Arava and Macule - a phase IV clinical study of FDA data

Summary:

Macule is reported as a side effect among people who take Arava (leflunomide), especially for people who are female, 50-59 old, have been taking the drug for 2 - 5 years also take Humira, and have Psoriatic arthropathy.

The phase IV clinical study analyzes which people have Macule 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 Macule?

Macule (a discoloured spot on the skin) is found to be associated with 315 drugs and 697 conditions by eHealthMe. Check the latest studies of Macule.



On Feb, 12, 2026

75,674 people reported to have side effects when taking Arava.
Among them, 11 people (0.01%) have Macule.

Could Arava cause Macule?

Among these 11 people:

How long have people been on Arava when they have Macule? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 50 %
  • 2 - 5 years: 50 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

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

  • female: 66.67 %
  • male: 33.33 %

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

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 37.5 %
  • 50-59: 37.5 %
  • 60+: 25.0 %

What are other drugs people take besides Arava? *

  1. Humira: 7 people, 63.64%
  2. Flexeril: 5 people, 45.45%
  3. Voltaren: 4 people, 36.36%
  4. Lyrica: 4 people, 36.36%
  5. Concerta: 4 people, 36.36%
  6. Cymbalta: 4 people, 36.36%
  7. Dexilant: 4 people, 36.36%
  8. Inflectra: 4 people, 36.36%
  9. Plaquenil: 4 people, 36.36%
  10. Valtrex: 4 people, 36.36%

What are other side effects people have besides Macule? *

  1. Pain: 8 people, 72.73%
  2. Itching: 7 people, 63.64%
  3. Joint Pain: 7 people, 63.64%
  4. Fatigue (feeling of tiredness): 7 people, 63.64%
  5. Skin Disorder (skin disease): 5 people, 45.45%
  6. Back Pain: 5 people, 45.45%
  7. Skin Atrophy (wasting of skin): 4 people, 36.36%
  8. Drug Effect Decreased: 4 people, 36.36%
  9. Pneumonia: 4 people, 36.36%
  10. Musculoskeletal Stiffness (stiffness of the body's muscles, joints, tendons, ligaments and nerves): 4 people, 36.36%

What are the existing conditions these people have? *

  1. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 6 people, 54.55%
  2. Psoriasis (immune-mediated disease that affects the skin): 2 people, 18.18%
  3. High Blood Pressure: 2 people, 18.18%
  4. Thyroid Diseases: 1 person, 9.09%
  5. Stress And Anxiety: 1 person, 9.09%
  6. Sleep Disorder: 1 person, 9.09%
  7. Post-Traumatic Stress Disorder: 1 person, 9.09%
  8. Pain: 1 person, 9.09%
  9. Labyrinthitis (inflammation of the labyrinth or inner ear): 1 person, 9.09%
  10. Diarrhea: 1 person, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Arava and have Macule?

- Check whether Macule 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:

Macule treatments and more:

How severe was Macule and when was it recovered:

Expand to all the drugs that have ingredients of leflunomide:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

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 Macule:

Browse all the conditions that are associated with Macule:


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.



Recent studies on eHealthMe: