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Minoxidil Pregnancy and Breastfeeding Warnings

Brand names: Loniten

Medically reviewed by Drugs.com. Last updated on Jul 30, 2025.

Minoxidil Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is not recommended.

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

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Use of adequate methods of contraception should be encouraged.
-Use should be avoided in women of childbearing potential who are not using contraception.

Animal studies have revealed evidence of increased fetal resorption when administered at 5 times the maximum recommended human dose. No evidence of teratogenicity was reported. Neonatal hypertrichosis has been reported following exposure during pregnancy. 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.

See references

Minoxidil Breastfeeding Warnings

Use is not recommended.
-According to some authorities: Use is not recommended unless potential benefit outweighs potential risk.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references

Does Minoxidil interact with my other drugs?

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See also

References for pregnancy information

  1. (2002) "Product Information. Loniten (minoxidil)." Pharmacia and Upjohn
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2024) "Product Information. Minoxidil (minoxidil)." Watson Pharmaceuticals

References for breastfeeding information

  1. (2002) "Product Information. Loniten (minoxidil)." Pharmacia and Upjohn
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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

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