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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.002878%
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.006235%
Actinic keratosis23.01.06.0010.001439%Not Available
Aggression19.05.01.001--Not Available
Alopecia23.02.02.001--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Aneurysm24.02.01.0010.000250%Not Available
Angina pectoris02.02.02.002; 24.04.04.002--
Angina unstable02.02.02.004; 24.04.04.004--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anxiety19.06.02.002--
Aortic dissection24.02.03.0020.000959%Not Available
Aortic stenosis24.04.01.0010.000250%Not Available
Arrhythmia02.03.02.0010.004796%Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Atrial fibrillation02.03.03.0020.006235%
Back pain15.03.04.0050.017745%
Basal cell carcinoma16.03.02.001; 23.08.02.0010.000959%Not Available
Bladder cancer16.08.01.001; 20.03.04.001--Not Available
Blindness06.02.02.001; 17.17.01.0030.003837%Not Available
Blister12.01.06.002; 23.03.01.001--Not Available
Blood creatinine increased13.13.01.004--
Blood glucose decreased13.02.02.0010.000959%Not Available
Blood glucose increased13.02.02.0020.001918%Not Available
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