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)
Seizure17.12.03.001--
Sexual dysfunction21.03.02.003; 19.08.05.0020.000293%Not Available
Shock24.06.02.002--Not Available
Sickle cell anaemia with crisis01.04.02.0010.000195%Not Available
Sinus bradycardia02.03.03.009--
Sinus congestion22.04.06.0010.000995%Not Available
Skin discolouration23.03.03.0050.000625%Not Available
Skin disorder23.03.03.007--Not Available
Skin fissures23.03.03.008--Not Available
Skin lesion23.03.03.010--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder17.02.08.003; 22.12.03.027; 19.19.02.0020.000976%Not Available
Splenic infarction24.04.08.024; 01.09.02.0040.000390%Not Available
Sputum discoloured22.02.03.0100.000390%Not Available
Squamous cell carcinoma16.16.01.0020.000293%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000293%
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000683%Not Available
Sudden death08.04.01.003; 02.03.04.0130.000195%
Supraventricular tachycardia02.03.03.0120.000195%
Swelling08.01.03.0150.003572%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.001913%Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.003240%
Systemic lupus erythematosus15.06.02.003; 10.04.03.004; 23.03.02.0060.000195%Not Available
Tachycardia02.03.02.0070.001971%Not Available
Testicular pain21.13.01.0050.000429%
Therapeutic response decreased08.06.01.016--Not Available
Therapeutic response unexpected08.06.01.001--Not Available
Thrombosis24.01.01.006--Not Available
Tinnitus17.04.07.004; 04.04.01.0020.003767%
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