Oxycodone in Pregnancy and Breastfeeding
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Oxycodone (Oxyir ®, Oxyfast ®, OxyContin ®, Percolone®, Roxicodone®)
Opioid analgesic. Molecular weight: 351.83

"Reproduction studies have been performed in rats and rabbits by oral administration at doses up to 8 mg/kg and 125 mg/kg, respectively. These doses are 3 and 46 times a human dose of 160 mg/day, based on mg/kg basis. The results did not reveal evidence of harm to the fetus due to oxycodone." [1]

Results of The Collaborative Perinatal Project found no increase in the incidence of major malformations among 8 pregnancies exposed during the first trimester to oxycodone [2].

Schick et. al. also found no significant increase in the incidence of major malformations  in 78 pregnancies after first trimester exposure to oxycodone [3].

Briggs et. al. reported that data from a surveillance study of Michigan Medicaid recipients did not support an association between oxycodone and major malformations in 281 newborns who had been exposed to oxycodone during the first trimester [4].

BREAST FEEDING: Oxycodone is excreted into breast milk [5, 6]. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone [1].

NEONATAL SIDE EFFECTS: Drowsiness and withdrawal symptoms in the neonate [7].


1. Physicians Desk Reference 57th ed. Montvale, NJ: Thomson PDR; 2004: 2856-57
2 Heinonen OP, Slone D, Shapiro S: Birth Defects and Drugs in Pregnancy. Publishing Sciences Group Inc., Littleton, MA, 1977.p 287
3. Schick B, et al. Preliminary analysis of first trimester exposure to oxycodone and hydrocodone.[Abstract] Reprod Toxicol. 1996;10:162.
4. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition,Baltimore, MD: Williams & Wilkins,2002 p 1053-1054
5. Marx CM, et al. Oxycodone excretion in human milk in the puerperium. [Abstract] Drug Intell Clin Pharm 1986;20:474.
6. Dickson PH, et al.The routine analysis of breast milk for drugs of abuse in a clinical toxicology laboratory.J Forensic Sci. 1994 Jan;39(1):207-14. PMID: MEDLINE
7.Rao R and Desai NS OxyContin and neonatal abstinence syndrome. J Perinatol. 2002 Jun;22(4):324-5. PMID: MEDLINE

Created: 11/17/2000
Updated: 11/30/2002
Updated: 1/10/2004

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