Sirolimus 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 Sirolimus (sirolimus), especially for people who are male, 30-39 old, have been taking the drug for 5 - 10 years also take Tacrolimus, and have Graft versus host disease.

The phase IV clinical study analyzes which people have Systemic sclerosis (scleroderma) when taking Sirolimus. It is created by eHealthMe based on reports of 11,812 people who have side effects when taking Sirolimus from the FDA, and is updated regularly.

What is Sirolimus?

Sirolimus has active ingredients of sirolimus. eHealthMe is studying from 11,823 Sirolimus users. Check the latest studies of Sirolimus.

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 493 drugs and 857 conditions by eHealthMe. Check the latest studies of Systemic sclerosis (scleroderma).

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 Jul, 25, 2026

11,812 people reported to have side effects when taking Sirolimus.
Among them, 61 people (0.52%) have Systemic sclerosis (scleroderma).

Could Sirolimus cause Systemic sclerosis (scleroderma)?

Among these 61 people:

How long have people been on Sirolimus when they have Systemic sclerosis (scleroderma)? *

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

female: 49.02 %
male: 50.98 %

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

What are other drugs people take besides Sirolimus? *

Tacrolimus: 38 people, 62.30%
Cyclosporine: 31 people, 50.82%
Ibrutinib: 18 people, 29.51%
Prednisone: 15 people, 24.59%
Methylprednisolone: 14 people, 22.95%
Methotrexate: 14 people, 22.95%
Mycophenolate Mofetil: 12 people, 19.67%
Bactrim: 8 people, 13.11%
Ciclosporin: 8 people, 13.11%
Azathioprine: 5 people, 8.20%

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

Disease Progression: 29 people, 47.54%
Drug Ineffective: 21 people, 34.43%
Joint Range Of Motion Decreased (disease of joint movement): 21 people, 34.43%
Skin Mass: 17 people, 27.87%
Chronic Graft Versus Host Disease (immune cells attack the host's body cells after transplant): 12 people, 19.67%
Chronic Graft Versus Host Disease In Skin (damage by immune cells to skin after grafting): 11 people, 18.03%
Graft Versus Host Disease In Skin (the donated bone marrow or stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the skin): 7 people, 11.48%
Rashes (redness): 5 people, 8.20%
Obliterative Bronchiolitis (bronchiolar inflammation): 4 people, 6.56%
Inflammatory Bowel Disease: 4 people, 6.56%

What are the existing conditions these people have? *

Graft Versus Host Disease (the donated bone marrow or stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body): 29 people, 47.54%
Chronic Graft Versus Host Disease (immune cells attack the host's body cells after transplant): 18 people, 29.51%
Acute Myeloid Leukaemia (acute cancer in which the bone marrow makes abnormal myeloblasts): 2 people, 3.28%
Acute Graft Versus Host Disease (acute complication following an allogeneic tissue/blood transplant): 2 people, 3.28%

* Approximation only. Some reports may have incomplete information.

Do you take Sirolimus 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 Sirolimus:

Sirolimus (11,823 reports)

Browse all side effects of Sirolimus:

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) (493 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 sirolimus (the active ingredients of Sirolimus) and Sirolimus (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.