Pregnancy and angioedema require immediate action.
Lisinopril can injure or kill a developing fetus: stop promptly and contact the prescriber when pregnancy is detected. Stop treatment and seek emergency care for swelling of the lips, tongue, or throat or difficulty breathing. Never overlap with sacubitril/valsartan; allow at least 36 hours in either direction.
Warnings and precautionsIndications
Hypertension, systolic heart failure, and early treatment after selected acute MI.
Labeled oral indications
Zestril treats hypertension in adults and children age 6 years and older, alone or with other antihypertensives. It reduces signs and symptoms of systolic heart failure.
It is also labeled to reduce mortality in hemodynamically stable patients treated within 24 hours of acute myocardial infarction, alongside appropriate standard care. It is not a treatment for an unstable patient after MI.
Albuminuric chronic kidney disease
KDIGO recommends ACE inhibitor or ARB therapy in selected albuminuric CKD populations: G1–G4 with A3 albuminuria without diabetes, and A2–A3 with diabetes; it suggests treatment for A2 without diabetes. Kidney protection is a guideline-supported class use, not a separate Zestril-labeled indication. Select and monitor treatment according to renal function, potassium, and tolerability.
Dosage and administration
Once-daily doses depend on indication, kidney function, and blood pressure.
Adult oral dosing
| Indication / population | Zestril directions |
|---|---|
| Hypertension | Start 10 mg once daily; usual maintenance 20–40 mg once daily. Doses of 80 mg have been used without greater apparent effect. |
| Hypertension while taking diuretics | Start 5 mg once daily. |
| Systolic heart failure | Start 5 mg once daily; if sodium <130 mEq/L, start 2.5 mg. Titrate as tolerated to maximum 40 mg once daily. |
| Acute MI · stable patient within 24 hours | 5 mg initially, 5 mg after 24 hours, 10 mg after 48 hours, then 10 mg daily; continue at least 6 weeks. |
Acute MI · blood pressure precautions
For systolic pressure ≤120 but >100 mmHg during the first 3 days after infarction, start 2.5 mg. If pressure falls to ≤100 mmHg, use 5 mg daily with temporary reduction to 2.5 mg when needed. Withdraw for systolic pressure <90 mmHg lasting more than 1 hour. Do not initiate in hemodynamic instability.
Renal impairment · adult initial doses
For CrCl 10–30 mL/min, titrate as tolerated to no more than 40 mg daily. Subsequent dosing requires individualized blood pressure, kidney function, and potassium assessment.
| Creatinine clearance | Initial-dose approach |
|---|---|
| >30 mL/min | No renal dose adjustment. |
| 10–30 mL/min, inclusive | Half the usual starting dose: hypertension 5 mg; systolic heart failure 2.5 mg; acute MI 2.5 mg. |
| <10 mL/min or hemodialysis | 2.5 mg once daily. |
Pediatric hypertension
For GFR >30 mL/min/1.73 m², start 0.07 mg/kg once daily, up to 5 mg initially. Adjust by blood pressure to a maximum studied dose of 0.61 mg/kg, not exceeding 40 mg daily. Not recommended below age 6 or with GFR <30 mL/min/1.73 m². The label’s dosing data do not establish a regimen at exactly GFR 30; obtain specialist guidance at that boundary.
Administration and hepatic considerations
Take orally once daily; food does not affect tablet bioavailability. Qbrelis is a ready-to-use 1 mg/mL solution: measure with an oral syringe. Do not apply its handling instructions to a pharmacy-compounded liquid.
The tablet label gives no specific hepatic adjustment regimen. Lisinopril is not metabolized, but rare ACE inhibitor-associated hepatic failure requires discontinuation for jaundice or marked liver enzyme elevation.
Safety
Fetal toxicity, angioedema, hypotension, hyperkalemia, and kidney injury.
Warnings and precautions
Stop promptly when pregnancy is detected. Angioedema can occur at any time, may obstruct the airway, and requires immediate discontinuation and urgent assessment. Intestinal angioedema can cause abdominal pain with or without nausea or vomiting.
