Can I take telmisartan while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Telmisartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations) . Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data) . When pregnancy is detected, discontinue telmisartan as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Telmisartan (oral), REMEDYREPACK INC. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

No information is available on the use of telmisartan during breastfeeding and the manufacturer advises avoidance of breastfeeding during telmisartan therapy. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

“Summary of Use during Lactation”, LactMed record “Telmisartan” (LM731), quoted verbatim. Everything LactMed reports about Telmisartan while breastfeeding.

8.2 Lactation Risk Summary There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production. Telmisartan is present in the milk of lactating rats (see Data). Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan. Data Telmisartan was present in the milk of lactating rats at concentrations 1.5 to 2 times those found in plasma from 4 to 8 hours after administration.

Prescribing label, section “8.2 Lactation”: Telmisartan (oral), REMEDYREPACK INC. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.