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SafetyScorer

Is Sildenafil safe?

Sildenafil

Sildenafil (Viagra for erectile dysfunction, Revatio for pulmonary arterial hypertension) has 28 years of wide use and a wide overdose margin. Headache and flushing are common; vision or hearing loss and priapism are rare. It must never be combined with nitrates, and many illegal 'sexual enhancement' products hide it.

High confidence#16 of 65 medicationsUpdated
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Brands
Viagra (erectile dysfunction), Revatio (pulmonary arterial hypertension), Viagra Connect (UK pharmacy), many generics
Viagra dose
50 mg about 1 hour before sex (30 minutes to 4 hours); 25 to 100 mg; no more than once a day
Revatio dose (adults)
20 mg three times a day, up to 80 mg three times a day
Never combine with
Nitrates or nitrites in any form (nitroglycerin, isosorbide, 'poppers'), riociguat
Boxed warning
None
Controlled substance
No
On the US market
Since 27 March 1998

How the score breaks down

The overall score is the weighted average of these factors. Scoring rules

  • Serious side effects30% of score

    82 out of 100, Good

    Serious effects are rare. The label warns of priapism, sudden vision loss (NAION, about twice the baseline risk in two studies) and sudden hearing loss. Headache (28% on 100 mg vs 7% on placebo) and flushing are common but mild.

  • Overdose margin20% of score

    88 out of 100, Excellent

    Wide. Healthy volunteers took single doses up to 800 mg, eight times the 100 mg maximum, with the same side effects as normal doses, only more often and stronger (Viagra label).

  • Interactions15% of score

    58 out of 100, Fair

    Few, but one is dangerous. Nitrates and riociguat are ContraindicationA situation in which a medicine should not be used, because the risk clearly outweighs any benefit, such as a known allergy to it.More in the glossary because blood pressure can fall sharply. Alpha-blockers need a 25 mg start, and ritonavir raises levels 11-fold (max 25 mg in 48 hours).

  • Dependence and misuse15% of score

    85 out of 100, Excellent

    Not a Controlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary and no withdrawal. It is used recreationally, sometimes with 'poppers' (amyl nitrite), a nitrite combination the label rules out.

  • Regulatory warnings10% of score

    78 out of 100, Good

    No Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary. Label warnings cover NAION, hearing loss and priapism. The MHRA warned in 2018 against unlicensed use in pregnancy after a trial found more lung problems and deaths in newborns.

  • Track record10% of score

    92 out of 100, Excellent

    Approved in the US on 27 March 1998 (NDA 020895), with decades of use by many millions of men and large trial data in erectile dysfunction and pulmonary hypertension.

Is sildenafil safe?

For most men who can safely have sex, yes. Sildenafil, sold as Viagra for erectile dysfunction and Revatio for pulmonary arterial hypertension (PAH), has been on the market since 1998. Its common side effects are a headache, flushing and indigestion that pass within hours. Overdoses are rarely dangerous.

The big exception is nitrates. Taken with nitroglycerin, isosorbide or recreational 'poppers', sildenafil can drop blood pressure to a dangerous level. The second risk is not the drug itself but where it comes from: fake pills and 'natural' supplements spiked with unknown amounts. We score sildenafil 81, level with finasteride (81).

What dose of sildenafil is safe?

The US label doses:

UseDose
Erectile dysfunction (Viagra)50 mg about 1 hour before sex (anywhere from 30 minutes to 4 hours); 25 to 100 mg; no more than once a day
Over 65, liver cirrhosis, severe kidney diseaseConsider starting at 25 mg
Taking an alpha-blockerStable on the alpha-blocker first, then start at 25 mg
Taking ritonavir25 mg, no more than 25 mg in 48 hours
PAH in adults (Revatio)20 mg three times a day, up to 80 mg three times a day
PAH in children 1 to 17 (Revatio)10 mg three times a day up to 20 kg; 20 mg three times a day above

In the UK, the MHRA agreed in November 2017 to let pharmacies sell Viagra Connect 50 mg without a prescription to men 18 and over, after a pharmacist check.

Why nitrates and sildenafil don't mix

Sildenafil works by relaxing blood vessels. Nitrates do the same through the same chemical pathway, and together the effect multiplies. The label contraindicates nitrates "in any form", taken regularly or now and then, and says it is unknown when after a sildenafil dose a nitrate could be safely given. That matters in an emergency: anyone with chest pain should tell paramedics if they have taken sildenafil.

Riociguat, a lung blood pressure drug, is also ruled out. Other combinations need care rather than a ban: alpha-blockers for prostate or blood pressure (doxazosin, tamsulosin), other blood pressure drugs such as amlodipine, and alcohol all add to the drop in blood pressure. Ritonavir raised sildenafil levels 11-fold in studies, and erythromycin, ketoconazole and itraconazole about 3-fold.

