Put New Acetaminophen Pregnancy Warnings in Perspective

Posted September 30, 2025: Article in Progress. We’re releasing this article ahead of our November 2025 issue to quickly provide information to our readers. The information contained in this version is based on the best evidence available to us as of the date of posting. The final version may include revised recommendations.

 

Pharmacists are asking how to answer questions about reported links between using acetaminophen during pregnancy and autism in kids.

Parents are concerned about FDA’s recent announcement that acetaminophen’s labeling will soon say its use in pregnancy is associated with increased risk of pediatric neurologic issues...autism, ADHD, etc.

But know that this change isn’t based on new, groundbreaking data.

Explain that some past studies suggest a small increased risk of these conditions with chronic acetaminophen use (over 1 month, etc). But this risk isn’t seen with short-term prn admin in pregnancy.

Clarify that results are conflicting...some studies found NO link. And most of the concerning data are from animals or limited observational human studies that only show an association...NOT causation.

Plus these studies can have a higher risk of bias and confounding. For example, many relied on moms to recall med use from months prior.

Emphasize that there is NO evidence that taking acetaminophen during lactation increases these neurologic risks. Similarly, several studies failed to show a link in young kids given acetaminophen after delivery.

Reassure expectant mothers that these label changes reinforce our current approach in pregnancy: it’s best to use acetaminophen at the lowest dose and shortest duration necessary.

Point out that FDA’s statement even says acetaminophen is still the safest analgesic in pregnancy when one is needed.

For example, we know po and topical NSAIDs generally are NOT alternatives due to their fetal risks...miscarriage, kidney defects, etc.

Continue to use a stepwise pain management approach in pregnancy.

Recommend nondrug measures up front, such as hot or cold packs, physical therapy, stretching, etc.

As a next step, consider topicals with menthol and/or lidocaine for musculoskeletal pain. But avoid topical salicylate products (muscle rubs, etc) due to possible absorption and fetal risks similar to NSAIDs.

Don’t jump to remove acetaminophen from labor and delivery order sets...but see if updates are needed to promote judicious use.

In pregnancy, advocate initial acetaminophen orders to be prn with clear indications (mild to moderate pain, fever over 102°F, etc).

After delivery, encourage using acetaminophen around the clock in many cases to help decrease the need for opioids.

Take a deeper look at the evidence using our Analgesics in Pregnancy and Lactation chart to help balance benefits and risks.

Review our Discussing Medical Misinformation chart for resources to help patients navigate conflicting info and make informed decisions.

 

REFERENCES

• FDA. FDA Responds https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy. (Accessed September 24, 2025).
• Gustavson K, Ystrom E, Ask H, et al. Acetaminophen use during pregnancy and offspring attention deficit hyperactivity disorder - a longitudinal sibling control study. JCPP Adv. 2021 Jun 22;1(2):e12020.
• Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen Use During Pregnancy and Children's Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024 Apr 9;331(14):1205-1214.
• Okubo Y, Hayakawa I, Sugitate R, Nariai H. Maternal Acetaminophen Use and Offspring's Neurodevelopmental Outcome: A Nationwide Birth Cohort Study. Paediatr Perinat Epidemiol. 2025 Sep 2. doi: 10.1111/ppe.70071. Epub ahead of print.
• Damkier P, Gram EB, Ceulemans M, et al. Acetaminophen in Pregnancy and Attention-Deficit and Hyperactivity Disorder and Autism Spectrum Disorder. Obstet Gynecol. 2025 Feb 1;145(2):168-176.
• Alemany S, Avella-García C, Liew Z, et al. Prenatal and postnatal exposure to acetaminophen in relation to autism spectrum and attention-deficit and hyperactivity symptoms in childhood: Meta-analysis in six European population-based cohorts. Eur J Epidemiol. 2021 Oct;36(10):993-1004.