Revised SPCs: Zofran (ondansetron) Tablets- all presentations
Section 4.6 has been updated to include information about the increased risk of ondansetron causing oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48).
Source:
electronic Medicines compendium
Resource links:
SPS commentary:
A Bumps factsheet written for members of the public by the UK Teratology Information Service (UKTIS) is available on use of ondansetron during pregnancy.