Voltaren and Leukoencephalopathy - a phase IV clinical study of FDA data

Summary:

Leukoencephalopathy is reported as a side effect among people who take Voltaren (diclofenac sodium), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Aredia, and have Rheumatoid arthritis.

The phase IV clinical study analyzes which people have Leukoencephalopathy when taking Voltaren. It is created by eHealthMe based on reports of 81,356 people who have side effects when taking Voltaren from the FDA, and is updated regularly.

What is Voltaren?

Voltaren has active ingredients of diclofenac sodium. It is often used in arthritis. eHealthMe is studying from 82,346 Voltaren users. Check the latest studies of Voltaren.

What is Leukoencephalopathy?

Leukoencephalopathy (disease of the white matter in the brain) is found to be associated with 378 drugs and 626 conditions by eHealthMe. Check the latest studies of Leukoencephalopathy.

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 Sep, 03, 2026

81,356 people reported to have side effects when taking Voltaren.
Among them, 32 people (0.04%) have Leukoencephalopathy.

Could Voltaren cause Leukoencephalopathy?

Among these 32 people:

How long have people been on Voltaren when they have Leukoencephalopathy? *

What is the gender of people who have Leukoencephalopathy when taking Voltaren? *

female: 43.75 %
male: 56.25 %

What is the age of people who have Leukoencephalopathy when taking Voltaren? *

What are other drugs people take besides Voltaren? *

What are other side effects people have besides Leukoencephalopathy? *

Depressed Level Of Consciousness: 10 people, 31.25%
Brain Oedema (excess accumulation of fluid in the intracellular or extracellular spaces of the brain): 7 people, 21.88%
High Blood Pressure: 5 people, 15.62%
Acute Kidney Failure: 4 people, 12.50%
Cardiac Failure: 4 people, 12.50%
Tremor (trembling or shaking movements in one or more parts of your body): 4 people, 12.50%
Confusion: 4 people, 12.50%
Diplopia (double vision): 3 people, 9.38%
Dementia (madness): 3 people, 9.38%
Nuclear Magnetic Resonance Imaging Brain Abnormal: 3 people, 9.38%

What are the existing conditions these people have? *

Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 10 people, 31.25%
Back Pain: 7 people, 21.88%
Pancytopenia (medical condition in which there is a reduction in the number of red and white blood cells, as well as platelets): 4 people, 12.50%
Fever: 4 people, 12.50%
Osteoporosis (bones weak and more likely to break): 2 people, 6.25%
Gastric Ulcer (stomach ulcer): 2 people, 6.25%
Breast Cancer Metastatic: 2 people, 6.25%
Psoriasis (immune-mediated disease that affects the skin): 1 person, 3.12%
Inflammation: 1 person, 3.12%
Infection: 1 person, 3.12%

* Approximation only. Some reports may have incomplete information.

Do you take Voltaren and have Leukoencephalopathy?

- Check whether Leukoencephalopathy 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 Voltaren:

Voltaren (82,346 reports)

Browse all side effects of Voltaren:

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 Leukoencephalopathy:

Leukoencephalopathy (378 drugs)

Browse all the conditions that are associated with Leukoencephalopathy:

Leukoencephalopathy (626 conditions)

How the study uses the data?

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