Profen and Systemic inflammatory response syndrome - a phase IV clinical study of FDA data

Summary:

Systemic inflammatory response syndrome is reported as a side effect among people who take Profen (ibuprofen), especially for people who are male, 60+ 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 Systemic inflammatory response syndrome 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 Systemic inflammatory response syndrome?

Systemic inflammatory response syndrome (an inflammatory state affecting the whole body, frequently a response of the immune system to infection) is found to be associated with 575 drugs and 906 conditions by eHealthMe. Check the latest studies of Systemic inflammatory response syndrome.

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, 28, 2026

239,319 people reported to have side effects when taking Profen.
Among them, 93 people (0.04%) have Systemic inflammatory response syndrome.

Could Profen cause Systemic inflammatory response syndrome?

Among these 93 people:

How long have people been on Profen when they have Systemic inflammatory response syndrome? *

What is the gender of people who have Systemic inflammatory response syndrome when taking Profen? *

female: 46.43 %
male: 53.57 %

What is the age of people who have Systemic inflammatory response syndrome when taking Profen? *

What are other drugs people take besides Profen? *

What are other side effects people have besides Systemic inflammatory response syndrome? *

Pneumonia: 21 people, 22.58%
Erythema Multiforme (a type of hypersensitivity reaction): 18 people, 19.35%
Acute Kidney Failure: 16 people, 17.20%
Cholestasis (a condition where bile cannot flow from the liver to the duodenum): 15 people, 16.13%
Fever: 15 people, 16.13%
Ards (Acute Respiratory Distress Syndrome) (sudden failure of the respiratory (breathing) system): 14 people, 15.05%
Drug Ineffective: 12 people, 12.90%
Multi-Organ Failure (multisystem organ failure): 11 people, 11.83%
Sepsis (a severe blood infection that can lead to organ failure and death): 11 people, 11.83%
Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 9 people, 9.68%

What are the existing conditions these people have? *

Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 11 people, 11.83%
Migraine (headache): 10 people, 10.75%
Fever: 8 people, 8.60%
Headache (pain in head): 7 people, 7.53%
High Blood Pressure: 7 people, 7.53%
Metastatic Renal Cell Carcinoma (spreadable kidney cell tumour): 6 people, 6.45%
Pharyngotonsillitis (inflammation of the pharynx and the tonsils): 6 people, 6.45%
Abdominal Pain Lower: 6 people, 6.45%
Influenza Like Illness: 6 people, 6.45%
Lemierre Syndrome (a disease that is usually caused by fusobacterium necrophorum with pus formation and blood clot filled with bacteria near tonsil): 5 people, 5.38%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Systemic inflammatory response syndrome?

- Check whether Systemic inflammatory response syndrome 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)

Systemic inflammatory response syndrome treatments and more:

Systemic inflammatory response syndrome (5,055 reports)

How severe was Systemic inflammatory response syndrome and when was it recovered:

Systemic inflammatory response syndrome in Profen

Expand to all the drugs that have ingredients of ibuprofen:

Systemic inflammatory response syndrome and drugs with ingredients of ibuprofen (128 reports)

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

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 Systemic inflammatory response syndrome:

Systemic inflammatory response syndrome (575 drugs)

Browse all the conditions that are associated with Systemic inflammatory response syndrome:

Systemic inflammatory response syndrome (906 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.