Vardenafil 5mg tablets
Requires a prescription from a doctor or prescriber
Safety information for pregnancy and breastfeeding
Pregnancy
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Vardenafil
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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Suspected adverse reactions reported for Vardenafil
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
15 branded products available
MHRA licensed products
View all licensed products for Vardenafil on the MHRA register
Levitra 5mg tablets
Vardenafil 5mg tablets
Vardenafil 5mg tablets
Vardenafil 5mg tablets
Vardenafil 5mg tablets
Vardenafil 5mg tablets
Vardenafil 5mg tablets
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
10 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(2)
Erectile dysfunction: Alprostadil cream (ESNM50)
Erectile dysfunction: avanafil (ESNM45)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & safety information
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Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 9 · Randomised trials: 4 · 2001–2026
Showing the 50 most relevant studies, sorted by most relevant.
Abouelmagd ME, Abdelmeseh M, Elrosasy A, et al.
2024
- Alzheimer Disease
- Phosphodiesterase 5 Inhibitors
- Vardenafil Dihydrochloride
BackgroundThe management of Alzheimer's disease (AD) poses considerable challenges, necessitating the pursuit of innovative therapeutic approaches. Recent research has spotlighted the promising role of phosphodiesterase type 5 inhibitors (PDE5Is) in reducing the prevalence of AD, utilizing their vasodilatory properties to suggest a potential neuroprotective effect. This meta-analysis and systematic review aims to assess the relationship between the use of PDE5Is and the risk of AD.MethodsA detailed examination was carried out across several electronic databases till March 2024, including PubMed, Web of Science, Scopus, CENTRAL, and Embase. The focus was on identifying studies that compare the occurrence of AD among PDE5I users vs non-users. Through a random-effects model, pooled hazard ratios (HRs) were calculated, in alignment with guidelines from the Cochrane Handbook for Systematic Reviews and Meta-Analysis and the PRISMA standards.ResultsThis analysis included six studies, cumulating a participant count of 8,337,313, involving individuals treated with sildenafil, tadalafil, and vardenafil, against a control group undergoing other or no treatments. The cumulative HR for AD risk among PDE5I users versus the control group was 0.53 (95% CI: 0.32-0.86, p = 0.008), signaling a markedly reduced likelihood of AD development in the PDE5I group. Particularly, sildenafil usage showed a significant risk reduction (HR: 0.46, 95% CI: 0.31-0.70, p ConclusionsOur findings suggest that the use of PDE5Is is associated with a reduced risk of AD, highlighting its potential as a protective agent against neurodegenerative diseases. Given the very low quality of evidence and the heterogeneity among the included studies, further high-quality research is warranted to confirm these findings and elucidate the underlying mechanisms. Register number PROSPERO 2024: CRD42024522197.
Abstract licence: CC BY
Shafiee A, Bahri RA, Teymouri Athar MM, et al.
2023
- Esophageal Achalasia
- Phosphodiesterase 5 Inhibitors
- Sulfones
van Raaij JJ, Serefoglu EC, van Amelsvoort TAMJ, et al.
2024
- Neurotransmitter Agents
- Premature Ejaculation
- Selective Serotonin Reuptake Inhibitors
IntroductionLifelong premature ejaculation (LPE) is a subtype of premature ejaculation. Genetic research on LPE has primarily focused on neurotransmitters such as serotonin, dopamine, and norepinephrine, whereas LPE treatment studies have focused on drugs such as selective serotonin reuptake inhibitors. However, findings from genetic association and pharmacotherapeutic studies have been inconsistent.ObjectivesTo provide a quality overview of neurobiological targets that are potentially associated with LPE by investigating genetic association and pharmacotherapeutic studies.MethodsThis scoping review was conducted per the PRISMA-ScR tool (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews). Five databases were searched in March 2023 without timeline- or language-related restrictions.ResultsAfter deduplication, 3949 records were obtained for review. Following screening and full-text review with citation tracking, 52 studies were included: 18 genetic and 34 pharmacotherapy studies. Serotonergic targets, such as the serotonin transporter and pre- and postsynaptic serotonergic receptors, were most often associated with LPE in genetic and pharmacotherapeutic studies. Mixed results were found among polymorphisms within genetic studies. This mechanism is in accordance with pharmacotherapeutic studies, as the highest efficacy was found for potent serotonergic antidepressants. Successful treatment was also observed with medication acting on phosphodiesterase-5 enzyme, such as tadalafil and vardenafil. Analyses of other genetic association studies did not yield any further evidence for associated targets.ConclusionsThis review is the first comprehensive scoping review on LPE. We found that serotonergic targets are most often associated with LPE, suggesting that the serotonergic pathway is a predisposing factor in LPE. Furthermore, there is some evidence for phosphodiesterase 5 inhibitors, which should be investigated. Other previously investigated neurobiological targets appear less likely to contribute to LPE. Future studies should focus on multiple targets, ideally in a genome-wide association study design.This review has been registered with the Open Science Framework (doi:10.17605/OSF.IO/JUQSD).
