FDA Warns of Vivitrol Skin Reactions

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The FDA has issued an alert to healthcare professionals about the risk of adverse skin reactions for individuals who receive an injection of Vivitrol, a drug given to treat alcohol dependence.

According to information posted on the FDA website on Tuesday, the agency has received 196 reports of Vivitrol skin reactions in patients treated with anti-alcohol injection, including abscesses, cellulitis, pain, swelling, tenderness, redness, bruising, bleeding and necrosis. In addition, 16 of the reports involved surgical treatments, such as incision and drainage for abscesses (fluid-filled cavities) and removal of dead tissue (necrosis).

Vivitrol (naltrexone) is manufactured by Alkermes Inc. and marketed by Cephalon Inc. In April 2006, the FDA approved the drug for treatment of alcohol dependence in outpatients who can abstain from drinking prior to initiation of therapy. It is the market name of extended release injectable suspension formulation of naltrexone. It is given by a healthcare provider as part of a comprehensive therapy for alcoholism, including group therapy or counseling along with medication. Annual sales of the drug are over $450 million.

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By binding to opioid receptors in the brain, Vivitrol dampens the desire for alcohol and may reduce the sensation of pleasure a person gets from drinking alcohol. The non-addictive drug has been shown to reduce the number of drinking days in a month for alcoholics and the number of heavy drinking days.

Vivitrol is administered as an intramuscular gluteal injection once a month in a 380 mg dose and is released into the body at a controlled rate. The FDA warned that the drug should not be injected subcutaneously, intravenously or into fatty tissue, as this increases the risk of tissue damage. Healthcare providers have also been urged to use a special 1 ½” needle supplied with the drug for injection and to make sure they inject the drug properly at the correct dosage.

The FDA has also asked physicians to instruct patients to monitor Vivitrol injection sites for reactions, such as redness, pain, swelling, itching and bruising. If symptoms persist or worsen within two weeks, they should be referred to a surgeon. Tissue damage may result in fluid-filled cavities (known as an abscess) or death of the tissue (known as necrosis). Women are more at risk of Vivitrol skin reactions, because they have a larger amount of gluteal fatty tissue.

Tags: Skin Reactions, Vivitrol

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112 Comments

Beth
I received the Vivitrol shot in January of this year. I got a lump the size of a golf ball, or slightly bigger, and it was hot to the touch. I attempted to go to my doctor multiple times to have ultrasound treatments to try to break up lumps. This did not work. My advice is if you’re not having any other symptoms such as fever, rash, or sores in your mouth, only time will heal them. As of today my lump has diminished to the size of a pebble and is barely noticeable.
Trystan
I received my first injection April 2017, which went well. My second shot has been a nightmare. It’s two months later and my lump grew so large I couldn’t put jeans on. The place I received the shot stated it was normal to have a lump, and dismissed me. I ended up at ER two weeks ago and they said it was a hematoma and sent me home. Two weeks later I started getting really sick, temp was high, I was vomiting so went back to the ER at a different hospital where they discovered I was almost septic, they did an emergency I &D and admitted me and put me on IV ABX. I now have a 1 and 1/2 inch incision that is 8 inches deep. It couldn’t be stitched because it’s such a big abscess, has to be packed daily until healed. Surgeon will see me in two weeks. So for anybody receiving this shot, if you end up with a lump the size of a tennis ball and it’s hot and painful, go to the ER, cause it will only get worse, and can kill you once infection sets in.
Patrick
I had the shot administererd after treatment at Betty Ford Hazelden. They were very mindful about how it was administered as well as having me sit and wait as well as messaging the are with a tennis ball for several days after the shot. Yes it felt like a donkey kicked me in the butt however it worked well for cravings. The second shot I received was administerd wrong at Kaiser Permenete. I was in instant pain the injection site was swollen to the size of a base ball and after a week of visits to urgent care I was rushed into an emergency surgery where they removed a handful of dead tissue. Recovery was long as the surgical site has to heal from the inside out. Further more they prescribed opiates (the reason I was taking the shot was to stay off opiates) Not being able to continue in my program of recovery for along period of time I relapsed and went down the rabbit hole once again this time getting a DUII landing in jail. I’m recovered now and off opiates the road was made that much harder do to the adverse side effects of the injection of V.
