This drug caused reproductive toxicity at all doses in animal studies. Intra-amniotic injection in pregnant women during the second trimester was associated with neonatal intestinal atresia and fetal death. Intra-amniotic injection hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress, and photosensitivity in the newborn. Following administration to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care.

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

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.

AU, UK: Use should be avoided.
US: Contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: X (for drug-induced methemoglobinemia); Not assigned (for acquired methemoglobinemia).

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Intra-amniotic injection during the second trimester has been associated with neonatal intestinal atresia and fetal death. This drug caused adverse developmental outcomes in animals when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.

See references

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding the presence of this drug human milk, the effects on the breastfed infant, or the effects on milk production.
-Because of the potential for serious adverse reactions, including genotoxicity, discontinue breastfeeding during and for up to 8 days after therapy.

See references