Sildenafil: uses, dosing, side effects & brands
Sildenafil is a phosphodiesterase 5 inhibitor sold in the U.S. under 5 brand and generic names, for pulmonary hypertension and vasculogenic impotence. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Phosphodiesterase 5 Inhibitor
- Treats (across its forms)
- Pulmonary Hypertension and Vasculogenic Impotence
- Available as
- Film · Injectable · Powder · Tablet · Suspension
- Sold as
- 5 products — Vybrique, Revatio and Viagra, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 4 hours
- What the pharmacy pays
- about $0.11 per ml — not your price
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How Vybrique is dosed
From the FDA label for Vybrique (application NDA210858). Other sildenafil products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Dosage For most patients, the recommended dosage is 50 mg orally, taken as needed, approximately 1 hour before sexual activity. However, VYBRIQUE may be taken anywhere from 30 minutes to 4 hours before sexual activity. ( 2.1 ) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg. ( 2.1 ) Maximum recommended dosing frequency is once per day. ( 2.1 ) Dosage Modifications for Drug Interactions: Refer to the full prescribing information for recommended dosage. ( 2.2 ) Recommended Dosage in Specific Populations: Refer to the full prescribing information for recommended dosage. ( 2.3 ) Administration Administer with or without food. Place oral film directly onto the tongue where it will disintegrate and can then be swallowed with saliva without the need for water or other liquids. Do not cut or chew VYBRIQUE. 2.1 Recommended Dosage For most patients, the recommended dosage is 50 mg orally administered on the tongue, taken as needed, approximately 1 hour before sexual activity. However, VYBRIQUE may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day. Based on effectiveness and tolerability the dosage may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg, not to exceed once per day. For administration instructions, see Dosage and Administration…
Everything below is the FDA label for Vybrique (film). Sildenafil is also sold as injectable, powder, tablet and suspension, and those are different medicines to take — follow the label for the one you were prescribed.
Vybrique side effects
The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions ( 5.1 )] Prolonged Erection and Priapism [see Warnings and Precautions ( 5.2 )] Effects on the Eye [see Warnings and Precautions ( 5.3 )] Hearing Loss [see Warnings and Precautions ( 5.4 )] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions ( 5.5 ) ] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions 5.6 )] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions ( 5.7 ) ] Effects on Bleeding [see Warnings and Precautions ( 5.8 ) ] The most common adverse reactions reported in clinical trials (≥ 2%) of sildenafil are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IBSA Pharma Inc. at 1-800-587-3513 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…
Who shouldn’t take Vybrique
Administration of VYBRIQUE to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. VYBRIQUE was shown to potentiate the hypotensive effect of nitrates. ( 4.1 , 7.1 , 12.2 ) Known hypersensitivity to sildenafil or any component of oral film. ( 4.2 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat. ( 4.3 ) 4.1 Nitrates Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology ( 12.1 , 12.2 ) ] , VYBRIQUE potentiates the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. After patients have taken VYBRIQUE it is unknown when nitrates, if necessary, can be safely administered. Although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [ see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 ) ]. 4.2 Hypersensitivity Reactions VYBRIQUE is contraindicated in patients with a known hypersensitivity to sildenafil or any VYBRIQUE component. Hypersensitivity reactions, including rash and urticaria, have been reported [ see Adverse Reactions ( 6.1 ) ] . 4.3 Concomitant Guanylate Cyclase (GC) Stimulators Do not use VYBRIQUE in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including VYBRIQUE, may potentiate the hypotensive effects of GC stimulators.
Vybrique drug interactions
VYBRIQUE can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives. ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate VYBRIQUE at 25 mg dose. ( 2.2 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin) increase VYBRIQUE exposure. ( 2.2 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48- hour period. ( 2.2 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg. ( 2.2 , 7.4 ) 7.1 Nitrates Administration of sildenafil with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, sildenafil was shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration ( 2.2 ), Contraindications ( 4.1 ), Clinical Pharmacology ( 12.2 ) ] . 7.2 Alpha-blockers Use caution when co-administering alpha-blockers with sildenafil because of potential additive blood pressure lowering effects. When sildenafil is co-administered with an alpha-blocker, patients should be stable on alpha blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [see Dosage and Administration ( 2.2 ),Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.2 ) ] . 7.3 Amlodipine When sildenafil 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.2 )]. 7.4 Ritonavir and other CYP3A4 inhibitors Co-administration of ritonavir, a strong CYP3A4 inhibitor, greatly increased the systemic exposure of sildenafil (11-fold increase in AUC). It is therefore recommended not to exceed a maximum single dose of 25 mg of sildenafil in a 48 hour period [ see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 ) ]. Co-administration of erythromycin, a moderate CYP3A4 inhibitor, resulted in 160% and 182% increases in sildenafil Cmax and AUC, respectively. Co-administration of saquinavir, a strong CYP3A4 inhibitor, resulted in 140% and 210% increases in sildenafil Cmax and AUC, respectively. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole could be expected to have greater effects than seen with saquinavir. A starting dose of 25 mg of sildenafil should be considered in patients taking erythromycin or strong CYP3A4 inhibitors (such as saquinavir, ketoconazole, itraconazole) [ see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 ) ]. 7.5 Alcohol In a drug-drug interaction study of sildenafil 50 mg given with alcohol 0.5 g/kg, in which mean maximum blood alcohol levels of 0.08% was achieved, sildenafil did not potentiate the hypotensive effect of alcohol in healthy volunteers [see Clinical Pharmacology ( 12.2 ) ] .
