revatio
Pharmaranks rates Revatio 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Revatio (Sildenafil Citrate) is a phosphodiesterase 5 inhibitor used to treat Pulmonary Hypertension, Vasculogenic Impotence.
Sildenafil Citrate · by Viatris
Available as a generic: Sildenafil Citrate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sildenafil Citrate
- Drug class
- Phosphodiesterase 5 Inhibitor
- Form
- Injectable, Powder, Tablet
- Strength
- Sildenafil Citrate EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- pulmonary hypertension, vasculogenic impotence
- Manufacturer
- Viatris
- Half-life
- about 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.11 per ml — not your price
- FDA application
- NDA022473
What is Revatio?
From the FDA label:REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. REVATIO (sildenafil) Tablets: REVATIO is formulated as white to off-white, film-coated, round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. REVATIO (sildenafil) Injection: REVATIO is supplied as a clear, colorless, sterile, ready to use solution in a single-dose vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate (equivalent to 0.8 mg sildenafil), 50.5 mg dextrose, and water for…
How to use
Revatio is sold in more than one form (Injectable, Powder and Tablet), and each is dosed differently. The instructions below come from the FDA label for application NDA022473 — follow the label that came with the product you were actually prescribed.
Adults: 20 mg orally three times a day. Dose may be increased based on symptoms and tolerability. ( 2.1 ) • Pediatric patients ( 2.2 ) o ≤ 20 kg: 10 mg three times a day o 20 kg to 45 kg: 20 mg three times a day o > 45 kg: 20 mg three times a day. Dose may be increased based on symptoms and tolerability. • Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection. ( 2.1 ) 2.1 Recommended Dosage in Adults Oral Dosage The recommended dosage of REVATIO is 20 mg three times a day. Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14) ] . Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14) ] . Intravenous Dosage The recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of REVATIO injection does not need to be adjusted for body weight. A 10-mg dose of REVATIO injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20-mg oral dose. 2.2 Recommended Dosage in Pediatric Patients Oral Dosage The recommended dosage in patients ≤ 20…
Side effects
The following serious adverse events are discussed elsewhere in the labeling: • Hypotension [see Warnings and Precautions (5.1) ] • Vision Loss [see Warnings and Precautions (5.4) ] • Hearing Loss [see Warnings and Precautions (5.5) ] • Priapism [see Warnings and Precautions (5.7) ] • Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8) ] Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back pain and diarrhea. ( 6.1 , 6.2 ) Children: Priapism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 REVATIO-treated adults with PAH (WHO Group I) [see Clinical Studies (14) ] the adverse reactions that were reported by at least 10% of REVATIO-treated patients in any dosing group, and were more frequent in REVATIO-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were…
Warnings
Important safety information
Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.1 ) • Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. ( 5.2 ) • Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.4 , 5.5 ) • Pulmonary hypertension (PH) secondary to sickle cell disease: REVATIO may cause serious vaso-occlusive crises. ( 5.8 ) 5.1 Hypotension REVATIO has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing REVATIO, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co‑administering blood pressure lowering drugs with REVATIO. 5.2 Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of REVATIO to patients with veno-occlusive disease, administration of REVATIO to such patients is not recommended. Should signs of pulmonary edema occur when REVATIO is administered, consider the possibility of associated PVOD. 5.3 Epistaxis The incidence of epistaxis was 13% in patients taking REVATIO with PAH secondary to CTD. This effect was not seen in idiopathic PAH (REVATIO 3%, placebo 2%) patients. The incidence of epistaxis was also higher in REVATIO-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist). The safety of REVATIO is unknown in patients with bleeding disorders or active peptic ulceration. 5.4 Visual Loss When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”). Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking REVATIO. There are no controlled clinical data on the safety or efficacy of REVATIO in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of REVATIO in patients with retinitis pigmentosa is not recommended. 5.5 Hearing Loss Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including REVATIO. In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of REVATIO, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including REVATIO. 5.6 Combination with Other PDE-5 Inhibitors Sildenafil is also marketed as VIAGRA ® . The safety and efficacy of combinations of REVATIO with VIAGRA or other PDE‑5 inhibitors have not been studied. Inform patients taking REVATIO not to take VIAGRA or other PDE‑5 inhibitors. 5.7 Priapism Use REVATIO with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result. 5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received REVATIO than by those randomized to placebo. The effectiveness and safety of REVATIO in the treatment of PH secondary to sickle cell disease has not been established.
