Tecfidera and Drowsiness - a phase IV clinical study of FDA data

Summary:

Drowsiness is reported as a side effect among people who take Tecfidera (dimethyl fumarate), especially for people who are female, 50-59 old, have been taking the drug for < 1 month also take Ampyra, and have Gait disturbance.

The phase IV clinical study analyzes which people have Drowsiness 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 Drowsiness?

Drowsiness is found to be associated with 2,876 drugs and 4,754 conditions by eHealthMe. Check the latest studies of Drowsiness.

On Sep, 26, 2025

129,391 people reported to have side effects when taking Tecfidera.
Among them, 1,162 people (0.9%) have Drowsiness.

Among these 1,162 people:

How long have people been on Tecfidera when they have Drowsiness? *

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

female: 78.37 %
male: 21.63 %

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

What are other drugs people take besides Tecfidera? *

What are other side effects people have besides Drowsiness? *

Fatigue (feeling of tiredness): 458 people, 39.41%
Skin Blushing/flushing (a sudden reddening of the face, neck): 264 people, 22.72%
Weakness: 216 people, 18.59%
Nausea (feeling of having an urge to vomit): 182 people, 15.66%
Diarrhea: 157 people, 13.51%
Memory Loss: 148 people, 12.74%
Headache (pain in head): 145 people, 12.48%
Gait Disturbance: 141 people, 12.13%
Pain: 133 people, 11.45%
Fall: 125 people, 10.76%

What are the existing conditions these people have? *

Gait Disturbance: 137 people, 11.79%
Depression: 32 people, 2.75%
Stress And Anxiety: 16 people, 1.38%
Insomnia (sleeplessness): 15 people, 1.29%
Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 11 people, 0.95%
High Blood Cholesterol: 9 people, 0.77%
High Blood Pressure: 9 people, 0.77%
Muscle Spasticity (tight or stiff muscles and an inability to control those muscles): 9 people, 0.77%
Pain: 8 people, 0.69%
Muscle Spasms (muscle contraction): 7 people, 0.60%

* Approximation only. Some reports may have incomplete information.

Do you take Tecfidera and have Drowsiness?

- Check whether Drowsiness 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:

Tecfidera (129,627 reports)

Drowsiness treatments and more:

Drowsiness (269,037 reports)

How severe was Drowsiness and when was it recovered:

Drowsiness in Tecfidera

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 Drowsiness:

Drowsiness (2,876 drugs)

Browse all the conditions that are associated with Drowsiness:

Drowsiness (4,754 conditions)

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.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.