Use is recommended only if clearly needed and the benefit outweighs the risk

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-This drug may be used in women undergoing cesarean section; it should be administered after delivery following clamping of the umbilical cord; this drug is not intended for vaginal labor and delivery.
- Chronic use of this drug in later pregnancy has been associated with neonatal opioid withdrawal syndrome.

Subcutaneous administration of morphine during the early gestational period in mice and hamsters has resulted in neurological, soft tissue, and skeletal abnormalities in the presence of maternal toxicity. Administration of morphine during the gestational periods of organogenesis in rats, rabbits, hamsters, and guinea pigs has been associated with embryotoxicity and neonatal toxicity including decreased litter size, reductions in embryofetal viability and fetal and neonatal body weights, delayed motor and sexual maturation, cyanosis, and hypothermia. In humans, the frequency of congenital anomalies among 70 women who received morphine during the first 4 months of pregnancy or 448 women who received morphine at any time during pregnancy was not greater than expected. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references