Skip to content

Is amoxicillin safe when pregnant? A comprehensive guide

3 min read

With millions of pregnant women receiving antibiotic prescriptions annually, many wonder: is amoxicillin safe when pregnant? The U.S. Food and Drug Administration (FDA) classifies amoxicillin as Pregnancy Category B, suggesting it is generally considered safe.

Quick Summary

Amoxicillin is commonly prescribed and largely considered safe during pregnancy, though some inconsistent data suggests a possible link to oral clefts during the first trimester. The benefits of treating infection often outweigh the potential risks.

Key Points

  • Generally Safe: Amoxicillin is considered a low-risk antibiotic during all stages of pregnancy.

  • FDA Category B: It is classified by the FDA as Pregnancy Category B, meaning animal studies show no risk, though human data is less controlled.

  • Treating Infections is Crucial: Untreated bacterial infections pose greater risks to both mother and fetus than properly administered amoxicillin.

  • Inconsistent Link to Oral Clefts: Some studies have suggested an unconfirmed link between first-trimester amoxicillin use and oral clefts, a claim not supported by larger, more recent population studies.

  • Consult Your Doctor: Always consult your healthcare provider before taking any medication, including amoxicillin, while pregnant.

  • Also Safe for Breastfeeding: Amoxicillin is considered compatible with breastfeeding, with very low levels passing into breastmilk.

  • Finish the Prescription: It is important to complete the entire course of medication to effectively treat the infection and prevent antibiotic resistance.

In This Article

What is amoxicillin and how is it used during pregnancy?

Amoxicillin is a broad-spectrum antibiotic from the penicillin family, effective against various bacterial infections. It works by preventing bacteria from building cell walls. During pregnancy, infections like UTIs and respiratory illnesses are common and require treatment to protect both mother and baby. For instance, an untreated UTI can lead to serious complications including preterm labor. Amoxicillin is often chosen due to its safety record.

Amoxicillin and FDA pregnancy categories

The FDA used a letter-based system to classify medication risks during pregnancy. Amoxicillin was designated Category B. This indicated that animal studies showed no fetal risk, and while human studies were limited, harm was considered unlikely based on the available data.

Note that the FDA now uses a detailed, risk-based approach (PLLR) instead of letter categories. However, older drugs are still often discussed using the previous system. Current practice emphasizes a discussion with a doctor to weigh treatment benefits against potential risks.

The debate over amoxicillin and oral clefts

Although many large studies show no link between amoxicillin and significant birth defects, some earlier research, like the Slone Epidemiology Center study, hinted at an inconsistent association with oral clefts, especially during the first trimester.

What the research says

  • Studies suggesting a link: The 2012 Slone study indicated a possible link between amoxicillin use in the third month of pregnancy and increased oral cleft risk.
  • Studies showing no link: Other large studies, such as a 2019 Israeli study, found no significant link between first-trimester amoxicillin exposure and major birth defects.
  • Limitations of older studies: Some studies suggesting a link used retrospective data, which can be less reliable due to recall bias. More recent studies using dispensing data have often shown reassuring results.

The potential risk is considered controversial and likely very small. Importantly, the risks from an untreated bacterial infection are generally much higher than the minimal potential risks of taking amoxicillin.

Amoxicillin vs. Amoxicillin-clavulanate (Augmentin)

Amoxicillin is sometimes combined with clavulanic acid (Augmentin) to help overcome antibiotic resistance. Both formulations are generally considered safe during pregnancy, with some minor differences noted in infant effects during breastfeeding studies. Your doctor will choose the best option for your specific needs.

Comparing amoxicillin and other pregnancy-safe antibiotics

When an antibiotic is necessary, doctors select the safest effective option. Amoxicillin is a common choice, but others are available depending on the infection type.

Feature Amoxicillin (Penicillin class) Cephalexin (Cephalosporin class) Clindamycin (Lincosamide class)
Pregnancy Category B (old system) B (old system) B (old system)
Effectiveness Broad-spectrum, effective against many common bacteria. Broad-spectrum, often used for skin infections and UTIs. Effective against certain bacteria, including some types of vaginal infections.
Known Fetal Risks Some inconsistent data on oral clefts in first trimester, though many larger studies find no link. Considered safe with a good track record in pregnancy. Considered safe with no evidence of major fetal harm.
Common Side Effects Nausea, diarrhea, upset stomach, rash. Nausea, diarrhea, stomach pain, yeast infection. Diarrhea, which can rarely be severe and require immediate medical attention.

Key considerations for taking amoxicillin during pregnancy

  • Always consult your doctor: Self-medication or using old prescriptions is not advised. A doctor will diagnose and prescribe the correct treatment.
  • Do not skip doses: Complete the full course of antibiotics as directed, even if you feel better. This ensures the infection is fully treated and helps prevent resistance.
  • Report all medications: Inform your doctor about all medications and supplements to avoid potential interactions.
  • Understand the risks of inaction: Untreated bacterial infections pose greater risks than taking a safe antibiotic like amoxicillin.

Conclusion

Amoxicillin is generally a safe and effective treatment for bacterial infections throughout pregnancy. While some older studies suggested an unconfirmed link to oral clefts in the first trimester, more recent and robust research has not supported this. Medical consensus is that the benefits of treating a bacterial infection significantly outweigh the small, unproven risks of amoxicillin. The FDA considers it low-risk, and the CDC lists penicillins as generally acceptable during pregnancy. Always consult your healthcare provider for proper diagnosis and treatment for your health and your baby's.

Further information can be found on the MotherToBaby fact sheet on Amoxicillin and Clavulanic Acid, a non-profit organization providing evidence-based information on medications during pregnancy and breastfeeding(https://mothertobaby.org/fact-sheets/amoxicillin-clavulanate/).

Frequently Asked Questions

Under the older system, amoxicillin was classified as FDA Pregnancy Category B. This means animal studies did not show a risk to the fetus, but there were no adequate and well-controlled human studies. The new labeling system no longer uses categories, but the overall assessment of amoxicillin remains favorable.

Yes, amoxicillin is generally considered safe during the first trimester. While some inconsistent studies have suggested a potential link to oral clefts, larger and more robust population-based research has not confirmed this risk.

Untreated bacterial infections can pose significant risks to both the mother and fetus, including preterm labor, premature rupture of membranes, low birth weight, and other serious health issues. In most cases, the benefits of treating the infection with a safe antibiotic like amoxicillin outweigh the risks.

Yes, depending on the specific infection, a doctor may prescribe other antibiotics considered safe during pregnancy, such as cephalosporins (like cephalexin) or clindamycin. The choice depends on the type of bacteria causing the infection.

Augmentin is a combination of amoxicillin and clavulanic acid. The addition of clavulanic acid helps combat antibiotic resistance. Both are generally considered safe during pregnancy. Your doctor will determine which is appropriate based on the infection.

Yes, amoxicillin is considered safe to use while breastfeeding. Only tiny amounts pass into breast milk, and it is not expected to cause adverse reactions in the infant. However, monitor your baby for potential mild side effects like diarrhea or rash.

If you discover you are pregnant after starting a course of amoxicillin, you should continue to take it as prescribed and contact your healthcare provider. There is likely nothing to worry about in terms of fetal health, but it is important to inform your doctor for proper monitoring.

References

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.