Lee
Please any updates on the lumps or pain at injection site? Please people who orginally posted let me know how long it took for pain/lump to go away. Did anyone else get an infection or need to have it removed? I need help. Thank u
Pat
I received a vivat roll shot 2 weeks ago. I have been taking for 16 months sometime sore, thou this time the area is swollen, sore and getting larger the size of a tennis ball now. What happened? Why now?
Karen
I got the V shot on 12/07/16. Decided not to go the second round. It works well to block wanting to use. My problem was within hours of getting the shot I was SO WIRED I never did sleep much for 2 or
tisha
Wilbur, I too have been fighting a rash and intense itching since receiving my last shot on 9/1/2016. I was due another yesterday, 9/29/2016 and didn’t go. I was blown off by my doctor and finally went to UTC and was given steroids and told to apply hydrocortisone cream. The swelling had gone down but the itching has remained the same and now that the steroids are gone, there are spots swelling back up. I have ruled out any other cause because nothing changed other than the shot. I can’t get into a dermatologist and no other doctor will do anything. UTC said they can’t do anything else. I’m hoping as this works it’s way out of my system the symptoms will disappear. I am tired of itching and bleeding from scratching, which is something you truly can’t help in the case of this rash.
Ada
The 1st time I got the vivitrol shot I had a headache for almost 2 weeks. I also had several sores on my tongue and inside my mouth in various places. It got so bad that in time I had sores all around the edge of my tongue and even more appeared in my mouth..I could not eat much due to the pain. I even got a rash on both elbows. I have now had 5 injections ( 5 months) and the 2 nd time I got the same sores in mouth and rash on elbows. Headaches everytime with 30 minutes of shot. I received my fifth shot a week ago and about 2 days afterwards my elbows are severely rashed up. I have a few of the same rash bumps on various other sites of my body. Like 2 on hand a few on my knee. I’m not sure if this is a allergic reaction but whatever it is..I know its from this shot. I even get pains around my liver area…is this really worth all this? I was court ordered this shot without them asking me if I was still using drugs. I was sober for months…before shot. I didn’t need it. But I was only doing what I was court ordered…but I’m sick of all these reactions
wilbur
I received my first vivitrol shot almost three weeks ago at a VA hospital. over the past five days i have been experiencing rashes and itching so bad i literally scratched until i was bleeding. wherever i scratch the area raises up into a lumpy rash. It is my opinion with 98% certainty that I have developed Dermatographia and that it is due to Vivitrol. i am not gonna take my next vivitrol shot due on september 28, 2016. The only warning I received was that the injection site may temporarily be sore and to rub it. Well I never experienced any persistent soreness. however this is a systemic outbreak and now when I attempt to shave my face start to swell up wherever the razor makes contact with my face in a lumpy rash. its like something you would see in a horror movie. and i am horrified. will this ever go away? this is really stressing me out which will in turn cause my body to release adrenaline or cortisol which are believed to exacerbate the symptoms.WTF
Tara
Tonya go back to your Dr. it sounds like an abscess, you may need antibiotics. Hopefully it won’t require surgery as some of us have gone thru. Just another update for me. I still have my open wound related to my MARCH injection. I switched surgeons and my new surgeon took me to the OR under GENERAL anesthesia this time for a deep excisional debridement of necrotic tissue. It’s surreal to think this was all from an injection that I never in a million years would imagine could cause this much damage. I had a wound vac on for weeks post surgery. I just got it off now back to every other day packing for me. I have nerve damage as well. To all who may be reading just make sure you make an informed decision before starting this drug. It works but make sure the benefits outweigh the risks. They did not in my case but I was ill informed. Best Wishes to All!
Tonya
Am experiencing a LARGE swollen mass around the injection site.. What should i do???
