Voltaren Gel Side Effects May Result in Liver Problems: FDA
Published: December 8th, 2009
The FDA has announced that it is requiring new warnings about potential side effects of Voltaren gel, an arthritis topical treatment that may cause liver damage.
On December 4, the FDA, Novartis Consumer Health and Endo Pharmaceuticals sent a letter to healthcare professionals alerting them to postmarketing reports that found that Voltaren gel has been linked to cases of drug-induced hepatoxicity that have resulted in liver damage, the need for liver transplants and death. It was unclear how many reports the FDA and manufacturers have received of Voltaren gel liver damage.
Voltaren gel (diclofenac sodium topical gel) is approved by FDA for the treatment of osteoarthritis pain in joints suitable for topical treatment, such as the hands and knees. It is a prescription non-steriodal anti-inflammatory drug (NSAID).
Also known as Solaraze, Voltaren Topical and used in the Flector Patch, Voltaren gel is also sometimes used to treat migraines, gout, and menstrual pain.
The new warning label changes indicate that the gel, and all products containing diclofenac sodium, have resulted severe hepatic reactions, including liver necrosis, jaundice, and liver failure. Symptoms began to appear in some cases within the first month of therapy.
The FDA and the manufacturers recommend that patients be given the lowest effective dose for the shortest duration possible in order to minimize the risk of liver damage. They also recommend that doctors measure transaminases periodically in patients undergoing long-term therapy with Voltaren gel. Elevated levels of transaminases can be an early indicator of future liver problems brought on by the gel.
Comment by Patricia on 4 March 2010:
My husband, George, is using Voltaren Gel every day and has been for a month or two. He says it’s a wonderful product, that it greatly reduces his pain where it’s applied. I decided to research this product and am concerned by the FDA’s letter stating that Voltaren Gel has been linked to liver damage. I printed this report out and will show it to my husband so he can, in turn, show it to his doctor so that George’s liver can be checked for damage.
Comment by Michelle on 8 March 2010:
There are absolutely ZERO reports to the FDA of liver damage with Voltaren Gel. The label was ONLY updated to bring tha label of ALL diclofenac containing products in line with the ORAL formulation. This drug is only 6% absorbed into the bloodstream relative to the oral. Drug concentration are 158 times lower than with the oral. Misinformation only serves to scare patients and is irresponsible. Check with the FDA to verify. NO reports of liver damage exist, so feel confident in your medication.
Comment by M.H. on 19 March 2010:
Has anyone had Voltaren Gel recommended for use on lower back or neck? I’ve used it the past 4 days there and it seems to help-I got samples from my family doctor, but she didn’t give me any warnings, or say those areas shouldn’t be treated with the gel. However the warnings on the package say that hip/back usage hasn’t been tested-!? Now I’m wondering if the close proximity of the back to the liver is a concern. Also, cardiovascular concerns – what is the cause of that warning with this gel?? I also must say that the relief is short-lived and pain comes back with a vengeance as the Voltaren wears off.
Comment by mhaner on 22 March 2010:
I think it is a wonderful gel. It helps greatly with the pain. I just hope that it will not cause more demage than I have already.
Comment by Michelle on 23 March 2010:
I used the flector patch 1 time and was admitted into the hospital for 3 days. I had major trouble with my heart rate, blood pressure, and liver. I still don’t know if there will be longtime damage to my liver. The doctors that cared for me run every test possible for the trouble I was having, and the only reasoning for it was the patch.
Comment by wanda on 26 March 2010:
I am concerned about this drug because I have a lot of nausea since i have used this drug,also i am prone to have stomach problems and I am concered about this also,i cannot take advail or medications that are like this drug..I fell like th voltaren gel has helped me and I need to know these things or is there another drug i might use that is or works the same as voltaren gel.
Comment by Leonard on 27 April 2010:
I began using the Flector Patch in late Jan., 2010 & had a stroke march 1, The Dr said I had none of the usual markers of a stroke ( weight, cholesterol ect ) & it was below the brain stem. The patch was the only new medicine. Has anyone else had this happen?
Comment by CONNIE on 17 May 2010:
I have been applying the voltaren Gel to the thoracic area of my spine and started to notice a redish burn in that area. Been using the gel now for about a month but the last two times I applied the gel I had severe thoracic burn and pain and thought I was having a heart attack After the first attack, I ended up in the emergency room and found out it was not my heart. The doctors there administered a combination drug of dilaudid and fennidryl (spelling) and the pain stopped in my middle back I was released and went home. This is 1-1/2 days later and I am experiencing another attack just like the first one that ended me in the ER. Called the doctor who ordered the Votlaren Gel and he said it could be a systemic reaction or just an alergic reaction. Still not sure if these symptoms are due to the gel but am in the process of seeking the answers.
