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Oxymetazoline topical Pregnancy and Breastfeeding Warnings

Brand names: Rhofade

Medically reviewed by Drugs.com. Last updated on Apr 25, 2023.

Oxymetazoline topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal models have revealed evidence of delayed skeletal ossification, increased pup mortality, and decreased pup weight at maternally toxic doses. There are no controlled data in human pregnancy. There is a theoretical association between renal collecting system anomalies and second-trimester exposure in patients using intranasal formulations.

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

Oxymetazoline topical Breastfeeding Warnings

Benefit should outweigh risk.

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

Comment: The effects in the nursing infant are unknown.

The effects of this drug on the quantity or rate of lactation are unknown.

See references

References for pregnancy information

  1. Product Information. Rhofade (oxymetazoline topical). Allergan Inc. 2017.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  2. Product Information. Rhofade (oxymetazoline topical). Allergan Inc. 2017.

Further information

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