Xolair and Sjogren syndrome - a phase IV clinical study of FDA data

Summary:

Sjogren syndrome is reported as a side effect among people who take Xolair (omalizumab), especially for people who are female, 50-59 old, have been taking the drug for < 1 month also take Singulair, and have Urticaria.

The phase IV clinical study analyzes which people have Sjogren syndrome when taking Xolair. It is created by eHealthMe based on reports of 77,224 people who have side effects when taking Xolair from the FDA, and is updated regularly.

What is Xolair?

Xolair has active ingredients of omalizumab. It is often used in asthma. eHealthMe is studying from 77,555 Xolair users. Check the latest studies of Xolair.

What is Sjogren syndrome?

Sjogren syndrome (a disease that causes dryness in the mouth and eyes) is found to be associated with 614 drugs and 969 conditions by eHealthMe. Check the latest studies of Sjogren syndrome.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Aug, 08, 2026

77,224 people reported to have side effects when taking Xolair.
Among them, 27 people (0.03%) have Sjogren syndrome.

Could Xolair cause Sjogren syndrome?

Among these 27 people:

How long have people been on Xolair when they have Sjogren syndrome? *

  • < 1 month: 50 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 25 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 25 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Sjogren syndrome when taking Xolair? *

  • female: 79.17 %
  • male: 20.83 %

What is the age of people who have Sjogren syndrome when taking Xolair? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 13.33 %
  • 20-29: 0.0 %
  • 30-39: 6.67 %
  • 40-49: 20.0 %
  • 50-59: 33.33 %
  • 60+: 26.67 %

What are other drugs people take besides Xolair? *

  1. Singulair: 5 people, 18.52%
  2. Benadryl: 3 people, 11.11%
  3. Synthroid: 3 people, 11.11%
  4. Symbicort: 3 people, 11.11%
  5. Spiriva: 3 people, 11.11%
  6. Sertraline: 2 people, 7.41%
  7. Rituxan: 2 people, 7.41%
  8. Nitrofurantoin: 2 people, 7.41%
  9. Prelone: 2 people, 7.41%
  10. Flonase: 2 people, 7.41%

What are other side effects people have besides Sjogren syndrome? *

  1. Urticaria (rash of round, red welts on the skin that itch intensely): 7 people, 25.93%
  2. Anaemia (lack of blood): 5 people, 18.52%
  3. Depression: 5 people, 18.52%
  4. Insomnia (sleeplessness): 4 people, 14.81%
  5. Fatigue (feeling of tiredness): 4 people, 14.81%
  6. Dry Eyes (lack of adequate tears): 3 people, 11.11%
  7. Osteoporosis (bones weak and more likely to break): 3 people, 11.11%
  8. Oropharyngeal Pain: 3 people, 11.11%
  9. Neutrophil Count Abnormal (abnormal number of neutrophil a type of blood cell): 3 people, 11.11%
  10. Respiratory Papilloma (benign tumour, as a polyp or wart, of the skin or mucous membrane of respiratory system): 3 people, 11.11%

What are the existing conditions these people have? *

  1. Urticaria (rash of round, red welts on the skin that itch intensely): 4 people, 14.81%
  2. Sleep Disorder: 2 people, 7.41%
  3. Pain: 2 people, 7.41%
  4. High Blood Pressure: 2 people, 7.41%
  5. Anaphylaxis (serious allergic reaction that is rapid in onset and may cause death): 2 people, 7.41%
  6. Vasculitis (inflammation of a blood vessel or blood vessels): 1 person, 3.70%
  7. Thyroid Diseases: 1 person, 3.70%
  8. Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1 person, 3.70%
  9. Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 1 person, 3.70%
  10. Ill-Defined Disorder: 1 person, 3.70%

* Approximation only. Some reports may have incomplete information.

Do you take Xolair and have Sjogren syndrome?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Xolair:

Sjogren syndrome treatments and more:

How severe was Sjogren syndrome and when was it recovered:

Expand to all the drugs that have ingredients of omalizumab:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Xolair:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Sjogren syndrome:

Browse all the conditions that are associated with Sjogren syndrome:


How the study uses the data?

The study uses data from the FDA. It is based on omalizumab (the active ingredients of Xolair) and Xolair (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.



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