Kalydeco and Respiratory tract haemorrhage - a phase IV clinical study of FDA data

Summary:

We study 6,134 people who have side effects when taking Kalydeco. Respiratory tract haemorrhage is found, especially among people who are female, 30-39 old, also take Novorapid and have C-reactive protein increased.

The phase IV clinical study analyzes which people take Kalydeco and have Respiratory tract haemorrhage. 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, 28, 2023

6,134 people reported to have side effects when taking Kalydeco.
Among them, 13 people (0.21%) have Respiratory tract haemorrhage.

What is Kalydeco?

Kalydeco has active ingredients of ivacaftor. Currently, eHealthMe is studying from 6,141 Kalydeco users.

What is Respiratory tract haemorrhage?

Respiratory tract haemorrhage (respiratory tract bleeding) is found to be associated with 428 drugs and 182 conditions by eHealthMe. Currently, we are studying 648 people who have Respiratory tract haemorrhage.

Number of Kalydeco and Respiratory tract haemorrhage reports submitted per year:

Could Kalydeco cause Respiratory tract haemorrhage?

Gender of people who have Respiratory tract haemorrhage when taking Kalydeco *:

female: 100 %
male: 0.0 %

Age of people who have Respiratory tract haemorrhage when taking Kalydeco *:

Common drugs people take besides Kalydeco *:

Common side effects people have besides Respiratory tract haemorrhage *:

Sputum Increased: 13 people, 100.00%
Oxygen Saturation Decreased: 13 people, 100.00%
Heart Rate Increased: 13 people, 100.00%
Bronchial Secretion Retention: 13 people, 100.00%
Secretion Discharge: 12 people, 92.31%
Diarrhea: 10 people, 76.92%
Blood Glucose Decreased: 10 people, 76.92%
Abscess Rupture (pus release from the point of abscess): 6 people, 46.15%

Common conditions people have *:

Cystic Fibrosis (disease of the secretary glands): 13 people, 100.00%
C-Reactive Protein Increased: 13 people, 100.00%

* Approximation only. Some reports may have incomplete information.

Do you take Kalydeco and have Respiratory tract haemorrhage?

Check whether Respiratory tract haemorrhage 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

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.

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.