Aleve and Hepatotoxicity - a phase IV clinical study of FDA data

Summary:

Hepatotoxicity is reported as a side effect among people who take Aleve (naproxen sodium), especially for people who are female, 60+ old, also take Norvasc, and have Scrotal pain.

The phase IV clinical study analyzes which people have Hepatotoxicity when taking Aleve. It is created by eHealthMe based on reports of 68,206 people who have side effects when taking Aleve from the FDA, and is updated regularly.

What is Aleve?

Aleve has active ingredients of naproxen sodium. It is often used in pain. eHealthMe is studying from 70,279 Aleve users. Check the latest studies of Aleve.

What is Hepatotoxicity?

Hepatotoxicity (chemical-driven liver damage) is found to be associated with 1,088 drugs and 1,249 conditions by eHealthMe. Check the latest studies of Hepatotoxicity.

On Jul, 04, 2026

68,206 people reported to have side effects when taking Aleve.
Among them, 11 people (0.02%) have Hepatotoxicity.

Among these 11 people:

What is the gender of people who have Hepatotoxicity when taking Aleve? *

female: 60 %
male: 40 %

What is the age of people who have Hepatotoxicity when taking Aleve? *

What are other drugs people take besides Aleve? *

What are other side effects people have besides Hepatotoxicity? *

Hepatic Failure (liver failure): 5 people, 45.45%
Ascites (accumulation of fluid in the abdominal cavity): 3 people, 27.27%
Rhabdomyolysis (a condition in which damaged skeletal muscle tissue breaks down): 2 people, 18.18%
Abdominal Pain: 2 people, 18.18%
Abdominal Tenderness: 2 people, 18.18%
Acute Kidney Failure: 2 people, 18.18%
Blood Bilirubin Increased: 2 people, 18.18%
Fatigue (feeling of tiredness): 2 people, 18.18%
Fever: 2 people, 18.18%
Hepatitis A: 2 people, 18.18%

What are the existing conditions these people have? *

Scrotal Pain: 2 people, 18.18%
Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 1 person, 9.09%
Toothaches (tooth pain): 1 person, 9.09%
Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 1 person, 9.09%
Scrotal Infection (infection in scrotum area): 1 person, 9.09%
Pain In Extremity: 1 person, 9.09%
Osteoporosis (bones weak and more likely to break): 1 person, 9.09%
Osteopenia (a condition where bone mineral density is lower than normal): 1 person, 9.09%
Lung Neoplasm Malignant (cancer tumour of lung): 1 person, 9.09%
Joint Pain: 1 person, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Aleve and have Hepatotoxicity?

- Check whether Hepatotoxicity 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 Aleve:

Aleve (70,279 reports)

Hepatotoxicity treatments and more:

Hepatotoxicity (23,823 reports)

Browse all side effects of Aleve:

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 Hepatotoxicity:

Hepatotoxicity (1,088 drugs)

Browse all the conditions that are associated with Hepatotoxicity:

Hepatotoxicity (1,249 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on naproxen sodium (the active ingredients of Aleve) and Aleve (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.