Prescription medication · Alpha/Beta-Blocker
labetalol
Also sold as Trandate. Labetalol is used to treat high blood pressure.
Data updated 2026-05-15
- 12,726
- FDA reportsModerately reported
- 1
- Recall record
What the data shows
labetalol (Trandate) is a prescription Alpha/Beta-Blocker, reported less often than most tracked drugs (12,726 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
labetalol (Trandate) is a prescription Alpha/Beta-Blocker. Labetalol is used to treat high blood pressure.
Labetalol is a medicine that lowers high blood pressure. It can be used alone or with other blood pressure medicines.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: LABETALOL HCL 100 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -19.4% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.1132/EA | - | 1 |
| December 18, 2024 | $0.0912/EA | -19.4% | 24 |
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.
The sections below are summarized in plain English from labetalol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 12,726 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for labetalol, by number of reports
- Foetal Exposure During Pregnancy
Foetal Exposure During Pregnancy
931 reports
- Maternal Exposure During Pregnancy
Maternal Exposure During Pregnancy
912 reports
- Hypertension
Hypertension
721 reports
- Premature Baby
Premature Baby
716 reports
- Chronic Kidney Disease
Chronic Kidney Disease
645 reports
- Acute Kidney Injury
Acute Kidney Injury
623 reports
- Exposure During Pregnancy
Exposure During Pregnancy
622 reports
- Fatigue
Fatigue
587 reports
- Renal Failure
Renal Failure
576 reports
- Nausea
Nausea
509 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for labetalol each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where labetalol sits
labetalol has more FDA adverse-event reports than 44% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is labetalol; the line is the median (50th percentile).
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
Reports Mentioning Death
1,314
10.3% of reports — not proof of cause
Hospitalization Reports
4,839
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | FOETAL EXPOSURE DURING PREGNANCY | 931 |
| 3 | MATERNAL EXPOSURE DURING PREGNANCY | 912 |
| 4 | HYPERTENSION | 721 |
| 5 | PREMATURE BABY | 716 |
| 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 |
| 16 | DIARRHOEA | 457 |
| 17 | PAIN | 429 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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?
What pregnancy or breastfeeding source fields are listed for labetalol?
Has labetalol been recalled?
Active Recalls
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc.
Related Medications in Alpha/Beta-Blocker
Other drugs grouped near labetalol - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with labetalol →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with labetalol →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with labetalol →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with labetalol →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with labetalol →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for labetalol: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 12,726.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.33%.
- nisoldipine Δ 0.00 pts · 1,191 reports · Calcium Channel Blocker 10.33%death share
- disulfiram Δ 0.01 pts · 1,076 reports · Aldehyde Dehydrogenase Inhibitor 10.32%death share
- duloxetine Δ 0.02 pts · 65,067 reports · Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 10.31%death share
- chlorzoxazone Δ 0.03 pts · 1,256 reports · Muscle Relaxant 10.35%death share
Medication Guides
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 12,726 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: November 27, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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