Filitra 40mg Review: Does Twice the Maximum Vardenafil Dose Do Anything More?

Filitra 40 is a vardenafil tablet labelled to contain 40 mg, twice the maximum dose in the vardenafil prescribing information. Men usually look at it for one of two reasons: 20 mg did not seem to work well enough, or they assume a bigger number means a stronger or longer effect. This review looks at what the evidence says about both.

We found no published clinical trials of Filitra itself, and no regulator in the US, UK, Australia or Canada has assessed it. The figures below come from the US prescribing information for vardenafil (the drug sold as Levitra) and from its trials. Where the evidence runs out, which for 40 mg it does quickly, we say so.

The short answer

In the main vardenafil trial, going from 10 mg to 20 mg raised the rate of successful intercourse from 64% to 65%. In men after prostate surgery, 20 mg did no better than 10 mg. The large trials behind the label stopped at 20 mg, and the one small study we found that tested 40 mg, in 21 men, found much the same erection rigidity as 20 mg, with slightly more headache, flushing and nasal congestion. So there is no good evidence that Filitra 40 works better than 20 mg, and some reason to expect more side effects. For most men, Filitra 10 or a 20 mg dose is the right place to be, and a man who gets nothing from 20 mg needs a doctor's review, not a double dose.

What Filitra 40 is

Filitra is a brand marketed by Fortune Healthcare in India. Each tablet is labelled to contain vardenafil hydrochloride, a phosphodiesterase type 5 (PDE5) inhibitor, the same class as sildenafil and tadalafil. Vardenafil helps an erection happen in response to sexual arousal; it does not cause one on its own.

FDA-approved generic vardenafil tablets come in 2.5 mg, 5 mg, 10 mg and 20 mg. No 40 mg vardenafil tablet is approved by the FDA or the European Medicines Agency, so there is also no reference product a 40 mg tablet could be tested against for bioequivalence. Our Filitra 40 product page has the packs, prices and delivery details; this page is about whether the dose makes sense.

The Filitra range at a glance

Product	Vardenafil	Where it sits against the label	Price per tablet (2 October 2026)
Filitra 10	10 mg tablet	The recommended starting dose for most men	$0.53 to $0.63
Filitra 20	20 mg tablet	The maximum recommended dose	$0.93 to $1.13
Filitra Professional	20 mg tablet sold for use under the tongue	Maximum dose in a different format	$0.93 to $1.13
Filitra 40	40 mg tablet	Twice the maximum recommended dose	$1.09 to $1.32

Prices are before shipping, which is $25 on orders under $149 and free from $149.

What the vardenafil label allows

The US prescribing information recommends 10 mg for most men, taken about 60 minutes before sexual activity. The dose can go up to a maximum of 20 mg, or down to 5 mg, depending on how well it works and how well it is tolerated. The maximum frequency is once a day. It can be taken with or without food, although a high-fat meal lowered peak levels by 18% to 50% in food-effect studies.

The label also starts some men lower: 5 mg is the suggested starting dose at age 65 and over, and in moderate liver impairment, where the maximum is 10 mg.

How fast vardenafil works and how long it lasts

Vardenafil reaches its peak in the blood between 30 minutes and 2 hours after a dose, with a median of 60 minutes, which is why the label suggests taking it about an hour before sex. Its half-life is about 4 to 5 hours, shorter than tadalafil's. A bigger dose raises the peak but does not change the half-life: in the 40 mg study described below it was 4.4 to 4.8 hours at both doses. Doubling the dose keeps levels above any given point for roughly one extra half-life, but there is no evidence that this gives a meaningfully longer useful effect, and side effects such as headache and flushing come with the higher levels.

The dose-response data: 10 mg against 20 mg

The clearest data come from the main North American fixed-dose trial, which evaluated 762 men on placebo, 5 mg, 10 mg or 20 mg. The results below are at three months; the improvement held at six months.

