Is Augmentin Safe in Pregnancy?
Yes, Augmentin (amoxicillin-clavulanate) is safe to use during pregnancy when clinically indicated for bacterial infections. 1, 2, 3
Safety Classification and Evidence Base
Augmentin is classified as FDA Pregnancy Category B, meaning animal reproduction studies have shown no evidence of harm to the fetus, though adequate well-controlled studies in pregnant women are limited. 3 The European Respiratory Society/Thoracic Society of Australia and New Zealand categorizes amoxicillin-clavulanate as "Compatible" for use during pregnancy. 2
Key Safety Data
Animal studies at doses up to 4 times the maximum human dose showed no teratogenic effects or fetal harm. 3
A large population-based case-control study (1991-1996) examined 6,935 pregnant women with offspring having congenital abnormalities versus 10,238 controls. The study found no increased risk of congenital abnormalities with Augmentin use (odds ratio 1.4,95% CI 0.9-2.0, not statistically significant). 4
Multiple gastroenterology and hepatology guidelines explicitly state that amoxicillin-clavulanic acid is safe and can be administered during pregnancy. 1
Clinical Recommendations for Use
When to Prescribe
Use Augmentin throughout pregnancy when bacterial infection requires treatment. 2, 5
The benefit of treating maternal infections generally outweighs theoretical risks to the fetus. 2, 5
Beta-lactam antibiotics, including Augmentin, are considered among the safest and most effective antibiotics in pregnancy. 5
Critical Exception - Preterm Delivery Risk
Do not use Augmentin in women at risk of preterm delivery due to a very low but documented risk of necrotizing enterocolitis in the fetus. 2 In these patients, select alternative antibiotics when clinically appropriate.
Dosing Considerations
Standard adult dosing does not require adjustment during pregnancy. 3
Physiologic changes in pregnancy (increased glomerular filtration rate, increased total body volume, enhanced cardiac output) may affect pharmacokinetics, but dose adjustments are not routinely needed for Augmentin. 5
Use During Breastfeeding
Augmentin is compatible with breastfeeding. 2 Amoxicillin is excreted in human milk and may lead to sensitization of infants, but this does not contraindicate use. 3 Limited human data support the safety of amoxicillin/clavulanic acid during breastfeeding. 1
Common Pitfalls to Avoid
Do not withhold necessary antibiotic therapy due to pregnancy concerns - untreated bacterial infections pose greater risks to both mother and fetus than Augmentin exposure. 5
Do not confuse Augmentin with contraindicated antibiotics - fluoroquinolones and tetracyclines should be avoided in pregnancy, but Augmentin is safe. 5
Screen for preterm delivery risk before prescribing - this is the only major contraindication for Augmentin in pregnancy. 2
Do not stop therapy prematurely - complete the full antibiotic course as prescribed to ensure adequate treatment of infection. 1