Hydrea and Mouth ulcers - a phase IV clinical study of FDA data

Summary:

Mouth ulcers is reported as a side effect among people who take Hydrea (hydroxyurea), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Jakafi, and have Primary myelofibrosis.

The phase IV clinical study analyzes which people have Mouth ulcers when taking Hydrea. It is created by eHealthMe based on reports of 8,922 people who have side effects when taking Hydrea from the FDA, and is updated regularly.

What is Hydrea?

Hydrea has active ingredients of hydroxyurea. It is often used in polycythemia vera. eHealthMe is studying from 9,083 Hydrea users. Check the latest studies of Hydrea.

What is Mouth ulcers?

Mouth ulcers is found to be associated with 1,365 drugs and 2,160 conditions by eHealthMe. Check the latest studies of Mouth ulcers.



On Jan, 28, 2026

8,922 people reported to have side effects when taking Hydrea.
Among them, 39 people (0.44%) have Mouth ulcers.

Could Hydrea cause Mouth ulcers?

Among these 39 people:

How long have people been on Hydrea when they have Mouth ulcers? *

  • < 1 month: 53.85 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 30.77 %
  • 2 - 5 years: 7.69 %
  • 5 - 10 years: 7.69 %
  • 10+ years: 0.0 %

What is the gender of people who have Mouth ulcers when taking Hydrea? *

  • female: 25 %
  • male: 75 %

What is the age of people who have Mouth ulcers when taking Hydrea? *

  • 0-1: 0.0 %
  • 2-9: 5.88 %
  • 10-19: 0.0 %
  • 20-29: 17.65 %
  • 30-39: 5.88 %
  • 40-49: 5.88 %
  • 50-59: 5.88 %
  • 60+: 58.82 %

What are other drugs people take besides Hydrea? *

  1. Jakafi: 8 people, 20.51%
  2. Vitamin C: 7 people, 17.95%
  3. Amlodipine: 7 people, 17.95%
  4. Norco: 6 people, 15.38%
  5. Crestor: 6 people, 15.38%
  6. Promethazine: 6 people, 15.38%
  7. Hydrocodone Bitartrate And Acetaminophen: 6 people, 15.38%
  8. Norvasc: 5 people, 12.82%
  9. Augmentin: 5 people, 12.82%
  10. Tamsulosin: 5 people, 12.82%

What are other side effects people have besides Mouth ulcers? *

  1. White Blood Cell Count Increased: 18 people, 46.15%
  2. Haemoglobin Decreased: 13 people, 33.33%
  3. Red Blood Cell Count Decreased: 12 people, 30.77%
  4. Weakness: 11 people, 28.21%
  5. Rashes (redness): 11 people, 28.21%
  6. Fatigue (feeling of tiredness): 10 people, 25.64%
  7. Hypoaesthesia (reduced sense of touch or sensation): 10 people, 25.64%
  8. Hernia (hernia happens when part of an internal organ or tissue bulges through a weak area of muscle): 9 people, 23.08%
  9. Night Sweats (sweating in night): 9 people, 23.08%
  10. Abdominal Pain: 9 people, 23.08%

What are the existing conditions these people have? *

  1. Primary Myelofibrosis (primary disorder of the bone marrow): 17 people, 43.59%
  2. Polycythaemia Vera (blood disorder in which the bone marrow makes too many red blood cells): 15 people, 38.46%
  3. High Blood Pressure: 11 people, 28.21%
  4. Hyperlipidaemia (presence of excess lipids in the blood): 7 people, 17.95%
  5. Rosacea (a skin condition that causes facial redness): 6 people, 15.38%
  6. Retinopathy (acute damage to the retina of the eye): 6 people, 15.38%
  7. Pain: 6 people, 15.38%
  8. Stress And Anxiety: 6 people, 15.38%
  9. Enlarged Prostate: 5 people, 12.82%
  10. Sinusitis (inflammation of sinus): 5 people, 12.82%

* Approximation only. Some reports may have incomplete information.

Do you take Hydrea and have Mouth ulcers?

- Check whether Mouth ulcers 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 Hydrea:

Mouth ulcers treatments and more:

How severe was Mouth ulcers and when was it recovered:

Expand to all the drugs that have ingredients of hydroxyurea:

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 Hydrea:

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 Mouth ulcers:

Browse all the conditions that are associated with Mouth ulcers:


How the study uses the data?

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