Comment by Nora on 14 June 2010:
I was given a sample of Voltaren Gel at an Orthopedic’s office for pain in my foot. The nurse suggested that I try it on my back even though it had not been studied for back pain. It worked well enough on my lower back that I asked my GP for a prescription and she happily granted my request. Since that time, I have also used it on a severe ankle sprain and for tension headaches at the base of my neck with positive results. I have had no side effects.
Comment by Barbara on 16 June 2010:
My husband used voltaren cream for muscle ache in both shoulders. He probably used it for 3-4 months when suddenly he was having a hard time breathing. About 5 days later he had a severe rash on his shoulders where he had been applying the cream. The family doctor prescribed a steroid which got rid of the rash after several days but now almost 3 months later he’s still having problems breathing. A side effect listed was both rash & severe shortness of breath. He hasn’t used the cream for 3 months so I’m wondering if the shortness of breath could still be related. He was a very healthy man with no medical problems before this.
Comment by Mohamed on 24 June 2010:
I have used Voltaren gel yesterday on my neck and back just beside my shoulder, it worked fine and reduced the pain. It was really bad and i couldn’t move or stand up if I was seated. I recommend it to all
Comment by Timothy on 16 August 2010:
I used the patch on my back. I had a car accident in 2005 and have severe back problems. My syadic nerve is compressed by two discs in my back. I used the patch and had an allergic reaction, my heart raced and I had blurry vision! I was very disoriented and took it off quickly. Be very carefull in using this patch, at first sign of something wrong, discontinue the patch!
Comment by Chris on 16 August 2010:
We have to be smarter ‘users’ of these drugs here my friends… Most doctors just throw pills at clients nowadays and people are surprised when they read about serious problems or even deaths due to the use of these drugs. Wake up! Do your homework and read the side effects, then determine if its worth the risk to fix whatever it is you’re suffering with. Weight the pros and cons out, because sadly this is not being done by doctors nowadays. If you hurt your ankle and this was prescribed, chances are you’re going to heal without this(though it may take longer). But think about it.. is a faster recovery worth a potential life threatening reaction?? What are the other routes with less risk of serious problems happening? If we continue to put our entire health on the line and not take part in any decision when it comes to these serious drugs and instead just pop them into our bodies, then we can expect more of these sad stories… please take care of yourselves when using these serious drugs, after all its YOUR health on the line, not the doctors. God bless.
Comment by fran on 3 September 2010:
Every time I use the flector patch, me heart races and I feel extremely tired, when I don’t use it, I have mega foot pain. Which was do I go?
Comment by MaryLee on 13 September 2010:
I have been useing Voltaren Gel on my knees for over a year. I would not be able to walk or sleep without it. Mainly use it at night when I go to bed. It does take away the pain. I have regular blood work and follow ups done with my doctor. My liver is fine and have never had any side effects. Will not stop useing it.
Comment by Jerry on 16 September 2010:
I use ketoprofen gel which is available in Europe (France : Ketum gel / Belgium : Fastum gel) I use it for knee osteoarthritis. It is the only topical NSAI which is not absorbed in the blood and it gives high tissue concentrations in knee joint.
Comment by Diana on 23 September 2010:
So Jerry does Ketoprofen gel work for you?? I have just started Voltaren gel and today it works to ‘Kill” the pain. But tomorrow will tell another story ….And the day after…
I can’t tolerate anything by mouth so anything topical is of interest to me.
Please share your topical( skin) med stories………..
Thanks Diana knee gimp
Comment by Carol on 1 October 2010:
I just start using Voltaren gel as of yesterday on my neck i feel some relieve. Have terrible neck and back pain. I do have a bit of a stiff neck since yesterday not sure if i slept wrong or if it is related to the gel.
Comment by June on 6 October 2010:
I had arthroscopic knee surgery in February for a torn meniscus, which had been extremely painful. The relief was immediate, but about 6-8 weeks later, a lot of the pain returned, to the point that walking was very uncomfortable, and turning over in bed was an ordeal. Another doctor applied a Flector Patch; the relief was immediate. My insurance would not cover the patch, but covered the gel. Using the gel twice daily for a couple of weeks, I was able to resume normal life with only occasional pain,. Now I use the gel rarely, but I’m glad it’s available if I need it. I hate overuse of meds, and I’m happy that I don’t need it often. I have not experienced any side effects. P.S. I’m over 70 years old.
