Animal studies have failed to reveal evidence of fetotoxicity or impaired fertility; in such studies, rabbits and rats were administered oral doses up to 300 mg/kg/day (12 times to 23 times the maximum recommended human dose, respectively, based on body surface area). There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus; according to some authorities, since treatment of onychomycosis or tinea capitis can be postponed until after pregnancy is completed, this drug should not be started during pregnancy.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

See references

LactMed: Infants should be monitored for signs of liver toxicity (including jaundice), especially younger infants who are exclusively breastfed.
-According to some authorities, breastfeeding is not recommended during use of this drug.
-According to some authorities, use is not recommended.

Excreted into human milk: Yes (after oral dosing)

Comments:
-The effects in the nursing infant are unknown; low drug levels in milk not expected to cause any side effects in nursing infants, especially if older than 2 months.

The ratio of drug in milk to plasma has been reported as 7:1; however, this ratio was derived from an animal study (species not provided). Such milk drug levels (7-fold maternal plasma drug levels) are much higher than milk drug levels observed in humans.

In a review article, total drug levels of 0.65 and 0.15 mg were collected from the milk of 2 healthy women (aged 32 and 33 years and weighing 57.9 and 53.1 kg, respectively) after a single 500 mg oral dose (administered after fasting 8 hours); these women were not breastfeeding, but were producing some milk. All milk was collected (every 6 hours for 72 hours after dosing); the highest milk drug levels were seen in the first 6-hour collection (7.3 and 7.9 mg/L, respectively). In the 6- to 12-hour sample, milk levels were 2 and 2.4 mg/L. In the 12- to 18-hour sample, milk levels were 0.15 and 0.25 mg/L. After 18 hours, drug was undetectable (less than 150 mcg/L) in milk. The major metabolite of this drug was undetectable (less than 150 mcg/L) in all samples. The cumulative amounts in milk over the 18 hours after dosing were 0.65 mg and 0.15 mg, respectively; milk production over the 18 hours was 218 mL and 41 mL, respectively. Using average milk levels over 24 hours from the 2 subjects, an exclusively breastfed infant would receive 3.8% of the maternal weight-adjusted dose of this drug.

See references