Accutane and Scleroma - a phase IV clinical study of FDA data

Summary:

Scleroma is reported as a side effect among people who take Accutane (isotretinoin), especially for people who are male, 10-19 old, have been taking the drug for 1 - 6 months.

The phase IV clinical study analyzes which people have Scleroma when taking Accutane. It is created by eHealthMe based on reports of 33,410 people who have side effects when taking Accutane from the FDA, and is updated regularly.

What is Accutane?

Accutane has active ingredients of isotretinoin. It is often used in acne. eHealthMe is studying from 35,221 Accutane users. Check the latest studies of Accutane.

What is Scleroma?

Scleroma (a hardened patch of tissue in the skin or mucous membranes) is found to be associated with 307 drugs and 493 conditions by eHealthMe. Check the latest studies of Scleroma.

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 Aug, 23, 2026

33,410 people reported to have side effects when taking Accutane.
Among them, 12 people (0.04%) have Scleroma.

Among these 12 people:

How long have people been on Accutane when they have Scleroma? *

What is the gender of people who have Scleroma when taking Accutane? *

female: 25 %
male: 75 %

What is the age of people who have Scleroma when taking Accutane? *

What are other side effects people have besides Scleroma? *

Colitis (inflammation of colon): 12 people, 100.00%
Multi-Organ Disorder (multiple organ disease): 12 people, 100.00%
Inflammatory Bowel Disease: 12 people, 100.00%
Rectal Haemorrhage (bleeding from anus): 12 people, 100.00%
Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 11 people, 91.67%
Intestinal Haemorrhage (bleeding from intestine): 11 people, 91.67%
Crohn's Disease (a condition that causes inflammation of the gastrointestinal tract): 11 people, 91.67%
Proctitis (inflammation of the rectum and anus): 11 people, 91.67%
Gastrointestinal Disorder (functional problems of gastrointestinal tract): 10 people, 83.33%
Perirectal Abscess: 9 people, 75.00%

* Approximation only. Some reports may have incomplete information.

Do you take Accutane and have Scleroma?

- Check whether Scleroma 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 Accutane:

Accutane (35,221 reports)

Scleroma treatments and more:

Scleroma (2,214 reports)

Browse all side effects of Accutane:

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 Scleroma:

Scleroma (307 drugs)

Browse all the conditions that are associated with Scleroma:

Scleroma (493 conditions)

Related publications that referenced our studies

Ersoy MA, Ersoy HT, "Manic symptoms associated with isotretinoin and methylphenidate combination: a case report", Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology, 2014 Sep .
Ersoy MA, Ersoy HT, "Manic symptoms associated with isotretinoin and methylphenidate combination: a case report", Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology, 2014 Sep .

How the study uses the data?

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