Sovaldi and Acute hepatic failure - a phase IV clinical study of FDA data

Summary:

Acute hepatic failure is reported as a side effect among people who take Sovaldi (sofosbuvir), especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months also take Olysio, and have Hepatitis c.

The phase IV clinical study analyzes which people have Acute hepatic failure 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 Acute hepatic failure?

Acute hepatic failure is found to be associated with 710 drugs and 1,182 conditions by eHealthMe. Check the latest studies of Acute hepatic failure.



On Jul, 28, 2026

12,681 people reported to have side effects when taking Sovaldi.
Among them, 20 people (0.16%) have Acute hepatic failure.

Could Sovaldi cause Acute hepatic failure?

Among these 20 people:

How long have people been on Sovaldi when they have Acute hepatic failure? *

  • < 1 month: 14.29 %
  • 1 - 6 months: 85.71 %
  • 6 - 12 months: 0.0 %
  • 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 Acute hepatic failure when taking Sovaldi? *

  • female: 70 %
  • male: 30 %

What is the age of people who have Acute hepatic failure when taking Sovaldi? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 5.26 %
  • 40-49: 15.79 %
  • 50-59: 26.32 %
  • 60+: 52.63 %

What are other drugs people take besides Sovaldi? *

  1. Olysio: 11 people, 55.00%
  2. Rebetol: 2 people, 10.00%
  3. Tilade: 1 person, 5.00%
  4. Revia: 1 person, 5.00%
  5. Ranolazine: 1 person, 5.00%
  6. Pegasys: 1 person, 5.00%
  7. Olmetec: 1 person, 5.00%
  8. Novorapid: 1 person, 5.00%
  9. Levemir: 1 person, 5.00%
  10. Lasix: 1 person, 5.00%

What are other side effects people have besides Acute hepatic failure? *

  1. Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 6 people, 30.00%
  2. Multi-Organ Failure (multisystem organ failure): 4 people, 20.00%
  3. Diarrhea: 4 people, 20.00%
  4. Ascites (accumulation of fluid in the abdominal cavity): 4 people, 20.00%
  5. Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 4 people, 20.00%
  6. Bronchopulmonary Aspergillosis (lung disorder caused by aspergillus fungi): 3 people, 15.00%
  7. Hyperbilirubinaemia (excess of bilirubin in the blood): 3 people, 15.00%
  8. Cough: 3 people, 15.00%
  9. Nausea And Vomiting: 3 people, 15.00%
  10. Fever: 3 people, 15.00%

What are the existing conditions these people have? *

  1. Hepatitis C: 10 people, 50.00%
  2. Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 5 people, 25.00%
  3. Varices Oesophageal (enlarged and swollen veins at the bottom of the oesophagus, near the stomach): 4 people, 20.00%
  4. Ocular Hyperaemia (an abnormally large amount of blood in eye): 3 people, 15.00%
  5. High Blood Pressure: 3 people, 15.00%
  6. Thrombocytopenia (decrease of platelets in blood): 1 person, 5.00%
  7. Oedema Peripheral (superficial swelling): 1 person, 5.00%
  8. Hepatic Encephalopathy (spectrum of neuropsychiatric abnormalities in patients with liver failure): 1 person, 5.00%
  9. Depression: 1 person, 5.00%
  10. Cholecystitis (infection of gallbladder): 1 person, 5.00%

* Approximation only. Some reports may have incomplete information.

Do you take Sovaldi and have Acute hepatic failure?

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Related studies:

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

Acute hepatic failure treatments and more:

How severe was Acute hepatic failure and when was it recovered:

Expand to all the drugs that have ingredients of sofosbuvir:

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 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 Acute hepatic failure:

Browse all the conditions that are associated with Acute hepatic failure:


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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