Profen and Acute psychosis - a phase IV clinical study of FDA data

Summary:

Acute psychosis is reported as a side effect among people who take Profen (ibuprofen), especially for people who are male, 40-49 old, have been taking the drug for < 1 month also take Xanax, and have Multiple sclerosis.

The phase IV clinical study analyzes which people have Acute psychosis 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 Acute psychosis?

Acute psychosis (period of mentally unstable behaviour) is found to be associated with 248 drugs and 542 conditions by eHealthMe. Check the latest studies of Acute psychosis.

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, 41 people (0.02%) have Acute psychosis.

Among these 41 people:

How long have people been on Profen when they have Acute psychosis? *

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

female: 45 %
male: 55 %

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

What are other drugs people take besides Profen? *

What are other side effects people have besides Acute psychosis? *

Insomnia (sleeplessness): 9 people, 21.95%
Agitation (state of anxiety or nervous excitement): 8 people, 19.51%
Suicidal Ideation: 8 people, 19.51%
Depression: 8 people, 19.51%
Delusion (a false belief or opinion): 8 people, 19.51%
Thinking Abnormal: 8 people, 19.51%
Rashes (redness): 7 people, 17.07%
Stress And Anxiety: 7 people, 17.07%
Hallucinations (sensations that appear real but are created by your mind): 7 people, 17.07%
High Blood Pressure: 7 people, 17.07%

What are the existing conditions these people have? *

Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 6 people, 14.63%
Stress And Anxiety: 3 people, 7.32%
Lower Respiratory Tract Infection: 3 people, 7.32%
Hepatitis C: 3 people, 7.32%
Bipolar I Disorder (mood disorder that is characterized by at least one manic or mixed episode): 2 people, 4.88%
Sleep Disorder: 2 people, 4.88%
Osteoarthritis (a joint disease caused by cartilage loss in a joint): 2 people, 4.88%
Cataplexy (loss of muscle tone accompanied by full conscious awareness): 2 people, 4.88%
Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 2 people, 4.88%
Joint Pain: 2 people, 4.88%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Acute psychosis?

- Check whether Acute psychosis 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)

Acute psychosis treatments and more:

Acute psychosis (3,864 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 Acute psychosis:

Acute psychosis (248 drugs)

Browse all the conditions that are associated with Acute psychosis:

Acute psychosis (542 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 .
Loebl T, Raskin S, "A novel case report: acute manic psychotic episode after treatment with niacin", The Journal of neuropsychiatry and clinical neurosciences, 2013 Jan .
Moslim MA, Sodeman TC, Nawras AT, "A Case of Suggested Ibuprofen-Induced Acute Pancreatitis", American journal of therapeutics, 2016 Nov .
Loebl T, Raskin S, "A novel case report: acute manic psychotic episode after treatment with niacin", The Journal of neuropsychiatry and clinical neurosciences, 2013 Jan .

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.