Is Acetaminophen Safe During Pregnancy?

Acetaminophen, commonly known by the brand name Tylenol or paracetamol in some countries, has long been considered the safest over-the-counter pain reliever and fever reducer for pregnant women. However, recent research has sparked important conversations about its safety profile during pregnancy. Understanding the current evidence, expert recommendations, and how to weigh risks and benefits is crucial for expectant mothers navigating medication decisions during this critical time.

Understanding Acetaminophen and Its Use in Pregnancy

Acetaminophen is the most commonly used pain and fever medication during pregnancy, with more than half of pregnant women worldwide using it at some point during their nine months. The medication has historically been preferred over alternatives like ibuprofen and opioids, which carry their own documented risks during pregnancy. Acetaminophen crosses the placental barrier and reaches the developing fetus, making questions about its safety particularly important for expectant mothers.

The medication is used to manage various pregnancy-related conditions, including headaches, general pain, fever, and other common discomforts. For many pregnant women, acetaminophen has represented a relatively safe option when other pain management strategies prove insufficient.

Recent Research on Acetaminophen and Neurodevelopmental Disorders

In 2025, a comprehensive systematic review led by researchers at Mount Sinai, Harvard T.H. Chan School of Public Health, and other institutions analyzed 46 previous studies incorporating data from more than 100,000 participants across multiple countries. This meta-analysis found evidence supporting an association between prenatal acetaminophen exposure and increased incidence of neurodevelopmental disorders (NDDs) including autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).

The research team noted that while the study does not demonstrate that acetaminophen directly causes these conditions, the findings strengthen the evidence for a potential connection. The association appears strongest when acetaminophen is taken for four weeks or longer during pregnancy. The study explored potential biological mechanisms, suggesting that acetaminophen may cross the placental barrier and trigger oxidative stress, disrupt hormones, and cause epigenetic changes that could interfere with fetal brain development.

Contrasting Evidence and Expert Perspectives

Despite the Mount Sinai-led research, significant disagreement exists within the medical community about acetaminophen safety. The American College of Obstetricians and Gynecologists (ACOG) maintains that acetaminophen is safe and plays an important role in the well-being of pregnant women. ACOG’s position, stated in September 2025, emphasizes that “in more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children.”

Large-scale studies provide conflicting findings. A 2025 Swedish study published in the Journal of the American Medical Association involving 2.5 million children found no relationship between maternal acetaminophen use and autism. Similarly, a Japanese study of 217,000 children published in 2025 found no causative link between prenatal acetaminophen exposure and autism spectrum disorder. These studies are among the highest-quality research available on this topic.

The Society for Maternal-Fetal Medicine, along with medication-safety authorities in the European Union, United Kingdom, and Australia, also support the view that acetaminophen does not cause autism. However, experts like Dr. Andrea Baccarelli, dean of the faculty at Harvard T.H. Chan School of Public Health, advocate for caution, particularly regarding prolonged or heavy use of the medication during pregnancy.

The FDA’s Recent Actions

In September 2025, the U.S. Food and Drug Administration initiated the process for a label change on acetaminophen products to reflect emerging evidence about potential associations with neurodevelopmental conditions. The FDA also issued a letter to clinicians nationwide alerting them to this body of evidence. FDA Commissioner Marty Makary stated that “the choice still belongs with parents,” noting that “it remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”

The FDA’s action reflects a balanced approach, acknowledging the evidence while recognizing that untreated fever and pain during pregnancy also carry risks. The agency emphasized that most low-grade fevers do not require treatment and that the precautionary principle may lead many to avoid acetaminophen during pregnancy.

Understanding the Risks of Untreated Pain and Fever

A crucial consideration in the acetaminophen safety discussion involves the risks associated with leaving pain and fever untreated during pregnancy. Maternal fever, particularly high fever, can raise the risk of neural tube defects and preterm birth. Additionally, pain left unmanaged can cause stress and discomfort that may negatively affect both mother and fetus.

Headaches can be an early sign of preeclampsia, a serious pregnancy complication that requires medical attention and management. Fever and pain are conditions that acetaminophen helps manage therapeutically, making the medication essential for pregnant women who need it. According to ACOG, the conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for both the pregnant person and the fetus.

Risk-Benefit Assessment and Medical Guidance

Experts across the board agree that pregnant women should not stop taking necessary medication without consulting their healthcare providers. The most prudent approach involves careful consideration of individual circumstances and professional medical guidance. Researchers from the Mount Sinai study recommend “judicious acetaminophen use—lowest effective dose, shortest duration—under medical guidance, tailored to individual risk-benefit assessments, rather than a broad limitation.”

