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)
Productive cough22.02.03.0050.000488%
Prostatic disorder21.04.01.001---
Prostatitis21.09.01.0010.000390%-
Pruritus23.03.12.001--
Pulmonary congestion02.05.02.002; 22.01.03.002; 24.03.08.0010.000995%-
Pulmonary embolism22.06.02.001; 24.01.06.001---
Pulmonary hypertension22.06.01.001; 24.08.03.0020.002440%
Pulmonary oedema02.05.02.003; 22.01.03.0030.002381%
Pulmonary thrombosis22.06.02.003; 24.01.06.0020.000195%-
Pulmonary veno-occlusive disease22.06.03.003; 24.01.06.0080.000195%-
Pupillary reflex impaired06.05.03.009; 17.02.11.0070.000195%-
Rash23.03.13.001---
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal colic20.02.03.0100.000195%
Renal disorder20.01.02.0020.000917%-
Renal failure20.01.03.0050.003240%-
Renal pain20.02.03.003---
Respiration abnormal22.02.01.0410.001386%-
Respiratory disorder22.02.07.0020.001015%-
Respiratory failure14.01.04.003; 22.02.06.0020.001952%
Retinal artery occlusion06.10.01.005; 24.01.07.0030.000293%-
Retinal detachment06.09.03.003; 12.01.04.0040.000976%
Retinal disorder06.08.03.005---
Retinal haemorrhage06.10.01.001; 24.07.05.003---
Retinal vascular occlusion06.10.01.008; 24.04.10.004---
Retinal vein occlusion06.10.01.010; 24.01.07.006---
Retinal vein thrombosis06.10.01.003; 24.01.07.002---
Rhinitis11.01.13.004; 22.07.03.006--
Right ventricular failure02.05.03.0020.000781%-
Scleroderma10.04.07.001; 15.06.01.002; 23.03.02.0050.000390%-
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