Abstract licence: CC BY
Uppal G, Shenoy A, Sayan S, et al.
2025
Hai Wang, Boda Guo, Zhongming Huang, et al.
Advances in Therapy, 2021
Liang Dong, Xiaojin Zhang, Xuhong Yan, et al.
The World Journal of Men's Health, 2021
Purpose: Male infertility is a worldwide problem with limitations in the treatment. Phosphodiesterase-5 inhibitors (PDE5is) is the first choice for the treatment of erectile dysfunction, more and more studies show that it has a certain effect on male infertility in recent years. But there was currently no high quality of systematic review to evaluate the effects of PDE5is on semen quality. Materials and Methods: We retrieved the electronic databases of MEDLINE, PubMed, Web of Science, EMBASE, etc. Related randomized controlled trials (RCTs) were collected and selected up to May 20, 2020. We have searched literature with terms “male infertility”, “phosphodiesterase-5 inhibitors”, “PDE5i”, “Tadalafil”, “Sildenafil”, “Vardenafil”, “Udenafil”, “Avanafil”, “semen”, and “sperm”. Mean value and its standard deviation were used to perform quantitative analysis. All statistical analyses were conducted by RevMan 5.3 and Stata software. Results: There were a total of 1,121 participants in the nine included studies. There was a statistically significant improvement treated with PDE5is compared with sham therapy, which including sperm concentration (mean difference [MD]=1.96, 95% confidence interval [CI]=1.70–2.21, p<0.001; MD=3.22, 95% CI=1.96–4.48, p<0.001), straight progressive motility (%) Grade A (MD=3.71, 95% CI=2.21–5.20, p<0.001), sperm motility (MD=8.09, 95% CI=7.83–8.36, p<0.001), morphologically normal spermatozoa (%) (MD=0.67, 95% CI=0.20–1.15, p=0.005; MD=1.27, 95% CI=0.02–2.52, p=0.05), sperm abnormalities (%) (MD=-0.64, 95% CI=-0.81–-0.47, p<0.001), and progressive motile sperm (MD=5.34, 95% CI=3.87–6.81, p<0.001). Conclusions: In this meta-analysis of nine RCTs, treatment with PDE5is could improve some indicators of male sperm.
Abstract licence: CC BY-NC
B. Venhuis, D. de Kaste
Journal of pharmaceutical and biomedical analysis, 2012
D. Santi, A. Granata, A. Guidi, et al.
European journal of endocrinology, 2016
T. Diab, K. Noah, M. Farag, et al.
International Urology and Nephrology, 2024
- Ureteral Calculi
- Indoles
- Vardenafil Dihydrochloride
K. Melehan, C. Hoyos, G. Hamilton, et al.
The Journal of Clinical Endocrinology & Metabolism, 2018
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
104 found
Half-life
4-5 hours
Mechanism
Vardenafil inhibits cyclic guanosine monophosphate (GMP) specific phosphodiester…
Food interactions
2 warnings
Human targets
3 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
20 mg
Half-life
4-5 hours
[L45563]
Protein binding
95%
Volume of distribution
208 L
[L45563]
Metabolism
26%
Elimination
91-95%
Clearance
56 L/h
[L45563]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
The FDA approved the use of vardenafil for the treatment of erectile dysfunction in 2003. Although other PDE5 inhibitors such as [sildenafil] and [tadalafil] have been associated with rare cases of acute liver injury, the use of vardenafil has not been linked to hepatotoxic effects.[A258313] The use of vardenafil as a monotherapy for the treatment of pulmonary arterial hypertension has also been evaluated.[A258308]
[L45563][L45568][L45573]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1203 interactions
In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.
