Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Labetalol
Drug ID BADD_D01236
Description Labetalol is a racemic mixture of 2 diastereoisomers where dilevalol, the R,R' stereoisomer, makes up 25% of the mixture.[L7730] Labetalol is formulated as an injection or tablets to treat hypertension.[L7727,L7730] Labetalol was granted FDA approval on 1 August 1984.[L7724]
Indications and Usage Labetalol injections are indicated to control blood pressure in severe hypertension.[L7727] Labetalol tablets are indicated alone or in combination with antihypertensives like thiazides and loop diuretics to manage hypertension.[L7730]
Marketing Status approved
ATC Code C07AG01
DrugBank ID DB00598
KEGG ID D08106
MeSH ID D007741
PubChem ID 3869
TTD Drug ID D0A8XN
NDC Product Code 10135-713; 10135-711; 10135-712
UNII R5H8897N95
Synonyms Labetalol | Labetolol | Albetol | Apo-Labetalol | Apo Labetalol | ApoLabetalol | Trandate | Labetalol Hydrochloride | Hydrochloride, Labetalol | Normodyne | Presolol | SCH-19927 | SCH 19927 | SCH19927 | AH-5158 | AH 5158 | AH5158 | Dilevalol | Labetalol, (R,R)-Isomer | R,R-Labetalol | R,R Labetalol
Chemical Information
Molecular Formula C19H24N2O3
CAS Registry Number 36894-69-6
SMILES CC(CCC1=CC=CC=C1)NCC(C2=CC(=C(C=C2)O)C(=O)N)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Purpura non-thrombocytopenic01.01.04.006--Not Available
Metabolic disorder14.11.01.001--Not Available
Pulseless electrical activity02.03.04.0200.000325%Not Available
Mental disorder19.07.01.002--Not Available
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Psychotic disorder19.03.01.002--
Food intolerance14.02.01.0050.000244%Not Available
Low birth weight baby18.04.02.0030.001382%Not Available
Brain injury19.07.03.007; 17.11.01.0030.000163%Not Available
Oropharyngeal discomfort07.05.05.008; 22.12.03.015--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Neurological decompensation17.02.05.030--Not Available
Acute kidney injury20.01.03.0160.000488%
Foetal growth restriction18.03.01.0020.000163%
Gestational hypertension24.08.07.004; 18.02.03.0040.000244%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000569%Not Available
Liver function test increased13.03.04.031--Not Available
Cerebral artery thrombosis24.01.04.008; 17.08.01.0260.000244%Not Available
Hyperbilirubinaemia neonatal18.04.08.003; 17.13.01.009; 14.11.01.038; 09.01.01.0140.000163%Not Available
Neonatal respiratory depression18.04.17.002; 22.11.02.009--Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000488%Not Available
Hyponatraemic encephalopathy17.13.01.011; 14.05.04.0070.000163%Not Available
Delivery18.08.02.0060.000163%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Lactation insufficiency21.05.02.006; 18.06.02.006--Not Available
Precipitate labour18.07.01.0100.000163%Not Available
Therapeutic product effect increased08.06.01.053--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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