Brian
I had a Vivitrol shot on June 10th. About a week ago I felt an intense itching feeling around the injection site. I couldn’t help but to scratch it. I developed what was very similar to a spider bite. I started to bleed at the site. I then developed a black sore with redness around the site that spread out about 3 inches around the diameter of the site. I also started having pain, especially when I stood up after sitting. I now have pain when sitting which intensifies when standing. It is now June 28th and the pain is getting worse. I did not realize that others were having complications such as this from the shot. I seriously thought this could have been a spider bite but I am questioning that now.
Stephania
I received my second shot one week ago, Friday and have since developed what the nurse called a sterile abscess. My shots were given at VA hospitals. I too wasn’t warned. While at my first injection nurse said I might get a bump, it wasn’t explained to me as I’m reading it here. I was simply told to massage the injection site. Which I’ve done. A “little bump” and a bump that can lead to necrosis and horrible pain for months are two different things. Even today when I saw the nurse she told me nothing about other people needing to have surgery to correct. I just feel stupid, specially when I don’t even have to be taking this shot. Unlike most of you, I’m not using this for alcohol addiction which it had been proven for. I have a gambling addiction and was advised by my psych that it has shown some potential in curtailing gambling habits. Hence me saying OK whatever can help me. But after reading the comments here, I’m scared. And empathize with you all. Dinner of you have had it pretty bad. The risk is totally not worth it for me anymore. I wish I was advised better and given the opportunity to make an informed decision. Good luck all!
Tara
Hello to Vivitrol user and potential user community. It’s been almost two months since my previous post and I am still going thru hell. I’ve had a total of three surgical procedures for the abscesses and still have a non healing wound caused by Vivitrol which requires daily packing by the VNA. I too have spoken with several attorneys who are leery of taking on Alkermes. I encourage anyone who develops and injection site reaction to report it! And, believe me with projected sales of $180-200 million for 2016 per Alkermes financial report, there will unfortunately be more preventable cases! Let’s continue to our part by spreading the word and letting people make INFORMED decisions. The drug does work, but people should be given ALL the facts so that they themselves can weigh their options before the damage has been done. The FDA issued the warning regarding injection site reactions (ISR) in 2008 and ISR are listed on package insert but I believe the problem is that the severity is not being adequately disclosed to the practitioners who are prescribing and even administering the drug! I think the reactions are downplayed and stated to be rare when in truth they occur fairly frequently. I also believe number wise that they are not being accurately tracked. Yes we call and notify Alkermes, but again I repeat that this blog was started in 2008…….They can do better and we as consumers deserve to know the truth. When I was in the depths of my addiction I wasn’t out surfing the internet. I relied on my trusted Mental Health Counselors, and Medical practitioners to give me sound advice. I truly believe that they thought the advice they gave was correct but they themselves were misinformed or mislead in terms of side effects of this particular drug. I encourage all to continue to post your stories, and concerns. I think this has only really just begun. 🙁
amy
My daughter got the Vivitrol shot in April and May of 2015. She has a lot of skin problems and keloid scarring already, so she was concerned and asked specific questions about scarring and ppl who have received the shot having issue with the injection site. She was reassured many times that no one in their office has ever had a reaction besides a sore spot which goes away. She got a lump after the first shot and it was VERY sore and kept being sore, which didnt go away by the time she received the second shot-and they told her it would go away. She refused to get a shot after the 2nd one, started taking the pills instead, but then lied and wasnt really taking them and relapsed shortly after. But during the shot she had actually shot up heroin to see if she would get high, she couldnt. She still has a small lump and a scar a year later which seems to be getting bigger. We are just angry b/c the Dr office gave us no warning that this would happen and reassured her it would NOT happen. Now here we are seeing all of these other people with similar issues. I would NOT recommend this shot to anyone, for this fact PLUS for the fact that many people we know have gotten the shot and it did not make them stop using.