Comment by S.Woelper on 9 November 2010:
I would like to know. I have used Volteren for about 2 months and I would like to know if it has any effect on fingernails, My nalsl were in very good condition, until I started to use the gel, they cracked and split and finally broke off.
Comment by Abner on 28 November 2010:
I have been using this product for several month. Granted not every day. I have no side side effects, but all the benifits. I want to thank my friend for sending me this link.
Comment by rishi on 7 December 2010:
i have been using since y’day pain relieved i would like to know whether there will be any side effects.
Comment by Peg on 25 December 2010:
I have been using the Valteren gel for months on my shoulder & neck. Although, I have used the gel as perscribed but at different times during my shoulder recovery I did stop use because of blisters, rash and also notices sometimes while putting the gel on, it felt like stinging in my shoulder?? I just use the gel until that happens. I think it is helping my shoulder thru. So, I also wonder what exactly is being absorbed thru my skin and into my body. My husband has also used the gel on his knees with no adverse effects but probably because he didn’t follow the perscription dose and for an extended period of time. I am still a little leery of the gel but in my mind I am hoping it is helping me recover a bit.
Comment by ellen on 12 January 2011:
I have severe osteoarthritis in my foot from an old injury. Nothing relieves the pain when it risks in except a lidoderm patch. It is usually used for shingles and with pre authorization, Medicaid covers it. Hope this helps someone.
Comment by Jackie on 4 February 2011:
I started with Arthotec pill for 1 1/2 weeks for heal pain, couldn’t tolerate the GI side effects, so was switched to a flector patch, which was difficult to use on the heal, then went to Voltaren gel for about a month,lower dose then suggested in the literature included, only 2gms three time day, and then I started urinating blood, with some right sided back pain, I will be evaluted for kidney damage or poss. liver damage, I had no previous medical issues exc. high chol. These both are listed as serious side effects. Wish me luck for no long term damage.
Comment by patricia on 20 February 2011:
i developed a very bad urinary tract infection. is it from the voltaren gel? i am diabetic and have 3 stents in my heart. neuropathy of the feet and legs and a bypass in my right leg and 3 stents in my rt lower leg.
Comment by Vanessa on 2 March 2011:
Voltaren Gel 1% samples were given to my husband from his physician for his severe back pain, it did not at all help him so he gave me the samples. I have Peripheral Neuropathy, lived with pain daily and have a burning sensation daily with pain on the bottom of my feet. I applied the Voltaren Gel to my feet and wow, this is the first time in my life that anything worked. I can walk better and I am now finally without that burning sensation. This is a great gel and I highly recommend this to anyone with the same problems as I.
Comment by nottheed on 18 March 2011:
my husband was givin a free sample of Veltaeen sample from his doctor for shoulder pain on a Friday and was dead by the next Wenesday.
Please don’t tuse this medicatios harmful !*****
a
Comment by Michael on 20 April 2011:
I started using Diclofenac 5% cream on my knee about a year ago. Diclofenac is the active ingredient in Voltaren. About 4 months ago,
I started using the same Diclofenac cream on both shoulders and
my neck, for arthritic pain and tendinitis. I have received much relief
from the pain of the inflammation, and have noticed no side effects
at all. We are not all made from the same mold and what may be a
God send remedy for some of us, might be harmful for others. I would
suggest that everyone use medications with the strict guidance
from their doctors only.
Comment by John on 22 June 2011:
Voltaren Gel was perscribed to my wife for joint inflamation (hip, knees, etc.) She found that it relieved her pain and soreness. To date she has had no side effects.
Since it worked well on her, I decided to try the gel on my own sore knees and leg muscles, in addition to applying it to my hand and wrist. After two days of use, I have had what I believe to be a significant side effect with the use of the gel. I have lost my sense of taste completely. This is continuing as I write this(two + weeks). In addition, the night after I had used the gel the most, in the most areas on my body, I awoke from a sound sleep with a tremendous,crushing pain in my chest, left side and back. At first, I thought that I was experiencing a heart attack the pain was so intense and constant. However, after 10 to 15 minutes the pain subsided and completely left. In the morning I had no pain from what awoke me the night before, however I could not taste anything, as noted above. This may be co-incidental, however, I will not use this medication again until a physician or medical tests indicate that this medication was the cause for what I have and am experiencing now.
