Exforge and Subdural haematoma - a phase IV clinical study of FDA data


We study 12,624 people who have side effects when taking Exforge. Subdural haematoma is found, especially among people who are male, 60+ old, have been taking the drug for 5 - 10 years, also take Pradaxa and have Atrial fibrillation/flutter.

The phase IV clinical study analyzes which people take Exforge and have Subdural haematoma. 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, 29, 2023

12,624 people reported to have side effects when taking Exforge.
Among them, 12 people (0.1%) have Subdural haematoma.

What is Exforge?

Exforge has active ingredients of amlodipine besylate; valsartan. It is used in high blood pressure. Currently, eHealthMe is studying from 13,029 Exforge users.

What is Subdural haematoma?

Subdural haematoma (blood collects between the skull and the surface of the brain) is found to be associated with 1,735 drugs and 1,062 conditions by eHealthMe. Currently, we are studying 16,982 people who have Subdural haematoma.

Number of Exforge and Subdural haematoma reports submitted per year:

Could Exforge cause Subdural haematoma?

Time on Exforge when people have Subdural haematoma *:

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 100 %
  • 10+ years: 0.0 %

Gender of people who have Subdural haematoma when taking Exforge *:

  • female: 27.27 %
  • male: 72.73 %

Age of people who have Subdural haematoma when taking Exforge *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 9.09 %
  • 60+: 90.91 %

Common drugs people take besides Exforge *:

  1. Pantoprazole: 3 people, 25.00%
  2. Pradaxa: 3 people, 25.00%
  3. Prandin: 2 people, 16.67%
  4. Eliquis: 2 people, 16.67%
  5. Januvia: 2 people, 16.67%
  6. Zocor: 2 people, 16.67%
  7. Carafate: 2 people, 16.67%
  8. Nitrostat: 2 people, 16.67%
  9. Betapace: 2 people, 16.67%
  10. Lipitor: 2 people, 16.67%

Common side effects people have besides Subdural haematoma *:

  1. Headache (pain in head): 3 people, 25.00%
  2. Fever: 2 people, 16.67%
  3. Speech Impairment (Adult) (inability to speak (adult)): 2 people, 16.67%
  4. Memory Loss: 2 people, 16.67%
  5. Blood Glucose Decreased: 1 person, 8.33%
  6. Blood Thyroid Stimulating Hormone Increased: 1 person, 8.33%
  7. Blood Calcium Decreased: 1 person, 8.33%
  8. Breathing Difficulty: 1 person, 8.33%
  9. Cardiac Failure Congestive: 1 person, 8.33%
  10. Nausea And Vomiting: 1 person, 8.33%

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): 5 people, 41.67%
  2. Pulmonary Embolism (blockage of the main artery of the lung): 2 people, 16.67%
  3. Urination - Painful: 1 person, 8.33%
  4. Iron Deficiency Anaemia: 1 person, 8.33%
  5. Arrhythmias (irregular heartbeat): 1 person, 8.33%
  6. Back Pain: 1 person, 8.33%
  7. Blood Calcium Abnormal: 1 person, 8.33%
  8. Constipation: 1 person, 8.33%
  9. Deep Venous Thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis): 1 person, 8.33%
  10. Embolism Venous (embolus may pass into the arterial system): 1 person, 8.33%

* Approximation only. Some reports may have incomplete information.

Do you take Exforge and have Subdural haematoma?

Check whether Subdural haematoma 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

Exforge side effects by duration, gender and age:

Subdural haematoma treatments and more:

Common drugs associated with Subdural haematoma:

All the drugs that are associated with Subdural haematoma:

Common conditions associated with Subdural haematoma:

All the conditions that are associated with Subdural haematoma:

How the study uses the data?

The study uses data from the FDA. It is based on amlodipine besylate; valsartan (the active ingredients of Exforge) and Exforge (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).


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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.

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