Codeine and Breakthrough pain - a phase IV clinical study of FDA data

Summary:

Breakthrough pain is reported as a side effect among people who take Codeine (codeine sulfate), especially for people who are female, 60+ old, also take Sandostatin, and have Abdominal pain.

The phase IV clinical study analyzes which people have Breakthrough pain when taking Codeine. It is created by eHealthMe based on reports of 41,713 people who have side effects when taking Codeine from the FDA, and is updated regularly.

What is Codeine?

Codeine has active ingredients of codeine sulfate. It is often used in pain. eHealthMe is studying from 42,342 Codeine users. Check the latest studies of Codeine.

What is Breakthrough pain?

Breakthrough pain is found to be associated with 271 drugs and 417 conditions by eHealthMe. Check the latest studies of Breakthrough pain.



On Aug, 07, 2026

41,713 people reported to have side effects when taking Codeine.
Among them, 28 people (0.07%) have Breakthrough pain.

Could Codeine cause Breakthrough pain?

Among these 28 people:

What is the gender of people who have Breakthrough pain when taking Codeine? *

  • female: 84 %
  • male: 16 %

What is the age of people who have Breakthrough pain when taking Codeine? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 16.67 %
  • 60+: 83.33 %

What are other drugs people take besides Codeine? *

  1. Sandostatin: 20 people, 71.43%
  2. Breo Ellipta: 14 people, 50.00%
  3. Gabapentin: 6 people, 21.43%
  4. Pancreatin: 4 people, 14.29%
  5. Gliclazide: 4 people, 14.29%
  6. Ms Contin: 3 people, 10.71%
  7. Zopiclone: 2 people, 7.14%
  8. Carbamazepine: 2 people, 7.14%
  9. Diazepam: 2 people, 7.14%
  10. Oxycontin: 2 people, 7.14%

What are other side effects people have besides Breakthrough pain? *

  1. Diarrhea: 21 people, 75.00%
  2. Chest Pain: 20 people, 71.43%
  3. Abdominal Pain Lower: 20 people, 71.43%
  4. High Blood Pressure: 20 people, 71.43%
  5. Pain In Extremity: 20 people, 71.43%
  6. Blood Urine Present: 20 people, 71.43%
  7. Dyspnea (difficult or laboured breathing): 20 people, 71.43%
  8. Urinary Tract Infection: 20 people, 71.43%
  9. Urination - Painful: 20 people, 71.43%
  10. Nausea And Vomiting: 17 people, 60.71%

What are the existing conditions these people have? *

  1. Diarrhea: 20 people, 71.43%
  2. Abdominal Pain: 20 people, 71.43%
  3. Seizures (abnormal excessive or synchronous neuronal activity in the brain): 15 people, 53.57%
  4. Hyperhidrosis (abnormally increased sweating): 15 people, 53.57%
  5. Carcinoid Syndrome (syndrome includes flushing and diarrhoea, and, less frequently, heart failure and bronchoconstriction): 13 people, 46.43%
  6. Gastrointestinal Carcinoma (cancer of stomach or intestine): 12 people, 42.86%
  7. Brain Neoplasm (tumour of brain): 12 people, 42.86%
  8. Cancer Pain: 3 people, 10.71%
  9. Constipation: 2 people, 7.14%
  10. Type 2 Diabetes: 1 person, 3.57%

* Approximation only. Some reports may have incomplete information.

Do you take Codeine and have Breakthrough pain?

- Check whether Breakthrough pain 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 Codeine:

Breakthrough pain treatments and more:

How severe was Breakthrough pain and when was it recovered:

Expand to all the drugs that have ingredients of codeine sulfate:

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 Codeine:

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 Breakthrough pain:

Browse all the conditions that are associated with Breakthrough pain:


How the study uses the data?

The study uses data from the FDA. It is based on codeine sulfate (the active ingredients of Codeine) and Codeine (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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