Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Labetalol hydrochloride
Drug ID BADD_D01237
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 D00600
MeSH ID D007741
PubChem ID 71412
TTD Drug ID D0A8XN
NDC Product Code 0591-0605; 0904-7109; 46016-0117; 29300-254; 36000-324; 0143-9320; 51407-614; 63629-2054; 63629-8902; 68382-798; 70518-2903; 71209-084; 71209-085; 71247-127; 71335-1410; 71335-2057; 71335-2063; 71335-2169; 0591-0607; 17337-0523; 58032-2025; 59349-0025; 17478-420; 23155-723; 47781-553; 63629-1164; 63629-1166; 63629-2212; 63629-2213; 63629-8900; 68083-111; 0409-2339; 70377-062; 70771-1163; 71209-083; 71247-130; 71335-2145; 24196-178; 82245-0203; 36000-320; 42806-329; 51407-615; 55154-4170; 68382-799; 70377-061; 63629-2215; 63629-2216; 70377-060; 70518-1546; 0615-8130; 72266-103; 72603-146; 72888-121; 53747-037; 0143-9366; 51407-616; 51662-1228; 55154-4747; 63629-1163; 68001-381; 70518-3411; 70518-3499; 70518-3557; 71247-126; 71930-035; 72611-738; 25021-317; 0143-9364; 0143-9622; 49884-122; 51655-322; 58657-603; 63629-1165; 65145-124; 68382-800; 71335-1242; 71930-037; 72611-734; 72888-120; 66039-962; 29300-252; 0143-9363; 49884-124; 50090-1290; 58657-602; 60687-439; 60760-628; 63629-2053; 63629-2214; 63629-8903; 65145-125; 68001-383; 71205-095; 71930-036; 0591-0606; 49452-3909; 51604-0017; 52423-0912; 23155-724; 0143-9623; 47781-554; 49884-123; 60760-784; 63629-1161; 63629-8901; 63629-9185; 0409-2267; 70518-1163; 70518-2728; 70771-1164; 70771-1165; 71335-9690; 0615-8131; 0904-7110; 50683-0590; 42806-328; 55154-2339; 60687-450; 63629-1162; 63629-2211; 63629-8898; 70518-1132; 72572-350; 72888-122; 0904-7111; 29300-253; 0143-9365; 42806-327; 50090-1161; 50090-1291; 55154-8192; 60687-461; 63629-2055; 63629-8899; 68001-382; 72266-102; 0641-6252; 12828-0070; 49452-3911; 66174-0003; 23155-725; 36000-322; 47781-586; 58657-604
UNII 1GEV3BAW9J
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 C19H25ClN2O3
CAS Registry Number 32780-64-6
SMILES CC(CCC1=CC=CC=C1)NCC(C2=CC(=C(C=C2)O)C(=O)N)O.Cl
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)
Abdominal pain07.01.05.002--
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Antimitochondrial antibody13.06.01.009--Not Available
Asthenia08.01.01.001--Not Available
Atrioventricular block02.03.01.002--Not Available
Blood urea increased13.13.01.006--Not Available
Bradycardia02.03.02.002--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Catatonia19.11.01.001--Not Available
Colitis ischaemic24.04.08.012; 07.08.01.004--Not Available
Depressed level of consciousness17.02.04.002--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry eye06.08.02.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Ejaculation failure21.03.01.003--Not Available
Erythema23.03.06.001--Not Available
Fatigue08.01.01.002--
Headache17.14.01.001--
Hepatic necrosis09.01.07.002--
Hepatitis09.01.07.004--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
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