Profen and Mitochondrial toxicity - a phase IV clinical study of FDA data

Summary:

Mitochondrial toxicity is reported as a side effect among people who take Profen (ibuprofen), especially for people who are female, 20-29 old, also take Clonazepam, and have Neuralgia.

The phase IV clinical study analyzes which people have Mitochondrial toxicity 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 Mitochondrial toxicity?

Mitochondrial toxicity (a condition in which the mitochondria of a body's cells become damaged or decline significantly in number;) is found to be associated with 86 drugs and 137 conditions by eHealthMe. Check the latest studies of Mitochondrial toxicity.

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, 20, 2026

239,319 people reported to have side effects when taking Profen.
Among them, 34 people (0.01%) have Mitochondrial toxicity.

Could Profen cause Mitochondrial toxicity?

Among these 34 people:

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

female: 96.97 %
male: 3.03 %

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

What are other drugs people take besides Profen? *

What are other side effects people have besides Mitochondrial toxicity? *

Overdose: 16 people, 47.06%
Drowsiness: 14 people, 41.18%
Alanine Aminotransferase Increased: 13 people, 38.24%
Abdominal Pain: 11 people, 32.35%
Metabolic Acidosis (body produces too much acid, or when the kidneys are not removing enough acid from the body): 11 people, 32.35%
Lactic Acidosis (low ph in body tissues): 11 people, 32.35%
International Normalised Ratio Increased: 10 people, 29.41%
Agitation (state of anxiety or nervous excitement): 9 people, 26.47%
Methaemoglobinaemia (a disorder characterized by the presence of a higher than normal level of methemoglobin in blood): 8 people, 23.53%
Leukocytosis (increased white blood cells): 8 people, 23.53%

What are the existing conditions these people have? *

Neuralgia (pain in one or more nerves): 13 people, 38.24%
Polyneuropathy (neurological disorder that occurs when many peripheral nerves throughout the body malfunction simultaneously): 10 people, 29.41%
Myoclonus (a brief, involuntary twitching of a muscle or a group of muscles): 10 people, 29.41%
Nervous System Disorder (a general class of medical conditions affecting the nervous system): 8 people, 23.53%
Suicide Attempt: 7 people, 20.59%
Suicidal Ideation: 2 people, 5.88%
Overdose: 2 people, 5.88%
Stress And Anxiety: 1 person, 2.94%
Mycobacterium Avium Complex Infection: 1 person, 2.94%
Initial Insomnia (feeling of inadequate or poor-quality sleep): 1 person, 2.94%

* Approximation only. Some reports may have incomplete information.

Do you take Profen and have Mitochondrial toxicity?

- Check whether Mitochondrial toxicity 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)

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 Mitochondrial toxicity:

Mitochondrial toxicity (86 drugs)

Browse all the conditions that are associated with Mitochondrial toxicity:

Mitochondrial toxicity (137 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.