labetalol
Brand names: Trandate
Labetalol is a medicine that lowers high blood pressure. It can be used alone or with other blood pressure medicines.
Drug Pricing (NADAC)
Generic Price
$0.09/unit
Generic Available
Yes (18 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Labetalol is used to treat high blood pressure.
Common side effects
Dizziness, Fatigue, Nausea
Key warnings
You should not take labetalol if you have asthma, heart failure, a slow heart rate, or certain other heart problems.
How It Works
Labetalol blocks certain receptors in your body. This helps to relax your blood vessels and slow down your heart rate. As a result, your blood pressure goes down.
How to Take It
Take labetalol tablets as your doctor tells you. The usual starting dose is 100 mg twice a day. Your doctor may increase your dose every 2 to 3 days until your blood pressure is controlled. Some people may need up to 1200 mg to 2400 mg per day.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if labetalol will harm your unborn baby. Talk to your doctor about the risks and benefits of taking labetalol during pregnancy.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store labetalol tablets at room temperature, away from light and moisture.
Side Effects (from patient reports)
Based on 7,396 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 12,726 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
12,726
Death-Related Reports
1,314
Hospitalization Reports
4,839
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 988 |
| 2 | FOETAL EXPOSURE DURING PREGNANCY | 931 |
| 3 | MATERNAL EXPOSURE DURING PREGNANCY | 912 |
| 4 | HYPERTENSION | 721 |
| 5 | PREMATURE BABY | 716 |
| 6 | OFF LABEL USE | 651 |
| 7 | CHRONIC KIDNEY DISEASE | 645 |
| 8 | ACUTE KIDNEY INJURY | 623 |
| 9 | EXPOSURE DURING PREGNANCY | 622 |
| 10 | FATIGUE | 587 |
| 11 | RENAL FAILURE | 576 |
| 12 | NAUSEA | 509 |
| 13 | PREMATURE DELIVERY | 491 |
| 14 | HEADACHE | 484 |
| 15 | DYSPNOEA | 478 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take labetalol if you have asthma, heart failure, a slow heart rate, or certain other heart problems.
Common Questions
Can I stop taking labetalol suddenly?
Can I drink alcohol while taking labetalol?
Will labetalol cure my high blood pressure?
How long does it take for labetalol to work?
Can labetalol cause weight gain?
Can labetalol cause hair loss?
Can I take labetalol with other medications?
What should I do if I feel dizzy after taking labetalol?
Does labetalol interact with caffeine?
Can labetalol affect my blood sugar?
What are the common side effects of labetalol?
What drug class is labetalol?
Is labetalol safe during pregnancy?
Has labetalol been recalled?
Active Recalls
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc.
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Other drugs grouped near labetalol — same-class peers and common alternatives.
acebutolol
Sectral
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aliskiren
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amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
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amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
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amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
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What the FDA Data Shows for labetalol
The FDA label for labetalol (sold under brand names such as Trandate) classifies it as a prescription-only medication in the Alpha/Beta-Blocker class. Labetalol is used to treat high blood pressure. Official labeling lists 4 commonly reported side effects, including Dizziness, Fatigue, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,396 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.09.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 27, 2023
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages