Irbesartan and Haemorrhagic stroke - a phase IV clinical study of FDA data


We study 33,218 people who have side effects when taking Irbesartan. Haemorrhagic stroke is found, especially among people who are male, 60+ old, have been taking the drug for 6 - 12 months, also take Xarelto and have Atrial fibrillation/flutter.

The phase IV clinical study analyzes which people take Irbesartan and have Haemorrhagic stroke. It is created by eHealthMe based on reports from the FDA, and is updated regularly. You may 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 700+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Sep, 26, 2023

33,218 people reported to have side effects when taking Irbesartan.
Among them, 62 people (0.19%) have Haemorrhagic stroke.

What is Irbesartan?

Irbesartan has active ingredients of irbesartan. It is used in high blood pressure. Currently, eHealthMe is studying from 33,691 Irbesartan users.

What is Haemorrhagic stroke?

Haemorrhagic stroke (stroke caused by the rupture of a blood vessel in the brain) is found to be associated with 1,631 drugs and 770 conditions by eHealthMe. Currently, we are studying 13,063 people who have Haemorrhagic stroke.

Number of Irbesartan and Haemorrhagic stroke reports submitted per year:

Could Irbesartan cause Haemorrhagic stroke?

Time on Irbesartan when people have Haemorrhagic stroke *:

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 50 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 50 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Haemorrhagic stroke when taking Irbesartan *:

  • female: 32.79 %
  • male: 67.21 %

Age of people who have Haemorrhagic stroke when taking Irbesartan *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 1.85 %
  • 40-49: 3.7 %
  • 50-59: 37.04 %
  • 60+: 57.41 %

Common drugs people take besides Irbesartan *:

  1. Aspirin: 9 people, 14.52%
  2. Xarelto: 9 people, 14.52%
  3. Tofacitinib Citrate: 8 people, 12.90%
  4. Tramadol: 7 people, 11.29%
  5. Furosemide: 7 people, 11.29%
  6. Acetaminophen: 7 people, 11.29%
  7. Spironolactone: 7 people, 11.29%
  8. Clopidogrel: 6 people, 9.68%
  9. Insulin: 6 people, 9.68%
  10. Finasteride: 6 people, 9.68%

Common side effects people have besides Haemorrhagic stroke *:

  1. Pain: 10 people, 16.13%
  2. Headache (pain in head): 10 people, 16.13%
  3. Arteriosclerosis Coronary Artery (thickening and hardening of arteries- coronary artery): 10 people, 16.13%
  4. Thalamic Infarction (tissue death of thalamus part of brain): 10 people, 16.13%
  5. Upper Gastrointestinal Haemorrhage (upper gastrointestinal bleeding): 8 people, 12.90%
  6. Consciousness - Decreased: 5 people, 8.06%
  7. Cardiac Arrest: 5 people, 8.06%
  8. Fall: 4 people, 6.45%
  9. Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 4 people, 6.45%
  10. Hemiparesis (weakness on one side of the body): 3 people, 4.84%

Common conditions people have *:

  1. Atrial Fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles): 18 people, 29.03%
  2. Diabetes: 14 people, 22.58%
  3. Renal Cell Carcinoma (a kidney cancer): 10 people, 16.13%
  4. High Blood Cholesterol: 8 people, 12.90%
  5. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 8 people, 12.90%
  6. Stroke (sudden death of a portion of the brain cells due to a lack of oxygen): 7 people, 11.29%
  7. Gout (uric acid crystals building up in the body): 6 people, 9.68%
  8. Bone Pain: 5 people, 8.06%
  9. Atrial Thrombosis (blood clot that develops in an artery): 4 people, 6.45%
  10. Cardiac Failure Congestive: 4 people, 6.45%

* Approximation only. Some reports may have incomplete information.

Do you take Irbesartan and have Haemorrhagic stroke?

Check whether Haemorrhagic stroke 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

Irbesartan side effects by duration, gender and age:

Haemorrhagic stroke treatments and more:

Common drugs associated with Haemorrhagic stroke:

All the drugs that are associated with Haemorrhagic stroke:

Common conditions associated with Haemorrhagic stroke:

All the conditions that are associated with Haemorrhagic stroke:

How the study uses the data?

The study uses data from the FDA. It is based on irbesartan (the active ingredients of Irbesartan) and Irbesartan (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 700+ 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 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.

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