Vardenafil
LEVITRA
What it isPDE5 inhibitor; erectile dysfunction.
Why this oneSimilar efficacy to sildenafil with an orally disintegrating form.
What limits itFatal hypotension with nitrates. More QT effect than the other PDE5 inhibitors; CYP3A4-dependent.
FDA-approved for
- erectile dysfunction (2003)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Erectile dysfunction | Adults | 10 mg PRN ~60 min before sexual activity (range 5–20 mg) | 10 mg PRN | 20 mg; max one dose/day |
| Erectile dysfunction | Geriatric ≥65 y | 5 mg PRN | 5 mg PRN | one dose/day |
Renal Not for use in patients on renal dialysis.
Hepatic Moderate impairment (Child-Pugh B): start 5 mg, max 10 mg. Severe (Child-Pugh C): do not use.
Maximum one dose per day.
Instructions
- With or without food; take ~60 min before sexual activity
- Maximum once per day
- On stable alpha-blocker therapy: start 5 mg
- CYP3A4 inhibitors: limit dose (e.g., ritonavir/cobicistat ≤2.5 mg/72 h; ketoconazole/itraconazole 400 mg, clarithromycin ≤2.5 mg/24 h; erythromycin ≤5 mg/24 h)
Contraindications
- Concomitant nitrates or nitric oxide donors
- Guanylate cyclase stimulators (e.g., riociguat)
Cautions
- Cardiovascular status — avoid if sexual activity is inadvisable
- Priapism (>4 h: seek immediate care)
- NAION (sudden vision loss)
- Sudden hearing loss
- Symptomatic hypotension with alpha-blockers
- QT prolongation (avoid with class IA/III antiarrhythmics or congenital long QT)
Adverse reactions
- Headache
- Flushing
- Nasal congestion/rhinitis
- Dyspepsia
- Sinusitis
- Flu syndrome
- Dizziness
- Increased creatine kinase
- Nausea
- Back pain
Pregnancy Not indicated for use in females.
Lactation Not indicated for use in females.
NO BOXED WARNINGS
Principal riskFatal hypotension with nitrates; more QT than the others
Cost, est. cash$10–$500/month
Generic entry2012
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Vardenafil ballicule
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