Is amoxicillin (amoxicillin) safe to use during pregnancy?

Amoxicillin Safety in Pregnancy

Amoxicillin is safe to use during pregnancy and is classified as compatible for use at all stages of gestation, including immediately before delivery. 1

Evidence Supporting Safety

Multiple guidelines and regulatory data confirm amoxicillin's safety profile during pregnancy:

• Amoxicillin is listed as "Compatible" for use during pregnancy in clinical practice guidelines from the European Respiratory Journal 1
• FDA drug labeling indicates reproduction studies in mice and rats at doses up to 2000 mg/kg (3-6 times the human dose) showed no evidence of harm to the fetus 2
• A large population-based study of 401 pregnant women in Denmark found no increased risk of adverse pregnancy outcomes, including low birth weight, preterm delivery, congenital malformations, spontaneous abortion, or perinatal death associated with amoxicillin exposure 3

Clinical Applications During Pregnancy

Amoxicillin is recommended as a first-line treatment option for multiple infections during pregnancy:

• CDC guidelines specifically recommend amoxicillin for treating Salmonella gastroenteritis in pregnant women (along with ampicillin, cefotaxime, ceftriaxone, or TMP-SMZ) to prevent extraintestinal spread that could lead to placental and amniotic fluid infection 4
• Amoxicillin serves as an alternative treatment for Chlamydia trachomatis infection when erythromycin cannot be tolerated, with high cure rates 1
• For anthrax post-exposure prophylaxis, amoxicillin 500 mg every 8 hours is recommended for pregnant women when susceptibility testing confirms the organism is susceptible to penicillins 4
• Amoxicillin is effective for treating asymptomatic bacteriuria during pregnancy, with cure rates of 74-77% 5

Advantages Over Other Antibiotics

Amoxicillin's safety profile is superior to several other antibiotic classes:

• Unlike tetracyclines and fluoroquinolones, which are contraindicated in pregnancy, amoxicillin has no known teratogenic effects 1, 6
• Fluoroquinolones should be avoided entirely during pregnancy 4
• Tetracyclines should not be administered after the fifth week of pregnancy and are deemed contraindicated 6
• Aminoglycosides carry nephrotoxicity and ototoxicity risks and should not be prescribed at any time during pregnancy except for life-threatening infections 6

Amoxicillin-Clavulanic Acid Considerations

The combination of amoxicillin with clavulanic acid is also safe but requires specific consideration:

• Amoxicillin-clavulanic acid is generally safe throughout pregnancy, including late pregnancy and immediately before delivery 7
• A 2001 concern about increased necrotizing enterocolitis risk in newborns has not been confirmed by subsequent studies published between 2001 and 2008 7
• The European Respiratory Journal notes theoretical caution in women at risk of preterm delivery, though current evidence does not support restricting its use 1
• A comparative trial showed amoxicillin-clavulanic acid was safe and effective for bacteriuria in pregnancy with no fetal toxicity observed 8

Common Pitfalls to Avoid

Key considerations when prescribing amoxicillin during pregnancy:

• Do not confuse amoxicillin's safety profile with contraindicated antibiotics like tetracyclines and fluoroquinolones 1
• Penicillins are considered first-line antibiotic treatment during pregnancy, with the exception of maternal penicillin allergy 6
• FDA labeling states amoxicillin should be used during pregnancy "only if clearly needed," but this reflects standard regulatory language rather than specific safety concerns, as animal and human data support its safety 2
• Dosing adjustments may be needed in neonates and young infants due to incompletely developed renal function, but this does not affect maternal dosing during pregnancy 2

Breastfeeding Safety

Amoxicillin is compatible with breastfeeding:

• The American Academy of Dermatology supports using amoxicillin in breastfeeding patients requiring systemic antibiotics 1, 9
• Penicillins are excreted in human milk and may lead to sensitization of infants, so caution should be exercised 2
• Mild gastrointestinal effects may occur in breastfed infants due to alteration of intestinal flora 9