Lisinopril
MedicationPrinivil, Qbrelis, Zestril
ACE inhibitor
Research strength: 3 / 5
MotherToBaby says it is not known whether lisinopril raises birth-defect chances in the first trimester, while the Qbrelis label says many studies did not separate ACE inhibitors from other blood-pressure medicines. Bateman et al. (2017) found no increase in major malformations after adjustment for chronic hypertension and other factors; lisinopril made up most exposed pregnancies. Cooper et al. (2006) found an increase in a smaller group of 209 exposed infants, so the studies conflict. The lisinopril boxed warning states: “When pregnancy is detected, discontinue lisinopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.” Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- MotherToBaby: Lisinopril fact sheetTeratology service
- DailyMed: Qbrelis lisinopril oral solution labelDrug company label
- DailyMed: Lisinopril tablet labelDrug company label
- Bateman et al., Obstetrics & Gynecology 2017: ACE inhibitors and congenital malformationsUS government
- Cooper et al., New England Journal of Medicine 2006: first-trimester ACE-inhibitor exposureUS government
Research strength: 3 / 5
MotherToBaby says ACE inhibitors should be avoided during the second and third trimesters and describes low amniotic fluid and fetal kidney problems. The Qbrelis label lists possible lung, bone, and skull changes, no urine, low newborn blood pressure, kidney failure, and death. Pryde et al. (1993) described three infants with adverse outcomes after ACE-inhibitor exposure. The lisinopril boxed warning states: “When pregnancy is detected, discontinue lisinopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.” Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 3 / 5
MotherToBaby says ACE inhibitors should be avoided during the second and third trimesters and describes low amniotic fluid and fetal kidney problems. The Qbrelis label lists possible lung, bone, and skull changes, no urine, low newborn blood pressure, kidney failure, and death. Pryde et al. (1993) described three infants with adverse outcomes after ACE-inhibitor exposure. The lisinopril boxed warning states: “When pregnancy is detected, discontinue lisinopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.” Ask your provider about your situation.
Last reviewed: 2026-10-14
Lisinopril — Breastfeeding
Research strength: 2 / 5
MotherToBaby reports small amounts of lisinopril in milk and no serious effects among five exposed infants. Chugh et al. (2025) measured milk in five women and found a relative infant dose of 0.06%; LactMed says infant blood levels were not reported. LactMed reports four infants had no effects, while one had unusual stool odor and color that may have been unrelated. The Qbrelis label advises women not to breastfeed and says human milk data are unavailable, while the 2025 study measured milk levels. NHS and SPS sources say lisinopril may be used with caution and advise watching for low infant blood pressure, so guidance differs. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- MotherToBaby: Lisinopril fact sheetTeratology service
- Chugh et al., Journal of Cardiovascular Pharmacology 2025: lisinopril in human milkUS government
- LactMed (NIH): LisinoprilUS government
- DailyMed: Qbrelis lisinopril oral solution labelDrug company label
- DailyMed: Lisinopril tablet labelDrug company label
- NHS: Lisinopril pregnancy and breastfeedingUK government
- NHS Specialist Pharmacy Service: Using ACE inhibitors during breastfeedingUK government
Pregnancy
Bateman et al. (2017) studied 1,333,624 Medicaid pregnancies linked to live-born infants; 4,107 had first-trimester ACE-inhibitor exposure. In the chronic-hypertension subgroup, lisinopril accounted for 1,437 of 2,631 ACE-inhibitor exposures. After propensity-score adjustment, first-trimester ACE-inhibitor exposure was not associated with an increase in overall major malformations (RR 0.89, 95% CI 0.75-1.06), cardiac malformations (RR 0.95, 95% CI 0.75-1.21), or central nervous system malformations (RR 0.54, 95% CI 0.26-1.11). Cooper et al. (2006) reported increased major malformations after ACE-inhibitor exposure among 209 infants (RR 2.71, 95% CI 1.72-4.27), with increased cardiac (RR 3.72, 95% CI 1.89-7.30) and central nervous system outcomes (RR 4.39, 95% CI 1.37-14.02). Cooper's cohort excluded pregnancies with maternal diabetes and compared exposed pregnancies with pregnancies without antihypertensive use. Bateman's later study adjusted for hypertension, diabetes, and other factors. For exposure after the first trimester, product labeling and MotherToBaby describe fetal kidney injury, low amniotic fluid, lung and skeletal effects, newborn skull hypoplasia, no urine, low blood pressure, kidney failure, and death. Pryde et al. (1993) described three infants with adverse outcomes and listed fetal hypotension, low or absent amniotic fluid, growth restriction, lung hypoplasia, kidney changes, and skull hypoplasia among features of ACE-inhibitor fetopathy.
Breastfeeding
Chugh et al. (2025) analyzed human milk samples from five women taking lisinopril. Mean milk concentration was 0.49 ng/mL per 10 mg daily dose and relative infant dose was 0.06%. LactMed reports that infant blood levels were not found. LactMed describes four infants with no reported adverse effects and one with unpleasant-smelling, often green stool; the relation to lisinopril is unclear. MotherToBaby also reports no serious side effects in five infants exposed through milk. These are very small numbers, and only five women contributed milk samples.
Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor that lowers blood pressure. MotherToBaby lists Prinivil, Qbrelis, and Zestril as brand names.
What was tested
Pregnancy research cited here includes a large population-based cohort (Bateman et al. 2017), a smaller historical cohort (Cooper et al. 2006), and a three-infant case series (Pryde et al. 1993). Breastfeeding research includes a five-volunteer milk pharmacokinetic study (Chugh et al. 2025) and infant follow-up summarized by LactMed. The cited pregnancy studies are observational or case-based; the human milk study measured milk levels, and LactMed reports no infant blood levels.
