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

Summary:

Macule is reported as a side effect among people who take Profen (ibuprofen), especially for people who are female, 40-49 old, have been taking the drug for < 1 month also take Cosentyx, and have Psoriasis.

The phase IV clinical study analyzes which people have Macule 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 245,305 Profen users. Check the latest studies of Profen.

What is Macule?

Macule (a discoloured spot on the skin) is found to be associated with 320 drugs and 695 conditions by eHealthMe. Check the latest studies of Macule.

On Nov, 03, 2025

239,319 people reported to have side effects when taking Profen.
Among them, 44 people (0.02%) have Macule.

Among these 44 people:

How long have people been on Profen when they have Macule? *

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

female: 79.41 %
male: 20.59 %

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

What are other drugs people take besides Profen? *

What are other side effects people have besides Macule? *

Rashes (redness): 27 people, 61.36%
Fatigue (feeling of tiredness): 13 people, 29.55%
Oral Disorder (mouth disease): 11 people, 25.00%
Psoriasis (immune-mediated disease that affects the skin): 11 people, 25.00%
Itching: 10 people, 22.73%
Haematemesis (vomiting of blood): 10 people, 22.73%
Papule: 9 people, 20.45%
Erythema Multiforme (a type of hypersensitivity reaction): 9 people, 20.45%
Malaise (a feeling of general discomfort or uneasiness): 9 people, 20.45%
Pain In Extremity: 8 people, 18.18%

What are the existing conditions these people have? *

Psoriasis (immune-mediated disease that affects the skin): 11 people, 25.00%
Ankylosing Spondylitis (type of arthritis affecting the spine): 10 people, 22.73%
Fever: 4 people, 9.09%
Influenza Like Illness: 4 people, 9.09%
Toothaches (tooth pain): 3 people, 6.82%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 3 people, 6.82%
Dysmenorrhea (painful menstruation): 3 people, 6.82%
Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 2 people, 4.55%
Asthma: 2 people, 4.55%
Blood Pressure Abnormal: 2 people, 4.55%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Macule?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Profen:

Profen (245,305 reports)

Macule treatments and more:

Macule (3,263 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 Macule:

Macule (320 drugs)

Browse all the conditions that are associated with Macule:

Macule (695 conditions)

Drugs similar to Profen and Macule :

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.