Linzess and Systemic sclerosis (scleroderma) - a phase IV clinical study of FDA data

Summary:

Systemic sclerosis (scleroderma) is reported as a side effect among people who take Linzess (linaclotide), especially for people who are female, 60+ old, also take Tracleer, and have Primary pulmonary hypertension.

The phase IV clinical study analyzes which people have Systemic sclerosis (scleroderma) when taking Linzess. It is created by eHealthMe based on reports of 23,558 people who have side effects when taking Linzess from the FDA, and is updated regularly.

What is Linzess?

Linzess has active ingredients of linaclotide. It is often used in constipation. eHealthMe is studying from 24,086 Linzess users. Check the latest studies of Linzess.

What is Systemic sclerosis (scleroderma)?

Systemic sclerosis (scleroderma) (an autoimmune or connective tissue disease. it is characterized by thickening of the skin) is found to be associated with 495 drugs and 857 conditions by eHealthMe. Check the latest studies of Systemic sclerosis (scleroderma).

On Apr, 18, 2026

23,558 people reported to have side effects when taking Linzess.
Among them, 17 people (0.07%) have Systemic sclerosis (scleroderma).

Could Linzess cause Systemic sclerosis (scleroderma)?

Among these 17 people:

What is the gender of people who have Systemic sclerosis (scleroderma) when taking Linzess? *

female: 94.12 %
male: 5.88 %

What is the age of people who have Systemic sclerosis (scleroderma) when taking Linzess? *

What are other drugs people take besides Linzess? *

What are other side effects people have besides Systemic sclerosis (scleroderma)? *

Weakness: 11 people, 64.71%
Nausea (feeling of having an urge to vomit): 11 people, 64.71%
Dyspnea (difficult or laboured breathing): 11 people, 64.71%
Chills (felling of cold): 11 people, 64.71%
Pneumonia: 11 people, 64.71%
Oedema Peripheral (superficial swelling): 10 people, 58.82%
Diarrhea: 10 people, 58.82%
Head Discomfort: 9 people, 52.94%
Gastric Disorder (disease of stomach): 9 people, 52.94%
Gait Disturbance: 9 people, 52.94%

What are the existing conditions these people have? *

Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 14 people, 82.35%
Pain: 3 people, 17.65%
Abdominal Discomfort: 2 people, 11.76%
Stress And Anxiety: 2 people, 11.76%
Pollakiuria (abnormally frequent passage of relatively small quantities or urine): 2 people, 11.76%
Depression: 2 people, 11.76%
Diabetes: 2 people, 11.76%
Gastric Ulcer (stomach ulcer): 1 person, 5.88%
Bleeding Disorders: 1 person, 5.88%
Deep Venous Thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis): 1 person, 5.88%

* Approximation only. Some reports may have incomplete information.

Do you take Linzess and have Systemic sclerosis (scleroderma)?

- Check whether Systemic sclerosis (scleroderma) 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 Linzess:

Linzess (24,086 reports)

Browse all side effects of Linzess:

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 Systemic sclerosis (scleroderma):

Systemic sclerosis (scleroderma) (495 drugs)

Browse all the conditions that are associated with Systemic sclerosis (scleroderma):

Systemic sclerosis (scleroderma) (857 conditions)

How the study uses the data?

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