Volume depletion, diuretics, heart failure, renal disease, or renal artery stenosis increase the risk of hypotension or acute kidney injury. Monitor renal function and potassium; reassess treatment for clinically significant deterioration. Rare cholestatic hepatitis can progress to liver failure: stop and evaluate jaundice or marked liver enzyme elevations.
Contraindications
- Prior ACE inhibitor-related angioedema or hypersensitivity; hereditary or idiopathic angioedema.
- Concurrent neprilysin inhibitor therapy. Do not give lisinopril within 36 hours before or after sacubitril/valsartan.
- Aliskiren together with lisinopril in a patient with diabetes.
Boxed warning · Fetal toxicity
The label warns that medicines acting on the renin–angiotensin system can injure or kill a developing fetus. Discontinue as soon as pregnancy is detected.
Adverse reactions and procedural precautions
Cough, dizziness, headache, and hypotension can occur; renal dysfunction and hyperkalemia require laboratory assessment. Rare neutropenia is reported: assess fever or sore throat. Tell the care team before surgery or anesthesia. Life-threatening anaphylactoid reactions have occurred with certain high-flux dialysis membranes, LDL apheresis, and venom desensitization.
Drug interactions
Avoid unsafe RAS combinations and review potassium, NSAIDs, and lithium.
Clinically relevant interactions
- Sacubitril/valsartan or other neprilysin inhibitors: contraindicated overlap; at least 36 hours separating lisinopril and sacubitril/valsartan in either direction.
- ARBs or aliskiren: generally avoid dual RAS blockade. Aliskiren is contraindicated with diabetes and should be avoided with GFR <60 mL/min.
- Potassium supplements, potassium salt substitutes, or potassium-sparing diuretics: increased hyperkalemia risk; monitor potassium frequently if a combination is needed.
- Diuretics: volume depletion can cause excessive hypotension; clinician-directed dose adjustment may be required.
- NSAIDs, including selective COX-2 inhibitors: reduced antihypertensive effect and possible renal injury; monitor renal function, particularly with dehydration or impaired kidneys.
- Lithium: possible toxicity; monitor serum lithium.
- Insulin or oral antidiabetics: increased hypoglycemia risk; monitor closely, particularly during the first month.
- mTOR inhibitors: increased angioedema risk. Injectable gold: rare flushing, nausea, vomiting, and hypotension reactions.
Use in specific populations
Pregnancy, breastfeeding, age, and renal clearance change treatment decisions.
Pregnancy
Do not use during pregnancy. Exposure, particularly in the second and third trimesters, can cause fetal renal failure, oligohydramnios, pulmonary or skeletal complications, and death. Stop promptly and arrange replacement therapy when pregnancy is detected. In-utero exposure warrants specialist fetal and neonatal assessment.
Lactation
The reviewed Zestril label states that human milk data are unavailable and advises women not to breastfeed during treatment. LactMed’s July 2026 review incorporates a five-woman study with very low milk transfer and considers adverse effects unlikely. Infant blood-level data remain unavailable; observations are small and do not establish safety for every infant. Discuss this discrepancy and treatment alternatives with the prescribing and infant-care clinicians.
Pediatric and geriatric considerations
Hypertension efficacy and safety were established in ages 6–16; the labeled indication and dosing apply to children 6 years and older with the renal limitations above. Pediatric heart failure or post-MI regimens are not established in this label. Age alone does not mandate a dose change in older adults, but renal function, volume status, and tolerability guide dosing.
Renal and hepatic considerations
Renal clearance drives exposure; reduce the starting dose at CrCl ≤30 mL/min or with hemodialysis. Renal artery stenosis or volume depletion increases acute kidney injury risk. No separate hepatic dosing schedule is supplied; promptly evaluate hepatic warning signs.
Clinical pharmacology
ACE inhibition reduces angiotensin II and aldosterone signaling.