amanda
I just received my second shot last week an I have three knots that came up in the injection site an they hurt really bad..I was told about this FDA stuff either
Tara
I received Vivitrol on 3/1/16 and the last few weeks have been painful to say the least. Developed injection site reaction right away. Returned to PCP who gave me the shot. He put me on antibx and told me swelling, pain, etc would go away eventually. It did not. Lump grew to softball size. Deep. Went to ER today and was told I had two abscesses which had to be drained. I now have two incisions w/drains in place and I’m back on antibx, etc. What a nightmare this has been. I would’ve just taken the pills had I known beforehand about this particular side effect like so many others have previously stated! So it’s been 8 years since some of the initial threads were written but looks like results are still the same. That’s bothersome to me!
Kimberly
It’s been 5 days since my 3rd shot-the 2nd on the right side. The area is much larger then the 1st 2 shots, it itches like crazy and more painful. The lump is visible through clothing, looks like I have oddly shaped behind. I am concerned about continuing this treatment for the suggested 3 months to 1 year. Any suggestions on reducing or eliminating the lump and skin irritation? Not happy!
sarah
I also have a hard lump shaped like a small plum tomoato – I am furious if this is necrotic tissue and needs to be surgically removed – it’s about 3 weeks since i had the shot – the dr. did tell me there’s a possibility of swolleness at the site and to just rub a cold bottle of water on it – whatever – it didn’t appear until a day or 2 later – it’s not painful but it’s ugly and if it’s dead tissue – well that’s a problem — if anyone does a class action suit let me know –
Ross
Second shot two days ago. First one on December 8 and no issues. Second one on January 7 and major painful swelling. Figure I’ll give it till Monday and call doctor. Wife couldn’t even look at it it is so bad. Didn’t know about this site till this happened. Wish I did.
sarah
I also have a hard lump shaped like a small plum tomoato – I am furious if this is necrotic tissue and needs to be surgically removed – it’s about 3 weeks since i had the shot – the dr. did tell me there’s a possibility of swolleness at the site and to just rub a cold bottle of water on it – whatever – it didn’t appear until a day or 2 later – it’s not painful but it’s ugly and if it’s dead tissue – well that’s a problem — if anyone does a class action suit let me know
Ryan
Been only 4 days since I got it, but when the nurse gave me the shot the needle clogged with the thick vivitrol solution she had to pull it out put on another needle and stick me again! Now I also have a painful lump that is extremely sore and hard It’s the size of a golf ball and I just have a bad feeling its going to get infected. My doctor wanted me to come back at the 2 week mark hopefully it will be gone by then.
Shauna
First 2 weeks, normal small hard bump. now 3 weeks in a tennis ball or mango sized bump. After reading all this i dont know what to do next.
chris
I received the vivitrol shot, 1/19/15 was in excruciating pain for 4 days with a large hard lump. (size of a soft ball) also had itching, redness, and swelling on my lower leg, back, side and butt. Went into the E.R. and they never even heard of the shot. Was put on antibiotics for 1 week. Redness is gone. Still itchy. Swelling has gone down. Redness is gone. The lump is still the size of a soft ball and still hurts like hell. Its been 21 days of hell because of this vivitrol shot. Now I may need surgery. Weigh your options. I will never get the vivitrol shot again!! I am now looking into lawsuits against the company that makes vivitrol and or also the place that iministered the shot. Please if you have received the vivitrol shot and had to have surgery, or need to have surgery, and or have had a negative or painful result. Please speak up and be known!!!!
Marc
Hip problems from vivitrol shots
Lyndsey
On Friday 01/09/15 I received my 5th injection. Every other time it was the same man who administered the injection. This time it was a woman, and this was the first visitors injection she’d done. Her supervisor shadowed her during the whole process. Immediately I noticed something was off. The timeline after that is as follows. Right After Injection (Friday at noon) – didn’t feel right at injection sight Evening of Day One (Friday 6:00pm) – noticed itching and redness, skin felt strange Day Two (Saturday) – noticed swelling, more redness and itching Day Three (Sunday) – noticed harness of swollen area, numbness, redness, itching, bump spreading. I wholeheartedly believe that all of the cases of adverse symptoms are due to improper administration. From what I’ve read, all these symptoms result from injection being administered subqutaneously or into fat tissue. I will be pursuing legal action against Safeway Pharmacies because my condition is due to malpractice on their part.
