Simethicone and Colitis - a phase IV clinical study of FDA data

Summary:

Colitis is reported as a side effect among people who take Simethicone (simethicone), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Ondansetron, and have Constipation.

The phase IV clinical study analyzes which people have Colitis when taking Simethicone. It is created by eHealthMe based on reports of 6,434 people who have side effects when taking Simethicone from the FDA, and is updated regularly.

What is Simethicone?

Simethicone has active ingredients of simethicone. It is often used in gas. eHealthMe is studying from 6,763 Simethicone users. Check the latest studies of Simethicone.

What is Colitis?

Colitis (inflammation of colon) is found to be associated with 1,592 drugs and 1,527 conditions by eHealthMe. Check the latest studies of Colitis.

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, 26, 2026

6,434 people reported to have side effects when taking Simethicone.
Among them, 76 people (1.18%) have Colitis.

Could Simethicone cause Colitis?

Among these 76 people:

How long have people been on Simethicone when they have Colitis? *

  • < 1 month: 88.89 %
  • 1 - 6 months: 11.11 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Colitis when taking Simethicone? *

  • female: 67.12 %
  • male: 32.88 %

What is the age of people who have Colitis when taking Simethicone? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 15.62 %
  • 20-29: 0.0 %
  • 30-39: 6.25 %
  • 40-49: 15.62 %
  • 50-59: 20.31 %
  • 60+: 42.19 %

What are other drugs people take besides Simethicone? *

  1. Ondansetron: 21 people, 27.63%
  2. Pantoprazole: 18 people, 23.68%
  3. Colace: 18 people, 23.68%
  4. Acetaminophen: 17 people, 22.37%
  5. Miralax: 17 people, 22.37%
  6. Morphine: 15 people, 19.74%
  7. Zofran: 15 people, 19.74%
  8. Oxycodone: 15 people, 19.74%
  9. Magnesium: 14 people, 18.42%
  10. Melatonin: 12 people, 15.79%

What are other side effects people have besides Colitis? *

  1. Diarrhea: 24 people, 31.58%
  2. Abdominal Pain: 20 people, 26.32%
  3. Nausea (feeling of having an urge to vomit): 13 people, 17.11%
  4. Pneumonia: 11 people, 14.47%
  5. Sepsis (a severe blood infection that can lead to organ failure and death): 10 people, 13.16%
  6. Dyspnea (difficult or laboured breathing): 10 people, 13.16%
  7. Stress And Anxiety: 10 people, 13.16%
  8. Weakness: 9 people, 11.84%
  9. Oedema Peripheral (superficial swelling): 9 people, 11.84%
  10. Dehydration (dryness resulting from the removal of water): 9 people, 11.84%

What are the existing conditions these people have? *

  1. Constipation: 17 people, 22.37%
  2. High Blood Pressure: 12 people, 15.79%
  3. Pain: 12 people, 15.79%
  4. Flatulence (flatus expelled through the anus): 11 people, 14.47%
  5. Nausea (feeling of having an urge to vomit): 10 people, 13.16%
  6. Abdominal Pain: 8 people, 10.53%
  7. Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 8 people, 10.53%
  8. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 6 people, 7.89%
  9. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 6 people, 7.89%
  10. Abdominal Distension: 5 people, 6.58%

* Approximation only. Some reports may have incomplete information.

Do you take Simethicone and have Colitis?

- Check whether Colitis is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously



Related studies:

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

Colitis treatments and more:

How severe was Colitis and when was it recovered:

Expand to all the drugs that have ingredients of simethicone:

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 Simethicone:

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 Colitis:

Browse all the conditions that are associated with Colitis:


How the study uses the data?

The study uses data from the FDA. It is based on simethicone (the active ingredients of Simethicone) and Simethicone (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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