Labetalol

What Labetalol is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Labetalol Hydrochloride is indicated in the management of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including beta adrenergic blockers. …

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Labetalol Hydrochloride, Method Pharmaceuticals, LLC; it covers 6 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 83 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 83 FDA labels for this medicine have a boxed warning.

Labetalol side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Hypotension [see Warnings and Precautions (5.1) Bradycardia [see Warnings and Precautions (5.2)] Cardiac failure [see Warnings and Precautions (5.3)] Ischemic heart disease [see Warnings and Precautions (5.4)] Nonallergic bronchospasm [see Warnings and Precautions (5.5))] Use in patients with pheochromocytoma [see Warnings and Precautions (5.7)] Hepatic injury [see Warnings and Precautions (5.8)] Risk of severe acute hypersensitivity reaction [see Warnings and Precautions …

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. This is part of the section. Read the full label on DailyMed →

Labetalol drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Concomitant use with negative chronotropes can increase risk of bradycardia (7.1) Beta blockers antagonize the bronchodilator effect of beta-receptor agonists. (7.2) Increase hypotension may occur with halothane anesthesia. (7.3) Nitroglycerin may result in additional hypotensive effects. (7.4) 7.1 Negative Chronotopes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate.

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Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension [see Warnings and Precautions (5.2)]. Coadministration of labetalol HCl with non-dihydropyridine calcium-channel antagonists (e.g., verapamil) is contraindicated [see Contraindications (4)]. 7.2 Bronchodilators Labetalol HCl antagonizes the bronchodilatory effect of beta-receptor agonist drugs; therefore, labetalol HCl is contraindicated in patients with bronchial asthma [see Contraindications (4)]. 7.3 Anesthesia Synergism has been shown between halothane anesthesia and intravenously administered labetalol. During controlled hypotensive anesthesia using labetalol in association with halothane, high concentrations (3% or above) of halothane should not be used because the degree of hypotension will be increased and because of the possibility of a large reduction in cardiac output and an increase in central venous pressure. 7.4 Nitroglycerin Coadministration of labetalol HCl and nitroglycerine will have an additive effect in lowering blood pressure. Additionally, labetalol HCl blunts the reflex tachycardia produced by nitroglycerin. If labetalol HCl is used in patients with angina pectoris on nitroglycerin, monitor patients’ blood pressure and adjust labetalol dose as needed. In these patients, avoid initiating Labetalol Hydrochloride Tablets. 7.5 Drug/Laboratory Test Interactions The presence of labetalol metabolites in the urine may result in falsely elevated levels of urinary catecholamines, metanephrine, normetanephrine, and vanillylmandelic acid (VMA) when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with labetalol, a specific method, such as a high-performance liquid chromatographic assay with solid phase extraction should be employed in determining levels of catecholamines. Labetalol has also been reported to produce a false positive test for amphetamine when screening urine for the presence of drugs using the commercially available assay methods. When patients being treated with labetalol have a positive urine test for amphetamine using these techniques, confirm using more specific methods, such as a gas chromatographic mass spectrometer technique. 7.1 Negative Chronotopes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension [see Warnings and Precautions (5.2)].

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. This is part of the section. Read the full label on DailyMed →

Labetalol dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

The recommended initial dosage is 100 mg twice daily, alone or added to a diuretic regimen. Titrate in increments of 100 mg twice daily every 2 or 3 days. Maintenance dosage is between 200 and 400 mg twice daily. (2.1) Severe Hypertension: May require from 1,200 to 2,400mg per day, with or without thiazide diuretics. Titrate in increments not to exceed 200 mg twice daily. (2.2) Elderly patients: Initiate at 100 mg twice daily.

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Titrate in increments of 100 mg twice daily as required for blood pressure control. Many elderly patients will require between 100 and 200 mg twice daily. (2.3) 2.1 Recommended Dosage Labetalol Hydrochloride dosage must be individualized. The recommended initial dosage of labetalol hydrochloride is 100 mg twice daily. Adjust dosage in increments of 100 mg twice daily at 2- to 3-day intervals based on response. The recommended maintenance dosage of labetalol hydrochloride is between 200 and 400 mg twice daily. 2.1 Recommended Dosage Labetalol Hydrochloride dosage must be individualized. The recommended initial dosage of labetalol hydrochloride is 100 mg twice daily. Adjust dosage in increments of 100 mg twice daily at 2- to 3-day intervals based on response. The recommended maintenance dosage of labetalol hydrochloride is between 200 and 400 mg twice daily.

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. Read the full label on DailyMed →

Labetalol in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary The extensive experience with use of labetalol in pregnant women, based on published interventional and observational studies, has not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Untreated hypertension during pregnancy can lead to serious adverse outcomes for the mother and the fetus (see Clinical Considerations).

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In animal reproductive studies, oral administration of labetalol to pregnant rats and rabbits during organogenesis at doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively, resulted in no fetal malformations; however, increased fetal resorptions were seen in both species at doses approximating the MRHD (see Data). 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. Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increase the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Labetalol crosses the placenta. Newonates born to mothers who are receiving labetalol during pregnancy, may be at risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Neonates should be monitored for symptoms of hypotension, bradycardia, hypoglycemia and respiratly depression and mange accordingly. Data Human Data Data from published interventional and observational studies did not demonstrate an association between major congenital malformations and the use of labetalol in pregnancy, however, most studies reported the maternal use of intravenous labetalol occurring after 20 weeks gestation. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth and perinatal mortality with maternal use of labetalol during pregnancy; however, these studies have methodological limitations hindering interpretation. These studies cannot definitively establish the absence of risk during pregnancy. Animal Data Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed. Increased fetal resorptions were seen in both species at doses approximating the MRHD. A teratology study performed with labetalol in rabbits at intravenous doses up to 1.7 times the MRHD revealed no evidence of drug-related harm to the fetus. Oral administration of labetalol to rats during late gestation through weaning at doses of two to four times the MRHD caused a decrease in neonatal survival.

