Kalydeco and Blood bilirubin increased - a phase IV clinical study of FDA data

Summary:

Blood bilirubin increased is reported as a side effect among people who take Kalydeco (ivacaftor), especially for people who are male, 30-39 old, have been taking the drug for 1 - 6 months also take Creon, and have Cystic fibrosis.

The phase IV clinical study analyzes which people have Blood bilirubin increased when taking Kalydeco. It is created by eHealthMe based on reports of 6,645 people who have side effects when taking Kalydeco from the FDA, and is updated regularly.

What is Kalydeco?

Kalydeco has active ingredients of ivacaftor. eHealthMe is studying from 6,652 Kalydeco users. Check the latest studies of Kalydeco.

What is Blood bilirubin increased?

Blood bilirubin increased is found to be associated with 1,623 drugs and 2,191 conditions by eHealthMe. Check the latest studies of Blood bilirubin increased.

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, 01, 2026

6,645 people reported to have side effects when taking Kalydeco.
Among them, 39 people (0.59%) have Blood bilirubin increased.

Could Kalydeco cause Blood bilirubin increased?

Among these 39 people:

How long have people been on Kalydeco when they have Blood bilirubin increased? *

What is the gender of people who have Blood bilirubin increased when taking Kalydeco? *

female: 35.14 %
male: 64.86 %

What is the age of people who have Blood bilirubin increased when taking Kalydeco? *

What are other drugs people take besides Kalydeco? *

What are other side effects people have besides Blood bilirubin increased? *

Blood Alkaline Phosphatase Increased: 22 people, 56.41%
Alanine Aminotransferase Increased: 20 people, 51.28%
Gamma-Glutamyltransferase Increased: 12 people, 30.77%
Aspartate Aminotransferase Increased: 9 people, 23.08%
Hepatic Enzyme Increased: 7 people, 17.95%
Agranulocytosis (a deficiency of granulocytes in the blood, causing increased vulnerability to infection): 7 people, 17.95%
Vitiligo (pigment is lost from areas of the skin): 6 people, 15.38%
Pneumonia: 6 people, 15.38%
Generalised Oedema (swelling all over the body): 6 people, 15.38%
Hypotension (abnormally low blood pressure): 6 people, 15.38%

What are the existing conditions these people have? *

Cystic Fibrosis (disease of the secretary glands): 39 people, 100.00%
Respiratory Tract Infection: 6 people, 15.38%
Infective Pulmonary Exacerbation Of Cystic Fibrosis (severe infective lung disease with production of abnormally thick mucus): 6 people, 15.38%
Gastrointestinal Disorder (functional problems of gastrointestinal tract): 6 people, 15.38%
Fever: 6 people, 15.38%
Cystic Fibrosis Lung (fibrosis with cyst in the lung): 6 people, 15.38%
Abdominal Pain: 6 people, 15.38%
Pseudomonas Infection (pseudomonas infection is caused by a bacterium, pseudomonas aeruginosa): 1 person, 2.56%
Pain: 1 person, 2.56%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 2.56%

* Approximation only. Some reports may have incomplete information.

Do you take Kalydeco and have Blood bilirubin increased?

- Check whether Blood bilirubin increased 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 Kalydeco:

Kalydeco (6,652 reports)

Browse all side effects of Kalydeco:

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 Blood bilirubin increased:

Blood bilirubin increased (1,623 drugs)

Browse all the conditions that are associated with Blood bilirubin increased:

Blood bilirubin increased (2,191 conditions)

How the study uses the data?

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