Can Acetaminophen Cause Birth Defects?

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Can Acetaminophen Cause Birth Defects?
Picture of pregnant woman taking medication pills. Pregnant woman taking pill against heartburn. A young pregnant woman is taking medications and drinking water.

Acetaminophen or paracetamol is a popular, over-the-counter pain reliever, anti-inflammatory, and fever-reducer medication. Expecting mothers often turn to acetaminophen, like Tylenol, for relief from common discomforts without knowing that exposure may lead to congenital disabilities or disorders.

Concerns about the potential for congenital disabilities have led to questions about the safety of acetaminophen use during pregnancy. Studies show that maternal medication intake can sometimes lead to birth defects in babies. This can happen if certain medications are taken during pregnancy, particularly during the first trimester when the baby’s organs develop.

The risk of birth defects can vary depending on the type and dosage of medication taken and the timing of exposure. In the U.S., almost 70% of pregnant women use acetaminophen up to their second trimester.

This post will explore the available research and provide insights into the possible link between acetaminophen and birth defects.

Acetaminophen and Pregnancy

For many years, acetaminophen has been considered a safe medication for use during pregnancy. It has been one of the few options recommended by healthcare professionals to alleviate mild to moderate pain and fever for pregnant women.

Acetaminophen, when used as directed, is generally considered safe for short-term use during all three trimesters of pregnancy. Currently, it is classified as a Pregnancy Category B drug, meaning it is safe for pregnant women though no clinical trials support this claim.

Pregnant women deserve the right to good information for themselves and their babies. Trusting without reservation poses potential risks and irreversible sequelae, which is probably why the Tylenol pregnancy lawsuit is gaining ground.

Current Research On The Effects Of Acetaminophen

The volume of research in the past that led doctors to believe that acetaminophen can be used without fear is challenged by newer findings. The link between acetaminophen and congenital conditions has been studied for several years. While past results were often inconclusive, recent research examining acetaminophen use during pregnancy reveals a solid connection to developing adverse neurobehavioral outcomes.

Other birth defects cannot be ruled out yet. Congenital disabilities are physical or functional abnormalities in a baby during pregnancy or birth. Altered development from acetaminophen exposure can affect how a baby looks, develops, or functions. Mild to severe inborn conditions can be caused by various factors, including genetic factors, environmental factors, and maternal medication intake.

The body of research behind the consensus statement by a team of 13 scientists—including one from the Yale School of Public Health—calling for preventive action includes:

One person is answering question about congenital abnormalities.

1. Acetaminophen and Neurobehavioral Effects

Danish research involving 64,322 children and mothers, where more than 50% of pregnant mothers used acetaminophen for pain and fever, established that long-term (over 20 weeks) or frequent intake of acetaminophen during pregnancy may be associated with an increased risk of adverse outcomes, such as attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) in children.

Other potential consequences are the following:

  • Epilepsy
  • Decreased intelligence quotient (IQ)
  • Delayed speech
  • Behavioral problems
  • Hyperactivity

2. Developmental Disorders

This research was corroborated by a Boston Birth Cohort study where aside from ADHD and ASD, developmental disorders/disabilities (DD) were also documented. Infants with high acetaminophen and its metabolites were followed up with these findings when they were almost nine years old:

  • ADHD 25.8% only
  • ASD 6.6%
  • ADHD and ASD 4.2%,
  • DDs 30.5%
  • Neurotypical (no developmental disorders) 32.8%

Developmental defects or birth defects in babies are abnormalities that occur during fetal development that affect how a baby grows and develops. These defects can affect a baby’s physical appearance, organ function, and ability to learn and develop skills. Some common examples of developmental defects include:

  • Neural tube defects: This defect affects the development of the brain and spinal cord. It can cause problems such as spina bifida and anencephaly.
  • Congenital heart defects: These are defects in the heart’s structure that can affect its ability to pump blood effectively.
  • Cleft lip and palate: This defect affects the face’s development, resulting in a split in the lip or palate.

However, the absolute risk of these birth defects remains low, and other factors, such as genetics or environmental factors, could also play a role.

3. Acetaminophen And Its Effect On The Sex Hormone Of The Male Fetus

Recent studies have suggested that prolonged or high-dose acetaminophen use during pregnancy may affect the sex hormones of male fetuses.

Specifically, acetaminophen use during pregnancy may decrease testosterone production in male fetuses, which could affect their reproductive health later in life. This effect is believed to be due to the ability of acetaminophen to inhibit the activity of certain enzymes involved in the production of testosterone.

However, it is essential to note that the evidence regarding the effects of acetaminophen on fetal sex hormones is still limited. Further research is needed to understand the extent and potential consequences of these effects fully.

What Pregnant Women Should Know

Aside from OTC and prescription medication, there are other ways pregnant women can combat pains and aches during this precious time when their bodies are changing and adjusting to accommodate a growing fetus. Some remedies that will not cause birth defects are maintaining proper posture, gentle exercise, acupressure, and wearing the right shoes.

To minimize the potential risks, pregnant women can do the following:

  • Follow the recommended dosage: Do not exceed the recommended dosage and duration of use as specified on the product label or prescribed by your healthcare provider.
  • Use only when necessary: Reserve acetaminophen when needed, such as when experiencing significant pain or fever that cannot be managed through other means.
  • Discuss alternative pain relief methods: Talk to your healthcare provider about alternative pain relief methods, such as massage, heat therapy, or relaxation techniques, to help alleviate discomfort during pregnancy.


Well-documented studies in recent years have not caused the FDA to reverse its opinion on the safety of acetaminophen for pregnant women. Though the overall risk appears low mainly when used occasionally and as directed, new evidence supports claims that acetaminophen can increase the risk for birth defects.

Pregnant women must discuss their specific needs and concerns with their healthcare provider to make informed decisions about medication use during pregnancy. It is equally important to keep abreast of what could impact your child’s development and be discerning of safety claims.

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