Sovaldi 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 Sovaldi (sofosbuvir), especially for people who are male, 60+ old, have been taking the drug for 1 - 6 months also take Zopiclone, and have Hepatitis c.

The phase IV clinical study analyzes which people have Mental status changes when taking Sovaldi. It is created by eHealthMe based on reports of 12,681 people who have side effects when taking Sovaldi from the FDA, and is updated regularly.

What is Sovaldi?

Sovaldi has active ingredients of sofosbuvir. eHealthMe is studying from 12,697 Sovaldi users. Check the latest studies of Sovaldi.

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 1,546 drugs and 1,731 conditions by eHealthMe. Check the latest studies of Mental status changes.



On Jul, 25, 2025

12,681 people reported to have side effects when taking Sovaldi.
Among them, 19 people (0.15%) have Mental status changes.

Could Sovaldi cause Mental status changes?

Among these 19 people:

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

  • < 1 month: 10 %
  • 1 - 6 months: 70 %
  • 6 - 12 months: 20 %
  • 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 Mental status changes when taking Sovaldi? *

  • female: 50 %
  • male: 50 %

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

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 26.67 %
  • 50-59: 33.33 %
  • 60+: 40.0 %

What are other drugs people take besides Sovaldi? *

  1. Zopiclone: 3 people, 15.79%
  2. Sertraline: 2 people, 10.53%
  3. Daklinza: 2 people, 10.53%
  4. Lasix: 2 people, 10.53%
  5. Melatonin: 2 people, 10.53%
  6. Olysio: 2 people, 10.53%
  7. Rebetol: 2 people, 10.53%
  8. Pegintron: 2 people, 10.53%
  9. Suboxone: 2 people, 10.53%
  10. Rifaximin: 1 person, 5.26%

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

  1. Fatigue (feeling of tiredness): 6 people, 31.58%
  2. Insomnia (sleeplessness): 5 people, 26.32%
  3. Dry Mouth: 5 people, 26.32%
  4. Agitation (state of anxiety or nervous excitement): 5 people, 26.32%
  5. Disturbance In Attention: 4 people, 21.05%
  6. Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 4 people, 21.05%
  7. Irritability: 4 people, 21.05%
  8. Personality Change: 4 people, 21.05%
  9. Eczema (patches of skin become rough and inflamed, with itching and bleeding blisters): 4 people, 21.05%
  10. Rectal Haemorrhage (bleeding from anus): 4 people, 21.05%

What are the existing conditions these people have? *

  1. Hepatitis C: 15 people, 78.95%
  2. Insomnia (sleeplessness): 4 people, 21.05%
  3. Swelling: 2 people, 10.53%
  4. High Blood Pressure: 2 people, 10.53%
  5. Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 2 people, 10.53%
  6. Pain: 1 person, 5.26%
  7. Depressed Mood: 1 person, 5.26%
  8. Cardiac Failure: 1 person, 5.26%
  9. Agitation (state of anxiety or nervous excitement): 1 person, 5.26%

* Approximation only. Some reports may have incomplete information.

Do you take Sovaldi 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
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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Sovaldi:

Mental status changes treatments and more:

How severe was Mental status changes and when was it recovered:

Browse all side effects of Sovaldi:

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:

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


How the study uses the data?

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