Samsca and Hyperammonaemia - a phase IV clinical study of FDA data

Summary:

Hyperammonaemia is reported as a side effect among people who take Samsca (tolvaptan), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Lasix, and have Fluid retention.

The phase IV clinical study analyzes which people have Hyperammonaemia when taking Samsca. It is created by eHealthMe based on reports of 8,134 people who have side effects when taking Samsca from the FDA, and is updated regularly.

What is Samsca?

Samsca has active ingredients of tolvaptan. eHealthMe is studying from 8,139 Samsca users. Check the latest studies of Samsca.

What is Hyperammonaemia?

Hyperammonaemia is found to be associated with 397 drugs and 562 conditions by eHealthMe. Check the latest studies of Hyperammonaemia.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Sep, 02, 2026

8,134 people reported to have side effects when taking Samsca.
Among them, 27 people (0.33%) have Hyperammonaemia.

Could Samsca cause Hyperammonaemia?

Among these 27 people:

How long have people been on Samsca when they have Hyperammonaemia? *

  • < 1 month: 50 %
  • 1 - 6 months: 30 %
  • 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 Hyperammonaemia when taking Samsca? *

  • female: 41.67 %
  • male: 58.33 %

What is the age of people who have Hyperammonaemia when taking Samsca? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 8.33 %
  • 30-39: 8.33 %
  • 40-49: 0.0 %
  • 50-59: 0.0 %
  • 60+: 83.33 %

What are other drugs people take besides Samsca? *

  1. Nexium: 9 people, 33.33%
  2. Lasix: 9 people, 33.33%
  3. Adcirca: 5 people, 18.52%
  4. Uptravi: 5 people, 18.52%
  5. Furosemide: 4 people, 14.81%
  6. Ambrisentan: 4 people, 14.81%
  7. Theophylline: 3 people, 11.11%
  8. Halcion: 3 people, 11.11%
  9. Potassium Gluconate: 2 people, 7.41%
  10. Nifedipine: 2 people, 7.41%

What are other side effects people have besides Hyperammonaemia? *

  1. Hepatic Encephalopathy (spectrum of neuropsychiatric abnormalities in patients with liver failure): 11 people, 40.74%
  2. Altered State Of Consciousness (altered state of mind): 6 people, 22.22%
  3. Diarrhea: 5 people, 18.52%
  4. Hepatic Function Abnormal: 5 people, 18.52%
  5. Blood Creatinine Increased: 4 people, 14.81%
  6. Dehydration (dryness resulting from the removal of water): 4 people, 14.81%
  7. Cardiac Failure: 3 people, 11.11%
  8. Hypernatraemia (an abnormally high plasma concentration of sodium ions): 3 people, 11.11%
  9. Fever: 3 people, 11.11%
  10. Blood Sodium Increased: 2 people, 7.41%

What are the existing conditions these people have? *

  1. Fluid Retention (an abnormal accumulation of fluid in the blood): 8 people, 29.63%
  2. Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 7 people, 25.93%
  3. Cardiac Failure: 5 people, 18.52%
  4. High Blood Pressure: 4 people, 14.81%
  5. Cardiac Failure Congestive: 4 people, 14.81%
  6. Diarrhea: 4 people, 14.81%
  7. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 4 people, 14.81%
  8. Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 4 people, 14.81%
  9. Hypokalemia (low potassium): 4 people, 14.81%
  10. Venous Thrombosis Limb (blood clot that forms in a vein in the limb): 3 people, 11.11%

* Approximation only. Some reports may have incomplete information.

Do you take Samsca and have Hyperammonaemia?

- Check whether Hyperammonaemia is associated with a drug or a condition
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Related studies:

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

Hyperammonaemia treatments and more:

How severe was Hyperammonaemia and when was it recovered:

Expand to all the drugs that have ingredients of tolvaptan:

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 Samsca:

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 Hyperammonaemia:

Browse all the conditions that are associated with Hyperammonaemia:


How the study uses the data?

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