Zofran and Canker sores - a phase IV clinical study of FDA data

Summary:

Canker sores is reported as a side effect among people who take Zofran (ondansetron hydrochloride), especially for people who are female, 40-49 old, have been taking the drug for < 1 month also take Acetaminophen, and have Insomnia.

The phase IV clinical study analyzes which people have Canker sores when taking Zofran. It is created by eHealthMe based on reports of 93,713 people who have side effects when taking Zofran from the FDA, and is updated regularly.

What is Zofran?

Zofran has active ingredients of ondansetron hydrochloride. It is often used in nausea. eHealthMe is studying from 94,987 Zofran users. Check the latest studies of Zofran.

What is Canker sores?

Canker sores (painful, open sore in the mouth) is found to be associated with 613 drugs and 1,225 conditions by eHealthMe. Check the latest studies of Canker sores.



On Jul, 13, 2026

93,713 people reported to have side effects when taking Zofran.
Among them, 61 people (0.07%) have Canker sores.

Could Zofran cause Canker sores?

Among these 61 people:

How long have people been on Zofran when they have Canker sores? *

  • < 1 month: 71.43 %
  • 1 - 6 months: 7.14 %
  • 6 - 12 months: 14.29 %
  • 1 - 2 years: 7.14 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Canker sores when taking Zofran? *

  • female: 80.77 %
  • male: 19.23 %

What is the age of people who have Canker sores when taking Zofran? *

  • 0-1: 15.38 %
  • 2-9: 7.69 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 53.85 %
  • 50-59: 0.0 %
  • 60+: 23.08 %

What are other drugs people take besides Zofran? *

  1. Acetaminophen: 22 people, 36.07%
  2. Lovenox: 16 people, 26.23%
  3. Ursodiol: 16 people, 26.23%
  4. Pantoprazole Sodium: 16 people, 26.23%
  5. Trazodone Hydrochloride: 15 people, 24.59%
  6. Alprazolam: 15 people, 24.59%
  7. Dexamethasone: 15 people, 24.59%
  8. Dronabinol: 15 people, 24.59%
  9. Emend: 15 people, 24.59%
  10. Euthyrox: 15 people, 24.59%

What are other side effects people have besides Canker sores? *

  1. Diarrhea: 25 people, 40.98%
  2. Thrombocytopenia (decrease of platelets in blood): 24 people, 39.34%
  3. Iron Deficiency Anaemia: 21 people, 34.43%
  4. Weakness: 19 people, 31.15%
  5. White Blood Cell Count Decreased: 18 people, 29.51%
  6. Agranulocytosis (a deficiency of granulocytes in the blood, causing increased vulnerability to infection): 17 people, 27.87%
  7. Pain: 16 people, 26.23%
  8. Blood Bilirubin Increased: 15 people, 24.59%
  9. Intracranial Pressure Increased (high pressure inside the skull and thus in the brain tissue and cerebrospinal fluid): 15 people, 24.59%
  10. General Physical Health Deterioration (weak health status): 15 people, 24.59%

What are the existing conditions these people have? *

  1. Diarrhea: 15 people, 24.59%
  2. Gamma-Glutamyltransferase Increased: 15 people, 24.59%
  3. Insomnia (sleeplessness): 15 people, 24.59%
  4. The Flu (the flu is caused by an influenza virus): 12 people, 19.67%
  5. Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 9 people, 14.75%
  6. Immunodeficiency Common Variable: 9 people, 14.75%
  7. Intracranial Pressure Increased (high pressure inside the skull and thus in the brain tissue and cerebrospinal fluid): 4 people, 6.56%
  8. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 3 people, 4.92%
  9. Vomiting In Pregnancy: 2 people, 3.28%
  10. Astrocytoma (tumour of the brain that originate in a particular kind of glial-cells): 2 people, 3.28%

* Approximation only. Some reports may have incomplete information.

Do you take Zofran and have Canker sores?

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Related studies:

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

Canker sores treatments and more:

How severe was Canker sores and when was it recovered:

Expand to all the drugs that have ingredients of ondansetron hydrochloride:

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 Zofran:

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 Canker sores:

Browse all the conditions that are associated with Canker sores:


How the study uses the data?

The study uses data from the FDA. It is based on ondansetron hydrochloride (the active ingredients of Zofran) and Zofran (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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