Is Augmentin (amoxicillin/clavulanate) safe to use during pregnancy?

Is Augmentin Safe for Pregnancy?

Yes, Augmentin (amoxicillin/clavulanate) is safe to use during pregnancy when clinically indicated for bacterial infections. 1, 2

Safety Classification and Evidence Base

Augmentin is explicitly classified as "Compatible" for use throughout all trimesters of pregnancy by major international respiratory and gastroenterology societies. 1, 2 This classification is supported by:

• Reproduction studies in mice and rats at doses up to 3-6 times the human dose showed no evidence of harm to the fetus or increased fetal malformations. 3
• A large population-based case-control study of 6,935 pregnant women with offspring having congenital abnormalities versus 10,238 controls found no increased risk of congenital abnormalities (crude OR 1.4,95% CI 0.9-2.0, not statistically significant). 4
• The benefit of treating maternal bacterial infections with Augmentin generally outweighs theoretical risks to the fetus. 1, 2

Clinical Decision-Making Algorithm

When considering Augmentin in pregnancy:

1. Confirm the need for antibiotic therapy based on clinical presentation and, when possible, culture results. 2

2. Consider Augmentin as a safe first-line option for appropriate bacterial infections during pregnancy, including:

   • Urinary tract infections 5
   • Skin and soft tissue infections 5
   • Upper and lower respiratory tract infections 5

3. Use throughout pregnancy when clinically indicated - there are no trimester-specific restrictions for standard use. 2

4. One important exception: Avoid in women at risk of preterm delivery due to a very low risk of necrotizing enterocolitis in the fetus. 2 In these patients, consider alternative antibiotics such as cephalexin. 6

Comparison to Other Antibiotics in Pregnancy

Augmentin belongs to the beta-lactam class, which is generally considered safe and effective in pregnancy. 5 Other safe options include:

• Cephalexin (also classified as "Compatible") 6, 7
• Azithromycin (evidence supports safety) 6
• Clindamycin (evidence supports safety) 6

Antibiotics to avoid in pregnancy include:

• Doxycycline and tetracyclines (risk of congenital anomalies, bone binding, tooth discoloration) 6
• Fluoroquinolones (potential cartilage damage) 7, 5
• Erythromycin (risk of elevated liver enzymes) 6

Breastfeeding Considerations

Augmentin is compatible with breastfeeding. 2 Penicillins are excreted in human milk and may lead to sensitization of infants, so caution should be exercised. 3

Important Caveats

• Physiologic changes in pregnancy (increased glomerular filtration rate, increased total body volume, enhanced cardiac output) may alter antibiotic pharmacokinetics, though standard dosing of Augmentin is typically appropriate. 5
• The FDA label notes that animal reproduction studies are not always predictive of human response, but emphasizes no evidence of harm was found in animal studies. 3
• Approximately 80% of prescription medications in pregnant women are antibiotics, with one in four women prescribed an antibiotic during pregnancy, underscoring the importance of evidence-based prescribing. 5