Result at 3 months	Placebo	5 mg	10 mg	20 mg
Erection firm enough for penetration (SEP2)	52%	65%	75%	80%
Erection lasting to successful intercourse (SEP3)	32%	51%	64%	65%
Erectile Function domain score (0 to 30)	15	18	21	21

Most of the benefit arrived by 10 mg. Doubling to 20 mg added 5 points on penetration, 1 point on completed intercourse, and nothing on the overall erectile function score. That is the label's own evidence for the doses it approved. Above 20 mg the large trials have no data, and the small study covered below found little extra benefit.

Men with diabetes or after prostate surgery

A common argument for 40 mg is that "harder to treat" men need more. The label includes two trials in exactly those men, each with its own placebo group:

Trial	Placebo	10 mg	20 mg
General ED (North American trial), SEP3	32%	64%	65%
Men with diabetes (n=439), SEP3	23%	49%	54%
After radical prostatectomy (n=427), SEP3	10%	37%	34%

Men with diabetes gained a little more from 20 mg than men in the general trial: 5 points of successful intercourse rather than 1. Men after prostate removal did not gain at all; the 20 mg result was slightly lower than 10 mg. Neither trial tested anything above 20 mg, so neither supports the idea that harder-to-treat men need 40 mg.

What is known about 40 mg

The phase 3 trials behind the label stopped at 20 mg. Above that there are a few smaller studies:

• A study in men with erectile dysfunction. In a 2001 crossover study, 21 men took placebo, 20 mg and 40 mg in random order and had their erections measured with a rigidity monitor during visual sexual stimulation. Compared with placebo, firm rigidity at the base of the penis lasted 42.9 minutes longer on 20 mg and 49.3 minutes longer on 40 mg, with overlapping confidence intervals; at the tip, both doses gave 34.6 minutes. The 40 mg dose caused slightly more headache, flushing and nasal congestion. This was a single-dose laboratory study, not a trial of sex at home over months.
• Eye safety. In 25 healthy men, a single 40 mg dose did not change visual acuity, eye pressure or eye examination findings, according to the label.
• Tolerability. The label's overdose section says single doses up to 80 mg, and 40 mg once daily for four weeks, were tolerated without serious adverse effects. When 40 mg was given twice a day, there were cases of severe back pain. The highest single dose with human data is 120 mg, in healthy volunteers; most had reversible back pain or muscle aches and changes in vision.
• Heart rhythm. An 80 mg dose was used in the QT study described further down.

Taken together, these show that 40 mg was tolerated in supervised studies and gave much the same rigidity as 20 mg in one small study. They do not show that it works better, and they were not done in men with heart disease, older men or men on interacting medicines. The label chose 80 mg for its QT study because that dose produces blood levels similar to 5 mg of vardenafil taken with the HIV drug ritonavir, which shows how easily some men reach very high levels without taking a large tablet.

Why 20 mg sometimes seems not to work

Many men who say a PDE5 inhibitor "failed" have not used it the way the trials did. A hospital study of 60 consecutive men who said sildenafil had not worked (sildenafil rather than vardenafil, but the principles are the same) found that 30% did not know sexual stimulation was needed, 60% had tried it fewer than four times, and 45% had never taken the maximum dose. After individual instruction and four doses of sildenafil 100 mg, the maximum dose, 24 of the 41 men followed up had successful intercourse.

For vardenafil, the practical checks are: take it about an hour before sex, avoid a heavy fatty meal just beforehand, allow for arousal, and judge it over several attempts at 10 mg and then 20 mg. If 20 mg used properly still does not work, the next step is a doctor, because the cause may be untreated diabetes, low testosterone, a medicine side effect or blood vessel disease, and the answer may be a different treatment rather than more vardenafil.

