Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Silodosin
Drug ID BADD_D02020
Description Silodosin is a selective antagonist of alpha(α)-1 adrenergic receptors that binds to the α1A subtype with the highest affinity. α1-adrenergic receptors regulate smooth muscle tone in the bladder neck, prostate, and prostatic urethra: the α1A subtype accounts for approximately 75% of α1-adrenoceptors in the prostate.[A231159] Silodosin was first approved by the FDA in October 2008 [A231159] and it is also approved in Europe and Canada. Silodosin is available as oral capsules with common trade names Rapaflo and Urorec. It is indicated for the symptomatic treatment of benign prostatic hyperplasia in adults.[L32368] Most commonly affecting males over the age of 40 years, benign prostatic hyperplasia is the non-malignant enlargement of the prostate gland, associated with lower urinary tract symptoms that have a negative impact on the quality of life of patients.[A231159] Silodosin works by binding to α1A-adrenoceptors with high affinity and relaxing the lower urinary tract, thereby improving urinary symptoms and alleviating bladder outlet obstruction.[A231229]
Indications and Usage Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). It is not indicated for the treatment of hypertension.[L32368]
Marketing Status approved
ATC Code G04CA04
DrugBank ID DB06207
KEGG ID D01965
MeSH ID C095285
PubChem ID 5312125
TTD Drug ID D0U0VU
NDC Product Code 42291-777; 83137-0011; 0023-6147; 69238-1421; 42291-778; 27241-144; 27241-145; 31722-635; 60219-1420; 60219-1421; 69539-053; 72789-090; 52544-151; 68180-741; 0023-6142; 59651-096; 62332-405; 69238-1420; 69539-052; 0781-2624; 52544-152; 59651-100; 73005-0002; 33342-385; 62332-406; 42334-001; 65977-0091; 33342-384; 46708-406; 68180-740; 72205-009; 72205-010; 14501-0074; 42765-005; 46708-405; 0781-2623; 31722-636; 59651-095
UNII CUZ39LUY82
Synonyms silodosin | 1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl)indoline-7-carboxamide | KMD 3213 | KMD-3213 | rapaflo
Chemical Information
Molecular Formula C25H32F3N3O4
CAS Registry Number 160970-54-7
SMILES CC(CC1=CC2=C(C(=C1)C(=O)N)N(CC2)CCCO)NCCOC3=CC=CC=C3OCC(F)(F)F
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)
Loss of consciousness17.02.04.0040.003110%Not Available
Melaena24.07.02.013; 07.12.02.0040.000566%Not Available
Nasal congestion22.04.04.0010.000566%
Nasopharyngitis11.01.13.002; 22.07.03.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.0200.000848%Not Available
Palpitations02.11.04.012--
Penis disorder21.12.01.0010.000566%Not Available
Pharyngeal oedema10.01.05.016; 23.04.01.016; 22.04.05.003--Not Available
Pollakiuria20.02.02.0070.001923%
Priapism24.04.12.007; 21.03.01.0050.000848%Not Available
Prostatic specific antigen increased13.23.01.003--Not Available
Pruritus23.03.12.0010.001244%
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.0030.000566%
Rash23.03.13.0010.001810%Not Available
Retrograde ejaculation21.03.01.0060.000848%Not Available
Rhinorrhoea22.12.03.0210.001244%
Seizure17.12.03.0010.000566%
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018--Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.003--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.001131%
Tachycardia02.03.02.007--Not Available
Urinary retention20.02.02.0110.002771%
Urticaria23.04.02.001; 10.01.06.001--
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
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