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Tacrolimus Pregnancy and Breastfeeding Warnings

Tacrolimus is also known as: Astagraf XL, Envarsus XR, Hecoria, Prograf

Medically reviewed by Last updated on Oct 3, 2019.

Tacrolimus Pregnancy Warnings

Use is not recommended.

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

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Infants exposed in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress. Administration to pregnant animals during organogenesis was associated with maternal toxicity/lethality, and an increased incidence of abortion, malformation, and embryofetal death.

-This drug can harm a developing fetus.
-Advise pregnant women of the potential risk to the fetus.
-Advise pregnant women whose children are fathered by male transplant recipients exposed to immunosuppressants of the potential risk to the fetus.
-A pregnancy exposure registry is available.
-This drug may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). Monitor maternal blood glucose levels regularly.
-This drug may exacerbate hypertension in pregnant women and increase pre-eclampsia. Monitor and control blood pressure.
There is an increased risk for premature delivery (less than 37 weeks) following transplantation and maternal exposure to this drug.

This drug crosses the placenta. Use in human pregnancy has been associated with premature delivery risk, neonatal hyperkalemia, and renal dysfunction. Animal studies revealed maternal toxicity, and decreases in pup weight, viability, and live births, and increases in abortions, late resorptions, fetal death in utero, fetal malformations, and developmental variations. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or

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.

See references

Tacrolimus Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

-Limited data indicate that amounts of this drug are low in breastmilk and probably do not adversely affect the breastfed infant. Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity if there is a concern.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Prograf (tacrolimus)." Fujisawa, Deerfield, IL.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Prograf (tacrolimus)." Fujisawa, Deerfield, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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