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

Summary:

Depression is reported as a side effect among people who take Kuvan (sapropterin dihydrochloride), especially for people who are female, 20-29 old, have been taking the drug for 6 - 12 months also take Vitamin B12, and have Attention deficit hyperactivity disorder.

The phase IV clinical study analyzes which people have Depression 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 Depression?

Depression is found to be associated with 3,169 drugs and 4,126 conditions by eHealthMe. Check the latest studies of Depression.

On Jul, 27, 2026

5,724 people reported to have side effects when taking Kuvan.
Among them, 99 people (1.73%) have Depression.

Among these 99 people:

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

What is the gender of people who have Depression when taking Kuvan? *

female: 71.91 %
male: 28.09 %

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

What are other drugs people take besides Kuvan? *

What are other side effects people have besides Depression? *

Stress And Anxiety: 42 people, 42.42%
Psychomotor Hyperactivity (feelings of extreme restlessness): 10 people, 10.10%
Aggression: 9 people, 9.09%
Mood Swings (an extreme or rapid change in mood): 8 people, 8.08%
Nervousness: 8 people, 8.08%
Anger: 6 people, 6.06%
Headache (pain in head): 6 people, 6.06%
Diarrhea: 5 people, 5.05%
Nausea And Vomiting: 4 people, 4.04%
Maternal Exposure During Pregnancy (use of substance during pregnancy): 4 people, 4.04%

What are the existing conditions these people have? *

Birth Control: 3 people, 3.03%
Attention Deficit Hyperactivity Disorder (a chronic condition including attention difficulty, hyperactivity, and impulsiveness): 3 people, 3.03%
Pain: 2 people, 2.02%
Nausea (feeling of having an urge to vomit): 2 people, 2.02%
Back Pain: 2 people, 2.02%
Stress And Anxiety: 1 person, 1.01%
Sleep Disorder: 1 person, 1.01%
Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 1 person, 1.01%
Reflux Gastritis (a condition in which the lining of a person's stomach becomes inflamed as a result of exposure to bile): 1 person, 1.01%
Metabolic Disorder (an abnormal function and pattern of body fat. insulin resistance refers to the diminished ability of cells to respond to the action of insulin in promoting the transport of the sugar glucose, from blood into muscles and other tissues): 1 person, 1.01%

* Approximation only. Some reports may have incomplete information.

Do you take Kuvan and have Depression?

- Check whether Depression 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:

Kuvan (5,732 reports)

Depression treatments and more:

Depression (652,144 reports)

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 Depression:

Depression (3,169 drugs)

Browse all the conditions that are associated with Depression:

Depression (4,126 conditions)

Related publications that referenced our studies

Pang, T., & Gudi, A., "Chest pain following the use of fluvoxamine in depression", Proceedings of Singapore Healthcare, 2018 Jan .
Pang, T., & Gudi, A., "Chest pain following the use of fluvoxamine in depression", Proceedings of Singapore Healthcare, 2018 Jan .

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.