Asacol and Oral pain - a phase IV clinical study of FDA data


Oral pain is found among people who take Asacol, especially for people who are female, 60+ old, have been taking the drug for < 1 month.

The phase IV clinical study analyzes which people take Asacol and have Oral pain. It is created by eHealthMe based on reports of 17,445 people who have side effects when taking Asacol from the FDA, and is updated regularly. You can use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Oct, 03, 2022

17,445 people reported to have side effects when taking Asacol.
Among them, 25 people (0.14%) have Oral pain.

What is Asacol?

Asacol has active ingredients of mesalamine. It is often used in ulcerative colitis. eHealthMe is studying from 18,161 Asacol users for its effectiveness, alternative drugs and more.

What is Oral pain?

Oral pain is found to be associated with 1,973 drugs and 1,327 conditions by eHealthMe.

Number of Asacol and Oral pain reports submitted per year:

Could Asacol cause Oral pain?

Time on Asacol when people have Oral pain *:

  • < 1 month: 100 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Oral pain when taking Asacol *:

  • female: 91.67 %
  • male: 8.33 %

Age of people who have Oral pain when taking Asacol *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 17.39 %
  • 50-59: 39.13 %
  • 60+: 43.48 %

Common drugs people take besides Asacol *:

  1. Prednisone: 8 people, 32.00%
  2. Vancomycin: 6 people, 24.00%
  3. Actos: 6 people, 24.00%
  4. Flagyl: 6 people, 24.00%
  5. Nexium: 6 people, 24.00%
  6. Aredia: 5 people, 20.00%
  7. Prevacid: 5 people, 20.00%
  8. Prilosec: 5 people, 20.00%
  9. Dilaudid: 5 people, 20.00%
  10. Vicodin: 5 people, 20.00%

Common side effects people have besides Oral pain *:

  1. Osteomyelitis (infection of bone): 8 people, 32.00%
  2. Mouth Ulcers: 8 people, 32.00%
  3. Pain In Jaw: 8 people, 32.00%
  4. Periodontitis (inflammation of the tissue around the teeth): 7 people, 28.00%
  5. Periodontal Disease (disease that attacks the gum and bone and around the teeth): 7 people, 28.00%
  6. Bone Fragmentation: 7 people, 28.00%
  7. Dental Caries: 7 people, 28.00%
  8. Tooth Disorder (tooth disease): 7 people, 28.00%
  9. Tooth Abscess (pus formation in tooth): 6 people, 24.00%
  10. Hypoaesthesia (reduced sense of touch or sensation): 6 people, 24.00%

Common conditions people have *:

  1. Osteoporosis (bones weak and more likely to break): 6 people, 24.00%
  2. Thrombocytopenia (decrease of platelets in blood): 4 people, 16.00%
  3. Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 4 people, 16.00%
  4. Stress And Anxiety: 2 people, 8.00%
  5. Depression: 2 people, 8.00%
  6. Otitis Externa (external ear infection): 2 people, 8.00%
  7. High Blood Cholesterol: 2 people, 8.00%
  8. Inflammatory Bowel Disease: 1 person, 4.00%
  9. Arrhythmias (irregular heartbeat): 1 person, 4.00%
  10. Bipolar Disorder (mood disorder): 1 person, 4.00%

* Approximation only. Some reports may have incomplete information.

Do you take Asacol and have Oral pain?

Check whether Oral pain is associated with a drug or a condition

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.

Related publications that referenced our studies

Related studies

How severe was Oral pain and when was it recovered:

Expand to all the drugs that have ingredients of mesalamine:

Alternative drugs to, pros and cons of Asacol:

Common Asacol side effects:

Browse all side effects of Asacol:

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

Oral pain treatments and more:

COVID vaccines that are related to Oral pain:

Common drugs associated with Oral pain:

All the drugs that are associated with Oral pain:

Common conditions associated with Oral pain:

All the conditions that are associated with Oral pain:

How the study uses the data?

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

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

DISCLAIMER: All material available on 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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