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Betamethasone Pregnancy and Breastfeeding Warnings

Brand names: Adbeon, Beta-Phos/AC, Celestone, Celestone Phosphate, Celestone Soluspan, Cell-U-Jec, Selestoject

Medically reviewed by Drugs.com. Last updated on Dec 20, 2023.

Betamethasone Pregnancy Warnings

Animal studies showed teratogenicity in many animal species at human dose equivalents, including increases in cleft palate. Corticosteroids may increase or decrease the number and motility of spermatozoa. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Comments:
-Corticosteroids are teratogenic in many animal species at human dose equivalents.

See references

Betamethasone Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Corticosteroids appear in human milk and may cause untoward effects including growth suppression and interference with endogenous corticosteroid production.

See references

See also

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
  2. Product Information. Celestone Soluspan (betamethasone). Merck & Co., Inc. 2019.

References for breastfeeding information

  1. Product Information. Celestone Soluspan (betamethasone). Merck & Co., Inc. 2019.

Further information

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

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