Follicle stimulating hormone Pregnancy and Breastfeeding Warnings

Brand names: Follistim, Follistim AQ, Follistim AQ Cartridge, Gonal-F Pen, Gonal-f, Gonal-f RFF, Gonal-f RFF Pen, Gonal-f RFF Redi-ject, Puregon

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Follicle stimulating hormone Pregnancy Warnings

Use is contraindicated.

Follitropin alpha:
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Follitropin beta:
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Follitropin delta:
AU TGA pregnancy category: D

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

In animal studies, no teratogenicity was seen with follicle stimulating hormone (FSH). Animal studies with FSH reported dystocia (and associated maternal death and stillborn pups) and pre- and post-implantation loss. There are no controlled data in human pregnancy. Limited data on human pregnancy indicate no malformative toxicity.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.

See references

Follicle stimulating hormone Breastfeeding Warnings

Use is contraindicated. (AU)
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (UK, US)

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

Comments: There is potential for serious adverse reactions in the nursing infant.

In animal studies, follitropin alpha was measured in the milk in early lactation; doses up to 40 international units/kg did not affect lactation, postnatal growth, or development of the offspring. There is no information available from clinical or animal studies on the excretion of follitropin beta in milk.

See references

Further information

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