Xolair Side Effects Linked to Heart Attacks, Strokes and Other Problems

Austin Kirk

By Austin Kirk
Posted July 17, 2009


An ongoing study of the asthma drug Xolair indicates that it could cause a number of heart-related side effects, some of which could be fatal. The FDA issued an early communication indicating that they are reviewing the potential Xolair side effects, but that no conclusions have been reached.

>>FDA EARLY COMMUNICATION: Xolair Heart Side Effect Review

According to the statement issued by the FDA on July 16, 2009, interim data from a study conducted by Genentch, the manufacturer of Xolair (omalizumab), suggests that users of the drug could face an increased risk of heart attacks, strokes and other potentially life-threatening problems. At this time, no conclusions have been reached by the FDA about the causal connection between the study findings and Xolair side effects, but the information was provided to inform the public about an ongoing safety review of the drug.

The study, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), compared the long-term safety of Xolair over five years use to a control group that was not using the drug. Out of 5,000 asthma suffers 12 years old or older, preliminary data has shown a disproportionate increase in:

  • Ischemic heart disease
  • Arrhythmias
  • Cardiomyopathy and Cardiac Failure
  • Pulmonary hypertension
  • Cerebrovascular disorders
  • Embolic, Thrombotic and Thrombophlebitic Events

Xolair was approved by the FDA in 2003 for treatment of moderate to severe persistent asthma caused by perennial airborne allergens, like pollen, grasses and dust. It is prescribed for those whose asthma cannot be controlled by inhaled corticosteroids.

The FDA is continuing to review the emerging safety issue and indicates that further guidance and recommendations will be provided after additional information is evaluated.


The product liability lawyers at Saiontz & Kirk, P.A. are closely following the FDA’s evaluation of the potential Xolair side effects to determine whether users who suffered heart attacks, strokes and other serious injuries may be entitled to compensation through an Xolair lawsuit.

Although legal claims are not actively being pursued at this time, if you, a friend or family member have experienced Xolair problems and wish to have a potential claim evaluated as part of our review, request a free consultation.

23 Comments • Add Your Comments

  • Laurie says:

    Most Xolair patients have multiple conditions which have prompted them to seek this treatment. It is only prescribed to patient’s with moderate to severe Asthma. Patient’s must also have positive allergy testing to qualify for Xolair. It would be very difficult to determine whether Xolair is the causitive factor for cardiac conditions. Xolair has improved the quality of life for many people.

    Posted on July 21, 2009 at 11:04 am

  • anna says:

    Does anyone know if the drug, Xolair contributes to: Thrombi loosening by decreased inflammation, or 2) sudden anaphylaxis from Xolair that spreads to vascular system, i.e., smooth muscle in the cardiac vascular system reacts in the same manner as the bronchial smooth muscles, e.g., they constrict.

    Posted on December 31, 2009 at 6:13 pm

  • Robert says:

    I have been on Xolair for over three years, and my original Doctor that started this therapy on me died of an aneurism in the office. I transfered to another Doctor that refuses to give the injections in his office, thereby causing his patients to go through the outpatient clinic at the hospital, and sometimes it takes three hours to get the damn Xolair mixed and delivered to the floor from the pharmacy. Working people cannot miss that much work. The medicine has been miraculous and I feel much better, but the delivery system needs to improve. There are a lot of medicines that can caus anaphylaxis, so why can’t we give this injection at home. If I had a reaction, my wife could call 911, and I could inject epinephrine. I have just decided to stop the hassle and let my symptoms come back. Disgusted in Springfield, Mo.

    Posted on November 20, 2010 at 11:51 pm

  • Stephanie says:

    Robert change doctors. My husband gets his shots from his Pulmo doctor. He calls the office and the nurse mixes it by the time he gets there it is ready to give. He is usually home in an hour. You can buy a mixer machine to mix the stuff your self and then go to the doctor’s office and have them give you the injection. We use to do this when we lived in a different state only because the doctor did not want to be bothered. We have a better doc now.

    Posted on July 22, 2011 at 11:43 pm

  • Sten says:

    To Robert: Did you try Vitamin D3, 5,000 i.u. softgels , 1 per day?
    In my opinion it is far better than a flu vaccine and significant reductions in Asthma attacks during Winter months. 2 instead of 12 attacks reported in the study. Google asthma japanese study vitamin d to find the articles. “Low Vitamin D levels linked to Asthma” – other study. Vitamin D is very cheap . Get your doctor to check D-levels or take at least 2,000 iu per day. I have taken 5,000 per day for over two years and colds and flus are now history here. “Anaphylaxis” is a very serious condition and because it can be caused by other medications as well does not make it less dangerous.

