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)
Gastrointestinal pain07.01.05.005--
Gingival bleeding24.07.02.010; 07.09.07.0010.000959%Not Available
Glaucoma06.03.01.0020.000959%
Haematocrit increased13.01.05.0020.000959%Not Available
Haematospermia24.07.03.008; 21.03.03.0030.002398%Not Available
Haematuria24.07.01.047; 20.02.01.0060.002878%
Haemoglobin13.01.05.018--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.0060.002398%Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.0080.000751%
Headache17.14.01.0010.055634%
Heart rate decreased13.14.04.0010.000959%Not Available
Heart rate increased13.14.04.0020.003837%Not Available
Hepatic failure09.01.03.0020.000500%
Herpes zoster23.09.03.002; 11.05.02.003--
Hip fracture15.08.03.001; 12.04.01.0010.001918%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkeratosis23.01.01.0010.001918%
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hyponatraemia14.05.04.002--
Hypotension24.06.03.0020.007674%
Hypoxia22.02.02.0030.001918%
Immune system disorder10.02.01.001--Not Available
Impaired gastric emptying07.02.02.0040.000959%
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.0010.003357%Not Available
Influenza like illness08.01.03.010--
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