Fluoxetine and Hepatocellular damage - a phase IV clinical study of FDA data

Summary:

Hepatocellular damage is reported as a side effect among people who take Fluoxetine (fluoxetine hydrochloride), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Lisinopril, and have Type 2 diabetes.

The phase IV clinical study analyzes which people have Hepatocellular damage when taking Fluoxetine. It is created by eHealthMe based on reports of 94,370 people who have side effects when taking Fluoxetine from the FDA, and is updated regularly.

What is Fluoxetine?

Fluoxetine has active ingredients of fluoxetine hydrochloride. It is often used in depression. eHealthMe is studying from 98,826 Fluoxetine users. Check the latest studies of Fluoxetine.

What is Hepatocellular damage?

Hepatocellular damage (liver damage) is found to be associated with 503 drugs and 610 conditions by eHealthMe. Check the latest studies of Hepatocellular damage.

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, 31, 2026

94,370 people reported to have side effects when taking Fluoxetine.
Among them, 46 people (0.05%) have Hepatocellular damage.

Could Fluoxetine cause Hepatocellular damage?

Among these 46 people:

How long have people been on Fluoxetine when they have Hepatocellular damage? *

What is the gender of people who have Hepatocellular damage when taking Fluoxetine? *

female: 39.13 %
male: 60.87 %

What is the age of people who have Hepatocellular damage when taking Fluoxetine? *

What are other drugs people take besides Fluoxetine? *

Lisinopril: 19 people, 41.30%
Alprazolam: 15 people, 32.61%
Levothyroxine Sodium: 13 people, 28.26%
Aspirin: 12 people, 26.09%
Rabeprazole Sodium: 12 people, 26.09%
Dothiepin Hydrochloride: 12 people, 26.09%
Clonazepam: 12 people, 26.09%
Temazepam: 10 people, 21.74%
Fentanyl: 9 people, 19.57%
Avandia: 5 people, 10.87%

What are other side effects people have besides Hepatocellular damage? *

Malaise (a feeling of general discomfort or uneasiness): 16 people, 34.78%
Cardiac Failure Congestive: 13 people, 28.26%
Hepatomegaly (abnormal enlargement of the liver): 13 people, 28.26%
Pleural Effusion (water on the lungs): 13 people, 28.26%
Constipation: 13 people, 28.26%
Alanine Aminotransferase Increased: 12 people, 26.09%
Dyspnea (difficult or laboured breathing): 11 people, 23.91%
Bundle Branch Block Right (absence of transmission of electric impulses from the atrioventricular (av) bundle of his to the right ventricle): 11 people, 23.91%
Lactic Acidosis (low ph in body tissues): 11 people, 23.91%
Diarrhea: 11 people, 23.91%

What are the existing conditions these people have? *

Type 2 Diabetes: 10 people, 21.74%
Sleep Disorder: 6 people, 13.04%
Panic Disorder: 3 people, 6.52%
Bipolar Disorder (mood disorder): 2 people, 4.35%
Wound Infection: 1 person, 2.17%
Restless Leg Syndrome (a powerful urge to move your legs): 1 person, 2.17%
Obsessive-Compulsive Disorder (an anxiety disorder characterized by intrusive thoughts that produce uneasiness, apprehension, fear, or worry;): 1 person, 2.17%
Ill-Defined Disorder: 1 person, 2.17%
Delusional Disorder, Unspecified Type: 1 person, 2.17%
Atrial Fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles): 1 person, 2.17%

* Approximation only. Some reports may have incomplete information.

Do you take Fluoxetine and have Hepatocellular damage?

- Check whether Hepatocellular damage 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 Fluoxetine:

Fluoxetine (98,826 reports)

Browse all side effects of Fluoxetine:

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 Hepatocellular damage:

Hepatocellular damage (503 drugs)

Browse all the conditions that are associated with Hepatocellular damage:

Hepatocellular damage (610 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on fluoxetine hydrochloride (the active ingredients of Fluoxetine) and Fluoxetine (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.