Orkambi and Irritability - a phase IV clinical study of FDA data

Summary:

Irritability is reported as a side effect among people who take Orkambi (ivacaftor; lumacaftor), especially for people who are male, 2-9 old, have been taking the drug for 1 - 2 years also take Pulmozyme, and have Cystic fibrosis.

The phase IV clinical study analyzes which people have Irritability when taking Orkambi. It is created by eHealthMe based on reports of 9,494 people who have side effects when taking Orkambi from the FDA, and is updated regularly.

What is Orkambi?

Orkambi has active ingredients of ivacaftor; lumacaftor. eHealthMe is studying from 9,496 Orkambi users. Check the latest studies of Orkambi.

What is Irritability?

Irritability is found to be associated with 1,696 drugs and 2,464 conditions by eHealthMe. Check the latest studies of Irritability.

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, 02, 2026

9,494 people reported to have side effects when taking Orkambi.
Among them, 37 people (0.39%) have Irritability.

Among these 37 people:

How long have people been on Orkambi when they have Irritability? *

What is the gender of people who have Irritability when taking Orkambi? *

female: 44.44 %
male: 55.56 %

What is the age of people who have Irritability when taking Orkambi? *

What are other drugs people take besides Orkambi? *

What are other side effects people have besides Irritability? *

Fatigue (feeling of tiredness): 13 people, 35.14%
Mood Swings (an extreme or rapid change in mood): 10 people, 27.03%
Chest Pain: 8 people, 21.62%
Abnormal Behavior: 7 people, 18.92%
Aggression: 6 people, 16.22%
Hair Loss: 6 people, 16.22%
Weight Increased: 6 people, 16.22%
Acne (skin problems that cause pimples): 5 people, 13.51%
Stress And Anxiety: 5 people, 13.51%
Sputum Increased: 5 people, 13.51%

What are the existing conditions these people have? *

Cystic Fibrosis (disease of the secretary glands): 35 people, 94.59%
Wheezing (a high-pitched whistling sound made while you breath): 3 people, 8.11%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 3 people, 8.11%
Cough: 3 people, 8.11%
Ovarian Cysts (fluid filled sacs of the ovary): 1 person, 2.70%
Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 1 person, 2.70%

* Approximation only. Some reports may have incomplete information.

Do you take Orkambi and have Irritability?

- Check whether Irritability 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 Orkambi:

Orkambi (9,496 reports)

Irritability treatments and more:

Irritability (71,614 reports)

Browse all side effects of Orkambi:

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 Irritability:

Irritability (1,696 drugs)

Browse all the conditions that are associated with Irritability:

Irritability (2,464 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.

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.