This approach acknowledges both the potential risks highlighted by recent research and the documented benefits of acetaminophen for managing pain and fever during pregnancy. Healthcare providers can help pregnant women weigh these factors based on their specific situations, medical history, and the conditions requiring treatment.

Alternative Pain Management Strategies

During pregnancy, several non-medication approaches can help manage pain and discomfort:

• Physical therapy and prenatal massage
• Heat therapy (warm compresses or baths)
• Relaxation techniques and prenatal yoga
• Acupuncture, which has some evidence supporting its safety in pregnancy
• Proper posture and ergonomic adjustments
• Adequate rest and sleep
• Support belts or maternity pillows for back and body support

These alternatives can complement or, in some cases, reduce the need for medication-based pain management. Discussing these options with healthcare providers can help pregnant women develop a comprehensive pain management plan.

Current Clinical Recommendations

The emerging consensus among medical professionals involves a more nuanced approach than either universal recommendation or universal avoidance of acetaminophen. Current guidance suggests:

• Use acetaminophen only when necessary and at the lowest effective dose
• Limit use to the shortest duration possible
• Prioritize non-medication pain management strategies when feasible
• Discuss acetaminophen use with healthcare providers before use
• Avoid prolonged or chronic use throughout pregnancy
• Seek medical attention for fever or pain rather than self-treating

These recommendations balance the potential risks identified in recent research with the well-established benefits of acetaminophen for managing pregnancy-related discomfort and medical conditions.

What Pregnant Women Should Know

Pregnant women navigating medication decisions should understand several key points. First, the evidence regarding acetaminophen and neurodevelopmental disorders remains complex and somewhat contradictory, with reputable studies reaching different conclusions. The highest-quality recent studies show no causative link between acetaminophen use and autism or ADHD.

Second, untreated pain and fever during pregnancy carry documented risks that should not be dismissed. Medical conditions requiring treatment—such as fever, headaches potentially indicating preeclampsia, and significant pain—warrant appropriate management under professional guidance.

Third, individual circumstances matter significantly. A pregnant woman with a low-grade fever might reasonably avoid acetaminophen, while another experiencing severe headaches or significant pain might benefit from its use under medical supervision. These decisions should be made collaboratively with healthcare providers who understand the patient’s complete medical picture.

The Role of Further Research

Researchers calling for caution about acetaminophen also emphasize the urgent need for further investigation to confirm findings and identify safer alternatives for managing pain and fever in expectant mothers. The scientific community recognizes that while current evidence raises concerns, more definitive research is necessary to establish causality and understand which populations might be at highest risk.

Additionally, there is a need for pharmaceutical innovation to develop safe alternatives specifically designed for use during pregnancy, providing expectant mothers with more options for managing pain and fever.

Frequently Asked Questions

Q: Does acetaminophen cause autism?

A: Current research does not establish a causative link between acetaminophen use and autism. While some studies suggest a potential association, the largest and highest-quality recent studies found no relationship between prenatal acetaminophen exposure and autism spectrum disorder. The American College of Obstetricians and Gynecologists states that no reputable study has concluded acetaminophen causes neurodevelopmental disorders.

Q: Is it safe to use acetaminophen during the first trimester?

A: ACOG affirms that acetaminophen is safe to use in any trimester of pregnancy. However, experts recommend using the lowest effective dose for the shortest duration necessary and consulting with healthcare providers about individual circumstances.

Q: What should I do if I have a fever during pregnancy?

A: Contact your healthcare provider before treating fever during pregnancy. While most low-grade fevers do not require treatment, higher fevers can pose risks to the developing fetus. Your provider can recommend the safest approach based on your specific situation.

Q: Are there safer alternatives to acetaminophen for pain relief during pregnancy?

A: Non-medication approaches including physical therapy, prenatal massage, heat therapy, relaxation techniques, and prenatal yoga can help manage pain. Discuss these options and other alternatives with your healthcare provider to develop a comprehensive pain management plan.

Q: How long is it safe to take acetaminophen during pregnancy?

A: Experts recommend limiting acetaminophen use to the shortest duration necessary. Research suggests that the potential risk may be strongest with prolonged use lasting four weeks or longer. Use only when necessary and under medical guidance.

Q: Should I stop taking acetaminophen if I’m pregnant?

A: Pregnant women should not stop taking necessary medication without consulting their healthcare providers. Untreated pain or fever can also harm the baby. Discuss your individual situation with your doctor to determine the safest approach for your specific needs.

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medha deb

 

Medha Deb is an editor with a master's degree in Applied Linguistics from the University of Hyderabad. She believes that her qualification has helped her develop a deep understanding of language and its application in various contexts.

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