Short answer: In the label's placebo-controlled trials of vardenafil 5, 10 or 20 mg, the most common side effects were headache (15% vs 4% on placebo), flushing (11% vs 1%), rhinitis or stuffy nose (9% vs 3%) and indigestion (4% vs 1%). Some rose with dose. 3.4% stopped because of side effects vs 1.1% on placebo. The Patient Information says these usually go away after a few hours. There is no boxed warning.
What Vardenafil is approved for: Vardenafil hydrochloride tablets are approved to treat erectile dysfunction (section 1). Vardenafil is the medicine in Levitra; there is no current Levitra-brand label on DailyMed, so this page uses Teva's generic film-coated tablet label in the same strengths. The orally disintegrating tablet (Staxyn) is a different product.
Source
Vardenafil hydrochloride tablets, for oral use, prescribing information and Patient Information. Teva Pharmaceuticals. DailyMed, version published January 25, 2024. DailyMed setid e593ab58-70a4-4095-8091-16a4b6d49e4d
No. The current Vardenafil label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Vardenafil.
| Adverse Reaction | Placebo N = 1,199 | Vardenafil hydrochloride N = 2,203 |
|---|---|---|
| Headache | 4% | 15% |
| Flushing | 1% | 11% |
| Rhinitis | 3% | 9% |
| Dyspepsia | 1% | 4% |
| Accidental Injury | 2% | 3% |
| Sinusitis | 1% | 3% |
| Flu Syndrome | 2% | 3% |
| Dizziness | 1% | 2% |
| Increased Creatine Kinase | 1% | 2% |
| Nausea | 1% | 2% |
Flexible-dose studies started everyone at 10 mg and allowed a change to 5 mg or 20 mg. The label says all events listed were adverse drug reactions except accidental injury. Stopping because of side effects: 3.4% on vardenafil vs 1.1% on placebo.
Back pain was reported in 2.0% on vardenafil and 1.7% on placebo. The trials suggested a dose effect for headache, flushing, indigestion, nausea and rhinitis across 5, 10 and 20 mg.
Across all vardenafil studies, film-coated and orally disintegrating tablets, in over 17,000 men, stopping because of side effects was 1.9% vs 0.8% on placebo. Less frequent reactions (under 2%) included visual disturbance and color distortion, palpitations, low blood pressure, muscle pain, fainting and priapism.
In healthy volunteers, vardenafil lowered supine blood pressure briefly by a mean maximum of 7 mmHg systolic and 8 mmHg diastolic.
Two observational studies suggested about a 2-fold higher risk of NAION (a sudden optic nerve problem) right after PDE5 inhibitor use, with risk estimates of 2.15 (95% CI 1.06, 4.34) and 2.27 (95% CI 0.99, 5.20). The label says this does not establish cause.
Reported after approval: NAION and other vision loss, seizure, seizure recurrence, transient global amnesia, and sudden decrease or loss of hearing.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Do not use with nitrates or riociguat. Vardenafil must not be used with nitrates, taken regularly or now and then, or nitric oxide donors, or with guanylate cyclase stimulators such as riociguat, because blood pressure can drop sharply. The label says a safe time gap before nitrates has not been determined.
Heart risk with sexual activity. Vardenafil is not for men whose heart condition makes sexual activity inadvisable. It is not recommended with unstable angina, resting systolic pressure under 90 mmHg, uncontrolled blood pressure over 170/110 mmHg, a stroke, life-threatening arrhythmia or heart attack in the last 6 months, or severe heart failure.
CYP3A4 inhibitors. Strong or moderate CYP3A4 inhibitors such as ritonavir, ketoconazole and erythromycin raise vardenafil levels, so the label lowers the maximum dose with them (see the dosing page).
Prolonged erection. Rare erections lasting more than 4 hours and priapism (painful erections over 6 hours) have been reported. An erection lasting more than 4 hours needs immediate medical help, as untreated priapism can permanently damage the penis.
Sudden vision loss. Sudden loss of vision in one or both eyes may be a sign of NAION. The label says to stop all PDE5 inhibitors and get medical attention. It is not recommended with inherited retinal disorders such as retinitis pigmentosa.
Sudden hearing loss. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, has been reported. The label says to stop PDE5 inhibitors and get prompt medical attention.
Alpha-blockers. Together with alpha-blockers, vardenafil can lower blood pressure enough to cause fainting. Men should be stable on the alpha-blocker first, and vardenafil starts at 5 mg (2.5 mg with certain CYP3A4 inhibitors).
QT prolongation. Vardenafil can lengthen the QT interval on an ECG. Men with congenital QT prolongation or taking Class 1A or Class III antiarrhythmics such as quinidine, amiodarone or sotalol should avoid it.
Liver and kidney. The dose is lowered with moderate liver impairment, and vardenafil is not used with severe liver impairment or in men on kidney dialysis.
Other ED treatments, bleeding and STDs. Combining it with other ED treatments is not recommended. It has not been given to people with bleeding disorders or active stomach ulcers. It offers no protection against sexually transmitted diseases, including HIV.
From the Patient Information that comes with Vardenafil:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.