Labetalol
Labetalol, Normozide, Trandate (labetalol) is a small molecule pharmaceutical. Labetalol was first approved as Trandate on 1984-08-01. It is used to treat angina pectoris, heart failure, malignant hypertension, and myocardial infarction in the USA. The pharmaceutical is active against alpha-1D adrenergic receptor, beta-2 adrenergic receptor, and beta-1 adrenergic receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Labetalol (discontinued: Labetalol, Normodyne, Trandate)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Labetalol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRANDATE HCT | GSK | N-019174 DISCN | 1987-04-10 | 4 products |
| NORMOZIDE | Merck & Co | N-019046 DISCN | 1987-04-06 | 4 products |
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Labetalol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE IN DEXTROSE | Hikma Pharmaceuticals | N-213330 RX | 2020-11-09 | 1 products, RLD, RS |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | Hikma Pharmaceuticals | N-213330 RX | 2020-11-09 | 3 products, RLD, RS |
| LABETALOL HYDROCHLORIDE | Hikma Pharmaceuticals | N-213330 RX | 2024-08-19 | 1 products, RLD, RS |
Show 5 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| labetalol | ANDA | 2018-04-06 |
| labetalol hcl | ANDA | 2025-04-02 |
| labetalol hcl in dextrose labetalol hcl in sodium chloride | New Drug Application | 2022-03-01 |
| labetalol hcl in dextrose labetalol hcl in sodium chloride labetalol hydrochloride | New Drug Application | 2024-09-20 |
| labetalol hydrochloride | ANDA | 2025-04-09 |
| trandate | New Drug Application | 2009-12-14 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C07: Beta-adrenergic blocking agents
— C07A: Beta blocking agents
— C07AG: Alpha and beta blocking agents
— C07AG01: Labetalol
— C07B: Beta blocking agents and thiazides
— C07BG: Alpha and beta blocking agents and thiazides
— C07BG01: Labetalol and thiazides
— C07C: Beta blocking agents and other diuretics
— C07CG: Alpha and beta blocking agents and other diuretics
— C07CG01: Labetalol and other diuretics
HCPCS
No data
Clinical
Clinical Trials
83 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 5 | 5 | 11 | 10 | 31 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 4 | 5 | 3 | 8 | 7 | 23 |
| Pregnancy-induced hypertension | D046110 | — | O13 | 2 | 4 | 3 | 7 | 2 | 16 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 4 | 1 | 1 | 2 | 8 |
| Eclampsia | D004461 | — | O15 | — | 3 | 2 | 1 | 3 | 7 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | 4 | 2 | 7 |
| Ischemic stroke | D000083242 | — | — | — | 2 | 2 | 2 | — | 6 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 3 | 2 | 5 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | 4 | — | 4 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | 3 | — | 3 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 1 | — | 5 | 8 |
| Cerebral hemorrhage | D002543 | — | — | — | 2 | 1 | — | 3 | 6 |
| Toxemia | D014115 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Essential hypertension | D000075222 | — | I10 | — | 1 | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood pressure | D001794 | EFO_0004325 | — | — | 3 | — | — | — | 3 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | — | — | 1 | 2 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | 1 | 1 | — | — | 1 | 2 |
| Thrombectomy | D017131 | — | — | — | 2 | — | — | — | 2 |
| Proteinuria | D011507 | — | R80 | 1 | 1 | — | — | 1 | 2 |
| Pheochromocytoma | D010673 | — | — | — | 1 | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | 1 | 1 | — | — | — | 1 |
| Heart rate | D006339 | EFO_0004326 | — | — | 1 | — | — | — | 1 |
| Craniotomy | D003399 | — | — | 1 | 1 | — | — | — | 1 |
| Paranasal sinus diseases | D010254 | — | — | — | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy complications | D011248 | — | — | 1 | — | — | — | — | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | — | 1 |
| Nasal surgical procedures | D059747 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 2 | 2 |
| Hyperaldosteronism | D006929 | — | E26 | — | — | — | — | 2 | 2 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 2 | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 2 | 2 |
| Hypokalemia | D007008 | — | E87.6 | — | — | — | — | 2 | 2 |
Show 79 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Labetalol |
| INN | labetalol |
| Description | Labetalol is a diastereoisomeric mixture of approximately equal amounts of all four possible stereoisomers ((R,S)-labetolol, (S,R)-labetolol, (S,S)-labetalol and (R,R)-labetalol). It is an adrenergic antagonist used to treat high blood pressure. It has a role as an antihypertensive agent, a sympatholytic agent, an alpha-adrenergic antagonist and a beta-adrenergic antagonist. It contains a (R,R)-labetalol, a (S,S)-labetalol, a (R,S)-labetolol and a (S,R)-labetolol. |
| Classification | Small molecule |
| Drug class | combined alpha and beta blockers |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(CCc1ccccc1)NCC(O)c1ccc(O)c(C(N)=O)c1 |
Identifiers
| PDB | — |
| CAS-ID | 36894-69-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL429 |
| ChEBI ID | 6343 |
| PubChem CID | 3869 |
| DrugBank | DB00598 |
| UNII ID | R5H8897N95 (ChemIDplus, GSRS) |
Target
Agency Approved
ADRA1D
ADRA1D
ADRB2
ADRB2
ADRB1
ADRB1
Organism
Homo sapiens
Gene name
ADRA1D
Gene synonyms
ADRA1A
NCBI Gene ID
Protein name
alpha-1D adrenergic receptor
Protein synonyms
adrenergic, alpha -1D-, receptor, adrenergic, alpha-1A-, receptor, Alpha-1A adrenergic receptor, Alpha-1D adrenoceptor, Alpha-1D adrenoreceptor, Alpha-adrenergic receptor 1a
Uniprot ID
Mouse ortholog
Adra1d (11550)
alpha-1D adrenergic receptor (Q61619)
Alternate
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Labetalol
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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4,173 adverse events reported
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