Profen and Gallstones - a phase IV clinical study of FDA data
Summary:
We study 225,403 people who have side effects when taking Profen. Gallstones is found, especially among people who are female, 20-29 old, have been taking the drug for 2 - 5 years, also take Yasmin and have Birth control.
The phase IV clinical study analyzes which people take Profen and have Gallstones. It is created by eHealthMe based on reports from the FDA, and is updated regularly. You may 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 700+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.
225,403 people reported to have side effects when taking Profen.
Among them, 1,943 people (0.86%) have Gallstones.
What is Profen?
Profen has active ingredients of ibuprofen. It is used in pain. Currently, eHealthMe is studying from 231,301 Profen users.
What is Gallstones?
Gallstones (stone formation by bile component) is found to be associated with 2,911 drugs and 2,059 conditions by eHealthMe. Currently, we are studying 48,349 people who have Gallstones.
Number of Profen and Gallstones reports submitted per year:

Time on Profen when people have Gallstones *:
Gender of people who have Gallstones when taking Profen*:
Age of people who have Gallstones when taking Profen *:
Common drugs people take besides Profen *:
Common side effects people have besides Gallstones *:
Common conditions people have *:
* Approximation only. Some reports may have incomplete information.
Do you take Profen and have Gallstones?
Check whether Gallstones is associated with a drug or a conditionHow 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
- Moslim MA, Sodeman TC, Nawras AT, "A Case of Suggested Ibuprofen-Induced Acute Pancreatitis", American journal of therapeutics, 2016 Nov .
Related studies
Profen side effects by duration, gender and age:
- Profen side effects (231,301 reports)
Gallstones treatments and more:
- Gallstones (48,349 reports)
Common drugs associated with Gallstones:
- Yasmin: 5,611 reports
- Yaz: 5,016 reports
- Aspirin: 2,291 reports
- Prednisone: 2,220 reports
- Metformin: 2,140 reports
- Humira: 2,012 reports
- Profen: 1,943 reports
- Ibu: 1,926 reports
- Ibuprofen: 1,865 reports
- Methotrexate: 1,686 reports
All the drugs that are associated with Gallstones:
- Gallstones (2,911 drugs)
Common conditions associated with Gallstones:
- Birth control: 3,414 reports
- High blood pressure: 3,234 reports
- Rheumatoid arthritis: 2,737 reports
- Multiple sclerosis: 2,269 reports
- Pain: 2,023 reports
All the conditions that are associated with Gallstones:
- Gallstones (2,059 conditions)
How the study uses the data?
The study uses data from the FDA. It is based on ibuprofen (the active ingredients of Profen) and Profen (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 700+ 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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