Mechanism of action and pharmacodynamics
Inhibition of ACE reduces angiotensin II formation and aldosterone secretion, lowering vascular resistance. ACE also degrades bradykinin. Blood pressure lowering begins about 1 hour after dosing and peaks around 6 hours; individual responses vary.
Pharmacokinetics
- Absorption
- Mean oral absorption about 25%, with wide variability; food does not alter bioavailability.
- Peak / effective half-life
- Peak serum concentration around 7 hours; effective half-life with repeated dosing about 12 hours.
- Metabolism / elimination
- Not metabolized; excreted unchanged in urine. Renal impairment increases exposure, especially below GFR 30 mL/min; hemodialysis can remove lisinopril.
Monitoring and counseling
Follow blood pressure, renal function, and serum potassium.
Monitoring parameters
- Assess blood pressure, creatinine or eGFR, potassium, and volume status before treatment and after changes.
- For CKD, KDIGO advises checking blood pressure, creatinine, and potassium within 2–4 weeks of initiation or dose increase, adjusted to baseline GFR and potassium. Higher-risk or symptomatic patients need closer assessment.
- In CKD, a creatinine rise >30% within 4 weeks warrants evaluation and treatment reassessment; assess dehydration, NSAIDs, and other reversible contributors.
- Follow heart failure symptoms or post-MI hemodynamics as appropriate; monitor glucose more closely with antidiabetic therapy and lithium levels with lithium.
Patient counseling information
- Report pregnancy immediately; discuss an alternative before a planned pregnancy.
- Stop and seek emergency care for lip, tongue, throat, or facial swelling, especially with breathing or swallowing difficulty.
- Discuss potassium supplements, salt substitutes, and OTC NSAIDs before use. Report fainting, vomiting, diarrhea, or dehydration.
- Take at the same time daily. If a dose is missed, take it when remembered unless nearly time for the next; skip then and never double.
- Use an oral syringe for liquid. Tell surgical, dialysis, and desensitization teams about lisinopril.
Product identification
Confirm the strength, imprint, and original packaging.
Representative oral product · Zestril 10 mg
Other manufacturers’ lisinopril tablets can look different. Ask a pharmacist to verify an unexpected appearance; a photograph alone is insufficient.
- Dosage form / strength
- Uncoated oral tablet · 10 mg
- Label distributor
- Upsher-Smith Laboratories, LLC
- Appearance
- Pink, round, biconvex; unscored
- Imprint
- ZESTRIL 10 / 131
- Example package NDC
- 24979-240-07 · bottle of 90
Dosage forms and strengths
- Zestril tablets
- 2.5, 5, 10, 20, 30, and 40 mg; only the 5 mg tablet is scored in this label.
- Qbrelis oral solution
- 1 mg/mL, clear to slightly opalescent, colorless solution; 150 mL bottle.
- Combination products
- Lisinopril/hydrochlorothiazide products have separate dosing and safety labels.
Storage and handling
Zestril: 20–25°C (68–77°F); protect from moisture, freezing, and excessive heat and dispense in a tight container. Qbrelis: 20–25°C in a tightly closed container; protect from freezing and excessive heat. Compounded liquids need their pharmacy-specific storage and beyond-use instructions.
References
Original sources for the clinical and product information.
- DailyMed / Upsher-Smith LaboratoriesZestril · Prescribing information
Tablet label revised November 2024; SPL version 2, effective January 2, 2025.
- DailyMed / Azurity PharmaceuticalsQbrelis · 1 mg/mL oral solution
Solution administration and storage. Prescribing information revised April 2023; DailyMed record updated December 16, 2025.
- MedlinePlus / National Library of MedicineLisinopril · Patient information
Administration, missed doses, and patient precautions.
- LactMed / National Library of MedicineLisinopril · Lactation
Revised July 15, 2026; includes newer human milk data than the reviewed tablet label.
- Kidney Disease: Improving Global OutcomesKDIGO 2024 · Chronic kidney disease guideline
Section 3.6: albuminuric CKD, RAS inhibitor monitoring, and avoiding dual blockade.