Rare but serious: vision, hearing and priapism

Vision. Sudden loss of vision in one or both eyes can be a sign of NAION, a stroke-like loss of blood flow to the optic nerve. The label puts the background rate at 2.5 to 11.8 cases per 100,000 men over 50 a year; two observational studies found about double the risk shortly after a PDE5 inhibitor dose, though causation is not proven. Men who have had NAION before are at higher risk. A temporary blue tint or light sensitivity is more common, reported by 11% on 100 mg.

Hearing. Sudden hearing loss, sometimes with ringing or dizziness, has been reported. The label says to stop and seek prompt care.

Priapism. An erection lasting more than 4 hours needs emergency treatment; left alone it can cause permanent damage. Men with sickle cell disease, leukaemia, multiple myeloma or a penis deformity such as Peyronie's disease should take care.

The heart. Sex itself puts strain on the heart. The label says sildenafil should not generally be used by men for whom sex is inadvisable, and there are no trial data in men who had a heart attack or stroke in the last 6 months.

Fake Viagra and spiked supplements

Sildenafil is one of the most counterfeited medicines. The FDA's tainted sexual enhancement list runs to hundreds of notices since 2012, with 30 in 2026 alone by late September. A typical case: in September 2026 the FDA found sildenafil and tadalafil, neither on the label, in a product sold as MAXMAN Coffee. Others came as honey sachets, sweets and capsules. In a 2024 UK case prosecuted by the MHRA, a dealer sold sildenafil on Amazon and eBay as a "100% natural remedy"; officers found 97,000 tablets at one address, from erectile dysfunction products to Controlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary.

The danger is twofold: an unknown dose, and men on nitrates who would never knowingly take sildenafil. Buy only from a pharmacy, and treat 'herbal Viagra', yohimbine blends and 'male enhancement' products with suspicion.

Who should be careful

Talk to your doctor or pharmacist before taking sildenafil if you use any nitrate or riociguat, have heart disease, very low or very high blood pressure, had a heart attack or stroke in the last 6 months, have had NAION or retinitis pigmentosa, have a bleeding disorder or stomach ulcer, or take alpha-blockers, HIV medicines or strong antifungals. Erectile problems can be an early sign of heart disease or diabetes, which is a good reason to see a doctor rather than buying pills online.

How we scored it

Track record (92), Overdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (88) and serious side effects (82) are strong. Interactions (58) is the weakest factor: the list is short, but the nitrate combination can be life-threatening. Regulatory warnings (78) reflect label warnings without a Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary. Counterfeit and spiked products are a real risk but sit outside the score, which rates the licensed drug.

Questions people ask

Is it safe to take Viagra with heart medication?

It depends on the medicine. Nitrates such as nitroglycerin sprays or isosorbide tablets must never be combined with sildenafil, because blood pressure can fall dangerously. Alpha-blockers and some blood pressure drugs need care and a lower starting dose. Ask your doctor or pharmacist before the first dose if you take any heart medicine.

How much sildenafil can I take in a day?

For erectile dysfunction the label maximum is 100 mg, no more than once a day; most men start on 50 mg. Men over 65, with liver disease or severe kidney disease may start at 25 mg. Revatio for pulmonary hypertension uses a different schedule of 20 mg three times a day, set by a specialist.

Can sildenafil cause blindness?

Rarely. The label describes sudden vision loss from NAION, a problem with blood flow to the optic nerve, in men taking PDE5 inhibitors, with about double the risk in two observational studies. The baseline risk is 2.5 to 11.8 cases per 100,000 men over 50 a year. Stop and get urgent care for sudden loss of vision in one or both eyes.

Are herbal Viagra alternatives safe?

Many are not what they claim. The FDA keeps a long list of 'sexual enhancement' products, from capsules to honey and coffee, found to contain hidden sildenafil or tadalafil, often at unknown doses. These are a particular risk for men on nitrates.

What should I do if an erection lasts more than 4 hours?

Get emergency medical help. The label warns that untreated priapism can damage penile tissue and cause permanent loss of potency.

Sources

  1. 1.VIAGRA (sildenafil citrate) tablets prescribing information (opens in a new tab) · DailyMed / Viatris, 2023
  2. 2.REVATIO (sildenafil) tablets, oral suspension and injection prescribing information (opens in a new tab) · DailyMed / Viatris, 2024
  3. 3.Sexual enhancement and energy product notifications (tainted products) (opens in a new tab) · US Food and Drug Administration, 2026
  4. 4.MAXMAN Coffee may be harmful due to hidden drug ingredients (opens in a new tab) · US Food and Drug Administration, 2026
  5. 5.Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn following in-utero exposure (opens in a new tab) · MHRA Drug Safety Update, 2018
  6. 6.Proposal to make sildenafil 50 mg film-coated tablets available from pharmacies (outcome) (opens in a new tab) · MHRA, 2017
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