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)
Strangury20.02.02.017--Not Available
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000325%Not Available
Swelling08.01.03.015--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000163%
Systemic lupus erythematosus10.04.03.004; 23.03.02.006; 15.06.02.003--Not Available
Tachycardia02.03.02.0070.000163%Not Available
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Urticaria10.01.06.001; 23.04.02.0010.000358%
Uterine atony18.07.02.012; 21.07.03.001--Not Available
Vaginal haemorrhage21.08.01.001; 24.07.03.0050.000163%
Ventricular arrhythmia02.03.04.006--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Wheezing22.03.01.009--
Yawning22.12.03.037--Not Available
Mental status changes19.07.01.0010.000163%Not Available
HELLP syndrome18.02.03.005; 09.01.02.006; 01.08.01.008; 24.08.07.0050.000488%Not Available
Blood pressure inadequately controlled24.06.01.0070.000163%Not Available
Facial paresis17.04.03.0020.000325%
Necrotising colitis07.08.01.0130.000163%Not Available
Haemodynamic instability24.03.02.0060.000602%Not Available
Diastolic dysfunction02.04.02.0220.000163%Not Available
Affect lability19.04.01.001--Not Available
Transaminases decreased13.03.04.035--Not Available
Haemorrhagic transformation stroke24.07.04.018; 17.08.01.0360.000244%Not Available
Foetal death18.01.02.003; 08.04.01.0110.000163%
Haemorrhage24.07.01.0020.000602%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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