Put FDA's New Acetaminophen Pregnancy Warning 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.

 

Pharmacy staff are asking how to answer questions about whether acetaminophen use during pregnancy increases the risk of autism in kids.

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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.

Some past studies suggest a very small association of these conditions with chronic acetaminophen use (over 1 month, etc)...but NOT with short-term prn admin.

Be aware that results are conflicting...some studies found NO link with ANY duration. And most of the concerning data are from animals or observational studies that only show an association...NOT causation.

Plus these studies tend to have flaws (bias, etc) that skew data. For example, many relied on moms to recall acetaminophen use from months in the past.

Keep in mind that there is NO evidence that taking acetaminophen while breastfeeding increases neurologic risks. Similarly, several studies failed to show a link in young kids given the med after delivery.

Anticipate your RPh to reassure expectant moms that these warnings don’t change our current approach in pregnancy: acetaminophen should only be used when needed...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, it’s best to avoid po and topical NSAIDs (ibuprofen, diclofenac, etc) due to fetal risks...miscarriage, kidney defects, etc.

Support using a stepwise approach to managing pain in pregnancy, when possible...to limit systemic exposure to meds and fetal risks.

Anticipate nondrug measures first, such as hot or cold packs, physical therapy, stretching, etc.

As a next step, you may see OTC topicals with menthol and/or lidocaine used...but NOT salicylate products, since they’re absorbed and have fetal risks similar risks to NSAIDs.

Then expect acetaminophen as a prn option for continued mild or moderate pain. For fever, it's okay to use acetaminophen carefully for temps over 102°F...high fevers in mom can be risky to the fetus.

Take a deeper look at the evidence using our Analgesics in Pregnancy and Lactation chart that discusses benefits and risks.

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

 

REFERENCES

  • FDA. FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy. September 22, 2025. 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.
  • 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.
  • 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.
  • 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.