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)
Spontaneous penile erection21.03.01.010--Not Available
Sudden cardiac death02.03.04.016; 08.04.01.0080.000390%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.001386%Not Available
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.0030.000195%Not Available
Blood pressure inadequately controlled24.06.01.0070.000195%Not Available
Facial paresis17.04.03.0020.000293%
Viral diarrhoea11.05.04.012; 07.19.02.008--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000488%Not Available
Conjunctival hyperaemia06.04.01.004--Not Available
Cyanopsia06.02.05.0030.001659%Not Available
Ocular discomfort06.08.03.0080.000429%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.0010.000293%Not Available
Skin swelling23.03.03.0390.000488%Not Available
Cerebral haematoma24.07.04.006; 17.08.01.0140.000195%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.002--
Hypertensive nephropathy24.08.05.003; 20.01.08.0040.000195%Not Available
Haemorrhage24.07.01.002--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000586%Not Available
Angiopathy24.03.02.007--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Ischaemic cerebral infarction24.04.06.013; 17.08.01.0220.000195%Not Available
Prostate cancer21.04.02.002; 16.25.01.0010.000878%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.0030.001971%Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infarction24.04.02.017--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Limb discomfort15.03.04.014--Not Available
Ischaemic stroke24.04.06.010; 17.08.01.0180.001171%Not Available
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