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Imiquimod topical Pregnancy and Breastfeeding Warnings

Brand names: Aldara, Zyclara

Medically reviewed by Drugs.com. Last updated on May 19, 2023.

Imiquimod topical Pregnancy Warnings

Use with caution; benefit should outweigh risk.
-According to some authorities: Use is not recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Animal studies have revealed evidence of adverse fetal effects at oral doses that also produced maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Imiquimod topical Breastfeeding Warnings

Caution is recommended.
-According to some authorities: Use is not recommended.

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

No adverse effects were demonstrated in animal studies with rats treated with this drug during gestation and lactation at doses up to 8 times the maximum human dose on a mg/m2 basis.

See references

See also

References for pregnancy information

  1. Product Information. Aldara (imiquimod topical). 3M Pharmaceuticals. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Product Information. Zyclara (imiquimod topical). Medicis Pharmaceutical Corporation. 2017.

References for breastfeeding information

  1. Product Information. Aldara (imiquimod topical). 3M Pharmaceuticals. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Product Information. Zyclara (imiquimod topical). Medicis Pharmaceutical Corporation. 2017.

Further information

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

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