carolyn
I have had to surgeries and Acell skin graphs since 1st and only injection. I was not made aware of FDA warning either, or advised how serious the adverse reactions were
Me
Hi guys! I got a lump at the injection site during my 1st time getting the Vivatrol shot. I continued to get it in my other side and developed no reaction. I went to the doctor who prescribed me antibiotics to make it go away. It’s been 4 months and the lump is gone. I’m not sure what happened but he told me that side of my butt might have been more sensitive. I also jumped during the injection and he said that might have caused it. Also make sure you are rubbing your injection site HARD to help the medicine disperse. I didn’t do that my first time. Make sure your provider is giving you the shot correctly since thats what the doctor thought was the cause of my now gone lump
Susan
I have been injected with Vivatrol for 1 year and have just started getting a reaction at injection site. On my butt cheek. Both sides have bump size of golf balls. I don\’t weigh much at all very uncomfortable. Doctor doesn\’t know what is going on. After reading your comments I am not having them removed. One started going down that\’s why I got injected this month will go back to the naltrexone pills.
Mindy
I got the shot on 10/15/2012. I was not told about the FDA warnings but that I should get this shot before I left rehab. Shortly after I developed a hard lump which grew to be the size of a tennis ball. It developed a black scab which got infected. The doctors told me it was dead tissue and removed the tissue on 1/6/13. It left a hole that has never healed. Doctor after doctor told me there was nothing that could be done and it would heal up on it’s own. I was having to go to wound care twice a week to get the dressings changed. I started packing the hole myself and the hole still wouldn’t close up. I was referred back to wound care a couple weeks ago and was told I have to have surgery on 6/5/13. The hole is getting deeper and is starting to tunnel through my body. I am probably going to get fired from my job because I can’t take anytime off work. I have no other choice now because it is infected and it doesn’t seem to be getting any better.
Karen
My husband had his first Vivitrol injection in February 2012, and was in the hospital in April 2012 for site reaction to the Vivitrol. They told him it was from sitting in bath water instead of showering. He took his last Vivitrol shot in early March 2013, and now has a red lump with numbnesssimilar to the one that landed him in the hospital last year. We are seeing a surgeon tomorrow. On the bright side, the drug did what it was supposed to do regarding his alcohol dependence. Best of luck to everyone!
Nicole
It is very disturbing to hear that so many more people are having this reaction and yet there havent been any lawsuits against this drug. I have tried but I was told by several attorneys that more people need to come forward and pursue it.
Teasha
Hello, I received my first Vivitrol shot 12/3/12. 9 days later I woke up in the middle of the night with, what felt like, a Charlie horse in my butt. When I finally got up I notice my butt, where the injection was, had a hand size protrusion. It’s swollen and hard and hurts when I put weight on the one side. Doctors have said there’s not much they can do if there’s no redness, its not warn to the touch, doesn’t itch etc… I feel like its getting bigger and almost feels tingly and numb. Advice?!
Virginia
I had to have a baseball sized blood clot removed from my hip in 2009 as a result of the Vivitrol shot. It was very painful, and very scary, and I had to wear a drainage bag for three weeks. I am still upset about the whole incident.
SJ
I received the shot last year and had a terrible reaction that I am still recovering from. I would like to know how people are doing now. What has helped you recover from the shot? Have any of you fully recovered? Please email me at anonlump@ hotmail.com.
David
It is concerning reading this. I’m 18 days into my first shot and it keeps hurting and getting more swollen. What should I do?
Marissa
I got my first shot November 10th 2011. I am still having problems with my injection site I have been to several doctors and been through it all . Its not a good thing my last doctor said that I have to have it surgically removed. I am not happy about this. If I would have known about this before the injection I would have never gotten it.