Comment by gwen on 4 August 2011:
I have used Voltaren Gel about two years and didn’t know of any side effects but I read about a rash and I have had some skin rash problems. I went to a dermatologist and they said it was dermatitis. I have used it on my neck to my toes, most times it is hands, back, shoulders though.
Everyone is different and should be careful of any medicine. I have had great pain releif with the Voltaren Gel and recommended it to about 4 friends who talked to their doctor. All are using it with no side effects but I use more of it than anyone. I use up to 5 tubes a month (as prescribed by my rheumatologist).
Comment by joe on 10 August 2011:
my wife had an abdominal mesh surgery for multiple hernias (first repaired 6 months earlier during a colon resection but those hernia repairs failed and burst…) and when she developed internal hematomas(described by the surgeon and staff as blood clots) she was handed off to a pain clinic which prescribed Flector patches over the two blood clots. It was opined that the pain from the clots would be addressed as well as to assist in disolving the clots and reabsorbing the drainagethat had solidified. after following the instructions (12 hours, change patch and apply fresh one another 12 hours ((24/7)) ) of the pain M.D. after 14 days religiously following directions she had developed a huge blister over one of the clots. My wife had discontinued the patches on her own and when she next visited the pain clinic the M.D.’s LPN prescribed voltaren with what turned out to be the same active ingredient as the flector patch. She discontinued the cream when the blister turned into a large open pus draining sore that became painful in it’s own right. She has since cancelled her appts. with this clinic and with OTC abx cream has finally had the sore begin to heal. This timeline was about 8 weeks from the last LPN visit until now that this patch induced open sore is finally closing and healing up. The original sore and blister took about a week to 10 days to become pronounced.
Comment by Roy on 22 August 2011:
I used a small sample of Voltaren Gel on My LEFT hand in May 2011 after surgery for trigger finger. Next day, my RIGHT big toe joint developed swelling and extreme pain. I reported this to my my doctor, who raised his eyebrows and suggested that I try the Voltaren again when the joint pain had dissipated.
As I was going on an overseas trip, I delayed the re-try until I returned. I tried another small application on my LEFT hand on August19th at about 3.00pm. By 9.00pm, my RIGHT big toe joint was again inflamed and extremely painful.
As the next day was Saturday August 20th, I went to the ER.
The ER Doc diagnosed the problem as PSEUOGOUT, and prescribed a pain reliever and an anti inflamatory medicine.
That Doctor raised his eyebrows too, as there did not seem to be a connection, however, this was the SECOND time this had happened.
Have there been others like this?
Comment by Vicki on 16 October 2011:
I’ve been using the Voltaren periodically for over a year on my low back. Within the last three months I’ve been using it almost daily in that same location. Recently I have developed a condition on both forearms where blood is pooling in different places, resulting in either bruising or just ugly red places. It is especially prevalent if I scratch or bump my arms. I quit taking Gingo Biloba as one of the side effects is thinning blood. But worried now that Voltaren could be the culprit? Any similar reactions out there?
Comment by TERESITA on 1 February 2012:
I HAVE USED VOLTAREN GEL 1% ON MY KNEES AND SHOULDERS WITHOUT ANY PROBLEMS.
Comment by Rena on 16 February 2012:
I have been usinng votaren gel for 6 mos now on my knees, lower back, wrist with significant pain relief and no noted s/e. I just learned from my pharmac that there is no more of this gel available in my area(south Worcester County) + noone knows when it will be. I am devastated! Is anyone else having trouble getting it?
Comment by ashok on 2 May 2012:
please suggest using votaren gel to my father who is 85 years old & he feel much pain in foot /toes and foot . figures.
Comment by ruth on 7 May 2012:
I used voltaren gel for nearly a year when suddenly my pharmist couldn’t get it for me. I am devastated as it was the only thing I could use for my extreme pain from artritis. My Dr had previously taken me off my oral med because I am diabetic and my kidneys are not working as well as they were. I am using over the counter cream now and it just isn’t cutting the pain. I hope Voltaren Gel comes avaible again soon as I can’t go on with this pain
Comment by Harry on 19 May 2012:
Using Voltaren Gel 1% for one week on knee. Stool turns black. This also happens when other inflammatory drugs have been used. Some stomach irritation and pain seems even worse when gel is discontinued.