Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vardenafil
Drug ID BADD_D02335
Description Vardenafil (Levitra) is an oral therapy for the treatment of erectile dysfunction. It is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMPspecific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP.
Indications and Usage Used for the treatment of erectile dysfunction
Marketing Status approved
ATC Code G04BE09
DrugBank ID DB00862
KEGG ID D08668
MeSH ID D000069058
PubChem ID 135400189
TTD Drug ID D0C9SY
NDC Product Code 33342-203; 46708-235; 70710-1070; 70771-1048; 51407-174; 70771-1050; 71610-477; 71610-643; 70710-1069; 47621-303; 70710-1068; 70771-1047; 70710-1071; 62332-235; 70771-1049
UNII UCE6F4125H
Synonyms Vardenafil Dihydrochloride | Dihydrochloride, Vardenafil | Vardenafil Hydrochloride Anhydrous | Anhydrous, Vardenafil Hydrochloride | Hydrochloride Anhydrous, Vardenafil | Vardenafil | 1-(((3-(3,4-dihydro-5-methyl)-4-oxo-7-propylimidazo(5,1-f)-as-triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethylpiperazine | Levitra | Vardenafil Hydrochloride Trihydrate | Hydrochloride Trihydrate, Vardenafil | Trihydrate, Vardenafil Hydrochloride | Vardenafil Hydrochloride | Hydrochloride, Vardenafil
Chemical Information
Molecular Formula C23H32N6O4S
CAS Registry Number 224785-90-4
SMILES CCCC1=NC(=C2N1N=C(NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)CC)OCC)C
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)
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred17.17.01.010; 06.02.06.007--
Visual acuity reduced06.02.10.012; 17.17.01.011--
Visual field defect06.02.07.003; 17.17.01.001--Not Available
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Visual brightness17.17.02.009; 06.02.06.015--Not Available
Sudden cardiac death02.03.04.016; 08.04.01.008--Not Available
Tachyarrhythmia02.03.02.008--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Cyanopsia06.02.05.003--Not Available
Ocular discomfort06.08.03.008--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Haemorrhage24.07.01.002--Not Available
Angiopathy24.03.02.007--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Allergic oedema10.01.03.025; 08.01.07.014--Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation11.09.01.001; 23.11.01.002--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Sudden hearing loss04.02.01.009--Not Available
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Hepatobiliary disease09.01.08.003--Not Available
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