    Posted on November 16, 2011 at 12:19 pm

  • scott says:

    dose any one ever feel like they are always dehydrated ive had one shot …

    Posted on March 4, 2012 at 12:01 pm

  • Brandt says:

    I was on large dose of Xolair two years ago, and suffered two pulmonary emboli. My health has still not fully recovered. I’m now on blood thinners, and about 6 other medications. We were supposed to have the findings back from FDA on their investigation by now. I’m concerned that this medication may increase the risk of heart attack, stroke, or other thrombotic episodes in people that are already at elevated risk. After my experience, I wouldn’t allow anyone in my family to take the drug.

    Posted on March 5, 2012 at 4:34 pm

  • ivania says:

    I have been on Xolair since september of 2011, I feel better but in the past two months i have been seeing the increase of itchyness on my ears and chin (which is funny). As well, I have been having excrusiating headaches and the top of my head is very tender. About two weeks ago I experienced an extreme migrane were i started seeing lights to the side to completly putting a shadow on my vision. I dont suffer from headaches but I am concern now in regards to what everyone is sharing. Oh one more thing, I am a student at 40 and in my second semester recently i have been having what seem like brain numbness were I can’t even remember what I just studied. Its getting frustrating, I really appreciate everyone’s comments.

    Posted on March 13, 2012 at 9:10 pm

  • Melissa says:

    I’ve been on Xolair 375, 2x a month since 2010. I was hospitalized 9x that year prior to starting it, I’m very concerned about the effects it’s having on my body, my asthma is stable but now I have heart palps that require Cardizem and my BP has been spiking 157/104. I never had BP issue and I’ve gained the belly fat and joint pains, my eye vision is weak and my memory is shot. I am considering discontinuing this drug.has anyone experienced the same?

    Posted on April 18, 2012 at 6:18 pm

  • donna says:

    i also have been taking xolair for two years now (every two weeks) i have mastosytosis. In the last few months after injection for several days i have heart palpatations and high blood pressure….also experiencing memory loss and vision problems (not sure if that is related or age induced :/)

    Posted on June 2, 2012 at 9:12 pm

  • Gina says:

    I have had two Xolair injections. My first injection went well ,but my second injection didn’t go as well. I’ve been going through Anixety attacks, not being able to work at a normal paste. It is very scary.

    Posted on July 6, 2012 at 10:44 pm

  • Money says:

    I have been taking oxlair for 2 months now. I had previously taken oxlair, but I lost my insurance for 4 months and now I am taking it again. The medication was a life saver for me as well. This is my first month taking it again, and I hope it is as effective as before. I know one thing while I was off my symptoms came back. Wish me luck!

    Posted on August 31, 2012 at 11:17 pm

  • Marla says:

    I have been on Xolair for approximately 3 yrs, 2 injections every 4 weeks. It has been a tremendous help with my asthma and year-round allergies; but, I am now concern about my usage after reading the comments left here. For the past 6 mos my bp has steadily been rising.I’ve had days where my top number has been over 200, and bottom in the 100s. I am now on so many bp medications (twice daily); yet, none of my drs have thought about that it could be related to my Xolair usage. I;ve noticed that my vision is getting a little worse; memory loss; and, anixiety spikes. I’ve even suffer from twitches in my hands. Granted, I do have a lot of other medical problems; but I don’t want go back to constantly having severe respiratory by stopping Xolair. Damned if your do; damned if you don’t.

    Posted on December 11, 2012 at 4:56 pm

  • jessica says:

    Ever since my amalgam fillings were improperly removed, I’ve had severe life-threatening asthma, which nothing short of getting magnesium sulfate & steroids at the hospital ER improved. That was until my pulmonologist placed me on Xolair back in 2010. I took it for 4 months & stopped when I felt my asthma was under control. I was fairly asthma-free for nearly a year. At the end of 2011, my asthma returned & I took 2 months worth of injections & stopped. Then in 2012 my asthma became absolutely out of control, where on one occasion I thought I would die & so did the EMT provider who was trying to stabilize me. I was finally put back on Xolair. I have taken it for 5 months. I am thinking of discontinuing to take it until my asthma is once again unmanageable. To me Xolair has been a great miracle drug. However, I don’t see why we should take a drug faithfully when we’re better, especially if it can come with side effects. As to side effects: the one I can say for definite is the feeling of being dehydrated all the time. I have memory issues & feel stressed out & angry, but I’m not sure if xolair is the cause or the lead & mercury poisoning from the improper removal.

