Augmentin Safety and Dosing in Pregnancy
Augmentin (amoxicillin-clavulanate) is safe for use throughout pregnancy and is classified as FDA Pregnancy Category B, with no evidence of fetal harm in animal or human studies. 1
Safety Profile
The combination of amoxicillin-clavulanate is compatible with all trimesters of pregnancy, with multiple high-quality guidelines and the FDA label confirming its safety. 2, 1
Reproduction studies in pregnant rats and mice at doses up to 1200 mg/kg/day (approximately 4 times the maximum human dose for amoxicillin and 9 times for clavulanate) revealed no evidence of fetal harm. 1
A prospective controlled study of 191 women exposed to amoxicillin-clavulanate in the first trimester showed major malformation rates of 1.9%, which did not differ from controls (3%) and was within baseline population risk. 3
A population-based case-control study of 6,935 cases and 10,238 controls found no increased risk of congenital abnormalities (OR 1.4,95% CI 0.9-2.0). 4
Recent 2024 gastroenterology guidelines specifically state that amoxicillin-clavulanic acid is safe and can be administered during pregnancy for conditions like inflammatory bowel disease. 5
Important Caveat
One specific caution exists: avoid Augmentin in women at high risk of preterm delivery due to theoretical risk of necrotizing enterocolitis in the fetus. 2 This is the only clinical scenario where alternative antibiotics should be considered.
Standard Adult Dosing for Pregnant Patients
For most infections, prescribe Augmentin 500 mg/125 mg every 12 hours OR 250 mg/125 mg every 8 hours. 1
For more severe infections or respiratory tract infections, prescribe Augmentin 875 mg/125 mg every 12 hours OR 500 mg/125 mg every 8 hours. 1
Dosing Administration Details
Take at the start of meals to enhance clavulanate absorption and minimize gastrointestinal intolerance. 1
Do NOT substitute two 250 mg/125 mg tablets for one 500 mg/125 mg tablet, as both contain the same amount of clavulanic acid (125 mg), making them non-equivalent. 1
Breastfeeding Compatibility
Augmentin is compatible with breastfeeding, though amoxicillin is excreted in breast milk and may lead to infant sensitization, so caution is advised. 2, 1
Comparison to Alternatives
Unlike tetracyclines (including doxycycline) and fluoroquinolones, which are contraindicated in pregnancy due to dental staining, bone growth impairment, and other risks, Augmentin has no known teratogenic effects. 6, 2
Other safe alternatives during pregnancy include cephalexin, azithromycin, and clindamycin, but Augmentin provides broader coverage including beta-lactamase-producing organisms. 2
Clinical Context from Guidelines
The 2016 Toronto Consensus and 2024 AGA guidelines for inflammatory bowel disease management specifically endorse amoxicillin-clavulanic acid as safe for treating perianal sepsis, pouchitis, and intra-abdominal abscesses during pregnancy. 5
The 2025 EULAR rheumatology guidelines do not list Augmentin specifically but confirm that amoxicillin is compatible with pregnancy at all stages. 5