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)
Paraesthesia23.03.03.094; 17.02.06.005--
Pericardial effusion02.06.01.0020.000163%
Peyronie's disease21.12.01.002--Not Available
Pleural effusion22.05.02.0020.000163%
Pollakiuria20.02.02.007--
Postpartum haemorrhage24.07.03.003; 18.06.01.001--Not Available
Pre-eclampsia24.08.07.002; 20.01.08.002; 18.02.03.0020.000650%Not Available
Pregnancy18.08.02.004--Not Available
Premature baby18.04.02.0010.001707%Not Available
Premature delivery18.07.01.0060.001057%
Premature labour18.07.01.0020.000325%Not Available
Premature rupture of membranes18.07.01.0030.000244%Not Available
Pruritus23.03.12.001--
Pulmonary hypertension24.08.03.002; 22.06.01.0010.000163%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000325%
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Raynaud's phenomenon24.04.03.0030.000602%Not Available
Respiratory arrest22.02.01.009--Not Available
Respiratory distress22.02.01.0120.000244%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000244%
Restlessness19.11.02.002; 17.02.05.0210.000244%
Seizure17.12.03.0010.000244%
Sensory loss17.02.07.007--Not Available
Shock24.06.02.0020.000163%Not Available
Skin discolouration23.03.03.0050.000520%Not Available
Skin lesion23.03.03.010--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Status epilepticus17.12.03.0050.000325%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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