    Posted on January 16, 2013 at 3:04 pm

  • Kobi says:

    My mom has got heart atack on the second injection of this shit drug.
    Don’t take it, i am sure i got to be this drug foult.
    in the hospital they checked her heart and it was healthy.

    Posted on July 7, 2013 at 4:41 am

  • Debra says:

    My 17year old has been on xolair for the pass 7 years every 2 weeks his Injected. He has complain of memory loss,headache, blurry vision. And body ache. Just today I was asking the nurse for recent reports on side affects. I wonder if I should stop the injections.

    Posted on July 26, 2013 at 1:10 am

  • kelly says:

    I had taken Xolair injections for about a year and my condition got worse towards the last few months. I became sicker and sicker and was finally found to have pulmonary embolisms and almost died from them. I am now on blood thinners for life and my health is not good. I had no previous history for anything of this type, clotting disorder or embolisms and I do believe this is a result of the Xolair shots. I was never warned of any thing of this type being a side affect before using the drug. It did not help my asthma at all either.

    Posted on September 10, 2013 at 12:50 am

  • Ruby says:

    I have been on Xolair since 2008. I have definitely noticed that I have terrible leg pain almost every time I get the injection. I also have become very frustrated as my memory is quite poor. Often my blood pressure is higher than normal after I receive the injection. My vision has steadily worsened every time I have them checked. I had terrible asthma due to allergies. I am trying to decide whether to stay on the injections or go back to having at least 3 hospitalizations every winter for asthma and bronchitis. lately I have developed a very bad rash on my arms and legs. Was not sure where it came from. Might be from being on the drug so long. Decisions, decisions, decisions. I am almost afraid to stop taking the medicine but I am tired of the symptoms.

    Posted on November 17, 2014 at 7:15 pm

  • Tara says:

    my husband took xolair for approx. 5 years. has had problems with joint pain, headaches, thyroid problems, up and down bp readings, problems with heart, and others. please know you are not alone.

    Posted on February 10, 2015 at 1:49 pm

  • mimi says:

    YES. Dries me right up. Blurry vision. Cotton mouth. Staying away from coffee helps. Using the toothpastes and mouthwash for dry mouth helps. This font especially is really hard to read because I had the shot yesterday.
    It’s obnoxious BUT I can use the normal rescue inhaler. I have gotten one cold and instead of it lasting months, it was 3 days!
    They are goiin to take me off of it as soon as allergy injections are at a monthly maintenance dose. I’m doing my best to speed that process up!

    Posted on April 18, 2015 at 10:21 am

  • Autumn says:

    I have been on Xolair for a year and 3 months now. I was uncontrolled allergies and asthma my entire life. It has been a miracle drug for me! I’m also in nursing school so I can attribute my stress, extreme anxiety to that. I am second guessing things at this moment just from these comments. Maybe it’s just a miracle for me, but I’m praying I never have side effects.

    Posted on July 25, 2015 at 12:52 am

  • Audrey says:

    Xolair shots have helped tremendously in reducing my hospitalizations and er visits for asthma and severe allergies. Took them for a brief period, insurance changed so I went off them. Have been taking them again every 2 wks since 2011. with a brief break Nov 2015 til Jan 2016 due to insurance issues. Have been suffering from extreme vertigo, ear itching and ringing, joint pain. Feel extremely dehydrated. Skin very tender and yesterday received injection. Took off bandaid today and a nickel sized circle of skin came off at the injection site down to the pink skin. It is raised and wet. Called nurse and she said if it got worse to call my doctor but in the mean time to put Neosporin on it and a light bandade. I didn’t put another bandade on for fear more skin will come off. Questioning whether to continue the shots now.

    Posted on January 22, 2016 at 8:24 pm

  • patricia says:

    I’m being injected with 300 mg of Xolair every four weeks for chronic idiopathic urticaria and must say, ti changed my life. . . and for the most part, for the better. Because I am currently stationed in Afghanistan however, I was unable to obtain in for about three months during which the hives, edema and other unpleasant symptoms surged back. It was during this time also however, that I developed insanely high blood pressure, diabetes and my cholesterol spiked. . when I went OFF the drug. . . Am reading these posts with great interest. My hunch is that most of those who require Xolair are dealing with myriad health issues already: hard to know what causes what . . . just wish there was a natural remedy for chronic hives. . . .damned if you do and damned if you don’t. ..

    Posted on February 28, 2016 at 12:04 pm

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