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 Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with [finasteride] for the treatment of benign prostatic hypertrophy (BPH).[L39095,L39439] It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with [macitentan] or other endothelin-1 antagonists.[L39100,L39105]
Marketing Status approved; investigational
ATC Code G04BE08
DrugBank ID DB00820
KEGG ID D02008
MeSH ID D000068581
PubChem ID 110635
TTD Drug ID D05MQK
NDC Product Code 75834-249; 76420-551; 76420-554; 82009-079; 0093-3016; 63275-9895; 65862-852; 66039-921; 69037-0015; 73377-080; 16714-076; 27241-113; 29300-286; 31722-645; 33342-267; 35573-461; 43063-969; 43547-050; 43598-574; 50090-6150; 51655-473; 0002-4462; 65862-853; 68180-914; 68180-922; 68382-897; 68382-898; 69238-1347; 70518-3001; 70518-3697; 70771-1477; 70934-795; 71205-268; 71821-009; 72789-184; 76420-542; 76420-543; 82009-077; 49452-7596; 62991-3128; 65862-850; 66039-843; 0093-3334; 27241-123; 31722-644; 35573-409; 35573-411; 35573-462; 42291-804; 42291-864; 43547-990; 46708-178; 46708-180; 50090-4660; 50090-5344; 50436-0372; 51293-839; 51293-841; 60219-1348; 60219-1349; 63629-8288; 65862-851; 65862-880; 68071-5272; 68180-920; 69238-1348; 71205-400; 76420-126; 53747-050; 62512-0056; 13668-567; 13668-568; 16729-370; 29300-288; 33342-266; 33342-268; 33342-278; 45865-991; 47335-011; 50268-739; 0002-4464; 61919-887; 62332-177; 63629-8157; 68071-2632; 68071-5202; 68180-921; 68382-899; 70518-3529; 70771-1475; 70771-1476; 71205-734; 71205-754; 71335-1823; 71821-006; 0002-4465; 61919-889; 68071-2421; 68071-2553; 68788-8465; 69097-374; 69097-526; 71335-1670; 71610-213; 62512-0063; 63415-0117; 65372-1173; 65862-719; 16714-077; 16729-371; 16729-372; 27241-111; 29300-289; 31722-646; 33342-265; 43547-047; 46287-045; 46708-177; 50268-738; 51293-842; 51655-063; 0002-4463; 60219-1346; 63629-8409; 68071-2613; 68071-5182; 68788-8445; 69238-1346; 71205-736; 71335-1400; 71335-1587; 75834-247; 76420-544; 82009-080; 0110-4465; 64220-173; 64552-4047; 71052-059; 0093-3019; 42291-866; 43598-573; 43598-575; 51655-487; 62332-178; 68071-2981; 70954-433; 71610-603; 72761-017; 81999-0006; 82393-302; 43547-051; 43598-578; 46708-179; 47335-009; 63629-7943; 67184-0526; 68788-8292; 69097-373; 69238-1349; 70518-2862; 70518-2972; 71335-1620; 71821-008; 72789-324; 0110-4462; 0110-4463; 46144-327; 90027-004; 13668-565; 16729-369; 0093-3017; 27241-112; 29300-287; 47335-010; 62332-180; 67184-0523; 67184-0524; 68071-2417; 68180-919; 71205-720; 71821-007; 72189-145; 38779-3062; 50379-0005; 51552-1550; 60592-742; 62756-028; 79572-033; 13668-581; 27241-114; 42291-865; 42291-867; 43547-049; 43598-576; 60219-1347; 62332-179; 66302-467; 67184-0525; 68071-2554; 68071-5186; 68382-896; 68788-8153; 69097-375; 69097-376; 70518-3434; 70954-434; 71205-269; 71335-1255; 71455-597; 71610-214; 71610-461; 76420-541; 76420-553; 0110-4467; 51927-5037; 68981-043; 0093-3018; 31722-647; 47335-012; 50090-5641; 70771-1478; 70954-435; 71205-418; 71205-502; 71205-735; 71335-1239; 71335-1491; 71335-1884; 71610-567; 71610-581; 72189-500; 75834-248; 75834-250; 76420-552; 0110-4464; 62128-0385; 66174-0021; 67835-5045; 13668-566; 16714-074; 16714-075; 31722-643; 35573-410; 35573-412; 35573-460; 35573-463; 50436-0370; 51293-840
UNII 742SXX0ICT
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
*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)
Torsade de pointes02.03.04.0050.000976%-
Transient global amnesia17.03.02.004; 19.20.01.0040.000390%-
Transient ischaemic attack17.08.04.001; 24.04.06.005--
Unresponsive to stimuli17.02.05.0310.000586%-
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urethral disorder20.07.01.002---
Urinary hesitation20.02.02.0090.000429%-
Urinary retention20.02.02.0110.000683%
Urinary tract disorder20.08.01.001---
Urinary tract infection11.01.14.004; 20.08.02.001--
Urine flow decreased20.02.02.012---
Urticaria10.01.06.001; 23.04.02.001--
Uterine haemorrhage21.07.01.005; 24.07.03.004--
Vaginal haemorrhage21.08.01.001; 24.07.03.005--
Ventricular arrhythmia02.03.04.006--
Ventricular fibrillation02.03.04.0080.000293%
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred06.02.06.007; 17.17.01.0100.013701%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000956%
Visual field defect06.02.07.003; 17.17.01.0010.000390%-
Visual impairment06.02.10.0130.005719%-
VIth nerve paralysis06.05.02.009; 17.04.02.0020.000293%-
Vitreous floaters06.09.01.005--
Vomiting07.01.07.003--
Wheezing22.03.01.0090.000625%
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.001054%-
Poor venous access24.03.02.017---
Deafness unilateral04.02.01.0110.000976%-
Hypoacusis04.02.01.0060.001815%
Peripheral swelling02.05.04.015; 08.01.03.0530.005289%-
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