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

Summary:

We study 9,378 people who have side effects when taking Orkambi. Blood bilirubin increased is found, especially among people who are male, 50-59 old, have been taking the drug for < 1 month, also take Bactrim and have Cystic fibrosis.

The phase IV clinical study analyzes which people take Orkambi and have Blood bilirubin increased. 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, 26, 2023

9,378 people reported to have side effects when taking Orkambi.
Among them, 10 people (0.11%) have Blood bilirubin increased.

What is Orkambi?

Orkambi has active ingredients of ivacaftor; lumacaftor. Currently, eHealthMe is studying from 9,380 Orkambi users.

What is Blood bilirubin increased?

Blood bilirubin increased is found to be associated with 2,377 drugs and 2,158 conditions by eHealthMe. Currently, we are studying 42,076 people who have Blood bilirubin increased.

Number of Orkambi and Blood bilirubin increased reports submitted per year:

Could Orkambi cause Blood bilirubin increased?

Time on Orkambi when people have Blood bilirubin increased *:

Gender of people who have Blood bilirubin increased when taking Orkambi *:

female: 40 %
male: 60 %

Age of people who have Blood bilirubin increased when taking Orkambi *:

Common drugs people take besides Orkambi *:

Bactrim: 4 people, 40.00%
Vitamin K: 3 people, 30.00%
Pulmozyme: 3 people, 30.00%
Creon: 3 people, 30.00%
Ursodeoxycholic Acid: 2 people, 20.00%
Symbicort: 2 people, 20.00%
Sulfamethoxazole And Trimethoprim: 2 people, 20.00%
Zithromax: 1 person, 10.00%
Zenpep: 1 person, 10.00%
Tobi: 1 person, 10.00%

Common side effects people have besides Blood bilirubin increased *:

Aspartate Aminotransferase Increased: 7 people, 70.00%
Blood Alkaline Phosphatase Increased: 5 people, 50.00%
Gamma-Glutamyltransferase Increased: 4 people, 40.00%
Alanine Aminotransferase Increased: 4 people, 40.00%
Breathing Difficulty: 3 people, 30.00%
Respiratory Acidosis (respiratory failure or ventilatory failure, causes the ph of blood and other bodily fluids to decrease): 2 people, 20.00%
Infection: 2 people, 20.00%
Fever: 2 people, 20.00%
Diabetes: 1 person, 10.00%
Rashes (redness): 1 person, 10.00%

Common conditions people have *:

Cystic Fibrosis (disease of the secretary glands): 10 people, 100.00%
Wheezing (a high-pitched whistling sound made while you breath): 1 person, 10.00%
Cough: 1 person, 10.00%

* Approximation only. Some reports may have incomplete information.

Do you take Orkambi and have Blood bilirubin increased?

Check whether Blood bilirubin increased 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

Orkambi side effects by duration, gender and age:

Orkambi side effects (9,380 reports)

Blood bilirubin increased treatments and more:

Blood bilirubin increased (42,076 reports)

Common drugs associated with Blood bilirubin increased:

All the drugs that are associated with Blood bilirubin increased:

Blood bilirubin increased (2,377 drugs)

Common conditions associated with Blood bilirubin increased:

High blood pressure: 1,697 reports
Hiv infection: 1,100 reports
Hepatitis c: 1,083 reports
Pain: 846 reports
Primary pulmonary hypertension: 822 reports

All the conditions that are associated with Blood bilirubin increased:

Blood bilirubin increased (2,158 conditions)

How the study uses the data?

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

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.