Side effects at the labelled doses

In placebo-controlled trials of 5 mg to 20 mg, these side effects were reported:

Side effect	Placebo (n=1,199)	Vardenafil 5 to 20 mg (n=2,203)
Headache	4%	15%
Flushing	1%	11%
Runny or blocked nose	3%	9%
Indigestion	1%	4%
Sinusitis	1%	3%
Flu-like symptoms	2%	3%
Dizziness	1%	2%
Raised creatine kinase (a muscle enzyme)	1%	2%
Nausea	1%	2%

3.4% of men on vardenafil stopped because of side effects, against 1.1% on placebo. These figures cover doses up to 20 mg only. The small 40 mg study reported slightly more headache, flushing and nasal congestion than on placebo, and the volunteer data point to back pain and vision changes as the dose climbs higher.

Men for whom any vardenafil dose rises sharply

Vardenafil is cleared mainly by the liver enzyme CYP3A4, so age, liver disease and several common medicines raise the amount in the blood from the same tablet:

Group or medicine	Rise in vardenafil exposure (AUC)	Label limit
Age 65 and over	52% higher	Consider starting at 5 mg
Moderate liver impairment	160% higher (2.6 times)	Start 5 mg, maximum 10 mg; severe impairment: do not use
Erythromycin	4 times	No more than 5 mg in 24 hours
Ketoconazole 200 mg daily	10 times	No more than 5 mg in 24 hours (2.5 mg with 400 mg daily)
Indinavir	16 times	No more than 2.5 mg in 24 hours
Ritonavir	49 times	No more than 2.5 mg in 72 hours

The label sets similar limits for other strong inhibitors: clarithromycin, itraconazole 400 mg daily, saquinavir and atazanavir (no more than 2.5 mg in 24 hours), cobicistat (2.5 mg in 72 hours) and itraconazole 200 mg daily (5 mg in 24 hours). Grapefruit juice is also expected to raise levels. For men with moderate liver impairment or taking these medicines, the limits run from 2.5 mg every 72 hours to 10 mg a day, so a 40 mg tablet is 4 to 16 times the limit before the extra exposure is counted. Older men keep the 20 mg maximum, but the label suggests they consider starting at 5 mg. Men on dialysis or with severe liver impairment should not take vardenafil at all.

The heart rhythm warning

Vardenafil lengthens the QT interval on an ECG. In a study in 59 healthy men, the rise at 10 mg and 80 mg was similar to that of moxifloxacin, an antibiotic known to prolong QT: 8 and 10 milliseconds against 8 with one correction method, and 4 and 6 against 7 with another. The study was not designed to compare doses. In a later study, vardenafil 10 mg plus gatifloxacin, another QT-prolonging antibiotic, added together to a 9 millisecond rise. The clinical effect of these changes is not known.

The label says these findings should be weighed for men with a history of QT prolongation or who take other medicines that prolong it, and that men with congenital long QT syndrome, or taking class 1A antiarrhythmics (such as quinidine or procainamide) or class III antiarrhythmics (such as amiodarone or sotalol), should avoid vardenafil.

Who should not take vardenafil, and who needs extra care

Do not take it (contraindicated):

• Nitrates and nitric oxide donors in any form, including nitroglycerin, isosorbide and poppers.
• Riociguat and other guanylate cyclase stimulators.

Should not be used, or not recommended:

• Men for whom sexual activity is not recommended because of their heart.
• Unstable angina, resting systolic blood pressure under 90 mmHg, uncontrolled blood pressure above 170/110 mmHg, a stroke, life-threatening arrhythmia or heart attack in the last six months, or severe heart failure.
• Severe liver impairment (Child-Pugh C) and kidney dialysis.
• Hereditary retinal disease such as retinitis pigmentosa.
• Any other erectile dysfunction treatment at the same time, including another vardenafil tablet.