Every sildenafil product we track (5)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Film | Generic | $0 | View → | |
| 2 | 70/100 | Prescription | Injectable | Generic | $0 | View → | |
| 3 | 70/100 | Prescription | Tablet | Generic | $0 | View → | |
| 4 | Not yet rated | Prescription | Suspension | Generic | $0 | View → | |
| 5 | Not yet rated | Prescription | Tablet | Generic | $0 | View → |
What sildenafil pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| RVT;20;VLE | 20 mg | white | round | — |
| PFIZER;RVT20 | 20 mg | white | round | — |
| 88 | 100 mg | blue | round | — |
| 100;SC | 100 mg | green | oval | — |
| 87 | 50 mg | blue | round | — |
Sildenafil recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long sildenafil keeps
No sildenafil label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does sildenafil expire? The in-use limits and storage rules from its labelsSildenafil and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for sildenafil: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited data indicate that sildenafil and its active metabolite in breastmilk are poorly excreted into breastmilk. Amounts ingested by the infant are far below doses given to treat infants and would not be expected to cause any adverse effects in breastfed infants.
National Institute of Child Health and Human Development, record revised January 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about sildenafil
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 23,849 reports naming sildenafil, and the FDA flagged 64% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea3,706 reports
- headache3,154 reports
- diarrhoea2,366 reports
- nausea2,018 reports
- cough1,925 reports
- fatigue1,922 reports
- dizziness1,741 reports
- hypotension1,163 reports
Read these as a signal, not a rate. A report does not mean sildenafil caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
How long sildenafil stays in your system
The elimination half-life of sildenafil is about 4 hours. 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.
Viagra- sildenafil citrate tablet, film coated (DailyMed) ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related guides
Related calculators
Frequently asked questions
What is Vybrique?
VYBRIQUE (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
What kind of drug is sildenafil?
The FDA classifies sildenafil as 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. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does sildenafil stay in your system?
The elimination half-life of sildenafil is about 4 hours — that is how long the body takes to clear half of a dose. 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. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take sildenafil with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run sildenafil against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is sildenafil sold under?
We track 5 sildenafil-containing products in the U.S.: Vybrique, Revatio, Viagra, Liqrev and Sildenafil Citrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does sildenafil come in?
Across the brands we track, sildenafil is currently marketed as film, injectable, powder, tablet and suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic sildenafil?
Yes. Our catalog lists 1 generic sildenafil product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has sildenafil been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions sildenafil. The most recent: SILDENAFIL CITRATE USP (Aug 3, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
What are the usual side effects of sildenafil, and how long do they last?
Headache, facial flushing, indigestion or heartburn, stuffy nose, back and muscle aches, and vision changes such as a color tinge to vision or light sensitivity. All of them come from the same blood-vessel relaxation that produces the effect you want, so they tend to arrive with the peak effect and fade as the drug clears — sildenafil's half-life is about 4 hours. They are also dose-related: the label's adverse-event rates climb as you go from 25 mg to 50 mg to 100 mg. One practical detail from the label — a high-fat meal delays the peak by a mean of 60 minutes and lowers it by a mean of 29%, so if it seems slow or weak, take it on a lighter stomach.
What can you absolutely not take with sildenafil?
Nitrates, in any form, at any time. That means nitroglycerin tablets, spray or patches, isosorbide mononitrate or dinitrate, and recreational "poppers" (amyl or butyl nitrite). The combination can drop blood pressure to a dangerous level, and it is a flat contraindication on the label. Riociguat, a guanylate cyclase stimulator, is also contraindicated. If you get chest pain after taking sildenafil, tell the paramedics and the ER exactly what you took and when: the label states it is unknown whether nitrates can be safely given even at 24 hours after a dose, so that timing changes how they treat you. Alpha-blockers for prostate or blood pressure (tamsulosin, doxazosin) can also cause fainting — the label says be stable on the alpha-blocker first, then start sildenafil at 25 mg.
Which sildenafil side effects mean go to the ER now?
An erection that persists longer than 4 hours, whether or not it is painful — the label says seek immediate medical assistance, because untreated priapism can cause penile tissue damage and permanent loss of potency. Do not wait it out overnight. Also emergency: sudden loss or dimming of vision in one or both eyes, which can be non-arteritic anterior ischemic optic neuropathy (NAION); sudden decrease or loss of hearing, sometimes with ringing or dizziness; and chest pain, severe dizziness or fainting during or after sex. For the vision and hearing events, the label's instruction is to stop the drug and seek prompt medical attention.
Is sildenafil safe if you have heart disease?
That depends on whether your heart can handle sex, not on the pill itself. The label states that in patients for whom sexual activity is not recommended because of their underlying cardiovascular status, ED treatments including sildenafil generally should not be used. Talk with your doctor first if you have unstable angina, had a heart attack or stroke in the last 6 months, have uncontrolled arrhythmias, low or poorly controlled blood pressure, or severe heart failure. Also flag it if you are on multiple blood pressure medicines — sildenafil lowers blood pressure modestly on its own, and stacking effects is what causes the dizziness and fainting.
Cite this page
- APA
- pharmaranks. (2026, July 24). Sildenafil: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/sildenafil
- MLA
- “Sildenafil: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/sildenafil.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for sildenafil on DailyMed (NIH) ↗.