Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vardenafil hydrochloride
Drug ID BADD_D02336
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 D09989
MeSH ID D000069058
PubChem ID 135438569
TTD Drug ID D0C9SY
NDC Product Code 73750-105; 52562-004; 62332-236; 69238-1152; 0093-7652; 0093-7655; 62332-237; 73750-103; 42291-847; 69238-1151; 71335-9688; 33342-151; 46708-239; 33342-152; 46708-238; 62332-239; 73750-104; 12658-0463; 42291-848; 46708-236; 0527-2801; 0527-2803; 71335-9696; 62332-238; 0527-2802; 69238-1153; 71335-9689; 73750-102; 67835-0014; 81999-0008; 0093-7654; 46708-237; 0527-2800; 71610-508; 0093-7653; 33342-153; 33342-154
UNII 5M8S2CU0TS
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 C23H33ClN6O4S
CAS Registry Number 224785-91-5
SMILES CCCC1=NC(=C2N1N=C(NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)CC)OCC)C.Cl
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)
Abdominal pain07.01.05.002--
Amnesia19.20.01.001; 17.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Blindness06.02.10.003; 17.17.01.003--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Colour blindness acquired06.02.09.002--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Diarrhoea07.02.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dry mouth07.06.01.002--
Dysaesthesia23.03.03.077; 17.02.06.003--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Erection increased21.03.01.004; 19.08.04.002--Not Available
Erythema23.03.06.001--Not Available
Eye pain06.08.03.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hypotension24.06.03.002--
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Intraocular pressure increased13.07.04.002--Not Available
Malaise08.01.01.003--
Myalgia15.05.02.001--
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