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Kuvan and Hypotension - a phase IV clinical study of FDA data

Summary:

Hypotension is reported as a side effect among people who take Kuvan (sapropterin dihydrochloride), especially for people who are female, 60+ old, have been taking the drug for < 1 month also take Risperidone, and have Diarrhea.

The phase IV clinical study analyzes which people have Hypotension when taking Kuvan. It is created by eHealthMe based on reports of 5,724 people who have side effects when taking Kuvan from the FDA, and is updated regularly.

What is Kuvan?

Kuvan has active ingredients of sapropterin dihydrochloride. It is often used in phenylketonuria. eHealthMe is studying from 5,732 Kuvan users. Check the latest studies of Kuvan.

What is Hypotension?

Hypotension (abnormally low blood pressure) is found to be associated with 3,359 drugs and 4,756 conditions by eHealthMe. Check the latest studies of Hypotension.

On Jul, 17, 2026

5,724 people reported to have side effects when taking Kuvan.
Among them, 11 people (0.19%) have Hypotension.

Could Kuvan cause Hypotension?

Among these 11 people:

How long have people been on Kuvan when they have Hypotension? *

  • < 1 month: 100 %
  • 1 - 6 months: 0.0 %
  • 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 Hypotension when taking Kuvan? *

  • female: 66.67 %
  • male: 33.33 %

What is the age of people who have Hypotension when taking Kuvan? *

  • 0-1: 0.0 %
  • 2-9: 14.29 %
  • 10-19: 14.29 %
  • 20-29: 0.0 %
  • 30-39: 28.57 %
  • 40-49: 14.29 %
  • 50-59: 0.0 %
  • 60+: 28.57 %

What are other drugs people take besides Kuvan? *

  1. Simvastatin: 2 people, 18.18%
  2. Palynziq: 2 people, 18.18%
  3. Famotidine: 2 people, 18.18%
  4. Timolol: 2 people, 18.18%
  5. Tegretol: 2 people, 18.18%
  6. Miconazole Nitrate: 2 people, 18.18%
  7. Naltrexone Hydrochloride: 2 people, 18.18%
  8. Nasonex: 2 people, 18.18%
  9. Risperidone: 2 people, 18.18%
  10. Fish Oil: 1 person, 9.09%

What are other side effects people have besides Hypotension? *

  1. Dehydration (dryness resulting from the removal of water): 4 people, 36.36%
  2. Tremor (trembling or shaking movements in one or more parts of your body): 3 people, 27.27%
  3. Arrhythmias (irregular heartbeat): 3 people, 27.27%
  4. Altered State Of Consciousness (altered state of mind): 2 people, 18.18%
  5. Itching: 2 people, 18.18%
  6. Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body): 2 people, 18.18%
  7. Dyspnea (difficult or laboured breathing): 2 people, 18.18%
  8. Drug Hypersensitivity: 2 people, 18.18%
  9. Respiratory Rate Increased (excess breathing rate/min): 2 people, 18.18%
  10. Nausea And Vomiting: 2 people, 18.18%

What are the existing conditions these people have? *

  1. Rabies (a viral disease that causes acute encephalitis in warm-blooded animals. spreads through dog bite): 1 person, 9.09%
  2. Diarrhea: 1 person, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Kuvan and have Hypotension?

- Check whether Hypotension is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously

Related studies:

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

Hypotension treatments and more:

How severe was Hypotension and when was it recovered:

Expand to all the drugs that have ingredients of sapropterin dihydrochloride:

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 Kuvan:

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 Hypotension:

Browse all the conditions that are associated with Hypotension:

How the study uses the data?

The study uses data from the FDA. It is based on sapropterin dihydrochloride (the active ingredients of Kuvan) and Kuvan (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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