Cyclosporine Pregnancy and Breastfeeding Warnings

Brand names: Gengraf, Neoral, Sandimmune

Medically reviewed by Drugs.com. Last updated on Jul 7, 2025.

Cyclosporine Pregnancy Warnings

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

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

Risk summary: In clinical studies, adverse pregnancy outcomes such as hypertension, preeclampsia, preterm birth, and low birth weight have been reported in patients treated with this drug. Animal studies have shown embryo-fetal toxicity at doses below the maximum recommended human dose based on BSA.

Comments:
-Some formulations of this drug contain ethanol or methanol which should be taken into consideration if it is taken by a pregnant woman.
-Women of childbearing potential should be appraised of the potential risk to the developing fetus.
-This drug may cause immunosuppression in the infant.
-A pregnancy exposure registry is available.

Animal studies have shown reproductive toxicity manifested by increased pre- and postnatal mortality, reduced fetal weight, and skeletal retardation. Limited human data have revealed evidence of premature birth (gestational period of 28 to 36 weeks) and low birth weight for gestational age.

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 visiting https://www.transplantpregnancyregistry.org

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

Cyclosporine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some formulations contain ethanol or methanol which is present in human milk and will be orally absorbed by the nursing infant.
-Breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity.

-Due to potential effects in the nursing infant, such as immunosuppression, neutropenia, growth retardation, and possible carcinogenesis, this drug is considered contraindicated for use in nursing mothers by the American Academy of Pediatrics.
-Concentration of this drug in human milk varies. Most infants studied did not have detectable blood levels, but 2 infants had measurable levels, one with blood levels in the therapeutic range despite relatively low maternal milk levels.
-Many infants have been breastfed during maternal use of this drug, usually with a concurrent corticosteroid and sometimes with concurrent azathioprine. No reports of adverse effects on infant growth, development, or kidney function were reported, although follow-up examinations have not always been performed or reported.

See references

Further information

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