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 For the management of hypertension (alone or in combination with other classes of antihypertensive agents), as well as chronic stable angina pectoris and sympathetic overactivity syndrome associated with severe tetanus. Labetalol is used parenterally for immediate reduction in blood pressure in severe hypertension or in hypertensive crises when considered an emergency, for the control of blood pressure in patients with pheochromocytoma and pregnant women with preeclampsia, and to produce controlled hypotension during anesthesia to reduce bleeding resulting from surgical procedures.
Marketing Status Prescription; Discontinued
ATC Code C07AG01
DrugBank ID DB00598
KEGG ID D00600
MeSH ID D007741
PubChem ID 71412
TTD Drug ID D0A8XN
NDC Product Code 50090-1291; 49884-123; 70518-2728; 58657-602; 51662-1228; 70518-2903; 51407-615; 71209-084; 70934-751; 68083-111; 71335-1242; 50090-4149; 55154-4747; 60760-231; 63629-1162; 0143-9363; 70771-1165; 70518-1163; 70518-3411; 72266-102; 50090-4917; 71247-126; 47781-553; 68382-799; 52423-0912; 65145-125; 71209-085; 63629-2053; 68382-800; 58032-2025; 63629-5268; 71335-2063; 47781-552; 63629-8899; 0591-0605; 58657-604; 60687-439; 47781-554; 23155-724; 0615-8131; 63629-2216; 0904-7109; 0409-2339; 72266-103; 51604-0017; 23155-725; 23155-723; 70518-1546; 70771-1163; 63629-2215; 0904-7111; 65145-124; 63629-8901; 51407-614; 55154-2339; 71930-036; 46016-0117; 71209-083; 0143-9320; 70377-061; 55154-8192; 60760-628; 0409-2267; 0591-0606; 49452-3909; 60687-461; 68382-798; 17478-420; 70934-913; 63629-1165; 68001-382; 63629-1163; 24196-178; 59349-0025; 36000-324; 63629-1161; 70771-1164; 50090-1290; 42806-329; 49452-3911; 63629-2211; 71930-035; 50090-3584; 17337-0523; 0904-5928; 0615-8130; 12828-0070; 63629-2054; 60687-450; 53747-037; 0591-0607; 0143-9622; 63629-2214; 72572-350; 66174-0003; 50090-1161; 63629-8900; 68001-381; 0143-9364; 49884-124; 36000-320; 0143-9623; 63629-1164; 0143-9365; 72611-734; 63629-8898; 0904-5930; 63629-2055; 55154-6877; 58657-603; 71247-130; 71247-127; 72888-120; 63629-8903; 42806-328; 63629-5311; 51407-616; 72888-121; 71335-2057; 71205-095; 71930-037; 36000-322; 55154-5876; 63629-2212; 50683-0590; 72611-738; 71335-1410; 72888-122; 63629-1166; 49884-122; 47781-586; 70377-060; 42806-327; 0904-7110; 70377-062; 63629-2213; 63629-8902; 0143-9366; 0641-6252; 68001-383
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Adverse drug reactionCytochrome P450 2D6P10635T57392Not Available
ADRs Induced by Drug
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
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry eye06.08.02.001--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Dyspnoea02.01.03.002; 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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