Chantix Stevens-Johnson Syndrome Side Effects Added to Warning Label

Austin Kirk

By Austin Kirk
Posted July 3, 2009


Since the Chantix black box warning was announced earlier this week, the focus has been on the increased risk of suicides and other behavior changes. However, Pfizer also quietly added new information to less prominent areas of the label about reports of serious skin reactions, such as Stevens-Johnson Syndrome, which our Chantix lawyers have been investigating for over a year.

>>PRIOR POST (6/11/2008): Chantix Stevens-Johnson Syndrome Side Effects
Added to Lawsuit Investigations

Stevens-Johnson Syndrome, commonly referred to as SJS, is a rare skin reaction that can occur as a side effect of several medications. It results in severe rashes and blistering of the skin and mouth, where the skin literally burns from the inside out. It often requires treatment in a hospital intensive care unit (ICU) or burn care unit, and it can result in death. If the top layer of the skin detaches from the lower layers and lesions cover more than 30% of the body, SJS is often diagnosed as Toxic Epidermal Necrolysis (TEN) or Lyell’s Syndrome.

Concerns about potential Chantix and Stevens-Johnson Syndrome arose after an independent report by the Institute for Safe Medication Practices examined FDA adverse event reports involving Chantix from the 4th quarter of 2007. Several users of the stop smoking drug reported suffering severe and debilitating skin reactions consistent with Stevens-Johnson Syndrome.

Last month, the potential Chantix SJS skin reactions were noted on a quarterly report by the FDA of drugs they were investigating for potential health risks that emerged between October 2008 and December 2008. The FDA indicated that Chantix was showing potential signals for “serious skin reactions,” as well as other problems.

According to a press release issued by Pfizer on July 1, 2009, in addition to the boxed warning about behavior changes and suicidal tendencies, the following new information was added to the Warnings and Precautions sections of the Chantix warning label:

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.


The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential Stevens-Syndrome lawsuits for individuals who have been diagnosed with the severe skin reaction, which could involve symptoms like:

  • Rash, blisters or red spots on the skin
  • Blisters in the mouth, eyes, ears, nose or genital area
  • Swelling of the eyelids
  • Fever or flu-like symptoms

Potential Chantix lawsuits are also being reviewed for suicides and suicide attempts, new on-set diabetes and catastrophic injuries from a fall or accident caused by seizures, black-outs, vision disturbances or other sudden problems.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

19 Comments • Add Your Comments

  • jo ann says:

    i was told about this chantix and my boyfriend was taking it to help him stop smoking whats worse is that he had a horrible skin reaction and is now in the hospital and has been now for a week. how this came about we dont know dr’s think staph but now that i have read this it is possible he has an allergic reaction to this. i am worried about this because my dr wants me to start taking it and now i am scared to try it because of walter.

    Posted on July 21, 2009 at 8:30 pm

  • greta says:

    Getting stevens_johnson syndrom in general is extremely rare. like getting struck by lightening or winning the lottery kind of rare. i’ve had it from something else and it was horrible but the odds of you and your boyfriend both having the genes to make you likely to get it are slim to none.

    Posted on February 25, 2010 at 5:54 pm

  • Michelle says:

    Some may say getting SJS is rare, however I have watched my mother die and suffer from it for several months. This or any drug that potienitally cuase this diease should not be on the market PEROPD. I purchased Chantix and read the symptoms then researched it and fond there are lawsuits out there for the exact same dieses I was afraid of. There is no way in HELL I would ever take this drug and hope one who reads this will take it either. I would not wish what my mother suffered through on my worst enemy. My heart is not that cruel. She was in a burn unit and unrecognizable after two weeks. PLEASE DO NOT TAKE THIS DRUG!!! I don\’t care if its one in one million I wouldn\’t wish it on that one millionth person. Why would you take the chance of that being you!

    Posted on May 15, 2013 at 4:57 pm

  • Chasity says:

    I started chantix for a week and I had this uncontrollable itching and I have been off for three days and the itching is still there….And now there are like hives forming and brusing going on….And I just want this bad itching on my back and legs to go away…

    Posted on January 18, 2016 at 10:30 pm

  • Dianna says:

    My 5TH day of taking Chantix I broke out in the front of my legs and chest I thought it was flee bites but it is side effect of this chantix. I took it a long time ago and had no side effects now I am miserable. If there is a interaction with and my other mess I wish my Dr would have told me. I stopped taking it hopefully this blisters and bumps go away

    Posted on June 30, 2016 at 9:25 am

  • Sarai says:

    I took one dose of Chantix about 2 days ago. The first day I took it I didn’t feel bad but had a bad feeling about it, so I didn’t take anymore. Today, I have red itchy skin all over, so I looked this up and realized that I’ve had SJS before from another medicine (which took two weeks to show symptoms) and I was nearly hospitalized. I am wondering if anyone had their rashy skin clear up quickly after they stopped taking it? I’m trying to avoid the doctor since I only took one dose.

