Animal studies have failed to reveal evidence of teratogenicity after oral doses up to 50 mg/kg/day (about 1000-fold higher than the maximum recommended ophthalmic dose); oral doses at least 150 mg/kg/day showed decreased fetal weight, atrial enlargement, and skeletal/craniofacial malformations or delayed ossification in rats, while increased late postimplantation loss and neonatal/perinatal mortalities were observed at 200 mg/kg/day. There are no controlled data in human pregnancy.

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.

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

US FDA pregnancy category: C

See references

Caution is recommended.

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

Comments:
-Maternal use of an ophthalmic or otic drop containing this drug poses negligible risk for a nursing infant.
-Placing pressure over the tear duct by the corner of the eye for at least 1 minute then removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches the breast milk after using eye drops.

Traditionally, systemic fluoroquinolones have not been used in infants due to concern over toxic effects on their developing joints; however, some studies suggest risk is low. Absorption of the small amounts of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove.

See references