Paracetamol and Anencephaly - a phase IV clinical study of FDA data

Summary:

Anencephaly is reported as a side effect among people who take Paracetamol (acetaminophen), especially for people who are female, 0-1 old, have been taking the drug for 1 - 6 months also take Oxymetazoline, and have Rheumatoid arthritis.

The phase IV clinical study analyzes which people have Anencephaly when taking Paracetamol. It is created by eHealthMe based on reports of 114,713 people who have side effects when taking Paracetamol from the FDA, and is updated regularly.

What is Paracetamol?

Paracetamol has active ingredients of acetaminophen. It is often used in pain. eHealthMe is studying from 115,650 Paracetamol users. Check the latest studies of Paracetamol.

What is Anencephaly?

Anencephaly (absence of a major portion of the brain, skull, and scalp that occurs during embryonic development) is found to be associated with 65 drugs and 62 conditions by eHealthMe. Check the latest studies of Anencephaly.

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

114,713 people reported to have side effects when taking Paracetamol.
Among them, 16 people (0.01%) have Anencephaly.

Could Paracetamol cause Anencephaly?

Among these 16 people:

How long have people been on Paracetamol when they have Anencephaly? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 100 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Anencephaly when taking Paracetamol? *

  • female: 100 %
  • male: 0.0 %

What is the age of people who have Anencephaly when taking Paracetamol? *

  • 0-1: 100 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 0.0 %
  • 60+: 0.0 %

What are other drugs people take besides Paracetamol? *

  1. Phenylephrine Hydrochloride: 1 person, 6.25%
  2. Oxymetazoline: 1 person, 6.25%

What are other side effects people have besides Anencephaly? *

  1. Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 10 people, 62.50%
  2. Abortion Induced (medically referred abortion): 2 people, 12.50%
  3. Pyloric Stenosis (narrowing of the passage between the stomach and the small intestine): 1 person, 6.25%
  4. Anal Stenosis (narrowing of the anal sphincter and opening): 1 person, 6.25%
  5. Cerebral Dysgenesis (abnormal brain development): 1 person, 6.25%
  6. Coarctation Of The Aorta (narrowing of the part of aorta): 1 person, 6.25%
  7. Craniosynostosis (a baby is born with an abnormally shaped skull or develops one during growth): 1 person, 6.25%
  8. Diaphragmatic Hernia (defect or hole in the diaphragm that allows the abdominal contents to move into the chest cavity): 1 person, 6.25%
  9. Ear Disorder: 1 person, 6.25%
  10. Exomphalos (weakness of the baby's abdominal wall where the umbilical cord joins it): 1 person, 6.25%

What are the existing conditions these people have? *

  1. Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 9 people, 56.25%
  2. Foetal Exposure During Pregnancy (exposing your unborn child to contraindicated in pregnancy leads birth defect): 4 people, 25.00%
  3. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 2 people, 12.50%

* Approximation only. Some reports may have incomplete information.

Do you take Paracetamol and have Anencephaly?

- Check whether Anencephaly 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 Paracetamol:

Anencephaly treatments and more:

How severe was Anencephaly and when was it recovered:

Expand to all the drugs that have ingredients of acetaminophen:

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 Paracetamol:

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 Anencephaly:

Browse all the conditions that are associated with Anencephaly:


How the study uses the data?

The study uses data from the FDA. It is based on acetaminophen (the active ingredients of Paracetamol) and Paracetamol (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: