Co-Amoxiclav in Pregnancy — Is It Safe?
Last reviewed: · Source: US FDA drug label database
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Co-amoxiclav can be used in pregnancy when necessary, but it's not the first choice — plain amoxicillin or other pregnancy-safe antibiotics are preferred where possible.
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- Large epidemiological studies have not found a consistent pattern of birth defects with co-amoxiclav in pregnancy.
- The ORACLE trial found an association with necrotising enterocolitis risk specifically in the context of preterm labour — a narrower concern than general pregnancy use.
- Plain amoxicillin is preferred first-line in pregnancy where it would be equally effective for the infection being treated.
- If your doctor has prescribed co-amoxiclav specifically, it's usually because the infection needs its broader coverage — take the full course as directed.
Is it safe to take Co-Amoxiclav with Pregnancy?
Co-amoxiclav (Augmentin) is used during pregnancy when the infection requires it and when plain amoxicillin is not appropriate (e.g. resistant organisms). Large epidemiological studies have not found a consistent pattern of birth defects. However, one large study (ORACLE trial) found an association between co-amoxiclav use in preterm premature rupture of membranes (PPROM) and neonatal necrotising enterocolitis (NEC) — a rare but serious bowel condition. For this reason, plain amoxicillin is usually preferred if the indication allows, particularly in the third trimester with PPROM. For most routine infections in pregnancy (UTI, chest infection, dental), co-amoxiclav is used when clinically indicated and is considered safer than untreated infection.
How do Co-Amoxiclav and Pregnancy interact?
Clavulanic acid (the additional component vs plain amoxicillin) appeared to drive the NEC association in the ORACLE PPROM trial, possibly through altered gut colonisation. The mechanism is not fully established. For most other pregnancy contexts (infection management), the pharmacological concern is the balance between antibiotic benefits and the small additional risk — untreated infection carries far greater risks than the antibiotic.
Data sourced from the US Food and Drug Administration (FDA) drug label database: NICE NG25 — preterm labour and birth; ORACLE trial data; OpenFDA co-amoxiclav label.
Interaction severity
Rated moderate: large epidemiological studies haven't found a consistent pattern of birth defects, but the ORACLE trial found a specific association with necrotising enterocolitis risk in certain preterm-labour contexts, which is why plain amoxicillin is preferred first-line where it would work equally well.
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Women with PPROM (preterm premature rupture of membranes) — co-amoxiclav is specifically avoided in this situation per NICE guideline NG25; erythromycin is the alternative. For all other indications in pregnancy, discuss with your prescriber.
What if I've already taken Co-Amoxiclav and Pregnancy?
If prescribed co-amoxiclav in pregnancy for a routine infection, the risks are small and the treated infection was the bigger risk. Complete the course and inform your midwife. Do not stop antibiotics mid-course without speaking to your GP.
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Frequently Asked Questions
Is co-amoxiclav safe in pregnancy?
It can be used when necessary. Plain amoxicillin is preferred for most infections in pregnancy; co-amoxiclav is used when indicated (e.g. resistant UTI or mixed infection).
Can I take Augmentin while pregnant?
Augmentin (co-amoxiclav) is used in pregnancy when the infection requires it. Discuss the specific indication with your GP or obstetrician.
Why is co-amoxiclav avoided in PPROM?
The ORACLE trial found an association between co-amoxiclav and neonatal necrotising enterocolitis (NEC) in women with PPROM. NICE recommends erythromycin instead in this specific situation.
What antibiotic is safest in pregnancy?
Penicillins (amoxicillin, flucloxacillin) are first-choice for most infections. Co-amoxiclav, cefalexin and erythromycin are also used when indicated. Always confirm with your prescriber which antibiotic is right for your specific infection.