Harvoni and Haemorrhage - a phase IV clinical study of FDA data


Haemorrhage is found among people who take Harvoni, especially for people who are male, 50-59 old, have been taking the drug for < 1 month.

The phase IV clinical study analyzes which people take Harvoni and have Haemorrhage. It is created by eHealthMe based on reports of 19,744 people who have side effects when taking Harvoni from the FDA, and is updated regularly. You can use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Sep, 21, 2023

19,744 people reported to have side effects when taking Harvoni.
Among them, 33 people (0.17%) have Haemorrhage.

What is Harvoni?

Harvoni has active ingredients of ledipasvir; sofosbuvir. eHealthMe is studying from 19,800 Harvoni users for its effectiveness, alternative drugs and more.

What is Haemorrhage?

Haemorrhage (bleeding) is found to be associated with 2,867 drugs and 2,312 conditions by eHealthMe.

Number of Harvoni and Haemorrhage reports submitted per year:

Could Harvoni cause Haemorrhage?

Time on Harvoni when people have Haemorrhage *:

  • < 1 month: 55.56 %
  • 1 - 6 months: 44.44 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Haemorrhage when taking Harvoni *:

  • female: 34.38 %
  • male: 65.62 %

Age of people who have Haemorrhage when taking Harvoni *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 3.57 %
  • 30-39: 0.0 %
  • 40-49: 10.71 %
  • 50-59: 46.43 %
  • 60+: 39.29 %

Common drugs people take besides Harvoni *:

  1. Rifaximin: 4 people, 12.12%
  2. Codeine: 4 people, 12.12%
  3. Rebetol: 3 people, 9.09%
  4. Paracetamol: 3 people, 9.09%
  5. Synthroid: 2 people, 6.06%
  6. Spiriva: 2 people, 6.06%
  7. Omnaris: 2 people, 6.06%
  8. Climara: 2 people, 6.06%
  9. Zantac: 1 person, 3.03%
  10. Diflucan: 1 person, 3.03%

Common side effects people have besides Haemorrhage *:

  1. Drug Ineffective: 5 people, 15.15%
  2. Hepatitis C: 5 people, 15.15%
  3. Liver Disorder (liver diseases): 4 people, 12.12%
  4. Infection: 4 people, 12.12%
  5. Disease Complication: 4 people, 12.12%
  6. Fatigue (feeling of tiredness): 3 people, 9.09%
  7. Thrombocytopenia (decrease of platelets in blood): 3 people, 9.09%
  8. Ascites (accumulation of fluid in the abdominal cavity): 3 people, 9.09%
  9. Varices Oesophageal (enlarged and swollen veins at the bottom of the oesophagus, near the stomach): 2 people, 6.06%
  10. Haemorrhagic Diathesis (bleeding tendency): 2 people, 6.06%

Common conditions people have *:

  1. Hepatitis C: 11 people, 33.33%
  2. High Blood Pressure: 2 people, 6.06%
  3. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 2 people, 6.06%
  4. Vitamin B12 Deficiency: 1 person, 3.03%
  5. Pollakiuria (abnormally frequent passage of relatively small quantities or urine): 1 person, 3.03%
  6. Oedema (fluid collection in tissue): 1 person, 3.03%
  7. Mediastinal Haematoma (blood clot in mediastinum): 1 person, 3.03%
  8. Laxative Supportive Care: 1 person, 3.03%
  9. Infection: 1 person, 3.03%
  10. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 1 person, 3.03%

* Approximation only. Some reports may have incomplete information.

Do you take Harvoni and have Haemorrhage?

Check whether Haemorrhage is associated with a drug or a condition

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

Related studies

How severe was Haemorrhage and when was it recovered:

Expand to all the drugs that have ingredients of ledipasvir; sofosbuvir:

Alternative drugs to, pros and cons of Harvoni:

Common Harvoni side effects:

Browse all side effects of Harvoni:

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

Haemorrhage treatments and more:

COVID vaccines that are related to Haemorrhage:

Common drugs associated with Haemorrhage:

All the drugs that are associated with Haemorrhage:

Common conditions associated with Haemorrhage:

All the conditions that are associated with Haemorrhage:

How the study uses the data?

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

Who is eHealthMe?

With medical big data and proven AI 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 600+ 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: 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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