Flumazenil Pregnancy and Breastfeeding Warnings

Brand names: Romazicon

Medically reviewed by Drugs.com. Last updated on Feb 10, 2025.

Flumazenil Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies showed no teratogenicity when given during organogenesis at up to 600 times the human exposure, however embryocidal effects (increased pre- and post-implantation losses) were seen in one animal model at 200 times the maximum recommended human exposure (the non-effect dose in this model was 60 times the human exposure). 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 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

Flumazenil Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The short elimination half-life (about 54 minutes) may lessen transfer of this drug to milk.
-Consider withholding breast feeding for a few hours after the last dose.

See references

Further information

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

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