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Fluocinolone topical Pregnancy and Breastfeeding Warnings

Brand names: Capex, Derma-Smoothe/FS, Derma-Smoothe/FS (Body Oil), Derma-Smoothe/FS (Scalp), Dermotic, FS Shampoo, Fluonid, Flurosyn, Synalar, Synalar Ointment, Synalar TS, Synalar-HP, Synemol

Medically reviewed by Drugs.com. Last updated on Dec 18, 2023.

Fluocinolone topical Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

US FDA pregnancy category: C

Comments: Topical corticosteroids should not be used extensively on pregnant patients, in large amounts or for extended periods of time.

Animal studies have shown the more potent corticosteroids to be teratogenic after dermal application. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects from topically applied corticosteroids.

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

Fluocinolone topical Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Topical steroids should not be applied to the breasts prior to breastfeeding.

See references

References for pregnancy information

  1. (2001) "Product Information. Synalar (fluocinolone topical)." Syntex Laboratories Inc
  2. (2003) "Product Information. Capex (fluocinolone topical)." Galderma Laboratories Inc
  3. "Product Information. Derma-Smoothe/FS (Body Oil) (fluocinolone topical)." Hill Dermaceuticals Inc
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

References for breastfeeding information

  1. (2001) "Product Information. Synalar (fluocinolone topical)." Syntex Laboratories Inc
  2. (2003) "Product Information. Capex (fluocinolone topical)." Galderma Laboratories Inc
  3. "Product Information. Derma-Smoothe/FS (Body Oil) (fluocinolone topical)." Hill Dermaceuticals Inc
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

Further information

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