Nafarelin Pregnancy and Breastfeeding Warnings

Brand names: Synarel

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Nafarelin Pregnancy Warnings

Use in women who are or may become pregnant is contraindicated.

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

Risk summary: This drug may cause fetal harm when administered to a pregnant woman. Animal studies have revealed evidence of major fetal abnormalities when administered during the period of organogenesis. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Pregnancy should be excluded prior to starting treatment, and barrier methods of contraception should be used for the duration of treatment.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Some experts recommend discontinuation of treatment if a patient becomes pregnant.
-The manufacturer product information should be consulted regarding recommendations.

Animal models have revealed evidence of dose-related increased fetal mortality and decreased fetal weight when given this drug intramuscularly. An animal model species revealed evidence of major fetal malformations when this drug was administered during organogenesis. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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

Nafarelin Breastfeeding Warnings

Use is contraindicated.

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

Comments: The effects in the nursing infant are unknown.

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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