[L45563][L45568]
No carcinogenic effects were detected in rats and mice given vardenafil daily for 24 months. Vardenafil was not mutagenic or clastogenic, and did not have an effect in fertility in male and female rats given up to 100 mg/kg/day for 28 days prior to mating in males, and for 14 days prior to mating and through day 7 of gestation in females.
[L45563][L45568]
Vardenafil should not be used in men for whom sexual activity is not recommended due to their underlying cardiovascular status. There is also a risk of developing prolonged erections that last longer than 4 hours, as well as priapism. In the event of a sudden loss of vision in one or both eyes, patients should stop using vardenafil. Patients taking PDE5 inhibitors, such as vardenafil, may also develop sudden hearing loss and experience a prolonged QT interval.[L45563][L45568]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L45563]
High-fat meals cause a Cmax reduction of 18%-50%; however, no changes were detected in AUC or Tmax.
[L45563][L45568]
[L45563]
[L45563]
[L45563]
[L45563]
[L45563]
[L45563]
Proteins and enzymes this drug interacts with in the body
PMID:15489334 PMID:9714779
Specifically regulates nitric-oxide-generated cGMP PMID:15489334
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that transport this drug across cell membranes
PMID:2897240 PMID:35970996 PMID:8898203 PMID:9038218 PMID:35507548
Catalyzes the flop of phospholipids from the cytoplasmic to the exoplasmic leaflet of the apical membrane. Participates mainly to the flop of phosphatidylcholine, phosphatidylethanolamine, beta-D-glucosylceramides and sphingomyelins .
PMID:8898203
Energy-dependent efflux pump responsible for decreased drug accumulation in multidrug-resistant cells PMID:2897240 PMID:35970996 PMID:9038218
ATC G04BE09
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Vardenafil
Additional database identifiers
Drugs Product Database (DPD)
13311
ChemSpider
99300
BindingDB
14776
PDB
VDN
ZINC
ZINC000018324776
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8784
GenAtlas
PDE5A
GeneCards
PDE5A
GenBank Gene Database
AF043731
GenBank Protein Database
3420185
Guide to Pharmacology
1304
UniProt Accession
PDE5A_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8789
GeneCards
PDE6G
GenBank Gene Database
M36476
GenBank Protein Database
189703
UniProt Accession
CNRG_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:8790
GeneCards
PDE6H
GenBank Gene Database
D45399
GenBank Protein Database
1311544
UniProt Accession
CNCG_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2638
GenAtlas
CYP3A5
GeneCards
CYP3A5
GenBank Gene Database
J04813
GenBank Protein Database
181346
Guide to Pharmacology
1338
UniProt Accession
CP3A5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2623
GenAtlas
CYP2C9
GeneCards
CYP2C9
GenBank Gene Database
AY341248
Guide to Pharmacology
1326
UniProt Accession
CP2C9_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2622
GenAtlas
CYP2C8
GeneCards
CYP2C8
GenBank Gene Database
M17397
Guide to Pharmacology
1325
UniProt Accession
CP2C8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2621
GeneCards
CYP2C19
GenBank Gene Database
M61854
GenBank Protein Database
181344
Guide to Pharmacology
1328
UniProt Accession
CP2CJ_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2625
GenAtlas
CYP2D6
GeneCards
CYP2D6
GenBank Gene Database
M20403
GenBank Protein Database
181350
Guide to Pharmacology
1329
UniProt Accession
CP2D6_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:40
GenAtlas
ABCB1
GeneCards
ABCB1
GenBank Gene Database
M14758
GenBank Protein Database
307180
Guide to Pharmacology
768
UniProt Accession
MDR1_HUMAN
DrugBank citations
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q424161), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.