Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tadalafil
Drug ID BADD_D02106
Description Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy.[L39100, L39105] It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like [sildenafil], tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.[A242287]
Indications and Usage Used for the treatment of erectile dysfunction.
Marketing Status Prescription
ATC Code G04BE08
DrugBank ID DB00820
KEGG ID D02008
MeSH ID D000068581
PubChem ID 110635
TTD Drug ID D05MQK
NDC Product Code 69238-1348; 16729-370; 42291-787; 68981-043; 62512-0063; 68071-5186; 71205-400; 65862-850; 31722-644; 53747-050; 50268-739; 68071-2613; 71821-008; 72303-0825; 72761-017; 68071-5092; 42291-865; 76420-126; 71610-581; 31722-643; 68071-2553; 69238-1346; 70518-2450; 0002-4463; 27241-113; 60219-1349; 70771-1476; 51293-840; 33342-267; 13668-566; 43598-578; 65862-853; 13668-568; 68071-2451; 63629-8288; 71610-213; 0093-3016; 47335-009; 63629-7943; 0093-3017; 71610-603; 33342-266; 69238-1347; 73377-080; 0110-4464; 66302-467; 0110-4467; 13668-581; 13668-567; 70771-1477; 0093-3019; 67184-0524; 68462-779; 27241-114; 66039-921; 79572-033; 0002-4462; 16729-372; 42291-789; 68180-921; 69238-1349; 75834-249; 68071-4912; 42291-864; 71205-418; 50090-4247; 71335-1255; 47335-011; 62128-0385; 71335-1239; 29300-288; 68180-922; 33342-268; 71821-007; 29300-287; 42291-866; 35573-412; 69037-0015; 69097-374; 65372-1173; 71610-214; 69097-376; 43598-575; 45865-991; 68071-2632; 68462-782; 50090-5724; 47335-012; 0395-8085; 72303-0822; 71052-059; 68382-899; 50268-738; 33342-278; 38779-3062; 65862-851; 50436-0370; 68071-2554; 71335-1670; 62332-178; 69097-375; 43063-236; 16714-077; 60219-1346; 71610-298; 16714-074; 0110-4462; 46144-327; 68071-5116; 68462-781; 27241-123; 65862-852; 63275-9895; 43598-576; 0002-4464; 70518-2862; 69097-526; 68382-898; 62512-0056; 60219-1347; 66174-0021; 71205-268; 31722-645; 46708-177; 27241-112; 62756-028; 31722-646; 71335-1620; 51552-1550; 62332-180; 71610-353; 61919-887; 35573-409; 68071-2421; 50090-4753; 71205-502; 72303-0823; 65862-719; 50090-5344; 71335-1587; 42291-788; 71205-269; 63629-8409; 68462-780; 71610-325; 69097-373; 71610-354; 68180-920; 50090-5627; 47335-010; 60219-1348; 70518-3001; 61919-889; 67835-5045; 68071-5110; 13668-565; 75834-248; 71335-1823; 42291-786; 42291-804; 35573-411; 42291-867; 71610-461; 43353-044; 50090-4660; 67184-0525; 75834-247; 50090-5641; 49452-7596; 71821-009; 68180-919; 29300-286; 35573-410; 71335-1400; 0093-3018; 71610-303; 68071-5272; 46708-841; 70771-1475; 67184-0526; 50379-0005; 68071-5138; 81999-0006; 27241-111; 68180-914; 66039-843; 50090-4276; 51293-842; 46708-178; 43063-969; 68071-5182; 62991-3128; 43353-070; 71610-567; 16729-369; 63415-0117; 67184-0523; 72189-145; 16729-371; 16714-075; 16714-076; 31722-647; 75834-250; 64552-4047; 65862-880; 0110-4463; 43598-573; 68788-8153; 50090-5187; 72789-184; 33342-265; 0002-4465; 70771-1478; 70518-2972; 71335-1884; 43353-857; 90027-004; 46708-179; 62332-179; 63629-8157; 51293-839; 68071-5202; 0093-3334; 46708-180; 43598-574; 71335-1491; 68382-897; 29300-289; 51293-841; 68071-2417; 62332-177; 68382-896; 0110-4465; 63629-4601; 71821-006; 60592-742; 51927-5037; 72303-0824; 71610-324
Synonyms Tadalafil | Pyrazino(1',2':1,6)pyrido(3,4-b)indole-1,4-dione, 6-(1,3- benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)- | IC351 | IC-351 | IC 351 | Cialis
Chemical Information
Molecular Formula C22H19N3O4
CAS Registry Number 171596-29-5
SMILES CN1CC(=O)N2C(C1=O)CC3=C(C2C4=CC5=C(C=C4)OCO5)NC6=CC=CC=C36
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Haemorrhoidal haemorrhage07.15.03.002; 24.10.02.001--
Haemorrhage24.07.01.002--Not Available
Abdominal infection11.01.07.014; 07.19.02.0070.000250%
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.001918%Not Available
Angiopathy24.03.02.007--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Ischaemic cerebral infarction24.04.06.013; 17.08.01.0220.000959%Not Available
Prostate cancer21.04.02.002; 16.25.01.0010.000876%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.01.01.003--Not Available
Connective tissue disorder15.06.01.006--Not Available
Infarction24.04.02.017--Not Available
Infestation11.09.01.001; 23.09.05.001--Not Available
Limb discomfort15.03.04.0140.000959%Not Available
Lung infection22.07.01.008; 11.01.09.0080.001918%
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Optic neuropathy06.02.08.002; 17.04.05.0050.001439%Not Available
Sudden hearing loss04.02.01.0090.000959%Not Available
Cardiac valve disease02.07.02.0010.001439%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.0010.006715%
Inner ear disorder04.04.02.002--Not Available
Ulcer haemorrhage24.07.01.040; 08.03.06.0030.001439%Not Available
Lower limb fracture15.08.03.004; 12.04.01.0040.001439%Not Available
Disease progression08.01.03.038--
Drug intolerance08.06.01.013--Not Available
Renal impairment20.01.03.010--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Unevaluable event08.01.03.0510.003837%Not Available
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