Fertility: Irbesartan had no adverse effects on fertility or mating behavior of male and female rats given oral doses off 650 mg/kg per day. The ≤650 mg/kg dose of Irbesartan represents approximately five times the MRHDD of 300 mg.
Pregnancy: Fetal exposure to drugs that act directly on the renin-angiotensin system during the second and third trimesters can cause hypotension, reversible or irreversible renal failure, anuria, neonatal skull hypoplasia, and death in the fetus or neonate. Irbesartan should be discontinued as soon as possible when pregnancy is detected, unless no alternative therapy can be used. If medication is continued, serial ultrasound examinations should be performed to assess the intra-amniotic environment. Perinatal diagnostic tests, such as contraction-stress testing (CST), a nonstress test (NST), or biophysical profiling (BPP) also may be appropriate during the applicable week of pregnancy. FDA Pregnancy Category C (first trimester). FDA Pregnancy Category D (second and third trimester).
Breast-feeding: It is not known whether Irbesartan is distributed into breast milk. but Irbesartan and/or its metabolite(s) is distributed into the milk of lactating rats at a low concentration. Because of the potential for adverse effects in the nursing infant, Irbesartan should not be administered to nursing mothers.