Profen and Application site burn - a phase IV clinical study of FDA data

Summary:

Application site burn is reported as a side effect among people who take Profen (ibuprofen), especially for people who are female, 30-39 old, also take Acetaminophen, and have Stress and anxiety.

The phase IV clinical study analyzes which people have Application site burn 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 245,312 Profen users. Check the latest studies of Profen.

What is Application site burn?

Application site burn is found to be associated with 221 drugs and 409 conditions by eHealthMe. Check the latest studies of Application site burn.

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 Sep, 02, 2026

239,319 people reported to have side effects when taking Profen.
Among them, 32 people (0.01%) have Application site burn.

Could Profen cause Application site burn?

Among these 32 people:

What is the gender of people who have Application site burn when taking Profen? *

female: 70.97 %
male: 29.03 %

What is the age of people who have Application site burn when taking Profen? *

What are other drugs people take besides Profen? *

Acetaminophen: 5 people, 15.62%
Clonazepam: 4 people, 12.50%
Lidocaine Hydrochloride: 4 people, 12.50%
Depakote Er: 4 people, 12.50%
Omeprazole: 4 people, 12.50%
Buspar: 4 people, 12.50%
Albuterol: 4 people, 12.50%
Tramadol Hydrochloride: 3 people, 9.38%
Paracetamol: 3 people, 9.38%
Maxalt: 3 people, 9.38%

What are other side effects people have besides Application site burn? *

Application Site Vesicles (small bubble within a cell at application site): 7 people, 21.88%
Hypersensitivity: 6 people, 18.75%
Rashes (redness): 6 people, 18.75%
Application Site Scab (hard coating on the skin formed at application site): 5 people, 15.62%
Application Site Irritation: 5 people, 15.62%
Back Injury: 5 people, 15.62%
Application Site Pain: 5 people, 15.62%
Application Site Discoloration: 5 people, 15.62%
Application Site Erythema (redness of the skin at application site): 4 people, 12.50%
Burning Sensation: 4 people, 12.50%

What are the existing conditions these people have? *

Stress And Anxiety: 9 people, 28.12%
Muscle Spasms (muscle contraction): 7 people, 21.88%
Joint Pain: 5 people, 15.62%
Fibromyalgia (a long-term condition which causes pain all over the body): 5 people, 15.62%
Muscle Strain (an injury to a muscle in which the muscle fibres tear): 5 people, 15.62%
Bipolar Disorder (mood disorder): 4 people, 12.50%
Neck Pain: 3 people, 9.38%
Headache (pain in head): 2 people, 6.25%
Prostate Cancer: 2 people, 6.25%
Insomnia (sleeplessness): 2 people, 6.25%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Application site burn?

- Check whether Application site burn 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 (245,312 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 Application site burn:

Application site burn (221 drugs)

Browse all the conditions that are associated with Application site burn:

Application site burn (409 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.