Edaravone Pregnancy and Breastfeeding Warnings

Brand names: Radicava, Radicava ORS

Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.

Edaravone Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: No data is available on the use of this drug in pregnant women to inform a drug-related risk.

Comments: Some authorities suggest the avoidance of this drug during pregnancy.

Animal studies have revealed evidence of adverse developmental effects (increased mortality, decreased growth, delayed sexual development, altered behavior) at clinically relevant doses; most of these effects occurred at doses that were also associated with maternal toxicity. Although IV administration of this drug (3, 20, or 200 mg/kg) prior to and throughout mating in male and female animals and continuing in females to gestation day 7 had no effect on fertility, disruption of the estrus cycle, and mating behavior were observed at the highest dose tested. No effects on reproductive function were observed at the lower doses, which are up to 3 times the recommended human dose on a body surface area basis. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3:
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Edaravone Breastfeeding Warnings

Safety has not been established

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: Animal studies indicate that this drug and its metabolites are excreted in the milk of lactating rats. The health benefits to the mother should outweigh the potential risks to breastfed infants.

In animal studies, rats were administered this drug from gestation day 17 throughout lactation, and adverse effects observed included maternal toxicity, increased stillbirths, delayed physical development (vaginal opening), and mortality in offspring.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer