Tecfidera and Neurological decompensation - a phase IV clinical study of FDA data

Summary:

Neurological decompensation is reported as a side effect among people who take Tecfidera (dimethyl fumarate), especially for people who are female, 40-49 old, have been taking the drug for 6 - 12 months also take Ampyra, and have Gait disturbance.

The phase IV clinical study analyzes which people have Neurological decompensation when taking Tecfidera. It is created by eHealthMe based on reports of 129,391 people who have side effects when taking Tecfidera from the FDA, and is updated regularly.

What is Tecfidera?

Tecfidera has active ingredients of dimethyl fumarate. It is often used in multiple sclerosis. eHealthMe is studying from 129,627 Tecfidera users. Check the latest studies of Tecfidera.

What is Neurological decompensation?

Neurological decompensation (inability of brain to maintain proper function) is found to be associated with 262 drugs and 451 conditions by eHealthMe. Check the latest studies of Neurological decompensation.

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, 26, 2026

129,391 people reported to have side effects when taking Tecfidera.
Among them, 12 people (0.01%) have Neurological decompensation.

Could Tecfidera cause Neurological decompensation?

Among these 12 people:

How long have people been on Tecfidera when they have Neurological decompensation? *

  • < 1 month: 20 %
  • 1 - 6 months: 40 %
  • 6 - 12 months: 40 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Neurological decompensation when taking Tecfidera? *

  • female: 58.33 %
  • male: 41.67 %

What is the age of people who have Neurological decompensation when taking Tecfidera? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 100 %
  • 50-59: 0.0 %
  • 60+: 0.0 %

What are other drugs people take besides Tecfidera? *

  1. Ampyra: 3 people, 25.00%
  2. Vitamin D2: 2 people, 16.67%
  3. Vitamin C: 2 people, 16.67%
  4. Rebif: 2 people, 16.67%
  5. Multivitamin: 2 people, 16.67%
  6. Copaxone: 2 people, 16.67%
  7. Zofran: 1 person, 8.33%
  8. Zeposia: 1 person, 8.33%
  9. Tysabri: 1 person, 8.33%
  10. Topamax: 1 person, 8.33%

What are other side effects people have besides Neurological decompensation? *

  1. Drug Ineffective: 4 people, 33.33%
  2. Fatigue (feeling of tiredness): 2 people, 16.67%
  3. Pneumonia: 2 people, 16.67%
  4. Urinary Tract Infection: 2 people, 16.67%
  5. Hypersensitivity: 1 person, 8.33%
  6. Hepatocellular Injury (liver injury): 1 person, 8.33%
  7. Heart Disease: 1 person, 8.33%
  8. General Symptom: 1 person, 8.33%
  9. General Physical Health Deterioration (weak health status): 1 person, 8.33%
  10. Gastrointestinal Motility Disorder (abnormal intestinal contractions): 1 person, 8.33%

What are the existing conditions these people have? *

  1. Gait Disturbance: 2 people, 16.67%
  2. Secondary Progressive Multiple Sclerosis (a stage of ms which comes after relapsing remitting ms in many cases): 1 person, 8.33%
  3. Nausea (feeling of having an urge to vomit): 1 person, 8.33%
  4. Clinically Isolated Syndrome (individual's first neurological episode, caused by inflammation or demyelination of nerve tissue): 1 person, 8.33%

* Approximation only. Some reports may have incomplete information.

Do you take Tecfidera and have Neurological decompensation?

- Check whether Neurological decompensation 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 Tecfidera:

Neurological decompensation treatments and more:

How severe was Neurological decompensation and when was it recovered:

Expand to all the drugs that have ingredients of dimethyl fumarate:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Tecfidera:

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 Neurological decompensation:

Browse all the conditions that are associated with Neurological decompensation:


How the study uses the data?

The study uses data from the FDA. It is based on dimethyl fumarate (the active ingredients of Tecfidera) and Tecfidera (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.

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