Somatropin Pregnancy and Breastfeeding Warnings

Brand names: Accretropin, Genotropin, HumatroPen, Humatrope, Norditropin, Norditropin FlexPro, Norditropin Nordiflex, Nutropin, Nutropin AQ, Nutropin Depot, Omnitrope, Saizen, Serostim, Tev-Tropin, Zomacton, Zorbtive

Medically reviewed by Drugs.com. Last updated on Feb 28, 2025.

Somatropin Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1 and B2
US FDA pregnancy category: Not assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Women of childbearing potential should use contraception.

Animal studies did not show any teratogenicity or adverse effects on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring; a slight increase in fetal death and increased body weight of pups, and reduced pregnancy rate, increased litter size, irregular estrus cycles, and decreased sperm motility in the parents were seen. 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.

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

Somatropin Breastfeeding Warnings

Caution is recommended.

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

Following subcutaneous administration of radiolabeled medication in animal studies, radioactivity was transferred to milk reaching four times the concentration found in maternal plasma. However, absorption of the intact protein in the gastrointestinal tract of the infant is considered extremely unlikely.

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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