Profen and Hypospadias - a phase IV clinical study of FDA data

Summary:

Hypospadias is reported as a side effect among people who take Profen (ibuprofen), especially for people who are 0-1 old, also take Lithium Carbonate, and have Depression.

The phase IV clinical study analyzes which people have Hypospadias 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 Hypospadias?

Hypospadias (an abnormal condition in males in which the urethra opens on the under surface of the penis) is found to be associated with 137 drugs and 59 conditions by eHealthMe. Check the latest studies of Hypospadias.

On Aug, 09, 2026

239,319 people reported to have side effects when taking Profen.
Among them, 31 people (0.01%) have Hypospadias.

Among these 31 people:

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

What are other drugs people take besides Profen? *

What are other side effects people have besides Hypospadias? *

Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 19 people, 61.29%
Small For Dates Baby (an unborn baby is growing more slowly and is smaller than most babies are at the same age): 6 people, 19.35%
Cerebral Calcification (abnormal deposits of calcium in certain areas of the brain): 6 people, 19.35%
Premature Baby: 4 people, 12.90%
Low Birth Weight Baby: 4 people, 12.90%
Neural Tube Defect (birth defects of the brain, spine, or spinal cord): 3 people, 9.68%
Maternal Exposure During Pregnancy (use of substance during pregnancy): 3 people, 9.68%
Premature Delivery: 3 people, 9.68%
Apgar Score Low: 3 people, 9.68%
Respiratory Distress Syndrome (Rds) In Infants (respiratory disease of newborn babies, especially premature babies, characterized by distressful breathing, cyanosis, and the formation of a glassy membrane over the alveoli of the lungs): 2 people, 6.45%

What are the existing conditions these people have? *

Headache (pain in head): 8 people, 25.81%
Depression: 8 people, 25.81%
Schizoaffective Disorder (a mental disorder characterized by disordered thought): 5 people, 16.13%
Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 5 people, 16.13%
Borderline Personality Disorder: 5 people, 16.13%
Indigestion: 3 people, 9.68%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 3 people, 9.68%
Fever: 3 people, 9.68%
Juvenile Rheumatoid Arthritis (joint inflammation in children due to systemic disease): 2 people, 6.45%
Stress And Anxiety: 1 person, 3.23%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Hypospadias?

- Check whether Hypospadias 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)

Hypospadias treatments and more:

Hypospadias (2,613 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 Hypospadias:

Hypospadias (137 drugs)

Browse all the conditions that are associated with Hypospadias:

Hypospadias (59 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.