Oxycodone

Pregnancy

MotherToBaby reports one study associating opioid use during the first 8 weeks, including oxycodone, with a slightly increased chance of miscarriage. Flannagan et al. prospectively followed 1,228 women attempting conception and found that loss risk rose with later opioid detection (RR 2.1 at week 4 and RR 2.5 at weeks 4 and 8); the study reports opioid-class results, not an oxycodone-only estimate. Kelty et al. compared 302 pregnancies with oxycodone dispensed during pregnancy with 604 comparison pregnancies. First-trimester exposure was not associated with a statistically significant increase in congenital anomalies (OR 1.74, 95% CI 0.78 to 3.87), an imprecise estimate. The same study associated second-trimester exposure with shorter gestation, lower birth weight, very preterm birth and special-care nursery admission, and third-trimester exposure with shorter gestation. In the 2025 New South Wales cohort of 509,971 births, any opioid dispensation was associated with modestly higher hazards of placental abruption and preterm birth; codeine and oxycodone monotherapy were also associated with elevated risks. These observational findings cannot establish that oxycodone caused an outcome; prescription records, underlying pain, other medicines and other factors can affect comparisons. Labels say available human oxycodone data do not establish a major birth-defect or miscarriage risk. Animal studies in rats and rabbits did not show embryo-fetal toxicity, while published rat studies reported offspring behavior changes. A 2026 linked cohort study of third-grade children found no meaningful academic impact for codeine or oxycodone exposure, although the abstract does not provide a separate oxycodone effect estimate.

Breastfeeding

LactMed reports that sedation and apnea have occurred in breastfed infants and that newborns may be more sensitive. Lam et al. retrospectively compared 533 mother-infant pairs and found maternal reports of infant CNS depression in 28 of 139 oxycodone-exposed infants (20.1%) and 1 of 184 acetaminophen-only infants (0.5%); the outcome was maternally reported and the design cannot establish causation. Seaton et al. measured milk and maternal levels in 50 mothers after cesarean delivery and found oxycodone in milk; only one of 41 sampled infants had a detectable plasma level during the first two days, when milk intake is low. Timm reported one intoxication case in a 4-day-old infant. Shah et al. enrolled 210 postpartum dyads; 77% of mothers received opioids and 13% of neonates had a composite opioid-related outcome, with a borderline association between higher maternal opioid consumption and the composite outcome (aRR 3.79, 95% CI 1.01 to 14.28; p=0.07). Wallace and Himmelbaum reported a 2026 case of apnea and desaturation temporally linked to maternal oxycodone during breastfeeding. The recent cohort was not specific to oxycodone exposure, and case reports cannot estimate how often an outcome occurs.

What was tested

Pregnancy evidence includes prospective and retrospective observational cohorts, including studies of opioid-class exposure and oxycodone-specific dispensing. These studies measure associations and may be affected by the reason for treatment, other medicines and other differences between groups. Breastfeeding evidence includes milk-level studies, retrospective maternal reports, short postpartum cohorts and case reports. It does not provide a precise incidence estimate for all formulations, doses or infant ages.