First-trimester major malformations after ACE-inhibitor exposure
- Source A says
- Cooper et al. (2006) reported increased major, heart, and central nervous system malformations in 209 ACE-inhibitor-exposed infants. (Cooper et al., New England Journal of Medicine 2006: first-trimester ACE-inhibitor exposure)
- Source B says
- Bateman et al. (2017) found no higher risk of major malformations after adjustment in a chronic-hypertension cohort; 1,437 of 2,631 exposed pregnancies involved lisinopril. (Bateman et al., Obstetrics & Gynecology 2017: ACE inhibitors and congenital malformations)
- Why they differ
- Cooper used a small exposed group, excluded pregnancies with maternal diabetes, and compared with pregnancies without antihypertensive exposure. Bateman used a much larger cohort and adjusted for hypertension, diabetes, and other factors; its cohort included pregnancies linked to live-born infants.
- Other sources
- MotherToBaby says the first-trimester birth-defect chance is not known. The Qbrelis label says most epidemiologic studies did not separate ACE inhibitors from other antihypertensive agents. (MotherToBaby: Lisinopril fact sheet, DailyMed: Qbrelis lisinopril oral solution label)
- What the evidence shows overall
- The human findings conflict. Bateman's adjusted cohort did not find an increased rate of major malformations among pregnancies complicated by chronic hypertension, but it cannot rule out every specific defect. The first-trimester risk remains uncertain, while the boxed warning still instructs discontinuation when pregnancy is detected.
Lisinopril use while breastfeeding
- Source A says
- The Qbrelis label advises women not to breastfeed because of potential severe reactions and states that human milk and infant-effect data are unavailable. (DailyMed: Qbrelis lisinopril oral solution label)
- Source B says
- LactMed says low milk levels would not be expected to cause infant effects. NHS says lisinopril may be taken while breastfeeding, and SPS says it can be used with caution, with infant monitoring. Chugh et al. measured low transfer in five women. (LactMed (NIH): Lisinopril, NHS: Lisinopril pregnancy and breastfeeding, NHS Specialist Pharmacy Service: Using ACE inhibitors during breastfeeding, Chugh et al., Journal of Cardiovascular Pharmacology 2025: lisinopril in human milk)
- Why they differ
- The label gives more restrictive advice and says human milk data are unavailable, although the 2025 study measured milk levels. The study involved only five women, and LactMed reports no infant blood levels, so the clinical infant evidence remains limited.
- Other sources
- MotherToBaby reports small amounts in milk and no serious side effects in five exposed infants. (MotherToBaby: Lisinopril fact sheet)
- What the evidence shows overall
- The 2025 study supports low milk transfer but does not establish infant clinical outcomes. The label is more restrictive than the cautious NHS and LactMed assessments. The limited evidence and differing advice support a guidance rating rather than broad compatibility or a claim of established infant harm.
- MotherToBaby says to talk with healthcare providers before making changes to how lisinopril is taken. (MotherToBaby)
- The NHS says a doctor will recommend an alternative medicine during pregnancy. (NHS)
- The lisinopril label describes serial ultrasound examinations to assess the amniotic-fluid environment and says fetal testing may be appropriate based on the week of pregnancy. (DailyMed: Lisinopril tablet label)
General research, not specific to pregnancy.
The MHRA says ACE-inhibitor angioedema can start after weeks to years and that product information for all ACE inhibitors is being updated. It says suspected angioedema calls for immediate discontinuation and no restart.
- The MHRA says swelling of the tongue, lips, face, or larynx can threaten the airway, and bradykinin-mediated angioedema may not respond to standard anaphylaxis treatment. (UK MHRA Drug Safety Update: ACE inhibitors and delayed-onset angioedema)
- If angioedema is suspected in a patient taking an ACE inhibitor, the MHRA says to discontinue it immediately and not restart it. (UK MHRA Drug Safety Update: ACE inhibitors and delayed-onset angioedema)
- The lisinopril label says angioedema may occur at any time during treatment. (DailyMed: Lisinopril tablet label)
- MotherToBaby: Lisinopril fact sheetTeratology serviceSecondary
- DailyMed: Lisinopril tablet labelDrug company labelTertiaryPage dated 2026-09-24
- DailyMed: Qbrelis lisinopril oral solution labelDrug company labelTertiaryPage dated 2025-12-18
- LactMed (NIH): LisinoprilUS governmentSecondaryPage dated 2026-07-15
- NHS: Lisinopril pregnancy and breastfeedingUK governmentSecondaryPage dated 2026-02-04Independent check
- NHS Specialist Pharmacy Service: Using ACE inhibitors during breastfeedingUK governmentSecondaryPage dated 2023-06-02Independent check
- Bateman et al., Obstetrics & Gynecology 2017: ACE inhibitors and congenital malformationsUS governmentPrimaryIndependent check
- Cooper et al., New England Journal of Medicine 2006: first-trimester ACE-inhibitor exposureUS governmentPrimary
- Pryde et al., Journal of the American Society of Nephrology 1993: ACE-inhibitor fetopathyUS governmentPrimaryIndependent check
- Chugh et al., Journal of Cardiovascular Pharmacology 2025: lisinopril in human milkUS governmentPrimary
- UK MHRA Drug Safety Update: ACE inhibitors and delayed-onset angioedemaUK governmentSecondaryPage dated 2026-06-16
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.
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