Granisetron Pregnancy and Breastfeeding Warnings
Brand names: Granisol, Kytril, Sancuso, Sustol
Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.
Granisetron Pregnancy Warnings
Animal studies given IV and oral formulations have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.
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.
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.
Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.
Granisetron Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant and on milk production are unknown.
-Some experts state that this drug may be used with caution.
When measured in lactating animal models, less than 1% of the administered IV dose was excreted in milk, some of which was potentially absorbed by the offspring.
See also
References for pregnancy information
- Product Information. Kytril (granisetron). SmithKline Beecham. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Sancuso (granisetron). ProStrakan Group. 2014.
References for breastfeeding information
- Product Information. Kytril (granisetron). SmithKline Beecham. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Sancuso (granisetron). ProStrakan Group. 2014.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
