Use is considered acceptable.

AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification.
US FDA pregnancy category: Not formally assigned to a pregnancy category.

Risk Summary: Malformative risk with use of this drug at recommended doses in pregnant women is unlikely.

Comments:
-Patients should limit their daily intake of calcium to 2500 mg.
-If patients require iron supplementation, the iron supplements should be taken at different times of the day.

There are no controlled data human pregnancy; however, based on years of use, the malformative risk is unlikely in humans. In some patients, permanent hypercalcemia has resulted in adverse events on the fetus.

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

Calcium is normally excreted in human milk.

Use is considered acceptable.

Excreted into human milk: Yes

Comments: This drug has been used without apparent harmful effects in the nursing infant.

See references