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

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

Animal studies have failed to reveal evidence of fetal harm, impaired fertility, or mating performance at doses 8 to 48 times the full therapeutic dose. In humans, this drug was shown to not influence spermatogenesis, sperm count, motility, morphology, or in vitro fertilizing capacity.

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.

See references

Use in nonlactating patients may increase prolactin secretion, which may result in gynecomastia and/or galactorrhea.

Fully breastfed infant exposure is predicted to be between 0.74 to 0.9 mg/kg/day, significantly less than the 5 to 10 mg/kg/day doses given directly to neonates.

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-The effects of this drug in the nursing infant are unknown.
-The American Academy of Pediatrics considers this drug compatible with breastfeeding.
-The WHO recommends that this drug should be avoided if possible, as there are insufficient data on long-term side effects.
-Some experts state this drug has the potential for causing liver enzyme inhibition; other drugs (e.g., famotidine, nizatidine, omeprazole, pantoprazole, ranitidine, sucralfate) may be preferred, especially in patients younger than 2 months.

See references