Use with care:

• Alpha-blockers such as tamsulosin or doxazosin: only once stable on the alpha-blocker, starting vardenafil at 5 mg (2.5 mg with certain CYP3A4 inhibitors), and with a time gap between doses.
• Other blood pressure medicines: in a study, 20 mg vardenafil lowered blood pressure by an average of 7/8 mmHg more than placebo.
• Narrowing of the heart's outflow, such as aortic stenosis.
• A previous NAION (sudden optic nerve damage): use only with caution and when the benefit outweighs the risk.
• Conditions that raise the risk of priapism, such as sickle cell anaemia, multiple myeloma or leukaemia, or a deformed penis (angulation, scarring or Peyronie's disease).
• Bleeding disorders or an active stomach ulcer: vardenafil has not been studied in these men.
• Phenylketonuria: US generic vardenafil tablets contain aspartame, a source of phenylalanine. Check the ingredients of any vardenafil product if you have PKU.

When to get urgent help

• An erection lasting more than 4 hours.
• Sudden loss of vision in one or both eyes.
• Sudden decrease or loss of hearing.
• Chest pain, fainting or palpitations during or after sex. Tell the emergency team you took vardenafil so that nitrates are not given.

Filitra Professional: does under the tongue help?

Filitra Professional is sold as a 20 mg vardenafil tablet for dissolving under the tongue. We found no published pharmacokinetic or clinical study of it, so any claim that it works in a set number of minutes is unsupported. It contains the label maximum of 20 mg, so the same limits apply, and it should never be taken on the same day as another vardenafil tablet.

Filitra 40 against other ED options

If a man wants a longer window rather than a stronger effect, a higher vardenafil dose is a poor way to get it: the half-life stays at about 4 to 5 hours. Tadalafil, with an effect reported up to 36 hours, is the drug designed for that. Our vardenafil, tadalafil and sildenafil comparison sets the three side by side, and the avanafil guide covers the fourth drug in the class.

Cost is not a reason to choose 40 mg either. Per milligram the bigger tablet is cheaper, but a man who needs 10 mg or 20 mg gets no benefit from the extra milligrams he pays for. Filitra 10 costs about half as much per tablet as Filitra 40.

Prescription and legal status

Vardenafil is a prescription medicine in the US, UK, Canada and Australia. Filitra is not approved by the FDA, MHRA, TGA or Health Canada, and the MHRA advises UK buyers to use only UK-registered pharmacies. In the US, the brand Levitra is no longer marketed, and FDA-approved generic vardenafil 20 mg cost pharmacies about $2.79 a tablet as of 30 September 2026 in the Medicaid NADAC survey. That is what pharmacies pay, not what patients pay, but it shows generic vardenafil is not expensive in the US, so a man with a prescription should compare local cash prices before ordering any import. The FDA also says that in most circumstances it is illegal for individuals to import drugs into the US for personal use, because products bought abroad usually have not been approved by the FDA.

A doctor's check before starting is worth it whichever product you use: erectile dysfunction can be an early sign of heart disease or diabetes, and the doctor needs to know about nitrates, alpha-blockers, antiarrhythmics and antibiotics. If you have a side effect, report it to your regulator (the MHRA Yellow Card scheme in the UK, FDA MedWatch in the US) as well as to the seller. The erectile dysfunction treatment page compares the main options.

Sources

• Vardenafil hydrochloride tablets, US prescribing information (Lannett), July 2026, sections 2, 4, 5, 6.1, 7.2, 8.5 to 8.7, 10, 12.2, 12.3 and 14. DailyMed
• LEVITRA (vardenafil hydrochloride) US prescribing information, section 14.
• Stark S et al. Vardenafil increases penile rigidity and tumescence in men with erectile dysfunction after a single oral dose. European Urology 2001. PMID 11528196.
• Jiann BP et al. Rechallenge prior sildenafil nonresponders. International Journal of Impotence Research 2004. PMID 14963473.
• Centers for Medicare and Medicaid Services. National Average Drug Acquisition Cost (NADAC), 2026 file, as of 30 September 2026. data.medicaid.gov
• US Food and Drug Administration. Personal Importation. FDA
• SafeRxPills price list, 2 October 2026.

This guide is for information only and is not medical advice. Vardenafil is a prescription medicine; speak to a doctor or pharmacist before using it.