Lioresal and Encephalopathy - a phase IV clinical study of FDA data

Summary:

Encephalopathy is reported as a side effect among people who take Lioresal (baclofen), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Tylenol, and have Muscle spasticity.

The phase IV clinical study analyzes which people have Encephalopathy when taking Lioresal. It is created by eHealthMe based on reports of 20,521 people who have side effects when taking Lioresal from the FDA, and is updated regularly.

What is Lioresal?

Lioresal has active ingredients of baclofen. It is often used in multiple sclerosis. eHealthMe is studying from 20,572 Lioresal users. Check the latest studies of Lioresal.

What is Encephalopathy?

Encephalopathy (functioning of the brain is affected by some agent or condition) is found to be associated with 1,459 drugs and 1,606 conditions by eHealthMe. Check the latest studies of Encephalopathy.

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, 01, 2026

20,521 people reported to have side effects when taking Lioresal.
Among them, 65 people (0.32%) have Encephalopathy.

Could Lioresal cause Encephalopathy?

Among these 65 people:

How long have people been on Lioresal when they have Encephalopathy? *

  • < 1 month: 71.43 %
  • 1 - 6 months: 14.29 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 14.29 %

What is the gender of people who have Encephalopathy when taking Lioresal? *

  • female: 41.27 %
  • male: 58.73 %

What is the age of people who have Encephalopathy when taking Lioresal? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 1.85 %
  • 20-29: 5.56 %
  • 30-39: 14.81 %
  • 40-49: 12.96 %
  • 50-59: 29.63 %
  • 60+: 35.19 %

What are other drugs people take besides Lioresal? *

  1. Tylenol: 15 people, 23.08%
  2. Cymbalta: 13 people, 20.00%
  3. Colace: 11 people, 16.92%
  4. Zofran: 10 people, 15.38%
  5. Gilenya: 9 people, 13.85%
  6. Neurontin: 9 people, 13.85%
  7. Keppra: 8 people, 12.31%
  8. Depakote: 8 people, 12.31%
  9. Vitamin D3: 7 people, 10.77%
  10. Ativan: 7 people, 10.77%

What are other side effects people have besides Encephalopathy? *

  1. Urinary Tract Infection: 15 people, 23.08%
  2. Confusional State: 14 people, 21.54%
  3. Fatigue (feeling of tiredness): 11 people, 16.92%
  4. Acute Kidney Failure: 8 people, 12.31%
  5. Drowsiness: 8 people, 12.31%
  6. Pneumonia: 8 people, 12.31%
  7. Weakness: 8 people, 12.31%
  8. Swallowing Difficulty: 7 people, 10.77%
  9. Sepsis (a severe blood infection that can lead to organ failure and death): 7 people, 10.77%
  10. Infection: 7 people, 10.77%

What are the existing conditions these people have? *

  1. Muscle Spasticity (tight or stiff muscles and an inability to control those muscles): 18 people, 27.69%
  2. Pain: 12 people, 18.46%
  3. Nausea (feeling of having an urge to vomit): 10 people, 15.38%
  4. Depression: 8 people, 12.31%
  5. Stress And Anxiety: 8 people, 12.31%
  6. Fever: 6 people, 9.23%
  7. Constipation: 6 people, 9.23%
  8. Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 5 people, 7.69%
  9. Seizures (abnormal excessive or synchronous neuronal activity in the brain): 5 people, 7.69%
  10. High Blood Pressure: 4 people, 6.15%

* Approximation only. Some reports may have incomplete information.

Do you take Lioresal and have Encephalopathy?

- Check whether Encephalopathy 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 Lioresal:

Encephalopathy treatments and more:

How severe was Encephalopathy and when was it recovered:

Expand to all the drugs that have ingredients of baclofen:

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 Lioresal:

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 Encephalopathy:

Browse all the conditions that are associated with Encephalopathy:

Related publications that referenced our studies


How the study uses the data?

The study uses data from the FDA. It is based on baclofen (the active ingredients of Lioresal) and Lioresal (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.



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