Arava and Ruptured eardrum - a phase IV clinical study of FDA data

Summary:

Ruptured eardrum is reported as a side effect among people who take Arava (leflunomide), especially for people who are female, 40-49 old, also take Actemra, and have Sinusitis.

The phase IV clinical study analyzes which people have Ruptured eardrum when taking Arava. It is created by eHealthMe based on reports of 75,674 people who have side effects when taking Arava from the FDA, and is updated regularly.

What is Arava?

Arava has active ingredients of leflunomide. It is often used in rheumatoid arthritis. eHealthMe is studying from 76,040 Arava users. Check the latest studies of Arava.

What is Ruptured eardrum?

Ruptured eardrum (tear in eardrum) is found to be associated with 302 drugs and 806 conditions by eHealthMe. Check the latest studies of Ruptured eardrum.

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, 03, 2026

75,674 people reported to have side effects when taking Arava.
Among them, 53 people (0.07%) have Ruptured eardrum.

Among these 53 people:

What is the gender of people who have Ruptured eardrum when taking Arava? *

female: 97.92 %
male: 2.08 %

What is the age of people who have Ruptured eardrum when taking Arava? *

What are other drugs people take besides Arava? *

What are other side effects people have besides Ruptured eardrum? *

Sinusitis (inflammation of sinus): 41 people, 77.36%
Weight Increased: 39 people, 73.58%
Headache (pain in head): 39 people, 73.58%
Urticaria (rash of round, red welts on the skin that itch intensely): 38 people, 71.70%
Nasopharyngitis (inflammation of the nasopharynx): 38 people, 71.70%
Joint Pain: 38 people, 71.70%
Fever: 38 people, 71.70%
Otitis (ear infection): 36 people, 67.92%
Paranasal Sinus Discomfort: 35 people, 66.04%
Psoriasis (immune-mediated disease that affects the skin): 35 people, 66.04%

What are the existing conditions these people have? *

Sinusitis (inflammation of sinus): 35 people, 66.04%
High Blood Pressure: 25 people, 47.17%
Restless Leg Syndrome (a powerful urge to move your legs): 20 people, 37.74%
Herpes Zoster: 13 people, 24.53%
Type 2 Diabetes: 1 person, 1.89%
Otitis (ear infection): 1 person, 1.89%

* Approximation only. Some reports may have incomplete information.

Do you take Arava and have Ruptured eardrum?

- Check whether Ruptured eardrum 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 Arava:

Arava (76,040 reports)

Browse all side effects of Arava:

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 Ruptured eardrum:

Ruptured eardrum (302 drugs)

Browse all the conditions that are associated with Ruptured eardrum:

Ruptured eardrum (806 conditions)

How the study uses the data?

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