Jennifer
I received my first shot just a little over a week ago and I have a lump about the size of a tennis ball where the medication was injected. It’s very painful! I haven’t seeked medical treatment because I thought I would do some research first before I went to the Dr.’s. I found this blog site and now this medication worries me. It’s in my best interest to recevie it, but if I’m going to keep getting a reaction like this every month, is it worth it?
Marissa
I got my first shot on November 10th 2011. It is now December 13 and my lump is the size of a tennis ball its painful and itchy. I went to the doctor first she put me on antibiotics then the next visit a week later she took me off them and she pulled some fluid out to test it for infection….no infection she told me it was dead skin tissue. i am still having pain and its uncomfortable to sleep at night. 🙁
DFS
I had one injection and 2 and 1/2 weeks later I discovered a hard lump about the size of a golf ball. Went to 4 doctors and no one knew what to do. Within 2 weeks it had grown to 5 1/2 inches by 5 inches and had to be surgically removed. This was 5 weeks ago and i have an 8 inch scar and no feeling in my hip.
Jennifer
I just had my first vivatrol shot a few days ago, and luckily no bump. A girl in my group session complained about the lump she received on her first shot, but she said it finally went away on its own after 3 months, but it indeed did go away eventually.
chris
I also had pain and a lump. One thing I have not heard from anyone else is that the pain was also accompanied with bloody stool. Had colon cancer scare, thank God that turned up negative. Anyone else seen any blood? A year later, I still have pain, not as sever. Also, my pain and lump were about an inch away from injection site. Anyone else? Location?
olinthia
I got my first shot about 3 weeks ago and have now a hard bluish lump at injection sight that keeps growing. Now about the size of the palm of a small womans hand. I have called my doctors office twice they just keep saying its normal,it will go away.
Katherine
HELP!! I have a HUGE lump that won’t go away. I can’t even wear the same clothes nor sleep on my back anymore; it hurts too much. Does anyone know what I can do or where I can go for help?
Tracie
I had the shot on dec. 16, 2010. Large hard mass developed. I had to have surgery on Jan.17 2011. I now have an open wound that must be packed daily. I am needing to b out of work and this is expensive out of pocket, as well as painful! I am NOT happy about any of this! I never would have had this injection had I known of this increasingly occurring reaction. I have reported my experience to Vivitrol and the FDA.
Nicole
Massaging can’t do any more damage, but I doubt it will go away without surgical intervention only because the hardness your feeling is most likely necrotic.And you can’t bring dead tissue back to life.
Gerry
I was administered the 1st shot of Vivitrol on 11/21/2010. I too experienced redness, itching, and a lump two weeks after at the injection site. Dr. prescribed a round of steroids. It is better, now it is almost Christmas, but the lump is still there and also disrupts sleeping. My question is, will the lump eventually go away? Does massage help?
Nicole
I received my first shot in November 2010 and also developed a rock hard mass the size of a tennis ball, that I was told is normal and to use warm compresses and it would go away….it did not. Then I was told to go to the ER where they were unable to aspirate. Then I had it surgically removed and now I’m temporarily left with an extremely painful and uncomfortable opened wound . AND not to mention that I will have to be out of work with out pay indefinately and it is Christmas!!!! I agree with you all, that if I was told of this possible side effect……..I would never have had it.
paula
I have similiar lumps. Why do they continue to administer this medication?
kathy
I received my 1st injection of Vivitrol on October 20, 2010. I saw my Doctor November 23rd and he advised me to go to the ER and they said I should see a surgeon in 1-2 days. I developed a site injection reaction that grew from a marble and is now this size of a hard, large egg. It has also changed color to a bluish color. I quit my job b/c I could not stand for 8 hrs or even sit for 8hrs much less do all the heavy lifitng without alot of pain. I was never told about this reaction by the Dr, nurse and the literature in the box does not reflect what the FDA demanded back in August 2008. Given informed patient consent, I would NEVER had done this and now may need surgery which I can’t afford. I also was never told the drug came in a pill form.
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