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. Read the full label on DailyMed →

When Labetalol should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Labetalol Hydrochloride Tablets are contraindicated in patients with: bronchial asthma or obstructive airway disease decompensated heart failure greater than first degree heart block cardiogenic shock severe bradycardia Hypersensitivity reactions, including anaphylaxis, to labetalol non-dihydropyridine calcium-channel antagonists Bronchial asthma or obstructive airway disease (4) Overt cardiac failure (4) Greater‑than‑first‑degree heart block (4) Cardiogenic shock (4) Severe bradycardia (4) Non-dihydropyridine calcium-channel antagonists (4)

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. Read the full label on DailyMed →

Labetalol overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Overdosage with labetalol hydrochloride causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. Treat symptoms of overdose with standard supportive care.

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If overdosage with labetalol hydrochloride follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion. Treat symptoms of overdose with standard supportive care. Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol hydrochloride from the general circulation (<1%). The oral LD50 value of labetalol hydrochloride in the mouse is approximately 600 mg/kg and in the rat is >2 g/kg. The IV LD50in these species is 50 mg/kg to 60 mg/kg.

— FDA label: Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025. Read the full label on DailyMed →

Forms and how it is given

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Bryant Ranch Prepack18 products
• A-S Medication Solutions13 products
• Hikma Pharmaceuticals USA Inc.8 products
• Cardinal Health 107, LLC6 products
• Method Pharmaceuticals, LLC6 products
• Advagen Pharma Ltd4 products
• Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
• NorthStar Rx LLC4 products
• Biocon Pharma Inc.4 products
• Baxter Healthcare Corporation3 products
• Chartwell RX, LLC3 products
• BluePoint Laboratories Inc.3 products
• BluePoint Laboratories3 products
• Zydus Pharmaceuticals USA Inc.3 products
• Remedyrepack Inc.3 products
• Fosun Pharma USA Inc.3 products
• Unichem Pharmaceuticals (USA), Inc.3 products
• Macleods Pharmaceuticals Limited3 products
• Zydus Lifesciences Limited3 products
• Major Pharmaceuticals3 products
• Golden State Medical Supply, Inc.3 products
• American Health Packaging3 products
• Cadila Pharmaceuticals Limited3 products
• Innogenix, Inc.3 products
• Epic Pharma, LLC3 products
• Marlex Pharmaceuticals, Inc.3 products
• Redpharm Drug2 products
• Coupler LLC2 products
• NCS HealthCare of KY, LLC dba Vangard Labs2 products
• Caplin Steriles Limited2 products
• Hospira, Inc.2 products
• Onesource Specialty Pharma Limited2 products
• Proficient Rx LP2 products
• St. Mary's Medical Park Pharmacy2 products
• Mullan Pharmaceutical Inc.2 products
• HF Acquisition Co LLC, DBA HealthFirst1 product
• Gland Pharma Limited1 product
• Sagent Pharmaceuticals1 product
• Amneal Pharmaceuticals LLC1 product
• Armas Pharmaceuticals Inc.1 product
• NuCare Pharmaceuticals, Inc.1 product
• Civica, Inc.1 product
• Northwind Health Company, LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (19)

• ANDA074787Heritage Pharma · August 3, 1998
• ANDA075133Watson Labs · August 3, 1998
• ANDA075303Hikma · May 28, 1999
• ANDA075215Innogenix · July 29, 1999
• ANDA075239Hospira · November 29, 1999
• ANDA075240Hospira · November 29, 1999
• ANDA076051Baxter Hlthcare Corp · July 5, 2002
• ANDA079134Onesource Specialty · February 3, 2010
• ANDA090699Gland Pharma Ltd · April 3, 2012
• ANDA200908Ph Health · July 10, 2012
• ANDA207743Zydus Pharms · September 19, 2017
• ANDA209603Appco · June 20, 2018
• ANDA211325Cadila Pharms Ltd · May 13, 2019
• ANDA212990Epic Pharma LLC · September 30, 2020
• ANDA211953Rubicon Research · August 18, 2021
• ANDA214533Caplin · September 7, 2021
• ANDA212719Unichem · August 8, 2022
• ANDA217949Macleods Pharms Ltd · September 23, 2025
• ANDA218870Amneal · October 2, 2025

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. May 20, 2024 · Class II · Ongoing · D-0565-2024

   Lack of Assurance of Sterility-The potential for incomplete crimp seals.

   Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 6004 — Pfizer Inc.

2. February 20, 2018 · Class II · Terminated · D-0576-2018

   Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

   Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake F — Hospira Inc. A Pfizer Company

3. May 16, 2014 · Class II · Terminated · D-1424-2014

   Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution

   Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20 — Hospira Inc.

Official identifiers

Next steps

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• Latest FDA drug recallsAll medicines, newest first
• Heart failureCondition named on the label: hospitals that treat it
• High blood pressureCondition named on the label: hospitals that treat it
• StrokeCondition named on the label: hospitals that treat it
• Bryant Ranch PrepackMaker or distributor
• A-S Medication SolutionsMaker or distributor
• Hikma Pharmaceuticals USA Inc.Maker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Labetalol Hydrochloride, Method Pharmaceuticals, LLC, effective December 23, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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