Revatio (sildenafil)
An approved treatment for Pulmonary Arterial Hypertension.
The same compound appears under different names depending on the context. Here is how to identify Sildenafil wherever you encounter it, plus the key facts at a glance.
- Generic name
- Sildenafil
- Brand name
- Revatio
- Drug class
- Phosphodiesterase-5 (PDE5) inhibitor
- Manufacturer
- Viatris
- How it's taken
- Adults take 20 mg by mouth 3 times daily; the dose may be raised based on symptoms, up to 80 mg 3 times daily.
An oral PDE5 inhibitor approved for PAH that relaxes the blood vessels in the lungs to lower pulmonary artery pressure. The same active ingredient as Viagra, but marketed under the brand name Revatio at a different dose for PAH.
Where Sildenafil fits
Oral PDE5 inhibitor and often part of first-line combination therapy for PAH. One of the most affordable PAH medications due to generic availability.
How Sildenafil works
Nitric oxide in the lungs activates guanylate cyclase, which produces cyclic GMP (cGMP). cGMP relaxes the smooth muscle around pulmonary blood vessels, lowering pressure. PDE5 normally breaks down cGMP, limiting this effect. Sildenafil blocks PDE5, allowing cGMP levels to stay elevated. The result is sustained relaxation and widening of pulmonary arteries.
Mechanism: PDE5 inhibitor that relaxes smooth muscle in pulmonary blood vessels by increasing cGMP levels
Side effects and safety
Common side effects include headache, flushing, indigestion, nasal congestion, and diarrhea. Sudden vision or hearing changes should be reported immediately. Must not be combined with nitrates or riociguat (Adempas). Low blood pressure can occur. The label also warns about nosebleeds, erections lasting more than 4 hours (get medical help right away), and taking it with Viagra or other PDE5 inhibitors. It is not recommended for people with pulmonary veno-occlusive disease (PVOD) because it may cause fluid in the lungs, and it may cause serious pain crises (vaso-occlusive crises) in people whose pulmonary hypertension is caused by sickle cell disease.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Sildenafil
Adults take 20 mg by mouth 3 times daily; the dose may be raised based on symptoms, up to 80 mg 3 times daily. Children ages 1 to 17 take 10 mg or 20 mg 3 times daily depending on weight. Also available as an oral suspension and as an IV injection (10 mg 3 times daily) for patients who cannot take pills. Generic versions are widely available.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
PDE5 inhibitor available in generic form with multiple manufacturers. Well-established small molecule synthesis originally developed for erectile dysfunction.
Help paying for Revatio
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible privately insured patients may pay as little as $0 for brand-name REVATIO; up to $1,000 per fill and $12,000 per year.
For: private insurance · source
Good to know: REVATIO is now marketed by Viatris, not Pfizer. The savings card applies only to brand-name REVATIO and excludes Medicare, Medicaid, TRICARE and VA. Generic sildenafil is widely available from many makers and is not covered by this program.
- From a charity · HealthWell FoundationPulmonary Hypertension (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
- From a charity · TotalAssist (formerly PAN Foundation)Pulmonary Hypertension fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $9,500 per year. Requires health insurance (any kind).
- From a charity · The Assistance FundPulmonary Hypertension fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
The SUPER-1 trial demonstrated significant improvement in 6-minute walk distance and reduction in mean pulmonary artery pressure versus placebo across all 3 dose groups tested (20, 40, and 80 mg).
Development history
Sildenafil was originally developed for angina and famously became Viagra for erectile dysfunction (1998). The PAH indication was approved in June 2005 as Revatio. Generic sildenafil for PAH became available in 2012, dramatically reducing cost.
Explore Pulmonary Arterial Hypertension trials
Other Pulmonary Arterial Hypertension treatments
Common questions about Sildenafil
▸What is Sildenafil (Revatio)?
An oral PDE5 inhibitor approved for PAH that relaxes the blood vessels in the lungs to lower pulmonary artery pressure. The same active ingredient as Viagra, but marketed under the brand name Revatio at a different dose for PAH.
▸How does Sildenafil work?
Nitric oxide in the lungs activates guanylate cyclase, which produces cyclic GMP (cGMP). cGMP relaxes the smooth muscle around pulmonary blood vessels, lowering pressure. PDE5 normally breaks down cGMP, limiting this effect. Sildenafil blocks PDE5, allowing cGMP levels to stay elevated. The result is sustained relaxation and widening of pulmonary arteries.
▸What are the side effects of Sildenafil?
Common side effects include headache, flushing, indigestion, nasal congestion, and diarrhea. Sudden vision or hearing changes should be reported immediately. Must not be combined with nitrates or riociguat (Adempas). Low blood pressure can occur. The label also warns about nosebleeds, erections lasting more than 4 hours (get medical help right away), and taking it with Viagra or other PDE5 inhibitors. It is not recommended for people with pulmonary veno-occlusive disease (PVOD) because it may cause fluid in the lungs, and it may cause serious pain crises (vaso-occlusive crises) in people whose pulmonary hypertension is caused by sickle cell disease.
▸How is Sildenafil taken?
Adults take 20 mg by mouth 3 times daily; the dose may be raised based on symptoms, up to 80 mg 3 times daily. Children ages 1 to 17 take 10 mg or 20 mg 3 times daily depending on weight. Also available as an oral suspension and as an IV injection (10 mg 3 times daily) for patients who cannot take pills. Generic versions are widely available.
▸Is Sildenafil FDA approved?
Yes, Sildenafil (Revatio) is FDA approved (2005) for the treatment of Pulmonary Arterial Hypertension.
▸Is Revatio the same drug as Viagra?
Yes, both contain sildenafil citrate. Viagra (25-100 mg) is prescribed for erectile dysfunction, while Revatio (20 mg 3 times daily) is the PAH-specific dosing. The drugs are identical in active ingredient but differ in dose, indication, and branding. For PAH, generic sildenafil 20 mg tablets are widely available and substantially less expensive than either brand name.
▸Why is sildenafil taken 3 times daily for PAH?
Sildenafil has a relatively short half-life (about 4 hours), which means its effect on pulmonary blood vessel relaxation wears off between doses. Three-times-daily dosing (every 4-6 hours) maintains more consistent cGMP levels and sustained vasodilation. Tadalafil (Adcirca), which has a much longer half-life, achieves similar results with once-daily dosing and may be preferred for convenience.
▸Can sildenafil be combined with other PAH drugs?
Yes. Sildenafil is commonly used in combination with endothelin receptor antagonists (ambrisentan, macitentan, bosentan) and prostacyclins. The AMBITION trial established combination therapy as standard of care. However, sildenafil must not be combined with riociguat (Adempas) because both increase cGMP through different mechanisms, and the combination can cause dangerous drops in blood pressure.
▸Is generic sildenafil available for PAH?
Yes. Generic sildenafil for PAH has been available since 2012, making it one of the most affordable targeted PAH therapies. Multiple manufacturers produce generic 20 mg tablets. Generic availability has been particularly important for PAH patients worldwide, improving access in lower-income settings where newer branded PAH drugs may be unaffordable.
▸Does sildenafil for PAH have the same side effects as Viagra?
The side effect profile is similar since it is the same drug, including headache, flushing, indigestion, nasal congestion, and dizziness. However, at the lower PAH dose (20 mg 3 times daily), some side effects may be less pronounced than at the higher erectile dysfunction doses. Rare but serious risks include sudden vision loss and sudden hearing loss, which should be reported immediately.