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 →
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.
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.
This is a plain-language summary of labetalol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of labetalol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of labetalol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store labetalol tablets at room temperature, away from light and moisture.
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
- The baby was exposed to the medicine during pregnancy
The baby was exposed to the medicine during pregnancy
931 reports
- The mother was exposed to the medicine during pregnancy
The mother was exposed to the medicine during pregnancy
912 reports
- High blood pressure
High blood pressure
721 reports
- Baby born too early
Baby born too early
716 reports
- Long-term kidney problems
Long-term kidney problems
645 reports
- Sudden kidney damage
Sudden kidney damage
623 reports
- Exposure to the medicine during pregnancy
Exposure to the medicine during pregnancy
622 reports
- Tiredness
Tiredness
587 reports
- Kidney failure
Kidney failure
576 reports
- Feeling sick to your stomach
Feeling sick to your stomach
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) 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.
Related Medications in Alpha/Beta-Blocker
Other drugs grouped near labetalol - same-class peers and common alternatives.
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amiloride
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amlodipine
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amlodipine/benazepril
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Lotrel is a combination medicine that contains amlodipine and benazepril.
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Medication Guides
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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 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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