Profen and Genital lesion - a phase IV clinical study of FDA data

Summary:

Genital lesion is reported as a side effect among people who take Profen (ibuprofen), especially for people who are female, 10-19 old, have been taking the drug for < 1 month also take Acetaminophen, and have Rheumatoid arthritis.

The phase IV clinical study analyzes which people have Genital lesion when taking Profen. It is created by eHealthMe based on reports of 239,319 people who have side effects when taking Profen from the FDA, and is updated regularly.

What is Profen?

Profen has active ingredients of ibuprofen. It is often used in pain. eHealthMe is studying from 245,311 Profen users. Check the latest studies of Profen.

What is Genital lesion?

Genital lesion (sores, warts, or blemishes that appear on the genitals) is found to be associated with 64 drugs and 195 conditions by eHealthMe. Check the latest studies of Genital lesion.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.

On Aug, 30, 2026

239,319 people reported to have side effects when taking Profen.
Among them, 17 people (0.01%) have Genital lesion.

Among these 17 people:

How long have people been on Profen when they have Genital lesion? *

What is the gender of people who have Genital lesion when taking Profen? *

female: 73.33 %
male: 26.67 %

What is the age of people who have Genital lesion when taking Profen? *

What are other drugs people take besides Profen? *

What are other side effects people have besides Genital lesion? *

Erythema Multiforme (a type of hypersensitivity reaction): 11 people, 64.71%
Rashes (redness): 8 people, 47.06%
Fever: 7 people, 41.18%
Oral Disorder (mouth disease): 5 people, 29.41%
Cough: 4 people, 23.53%
Blister (small pocket of fluid within the upper layers of the skin caused by forceful rubbing (friction), burning, freezing, chemical exposure): 4 people, 23.53%
Pharyngeal Lesion: 3 people, 17.65%
Stomatitis (inflammation of mucous membrane of mouth): 3 people, 17.65%
Conjunctivitis (pink eye): 3 people, 17.65%
Pleural Effusion (water on the lungs): 2 people, 11.76%

What are the existing conditions these people have? *

Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 3 people, 17.65%
Tonsillitis (inflammation of tonsil): 2 people, 11.76%
Renal Cell Carcinoma (a kidney cancer): 1 person, 5.88%
Headache (pain in head): 1 person, 5.88%
Fever: 1 person, 5.88%
Epilepsy (common and diverse set of chronic neurological disorders characterized by seizures): 1 person, 5.88%
Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body): 1 person, 5.88%
Attention Deficit Hyperactivity Disorder (a chronic condition including attention difficulty, hyperactivity, and impulsiveness): 1 person, 5.88%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Genital lesion?

- Check whether Genital lesion 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 Profen:

Profen (245,311 reports)

Browse all side effects of Profen:

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 Genital lesion:

Genital lesion (64 drugs)

Browse all the conditions that are associated with Genital lesion:

Genital lesion (195 conditions)

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 .
Moslim MA, Sodeman TC, Nawras AT, "A Case of Suggested Ibuprofen-Induced Acute Pancreatitis", American journal of therapeutics, 2016 Nov .

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.

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.