Labetalol: uses, dosing, side effects & brands
Labetalol is a medicine sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Tablet
- Sold as
- 2 products — Normodyne and Trandate
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Half-life
- about 6 to 8 hours after an oral dose (about 5.5 hours after an intravenous dose)
- What the pharmacy pays
- about $4 for a 30-count supply — not your price
Every labetalol product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Tablet | Generic | $4 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $4 | View → |
What labetalol pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing labetalol
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Labetalol recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long labetalol keeps
The date on a sealed pack is not the only one: some labetalol labels start a second clock once the product is opened or mixed, as short as 24 hours.
The in-use limits labetalol labels print, quotedLabetalol and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for labetalol: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause of the low levels of labetalol in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in fullterm breastfed infants. No special precautions are required in most infants. However, other agents may be preferred while nursing a preterm infant. Labetalol may predispose nursing mothers to Raynaud’s phenomenon of the nipple.
National Institute of Child Health and Human Development, record revised November 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about labetalol
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,054 reports naming labetalol, and the FDA flagged 69% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- maternal exposure during pregnancy182 reports
- premature baby143 reports
- foetal exposure during pregnancy139 reports
- fatigue127 reports
- hypertension124 reports
- nausea113 reports
- diarrhoea100 reports
- exposure during pregnancy93 reports
Read these as a signal, not a rate. A report does not mean labetalol caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long labetalol stays in your system
The elimination half-life of labetalol is about 6 to 8 hours after an oral dose (about 5.5 hours after an intravenous dose). The FDA label gives two numbers depending on route: roughly 6 to 8 hours after an oral dose and about 5.5 hours after IV infusion. The label states that in people with reduced liver or kidney function the elimination half-life of labetalol is NOT changed — but in liver impairment more of an oral dose reaches the bloodstream, because less of it is broken down on first pass through the liver, so the same dose produces higher levels. Labetalol is cleared mainly by conjugation to glucuronide metabolites, excreted in urine and bile; the label describes no active metabolite that outlasts the parent drug. Neither hemodialysis nor peritoneal dialysis removes a meaningful amount (less than 1%). There is no extended-release labetalol marketed in the US — only immediate-release tablets and the injection.
Labetalol Hydrochloride Injection — FDA prescribing information, Clinical Pharmacology (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
How long does labetalol stay in your system?
The elimination half-life of labetalol is about 6 to 8 hours after an oral dose (about 5.5 hours after an intravenous dose) — that is how long the body takes to clear half of a dose. The FDA label gives two numbers depending on route: roughly 6 to 8 hours after an oral dose and about 5.5 hours after IV infusion. The label states that in people with reduced liver or kidney function the elimination half-life of labetalol is NOT changed — but in liver impairment more of an oral dose reaches the bloodstream, because less of it is broken down on first pass through the liver, so the same dose produces higher levels. Labetalol is cleared mainly by conjugation to glucuronide metabolites, excreted in urine and bile; the label describes no active metabolite that outlasts the parent drug. Neither hemodialysis nor peritoneal dialysis removes a meaningful amount (less than 1%). There is no extended-release labetalol marketed in the US — only immediate-release tablets and the injection. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take labetalol with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run labetalol against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is labetalol sold under?
We track 2 labetalol-containing products in the U.S.: Normodyne and Trandate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does labetalol come in?
Across the brands we track, labetalol is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic labetalol?
We do not currently list a generic-labelled labetalol product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has labetalol been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions labetalol. The most recent: Labetalol Hydrochloride Injection (May 20, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Labetalol: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/labetalol
- MLA
- “Labetalol: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/labetalol.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for labetalol on DailyMed (NIH) ↗.