Summary of Use during Lactation

With the exception of one adverse reaction in a breastfed infant, no information is available on the use of olmesartan during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A 6-day-old healthy full-term newborn was exposed to olmesartan in breastmilk. The maternal dose of olmesartan and extent of nursing were not reported. Weight gain was normal during the first two weeks of life, but at the pediatric checkup on the 17^th day postpartum, an abrupt decrease in body weight was recorded. He was hospitalized on the 21^st day, and mixed feeding with milk and formula was started. Biochemical examinations showed aspartate-aminotransferase (AST) 250 mg/dL, and regular urinalysis. Virologic and metabolic causes of elevated transaminase were ruled out. The baby started to regain weight and his AST gradually normalized to 50 mg/dL by the 24^th day. Olmesartan intake was stopped and the child was discharged on the 24^th day of life.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Candesartan, Captopril, Benazepril, Enalapril, Quinapril

References

1.

Salimova M, Maggi M, Crevani M, et al. Olmesartan-induced reversible transaminase elevation in a breastfed newborn. A case report. Neurotoxicol Teratol 2023;98:24. doi:10.1016/j.ntt.2023.107236 [CrossRef]

Substance Name

Olmesartan

CAS Registry Number

144689-24-7

Drug Class

Breast Feeding

Lactation

Milk, Human

Antihypertensive Agents

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Blockers

ARBs