Topiramate and Limb malformation - a phase IV clinical study of FDA data

Summary:

Limb malformation is reported as a side effect among people who take Topiramate (topiramate), especially for people who are female, 30-39 old, also take Oxcarbazepine, and have Drug exposure during pregnancy.

The phase IV clinical study analyzes which people have Limb malformation when taking Topiramate. It is created by eHealthMe based on reports of 48,099 people who have side effects when taking Topiramate from the FDA, and is updated regularly.

What is Topiramate?

Topiramate has active ingredients of topiramate. It is often used in migraine. eHealthMe is studying from 49,809 Topiramate users. Check the latest studies of Topiramate.

What is Limb malformation?

Limb malformation (abnormal birth defect of leg) is found to be associated with 89 drugs and 188 conditions by eHealthMe. Check the latest studies of Limb malformation.

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, 27, 2026

48,099 people reported to have side effects when taking Topiramate.
Among them, 18 people (0.04%) have Limb malformation.

Could Topiramate cause Limb malformation?

Among these 18 people:

What is the gender of people who have Limb malformation when taking Topiramate? *

female: 90 %
male: 10 %

What is the age of people who have Limb malformation when taking Topiramate? *

What are other drugs people take besides Topiramate? *

Oxcarbazepine: 7 people, 38.89%
Lamotrigine: 3 people, 16.67%
Lamictal: 3 people, 16.67%
Valproate Sodium: 2 people, 11.11%
Trileptal: 2 people, 11.11%
Valproic Acid: 1 person, 5.56%
Phenytoin: 1 person, 5.56%
Nicardipine Hydrochloride: 1 person, 5.56%
Levetiracetam: 1 person, 5.56%
Folic Acid: 1 person, 5.56%

What are other side effects people have besides Limb malformation? *

Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 7 people, 38.89%
Dysmorphism (difference of body structure that is suggestive of a congenital disorder): 7 people, 38.89%
Pericardial Effusion (fluid around the heart): 6 people, 33.33%
Enlarged Heart: 6 people, 33.33%
Single Functional Kidney (single kidney): 6 people, 33.33%
Retrognathia (a condition in which either or both jaws recede with respect to the frontal plane of the forehead): 5 people, 27.78%
Oligohydramnios (a condition in pregnancy characterized by a deficiency of amniotic fluid): 4 people, 22.22%
Craniosynostosis (a baby is born with an abnormally shaped skull or develops one during growth): 3 people, 16.67%
Limb Reduction Defect (a birth defect in which all or some of the limbs of a foetus do not completely form while in utero): 3 people, 16.67%
Cardiac Murmur (an heart sound in valve abnormality): 2 people, 11.11%

What are the existing conditions these people have? *

Drug Exposure During Pregnancy: 3 people, 16.67%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1 person, 5.56%
Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 1 person, 5.56%

* Approximation only. Some reports may have incomplete information.

Do you take Topiramate and have Limb malformation?

- Check whether Limb malformation 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 Topiramate:

Topiramate (49,809 reports)

Browse all side effects of Topiramate:

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 Limb malformation:

Limb malformation (89 drugs)

Browse all the conditions that are associated with Limb malformation:

Limb malformation (188 conditions)

Related publications that referenced our studies

Baloch M, Siddiqui MA, "Topiramate induced sudden loss of vision", JPMA, 2012 Oct .
Kocamaz, M., & Karadag, O., "Topiramate-Induced Acute Myopia, Diplopia, and Photosensitivity: A Case Report", Beyoglu Eye Journal, 2019 Jan .
Baloch M, Siddiqui MA, "Topiramate induced sudden loss of vision", JPMA, 2012 Oct .
Kocamaz, M., & Karadag, O., "Topiramate-Induced Acute Myopia, Diplopia, and Photosensitivity: A Case Report", Beyoglu Eye Journal, 2019 Jan .

How the study uses the data?

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