    Posted on July 6, 2016 at 11:31 pm

  • Bernadette says:

    After the first week of chantix, I got really sick, upper respitory. Fever, out of sorts. I developed a rash and burning on day 10. I quit taking chantix at that point. 3 different doctor visits, at least 7 different prescriptions, shots and a biopsy, I was diagnosed with a mild case of Steven Johnson Syndrome. I was completely miserable and at a loss to what to do. Nothing helped. I feel very thankful I only had a mild case!! Non the less, I will never take chantix again. I am now healing and am peeling like crazy.

    Posted on January 28, 2017 at 5:27 am

  • Paul says:

    I’ve been taking chantix for three weeks. Yesterday I woke up with a swollen lower right lip. It went away during the day. That night I had a terrible allergic reaction with extremely itchy skin and swollen throat. And my skin turned really red. I went to the E.R. They fixed me up. The doctor told me the chantix was most likely the culprit and to stop taking it. Does this make sense to you. Thanks. P.P.

    Posted on July 11, 2017 at 5:57 pm

  • Dianna says:

    I have been taking Chantix for about a month or two and I have had skin changes, it is flaky and like it could be peeled off, I am also itching like crazy so I’m not sure what to do?It does help me with my smoking so what to do? Hmmmm?

    Posted on September 18, 2018 at 3:51 pm

  • Michelle says:

    I have been suffering from severe itchy skin with hives for years. I took Chantix about 7-8 years ago and have had this problem bother me daily since. I have gone to the ER and have seen doctors. No conclusion as to what it is.

    Posted on September 30, 2018 at 12:26 am

  • Sharon says:

    I took chantix twice. The second time my scalp started peeling, itching, and I had blisters. The rash has now spread down the back of my neck.

    Posted on October 2, 2018 at 12:57 am

  • Mark says:

    2nd time taking chantix. First time, no reactions whatsoever. (3 months of treatments….started 10/16) This time (9/18) broke out in a rash about a week after starting. Legs, arms, chest. Didn’t itch at first. Rash persisted, peeled, (only on the “rash bumps”), and didn’t get worse, so I continued treatment for the full 1st months worth of treatments. That’s where I’m at now. The Chantix seems to have worked, and I’ve been smoke-free for a solid month now. Do not plan to continue Chantix for the 2nd month of treatment due to the rash….hoping the rash will go away now. (also hoping to keep up the smoking resistance!)

    Posted on November 15, 2018 at 9:20 pm

  • James says:

    My Son did the Chantex thing to try and quit. Blisters to hands, feet and forearms. Continued dry peeling skin. Itches and stings like ants biting below the surface. It is not only bad for him but is tearing me apart. I’m watching a hard working, great Dads hands bust open and bleed. At 31 years old he wondering how long he can work with these hands. Legal to sell this shit that only foes this to some is equal to saying- I only shot into the crowd! I didn’t hit everyone! ! !

    Posted on January 8, 2019 at 3:30 pm

  • Patrick says:

    I took this crap to quit smoking. Made me smoke more, and really brought my A personally out. Broke out with this rash been almost three years ago. Still have rash and itch always. Bad stuff

    Posted on June 12, 2019 at 5:54 pm

  • Robert says:

    Was taking chantix never helped me quit or desire too but two weeks later developed sjs with tens over 80 percent of my body suffered excruciating pain unlike never before skin peeled off arms legs chest back palms and soles of feet

    Posted on June 27, 2019 at 2:58 pm

  • Hugh says:

    Took for a month rash hands legs privates itch very bad

    Posted on July 28, 2019 at 2:32 pm

  • wesley says:

    I took Chantix, morning and night for 16 days. I first developed a rash on the inside of arms, when I stopped and then in 2 days it spread to my chest, stomach and back . I did visit my doctor who advised to give it a week and see what happens. Now trying to trying to make a second appointment with my doctor. I strongly recommend that no one should take this drug. There should be more warnings about the drug + everyone who is thinking of taking it , should be shown pictures of how bad the rash / other side effects are .. There should also be pictures on Chantix packaging. PLEASE DO NOT TAKE THSI POISON!

    Posted on February 1, 2020 at 6:33 am

  • Robert says:

    Chantix put me in intensive care with toxic epidermal necrolosys. Contacted several attorneys none of which would file a suit. It’s a dangerous medication that shouldn’t have fda approval.

    Posted on July 29, 2020 at 5:15 pm

  • Amber says:

    I took 1 pill and within 6 hours I swelled up around my neck and face and my skin was BURNING! My arms were bright red and hot to the touch. Not that you could touch me because it was so painful. It was just like a horrible sunburn! It finally blistered on days 2-3 and 4 days later- it’s still peeling and itches like crazy! All over my body. I only took 1 pill. 4 Benadryl on the first day did NOTHING. I felt like I was on fire for 24 hours after it started. It died down pain-wise when it started peeling, but it’s progressively getting worse peeling/itching wise as they days go on. Chantix is now on my allergy list at the hospital.

    Posted on February 23, 2021 at 10:56 am

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