This sheet is about exposure to amoxicillin and clavulanic acid in pregnancy and while breastfeeding. This information is based on available published literature. It should not take the place of medical care and advice from your healthcare provider.

What are amoxicillin and clavulanic acid?

Amoxicillin is a penicillin-like antibiotic. Clavulanic acid is a medication that helps amoxicillin work better. These two medications are combined to make an antibiotic that has been used to treat infections caused by bacteria. Some brand names include Amoclav®, Augmentin XR® and Clavamox®.

Sometimes when people find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take your medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.

I take amoxicillin and clavulanic acid. Can it make it harder for me to get pregnant?

It is not known if taking amoxicillin and clavulanic acid can make it harder to get pregnant.

Does taking amoxicillin and clavulanic acid increase the chance of miscarriage?

Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if taking amoxicillin and clavulanic acid can increase the chance of miscarriage.

Does taking amoxicillin and clavulanic acid increase the chance of birth defects?

Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Most studies have not found an increased chance of birth defects when amoxicillin and clavulanic acid are taken during the first trimester. However, there are very few studies available about this combination medication. There are more studies looking at the use of amoxicillin only during pregnancy. A few of these studies have shown a higher chance of cleft lip and/or cleft palate (an opening in the upper lip and/or the roof of the mouth that needs surgery to correct) when amoxicillin is taken during the first trimester. Other studies on amoxicillin use have not found a higher chance of cleft lip and/or palate. Overall, the chance of cleft lip and/or palate is expected to be low if a person takes amoxicillin and clavulanic acid in the first trimester of pregnancy.

Does taking amoxicillin and clavulanic acid in pregnancy increase the chance of other pregnancy-related problems?

Taking amoxicillin and clavulanic acid is not expected to increase the chance of pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth).

Studies have looked at pregnancy outcomes in people treated with antibiotics to help prevent infection following preterm premature rupture of membranes (PPROM). PPROM is when the fluid-filled sac surrounding the fetus breaks open before 37 weeks of pregnancy. Some studies have suggested that using amoxicillin with clavulanic acid following PPROM increases the chance of a serious bacterial infection known as necrotizing enterocolitis (NEC) in the newborn. NEC is a condition that can injure a baby’s intestines. Although the chance of NEC in the newborn is likely to be low with the use of amoxicillin with clavulanic acid following PPROM, other antibiotics might be preferred in these cases, if needed.

Does taking amoxicillin and clavulanic acid in pregnancy affect future behavior or learning for the child?

A study that followed hundreds of children up to age 11 years did not find that using amoxicillin and clavulanic acid in pregnancy causes learning or behavior problems in the child.

Breastfeeding while taking amoxicillin and clavulanic acid:

Amoxicillin and clavulanic acid enter the breast milk in small amounts. These small amounts are not expected to cause side effects for most nursing infants. In a study of 67 breastfeeding infants, there were no serious side effects from this medication in the breast milk. Some babies had rash, diarrhea, irritability, or constipation, but these reactions did not last long. If you suspect the baby has any symptoms (such as rash or diarrhea), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.

If a male takes amoxicillin and clavulanic acid, could it affect fertility or increase the chance of birth defects?

Studies have not been done to see if amoxicillin and clavulanic acid could affect male fertility (ability to get partner pregnant) or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.

Selected References:

• American College of Obstetricians and Gynecologists. 2020. Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstetrics & Gynecology 135(3):p e80-e97. [PubMed: 32080050]
• Benyamini L, et al. 2005. The safety of amoxicillin/clavulanic acid and cefuroxime during lactation. Ther Drug Monit 27:499-502. [PubMed: 16044108]
• Berkovitch M, et al. 2004. First-trimester exposure to amoxicillin/clavulanic acid: a prospective controlled study. Br J Clin Pharmacol 58:298-302. [PMC free article: PMC1884575] [PubMed: 15327589]
• Campbell AC, et al. 1991. The excretion of amoxicillin in breastmilk and its effect on the suckling infant. Br J Clin Pharmacol 31:230p.
• Czeizel AE, et al. 2001. Augmentin treatment during pregnancy and the prevalence of congenital abnormalities: a population-based case-control teratologic study. Eur J Obstet Gynecol Reprod Biol 97:188-92. [PubMed: 11451547]
• Daniel S, et.al. 2019. The safety of amoxicillin and clavulanic acid use in the first trimester of pregnancy. Br J Clin Pharmacol 85:2856-63. [PMC free article: PMC6955403] [PubMed: 31486528]
• Grantham J, et al. 2002. Association between co-amoxiclav used antenatally with necrotising enterocolitis in the neonate. Am J Obstet Gynecol 187:S90.
• Jepsen P, et al. 2003. A population-based study of maternal use of amoxicillin and pregnancy outcome in Denmark. Br J Clin Pharmacol 55:216-221. [PMC free article: PMC1894737] [PubMed: 12580995]
• Kafetzis D, et al. 1981. Passage of cephalosporins and amoxicillin into the breast milk. Acta Paediatr Scand 70:285-8. [PubMed: 7246123]
• Kenyon SL, et al. 2001. ORACLE Collaborative Group. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group. Lancet 357:979-88. [PubMed: 11293640]
• Kenyon SL, et al. 2001. ORACLE Collaborative Group. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group. Lancet 357:989-94. [PubMed: 11293641]
• Kenyon S, et al. 2002. ORACLE--antibiotics for preterm prelabour rupture of the membranes: short-term and long-term outcomes. Acta Paediatr Suppl 437:12-15. [PubMed: 12200889]
• Kenyon S, et al. 2008. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 372 (9646):1319-27. [PubMed: 18804276]
• Kenyon S, et al. 2013. Preterm Labour, Antibiotics and Cerebral Palsy. Scientific Impact Paper No.33, Royal College of Obstetrics and Gynaecologists.
• Lin KJ, et al. 2012. Maternal exposure to amoxicillin and the risk of oral clefts. Epidemiology 23(5):699-705. [PMC free article: PMC3729019] [PubMed: 22766750]
• Marlow N, et al. 2017. The ORACLE Children Study: educational outcomes at 11 years of age following antenatal prescription of erythromycin or co-amoxiclav. Arch Dis Child Fetal Neonatal Ed 102(2):F131-F135. [PMC free article: PMC5339554] [PubMed: 27515985]
• Meeraus WH, et al. 2015. Association between antibiotic prescribing in pregnancy and cerebral palsy or epilepsy in children born at term: A cohort study using the health improvement network. PLoS ONE 10(3):e0122034. [PMC free article: PMC4373729] [PubMed: 25807115]
• Mercer BM, et al. 1997. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. JAMA 278:989-995. [PubMed: 9307346]
• Merkel TA, et al. 2014. Predicting disease severity of necrotizing enterocolitis: how to identify infants for future novel therapies. J Clin Neonatol 3(1):1-9. [PMC free article: PMC3982330] [PubMed: 24741531]
• Padberg, S. 2015. Anti-infective Agents. In C Schaefer, P Peters, R Miller (Eds.), Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment. Pg 116. London: Elsevier.
• Puho EH, et al. 2007. Drug treatment during pregnancy and isolated orofacial clefts in Hungary. Cleft Palate Craniofac J 44:194-202. [PubMed: 17328645]