Gentamicin Pregnancy and Breastfeeding Warnings

Brand names: Cidomycin, Garamycin, Septopal

Medically reviewed by Drugs.com. Last updated on Jul 24, 2025.

Gentamicin Pregnancy Warnings

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

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

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

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.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have failed to reveal evidence of fetotoxicity, fetal harm, or impaired fertility with this drug. 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 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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Gentamicin Breastfeeding Warnings

Use is not recommended and 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: Yes

Comments:
-The American Academy of Pediatrics considers this drug compatible with breastfeeding.
-The WHO considers this drug compatible with breastfeeding; breastfed infants should be monitored for thrush and diarrhea.
-Breastfed infants should be monitored for candidiasis and gastrointestinal side effects (e.g., diarrhea, thrush, diaper rash, antibiotic-associated colitis).

See references

Further information

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