Gastrointestinal inflammation and drugs of ingredients of adalimumab - a phase IV clinical study of FDA data


Summary:

Gastrointestinal inflammation is found among people who take drugs with ingredients of adalimumab, especially for people who are female, 30-39 old , have been taking the drugs for < 1 month. This phase IV clinical study is created by eHealthMe based on reports of 616,961 people who have side effects when taking drugs with ingredients of adalimumab from the FDA, and is updated regularly.

Drug(s) considered in the study (i.e. both brand name and generic drugs): Humira.

With medical big data and AI algorithms, eHealthMe enables everyone to run phase IV clinical trial to detect adverse drug outcomes and monitor effectiveness. Our original studies have been referenced on 600+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Most recently, phase IV clinial trails for COVID 19 vaccines have been added, check here.


On Jun, 25, 2022

616,961 people reported to have side effects when taking drugs with ingredients of adalimumab.
Among them, 2,718 people (0.44%) have Gastrointestinal inflammation


What is Gastrointestinal inflammation?

Gastrointestinal inflammation (inflammation of stomach and intestine) is found to be associated with 755 drugs and 490 conditions by eHealthMe.

Number of reports submitted per year:

Could drugs with ingredients of adalimumab cause Gastrointestinal inflammation?

Time on drugs with ingredients of adalimumab when people have Gastrointestinal inflammation *:

  • < 1 month: 31.46 %
  • 1 - 6 months: 20.49 %
  • 6 - 12 months: 13.51 %
  • 1 - 2 years: 13.87 %
  • 2 - 5 years: 15.87 %
  • 5 - 10 years: 3.81 %
  • 10+ years: 1.0 %

Gender of people who have Gastrointestinal inflammation when taking drugs with ingredients of adalimumab *:

  • female: 59.01 %
  • male: 40.99 %

Age of people who have Gastrointestinal inflammation when taking drugs with ingredients of adalimumab *:

  • 0-1: 0.0 %
  • 2-9: 0.17 %
  • 10-19: 7.52 %
  • 20-29: 17.91 %
  • 30-39: 20.38 %
  • 40-49: 16.76 %
  • 50-59: 17.74 %
  • 60+: 19.52 %

Conditions people have *:

  1. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 305 people, 11.22%
  2. High Blood Pressure: 133 people, 4.89%
  3. Pain: 129 people, 4.75%
  4. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 79 people, 2.91%
  5. Ankylosing Spondylitis (type of arthritis affecting the spine): 72 people, 2.65%
  6. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 72 people, 2.65%
  7. Stress And Anxiety: 70 people, 2.58%
  8. High Blood Cholesterol: 62 people, 2.28%
  9. Depression: 59 people, 2.17%
  10. Psoriasis (immune-mediated disease that affects the skin): 50 people, 1.84%

Other drugs people take *:

  1. Imuran: 128 people, 4.71%
  2. Vitamin D: 97 people, 3.57%
  3. Remicade: 97 people, 3.57%
  4. Pentasa: 90 people, 3.31%
  5. Vitamin B12: 87 people, 3.20%
  6. Methotrexate: 73 people, 2.69%
  7. Prednisone: 66 people, 2.43%
  8. Calcium: 60 people, 2.21%
  9. Enbrel: 58 people, 2.13%
  10. Nexium: 50 people, 1.84%

Other side effects people have besides Gastrointestinal inflammation *:

  1. Diarrhea: 569 people, 20.93%
  2. Drug Ineffective: 553 people, 20.35%
  3. Abdominal Pain: 543 people, 19.98%
  4. Intestinal Obstruction: 332 people, 12.21%
  5. Pain: 262 people, 9.64%
  6. Nausea And Vomiting: 258 people, 9.49%
  7. Weight Decreased: 234 people, 8.61%
  8. Nausea (feeling of having an urge to vomit): 196 people, 7.21%
  9. Intestinal Stenosis (partial obstruction that causes the centre opening of the intestine to become narrower): 195 people, 7.17%
  10. Fatigue (feeling of tiredness): 172 people, 6.33%

* Approximation only. Some reports may have incomplete information.


How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

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How the study uses the data?

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

Who is eHealthMe?

With medical big data and proven AI 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 600+ 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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