Who should not take Revatio
REVATIO is contraindicated in patients with: • Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1) ] . • Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. • Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. • Use with organic nitrates or riociguat. ( 4 ) • History of hypersensitivity reaction to sildenafil or any component of the tablet, injection, or oral suspension. ( 4 )
Overdose — what happens if you take too much
In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Nitrates Concomitant use of REVATIO with nitrates in any form is contraindicated [see Contraindications (4) ] . Strong CYP3A Inhibitors Concomitant use of REVATIO with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3) ] . Moderate-to-Strong CYP3A Inducers Concomitant use of REVATIO with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. Dose up-titration of REVATIO may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of REVATIO to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . • Use with strong CYP3A inhibitors: Not recommended. ( 7 , 12.3 ) • Concomitant PDE-5 inhibitors: Avoid use with Viagra ® or other PDE-5 inhibitors. ( 5.6 )
How long does Sildenafil Citrate stay in your body?
The elimination half-life of sildenafil citrate is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Sildenafil's active N-desmethyl metabolite also has a terminal half-life of about 4 hours, so it is not materially longer. In older adults and in people with significant kidney or liver impairment, the label reports reduced drug clearance and higher blood levels (AUC/Cmax) of sildenafil — the label does not state the half-life itself is longer.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Viagra- sildenafil citrate tablet, film coated (DailyMed).
Drug class
How this class works, per PDE5 Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Revatio ranks — best-rated phosphodiesterase 5 inhibitor for:
Dosage forms
Injectable, Powder and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Revatio treat?
- Revatio (Sildenafil Citrate) may be used to treat pulmonary hypertension, vasculogenic impotence, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Revatio work?
- Revatio is a phosphodiesterase 5 inhibitor. PDE5 inhibitors block the enzyme that breaks down cGMP, a signal that relaxes blood vessels. Letting cGMP build up widens vessels and boosts blood flow, which helps erectile dysfunction and eases pressure in the lung arteries.
- How is Revatio rated?
- pharmaranks gives Revatio a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Revatio cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.11 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Revatio?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Revatio. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Revatio?
- Revatio is marketed by Viatris. You can see Viatris's full profile, rating, and other products on pharmaranks.
- Is Revatio a brand-name or generic drug?
- Revatio is a brand-name product with the active ingredient Sildenafil Citrate. Lower-cost generic equivalents containing Sildenafil Citrate are available — ask your pharmacist.
- Is Revatio available over the counter?
- No. Revatio is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Revatio come in?
- Revatio is currently marketed as injectable, powder and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Revatio?
- Revatio is classified as phosphodiesterase 5 inhibitor, per the FDA's Established Pharmacologic Class.
- Is Revatio FDA-registered?
- Revatio is on record with the U.S. FDA under application number NDA022473. You can verify this on its official FDA label.
- Has Revatio been recalled by the FDA?
- Revatio has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Revatio safe?
- There's no single safe-or-not verdict. pharmaranks gives Revatio a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Revatio?
- Revatio's side effects are taken directly from its FDA label. From the label: The following serious adverse events are discussed elsewhere in the labeling: • Hypotension [see Warnings and Precautions (5.1) ] • Vision Loss [see Warnings and Precautions (5.4) ] • Hearing Loss [see Warnings and Precautions (5.5) ] • Priapism [see Warnings and Precautions (5.7) ] • Vaso-occlusive… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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