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)
Bone disorder15.02.04.004--Not Available
Breast pain21.05.05.0030.000429%
Bronchitis22.07.01.001; 11.01.09.001--
Cardiac failure02.05.01.0010.002537%
Cardiac failure acute02.05.01.0050.000195%Not Available
Cardiac failure congestive02.05.01.0020.002147%Not Available
Cardiogenic shock24.06.02.006; 02.05.01.0030.000195%Not Available
Cardiovascular disorder24.03.02.009; 02.11.01.0100.000195%Not Available
Cataract06.06.01.0010.000956%
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.001464%Not Available
Cerebral infarction17.08.01.004; 24.04.06.0020.000683%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.002342%
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.001913%Not Available
Chest pain08.01.08.002; 02.02.02.011; 22.12.02.0030.003240%Not Available
Cholangiocarcinoma09.04.02.009; 16.07.01.0020.000195%Not Available
Chromatopsia06.02.05.001--Not Available
Chronic obstructive pulmonary disease22.03.01.0070.001171%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000488%Not Available
Colon cancer07.21.01.001; 16.13.01.001--Not Available
Colour blindness acquired06.02.09.002--Not Available
Condition aggravated08.01.03.0040.004040%Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cor pulmonale02.05.03.001; 24.08.03.001; 22.06.01.0030.000195%Not Available
Coronary artery disease24.04.04.006; 02.02.01.0010.000293%Not Available
Cough22.02.03.001--
Cyanosis24.03.01.007; 22.02.02.007; 23.06.04.005; 02.11.04.0040.000625%
Deafness04.02.01.0010.001971%Not Available
Deafness neurosensory17.04.07.001; 04.02.01.0020.000586%Not Available
Death08.04.01.0010.029042%
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