near that drug again:) And jokes apart, I think it must be dangerous to elderly or sick people, I am young and generally healthy, and it still affected me just after one pill… ok, maybe I am in the risk group, but how would you know then?

I learned a year ago that I’ve started to get osteoarthritis in my right knee from a compound fracture of my right femur that happened in an auto accident when I was a teenager. (I used to jog & play Bball but had to quit.) Since I was limping in pain for four months, I started to use Voltaren gel on my knee and the pain was lessened. I liked the stuff at first until I read Medical reports which said that nsaids speeded up cartilage breakdown in the knees and other joints. So now that my knee pain is lessened (I am no longer limping, usually), I only use the gel twice a week, before I do leg presses (I’ve learned the hard way that leg extensions & leg curls are bad for the knees).
So now I wonder, is this OK & helpful, or will even this infrequent use hurt my knee? I just don’t know.

I was prescribed Voltaren Gel for treatment of persistent groin pain related to a running injury. While it did offer some relief, it was no better than taking aspirin. However, I had serious gastrointestinal discomfort; gas, heartburn, painful swallowing. These side effects would clear up within a day or two after discontinuing use of the product. Again, effectiveness no better than extra strength aspirin, with more serious gastrointestinal side effects.

My Mom, a type 2 diabetic, tried Voltaren gel on the advice of her neurologist, after getting the shingles virus on one of her legs and feet. Nothing else helped her pain. Today she uses it on those very bad days and she’s very pleased with it. I think with anything, too much of a good thing can be bad especially when it’s medicinal and if you choose to use this gel, you should use it only when nothing else will do the trick and as a last resort for pain relief.

My mother had been using voltaren for a few years. She passed away due to upper gastrointestinal bleeding. I would be very careful using this drug.

I just started using Voltaren. I’m three doses into it. I just hope it’s as safe as some have said including my PCP. I have terrible neck pain on both sides. Fingers are crossed, and I hope there is some relief coming my way.

A few years back, I started getting pain in my hips from riding a Trikke for extended periods. Tried typical physical therapy that didn’t do much. The doc recommended trying Voltaren gel and the problem was gone in a couple days! I highly recommend it.

I am allergic to aspirin and Aleve along with several other anti inflammatory drugs. I have intractable pain and have used Volteran gel for about 12 yrs since my pain specialist gave me a sample. I buy the from Volteran max when traveling out of the country. I use it on my cervical spine lumbar shoulders and neck and down my arms. I wouldn’t be without it for break thru pain it works great I’ve never had side effects.

Hi . Last spring I had a terrible pain in lower back and left buttock. Could barely move, so I used the Voltaren gel maybe too liberaly. It had been given to me so I did not realize that it was a script.

Next day, going out to my car was short of breath and have been so since. Only used it once or twice. V Hunt. Doctor did not really know what to do. Now I use inhalers.

I find I can get by fairly well by using Voltarol gel on my neck and back.
I am alarmed by today’s news that diclophenic can increase risk of heart attacks by 19% but I am hoping that the gel will be safer!
I have rheumatoid arthritis and fibromyalgia and have to use some pain relief of some sort- thought paracetamol exacerbated headaches.

Another use for diclofenac gel is to treat actinic keritosis (scaly skin lesions). It is marketed as Solaraze, but is identical to Voltaren. Very different purposes!

A few years ago, my doctor gave me a sample of Voltaren gel for knee pain. It worked well, no side effects. Then he gave me a prescription, which I had filled (3 tubes). After using the prescription version a few days, I got bad stomach and abdominal cramps. Were the sample and prescription versions different?

Of course, I discontinued use and had to trash the tubes. I have found that BioFreeze affects me the same way. Don’t know if they have like ingredients or not.

Just a reminder to those not aware, ibuprofen can cause hearing loss in some people, if used too long. My loss is in both ears and there is no other explanation for it, no family history etc. Please be careful!

A meta-analysis in 2015 found varied results with respect to ibuprofen and hearing loss:

My husband and I have been using Voltaren for years. I am bone on bone on both knees and feel that without Voltaren, I would not be able to walk. I put a small amount on my knees in the morning and then get on with life. My husband has some serious back issues so he puts Voltaren on at night. At 84 he is able to function quite well, including gardening, mowing the lawn, etc.

Voltaren is OTC in Canada so we cross the border several times a year to replenish our supply. No problem bringing it back into the US. No adverse reactions.

I experienced heartburn after using ibuprofen gel on my knee for four days.

I quit nsaids several years as my doctor advised because of early stage kidney disease. After a bad knee injury a specialist put me on voltarin gel for 9 months. Now I am in stage 4 kidney disease. I had been stable for several years before the daily use of voltarin gel.

Do you think the Volrarin gel cased the kidney issues?

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