Neomycin Pregnancy and Breastfeeding Warnings

Brand names: Mycifradin, Neo-Fradin, Neo-Tab

Medically reviewed by Drugs.com. Last updated on Jun 16, 2025.

Neomycin Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

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

Risk summary: This drug can cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Therapeutic blood levels in the mother do not equate with safety for the fetus.
-Some experts recommend: Aminoglycosides should be considered potentially ototoxic and nephrotoxic to the fetus.

Animal studies have not been reported. There are reports of total irreversible, bilateral congenital deafness in children whose mothers used streptomycin during pregnancy. Evidence of (probably reversible) damage to immature nephrons of the fetal kidney associated with gentamicin use, and eighth cranial nerve damage associated with aminoglycoside exposure in utero have been reported. 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.

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Neomycin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-Breastfed infants should be monitored for gastrointestinal effects (e.g., diarrhea, candidiasis [thrush, diaper rash], possible antibiotic-associated colitis indicated by blood in the stool).
-Other aminoglycoside antibiotics are excreted into human milk.

This drug was excreted into cow milk following a single IM injection.

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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