Acetaminophen Use During Pregnancy

Safety Profile and Recommendations

The Society for Maternal-Fetal Medicine (SMFM) supports acetaminophen use during pregnancy when medically indicated, as it is considered safe for treating pain and fever in pregnant women 1

Recent observational studies have suggested possible associations between prenatal acetaminophen use and neurodevelopmental outcomes in children, including ADHD and autism spectrum disorders, although the evidence is inconclusive and systematic reviews have concluded that evidence is insufficient to establish a causal relationship between maternal acetaminophen use and neurodevelopmental disorders 1
These studies have limitations, including self-reported medication use, lack of information on dosage and duration of exposure, and assessment of outcomes through parental surveys rather than clinical evaluation, which may introduce recall bias and other biases 1
The FDA has reviewed these studies and determined that the weight of evidence is inconclusive regarding a possible connection between acetaminophen use in pregnancy and ADHD in children, highlighting the need for further research 1

ACE inhibitors and angiotensin receptor blockers are contraindicated during pregnancy due to risk of fetal renal dysplasia, oligohydramnios, and growth restriction, making acetaminophen a safer alternative for pain and fever relief 2

The Advisory Committee on Immunization Practices recommends acetaminophen as the first-line medication for treating fever in pregnant women 3
For moderate to severe pain or fever during pregnancy, acetaminophen remains the first-line recommendation, as advised by the Advisory Committee on Immunization Practices 3

For mild pain, non-pharmacological approaches may be considered before medication use, according to recent research 4

NSAIDs should be avoided during the first and third trimesters of pregnancy, as recommended by recent studies 4

The FDA concluded that the weight of evidence is inconclusive regarding a possible connection between acetaminophen use in pregnancy and ADHD or autism in children, based on a review of available studies in 2015 5

Earlier observational studies showing associations between prenatal acetaminophen use and ADHD/ASD had critical limitations, including self-reported medication use, no information on dosage or duration of exposure, and failure to control for familial/genetic confounding 6, 5
Multiple meta-analyses from 2018-2022 reported weak associations between prenatal acetaminophen and ADHD/ASD, but acknowledged substantial heterogeneity (I² = 68-93%) and significant methodological flaws 7, 8

Use acetaminophen during pregnancy only when medically needed, at the lowest effective dose, for the shortest duration, as recommended by the American College of Obstetricians and Gynecologists 7, 6
Avoid prolonged or excessive use (>28 days cumulative exposure) of acetaminophen during pregnancy, as this was associated with stronger associations in older observational studies, even though causality remains unproven 7, 8
Balance the risks of untreated fever and pain during pregnancy, which carry their own risks to maternal and fetal health, against theoretical neurodevelopmental concerns related to acetaminophen use 6, 5

Acetaminophen is the only universally safe first-line medication for treating cold symptoms throughout all trimesters of pregnancy, and should be used at the lowest effective dose for the shortest duration needed, as recommended by the American College of Obstetricians and Gynecologists 9, 10, 11, 12
Fever itself poses risks to fetal development, making treatment medically necessary rather than optional, according to the Centers for Disease Control and Prevention 9, 10, 11, 12

NSAIDs, such as ibuprofen and naproxen, are contraindicated in the first and third trimesters due to risks of miscarriage, cardiac defects, and premature closure of ductus arteriosus, as stated by the American College of Rheumatology 13
Short-term use of NSAIDs in the second trimester only may be considered if absolutely necessary, but acetaminophen remains vastly preferable, as recommended by the American College of Rheumatology 13

If influenza is suspected or confirmed, oseltamivir or zanamivir should be initiated immediately regardless of trimester, as pregnant women are at high risk for severe complications and mortality from influenza, according to the Centers for Disease Control and Prevention 9, 10, 11, 12
Treatment should not be delayed for diagnostic testing—clinical suspicion alone warrants antiviral therapy, as recommended by the Centers for Disease Control and Prevention 9, 10, 11, 12