Is acetaminophen safe during pregnancy?
Sensible steps you can take.
- Reviewed by Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing
For years, products containing acetaminophen, such as the pain reliever Tylenol, were largely viewed as safe to take during pregnancy. Hundreds of widely available over-the-counter remedies, including popular cold, cough, and flu products, contain acetaminophen. And because other fever-reducing medicines and pain relievers are not recommended during pregnancy, it’s not surprising that up to 65% of women in the US report taking it at some during their pregnancy.
But in 2021, a group of doctors and scientists issued a consensus statement about acetaminophen use during pregnancy. They noted evidence of its potential to interfere with fetal development, possibly leaving lingering effects on the brain, reproductive and urinary systems, and genital development. And while the issue they raise is important, it’s worth noting that the concerns come from studies done in animals and human observational studies. These types of studies cannot prove that acetaminophen is the actual cause of any of these problems.
Why might acetaminophen cause trouble if taken during pregnancy?
One reason may be that it's a known endocrine disruptor. That means it can interfere with chemicals and hormones involved in healthy growth, possibly throwing it off track.
According to the consensus statement, some research suggests that exposure to acetaminophen during pregnancy — particularly high doses or frequent use — potentially increases risk for early puberty in girls, or male fertility problems such as low sperm count. It may also be associated with other issues such as undescended testicles, or a birth defect called hypospadias where the opening in the tip of the penis is not in the right place. It might even play a role in attention deficit disorder and negatively affect IQ.
What the research says about acetaminophen and autism
As highlighted during President Trump’s September 2025 press conference, there is also some concern that acetaminophen might be a cause of autism. For example, a review published in August 2025 analyzed results from 46 prior studies — only seven of which looked specifically at acetaminophen and autism. These studies found a correlation between acetaminophen use during pregnancy and autism.
But, again, this type of research cannot prove that acetaminophen exposure actually caused any cases of autism. One reason is that factors other than acetaminophen could affect the results. For example, if pregnant women taking acetaminophen had high fevers (leading them to take acetaminophen in the first place), the fever or the illness causing the fever could be the trigger for autism rather than acetaminophen. When other factors are not accounted for in an analysis it’s called confounding, and it is a common reason that observational studies are rarely definitive when it comes to figuring out the cause of disease.
Not mentioned at the press briefing was another recent study that included nearly 2.5 million children in Sweden. It concluded that there was no connection between acetaminophen use and autism, and that the possible link reported by some prior studies were likely due to confounding.
After the president’s press conference, the FDA issued a news release and a letter to physicians appropriately emphasizing that “a causal relationship has not been established” between acetaminophen use and autism, and that studies of this relationship are inconclusive.
Is it okay to take acetaminophen during pregnancy?
Experts agree that it is important to consider potential risks when taking any over-the-counter or prescription medicines during pregnancy. If you took acetaminophen during a current or past pregnancy, this might sound pretty scary — especially since you’ve probably always considered this medicine harmless.
However, you shouldn’t panic. Chances are quite good that if you took acetaminophen during a pregnancy, your baby did not and will not suffer any ill effects.
We’ll need more research to confirm the overall safety of acetaminophen use during pregnancy. However, there is widespread consensus among experts that the available scientific information does not warrant a prohibition of its use during pregnancy.
Importantly, not taking acetaminophen can also come with risks in certain situations. For example, prolonged high fever may increase the risk of miscarriage or birth defects. The American College of Obstetricians and Gynecologists and other medical experts consider acetaminophen acceptably safe when taken as directed, and continue to recommend acetaminophen during pregnancy if needed.
Sensible steps if you’re pregnant
Three common-sense steps can help protect you and your baby until more is known on this topic:
- Avoid acetaminophen during pregnancy when possible. Acetaminophen use during pregnancy should be limited to situations where it is really needed.
- Consult with your doctor. Always clear acetaminophen use with your doctor, particularly if you are going to be using the medicine for a long period of time. They might agree that taking it is the best option — or suggest an alternative.
- Minimize use. If you do need to take acetaminophen during pregnancy, take it for the shortest amount of time possible and at the lowest effective dose to reduce fetal exposure.
About the Reviewer

Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing
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