Is amoxicillin safe in pregnancy?

From the Guidelines

Amoxicillin is safe to use during pregnancy.

Key Points

• The use of amoxicillin during pregnancy has been studied, and the evidence suggests that it is safe [(1, 2, 3)].
• According to the European Respiratory Journal, amoxicillin is classified as category B, indicating that animal studies have failed to demonstrate a risk to the fetus, and there are no adequate and well-controlled studies in pregnant women 1.
• The Toronto Consensus Statements for the management of inflammatory bowel disease in pregnancy found no increased risk of malformations or musculoskeletal abnormalities with the use of amoxicillin-clavulanic acid 2.
• The AGA Clinical Practice Update on pregnancy-related gastrointestinal and liver disease states that amoxicillin-clavulanic acid is safe to administer during pregnancy 3.
• However, it is essential to note that there is a low risk of oral clefts associated with exposure to amoxicillin during organogenesis 1.
• Additionally, amoxicillin-clavulanic acid is not recommended in women at risk of pre-term delivery due to the low risk of necrotising enterocolitis in the fetus 1.
• In general, penicillin and cephalosporin are considered the safest classes of antibiotics during pregnancy 4.

From the FDA Drug Label

8. 1 Pregnancy Teratogenic Effects: Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well

-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.

Amoxicillin may be used during pregnancy if clearly needed, but there are no adequate and well-controlled studies in pregnant women to fully assess its safety. The decision to use amoxicillin in pregnancy should be made with caution, considering the potential benefits and risks, as animal studies do not always predict human response [5] [6]. Key considerations include:

• Teratogenic effects: No evidence of harm to the fetus in animal studies.
• Human studies: No adequate and well-controlled studies in pregnant women.
• Use in pregnancy: Should be used only if clearly needed.

From the Research

Safety of Amoxicillin in Pregnancy

• The use of amoxicillin in pregnancy has been studied in various research papers, with some indicating its safety and others suggesting potential risks 7, 8, 9.
• A study published in 2022 found that the results available to date do not support an increased risk of necrotizing enterocolitis with the use of amoxicillin-clavulanic acid in late pregnancy 7.
• However, a 2024 study on mice found that prenatal amoxicillin exposure could inhibit physical development and reduce the survival rate of fetuses, especially during mid-pregnancy 10.
• A population-based study in Denmark found no increased risk of adverse pregnancy outcome associated with amoxicillin exposure during pregnancy, but suggested that additional studies are warranted 8.
• A systematic review published in 2023 found that although no major congenital anomaly was reported for the administration of amoxicillin, there is a possibility that amoxicillin administration in pregnancy might be related to some anomalies, including cleft palate 11.
• A prospective, controlled study published in 2004 found that exposure to amoxycillin/clavulanic acid during pregnancy is unlikely to be associated with an increased risk of malformations 9.

Potential Risks and Considerations

• The use of amoxicillin in pregnancy may be associated with an increased risk of certain anomalies, such as cleft palate 11.
• Prenatal amoxicillin exposure may inhibit physical development and reduce the survival rate of fetuses, especially during mid-pregnancy 10.
• The safety of amoxicillin in pregnancy may depend on the stage of pregnancy, with some studies suggesting that it is safer to use in the first trimester 9.
• More research is needed to fully understand the potential risks and benefits of using amoxicillin in pregnancy 7, 8, 11.