Sotret and Lip swelling - a phase IV clinical study of FDA data

Summary:

Lip swelling is reported as a side effect among people who take Sotret (isotretinoin), especially for people who are female, 20-29 old, have been taking the drug for < 1 month also take Doxycycline, and have Headache.

The phase IV clinical study analyzes which people have Lip swelling when taking Sotret. It is created by eHealthMe based on reports of 8,745 people who have side effects when taking Sotret from the FDA, and is updated regularly.

What is Sotret?

Sotret has active ingredients of isotretinoin. It is often used in acne. eHealthMe is studying from 9,023 Sotret users. Check the latest studies of Sotret.

What is Lip swelling?

Lip swelling is found to be associated with 1,246 drugs and 1,582 conditions by eHealthMe. Check the latest studies of Lip swelling.

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, 30, 2026

8,745 people reported to have side effects when taking Sotret.
Among them, 16 people (0.18%) have Lip swelling.

Among these 16 people:

How long have people been on Sotret when they have Lip swelling? *

What is the gender of people who have Lip swelling when taking Sotret? *

female: 56.25 %
male: 43.75 %

What is the age of people who have Lip swelling when taking Sotret? *

What are other drugs people take besides Sotret? *

What are other side effects people have besides Lip swelling? *

Rashes (redness): 3 people, 18.75%
Urticaria (rash of round, red welts on the skin that itch intensely): 2 people, 12.50%
Cheilitis (infection of lips): 2 people, 12.50%
Joint Pain: 2 people, 12.50%
Swollen Tongue (swelling of tongue): 2 people, 12.50%
Staphylococcal Infection (an infection with staphylococcus bacteria): 1 person, 6.25%
Skin Discoloration: 1 person, 6.25%
Abscess (pus): 1 person, 6.25%
Angioedema (rapid swelling of the dermis): 1 person, 6.25%
Auricular Swelling (swelling in the ear): 1 person, 6.25%

What are the existing conditions these people have? *

Skin Cancer: 1 person, 6.25%
Scar: 1 person, 6.25%
Nasopharyngitis (inflammation of the nasopharynx): 1 person, 6.25%
Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 1 person, 6.25%
Hidradenitis (chronic disease of a type of sweat gland): 1 person, 6.25%
Headache (pain in head): 1 person, 6.25%

* Approximation only. Some reports may have incomplete information.

Do you take Sotret and have Lip swelling?

- Check whether Lip swelling 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 Sotret:

Sotret (9,023 reports)

Lip swelling treatments and more:

Lip swelling (33,385 reports)

Browse all side effects of Sotret:

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 Lip swelling:

Lip swelling (1,246 drugs)

Browse all the conditions that are associated with Lip swelling:

Lip swelling (1,582 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 Sotret) and Sotret (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.