Fabrazyme and Mental status changes - a phase IV clinical study of FDA data

Summary:

Mental status changes is reported as a side effect among people who take Fabrazyme (agalsidase beta), especially for people who are male, 50-59 old, have been taking the drug for 10+ years also take Mycobutin, and have Fabry's disease.

The phase IV clinical study analyzes which people have Mental status changes when taking Fabrazyme. It is created by eHealthMe based on reports of 10,390 people who have side effects when taking Fabrazyme from the FDA, and is updated regularly.

What is Fabrazyme?

Fabrazyme has active ingredients of agalsidase beta. eHealthMe is studying from 10,406 Fabrazyme users. Check the latest studies of Fabrazyme.

What is Mental status changes?

Mental status changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation) is found to be associated with 1,491 drugs and 1,760 conditions by eHealthMe. Check the latest studies of Mental status changes.

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, 02, 2026

10,390 people reported to have side effects when taking Fabrazyme.
Among them, 15 people (0.14%) have Mental status changes.

Could Fabrazyme cause Mental status changes?

Among these 15 people:

How long have people been on Fabrazyme when they have Mental status changes? *

What is the gender of people who have Mental status changes when taking Fabrazyme? *

female: 15.38 %
male: 84.62 %

What is the age of people who have Mental status changes when taking Fabrazyme? *

What are other drugs people take besides Fabrazyme? *

Zyrtec: 2 people, 13.33%
Fioricet: 2 people, 13.33%
Ethambutol Hydrochloride: 2 people, 13.33%
Lasix: 2 people, 13.33%
Lexapro: 2 people, 13.33%
Lisinopril: 2 people, 13.33%
Dilantin: 2 people, 13.33%
Marinol: 2 people, 13.33%
Melatonin: 2 people, 13.33%
Mycobutin: 2 people, 13.33%

What are other side effects people have besides Mental status changes? *

Infection: 7 people, 46.67%
Dehydration (dryness resulting from the removal of water): 7 people, 46.67%
Stroke (sudden death of a portion of the brain cells due to a lack of oxygen): 7 people, 46.67%
Tremor (trembling or shaking movements in one or more parts of your body): 6 people, 40.00%
Fall: 6 people, 40.00%
Hypotension (abnormally low blood pressure): 6 people, 40.00%
Urosepsis (secondary infection that occurs when a urinary tract infection spreads to the bloodstream): 5 people, 33.33%
Confusion: 5 people, 33.33%
Urinary Tract Infection: 5 people, 33.33%
Fainting (loss of consciousness and postural tone): 5 people, 33.33%

What are the existing conditions these people have? *

Fabry's Disease (build up of a particular type of fat, called globotriaosylceramide, in the body's cells): 15 people, 100.00%
Pain: 1 person, 6.67%
Multiple Myeloma (cancer of the plasma cells): 1 person, 6.67%

* Approximation only. Some reports may have incomplete information.

Do you take Fabrazyme and have Mental status changes?

- Check whether Mental status changes 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 Fabrazyme:

Fabrazyme (10,406 reports)

Browse all side effects of Fabrazyme:

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 Mental status changes:

Mental status changes (1,491 drugs)

Browse all the conditions that are associated with Mental status changes:

Mental status changes (1,760 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on agalsidase beta (the active ingredients of Fabrazyme) and Fabrazyme (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.