Sildenafil
Sildenafil is a PDE-5 inhibitor (a type of blood-vessel-relaxing medicine) used to treat pulmonary arterial hypertension (high blood pressure in the lungs) in some products and erectile dysfunction in others.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 186 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sildenafil is a PDE-5 inhibitor (it blocks an enzyme so blood vessels relax), the usual first choice for erectile dysfunction and a standard treatment for pulmonary arterial hypertension (high blood pressure in the lungs), on the market since about 1998 and widely available as a generic. Most people tolerate it well; headache, flushing, a stuffy nose and indigestion are the usual complaints. Never take it with nitrates such as nitroglycerin for chest pain, or with riociguat, because blood pressure can drop dangerously. Get urgent help for an erection lasting over 4 hours or sudden loss of vision or hearing.
Clinical pearls
- Revatio and Viagra contain the same drug, so take only your prescribed product and never add tadalafil or another sildenafil.
- For erectile dysfunction, take it about an hour before sex, at most once daily; it needs sexual stimulation to work.
- If you take an alpha-blocker such as tamsulosin, get stable on it first and start sildenafil at the lowest dose.
- Ritonavir raises sildenafil levels a lot, and ketoconazole, itraconazole or erythromycin do too, so the dose may need lowering.
Patient information guide A plain-language walkthrough of Sildenafil, written from its FDA label.
What Sildenafil is used for
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Sildenafil products are approved for different conditions depending on the product.
- Pulmonary arterial hypertension (PAH): Revatio and generic sildenafil tablets, oral suspension and injection improve exercise ability and delay clinical worsening in adults.
- Revatio, sildenafil injection and some sildenafil tablets and oral suspension also list use in children 1 to 17 years old with PAH.
- Some generic sildenafil products for PAH do not carry pediatric information.
- Adding sildenafil to bosentan did not help exercise capacity, according to some tablet labels.
- Erectile dysfunction (ED): Viagra, Vybrique, sildenafil oral film and some sildenafil tablets.
How Sildenafil works
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Sildenafil blocks PDE5, an enzyme that breaks down cGMP. With sexual stimulation, nitric oxide is released and raises cGMP, which relaxes smooth muscle and lets blood flow into the penis. Sildenafil keeps cGMP higher, so this effect is stronger. It has no effect without sexual stimulation.
Sildenafil is much more selective for PDE5 than for most other enzymes. It is only about 10-fold more potent for PDE5 than PDE6 in the retina, which is thought to explain color vision changes.
Sildenafil dosage
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How sildenafil is taken depends on the product.
- ED products (Viagra, Vybrique, sildenafil oral film and some tablets): taken as needed, usually about 1 hour before sexual activity, no more than once a day, with or without food. Oral films dissolve on the tongue and should not be cut or chewed.
- PAH products (Revatio and generic tablets and oral suspension): taken by mouth three times a day. Revatio injection is given into a vein by a healthcare professional.
Follow your prescriber and your product’s label.
Dosing details from the FDA-approved label
From the Sildenafil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Erectile dysfunction (most patients)
- 50 mg taken as needed, approximately 1 hour before sexual activity
- May be taken anywhere from 30 minutes to 4 hours before sexual activity
- May be increased to 100 mg or decreased to 25 mg based on effectiveness and tolerability
- Maximum: 100 mg; maximum recommended dosing frequency is once per day
- May be taken with or without food; Vybrique oral film is placed on the tongue and not cut or chewed
- Concomitant alpha-blocker therapy
- Initiate at 25 mg
- Patients should be stable on alpha-blocker therapy prior to initiating
- Concomitant ritonavir
- 25 mg prior to sexual activity
- Maximum: 25 mg within a 48 hour period
- Concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir) or erythromycin
- Starting dose of 25 mg
- Patients greater than 65 years of age
- Starting dose of 25 mg
- Severe renal impairment (creatinine clearance less than 30 mL/minute)
- Starting dosage of 25 mg
- Mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 49 mL/min) renal impairment
- Starting dosage of 50 mg
- Hepatic impairment (any degree)
- Starting dosage of 25 mg
- Sildenafil clearance reduced in mild and moderate hepatic impairment; severe (Child-Pugh Class C) not studied
- Pulmonary arterial hypertension, adults (oral)
- 20 mg three times a day
- May be titrated based on symptoms and tolerability
- Maximum: 80 mg three times a day
- Injection: 10 mg intravenous bolus three times a day, no body weight adjustment
- Pulmonary arterial hypertension, pediatric patients (oral)
- 20 kg or less: 10 mg three times a day
- 20 kg to 45 kg: 20 mg three times a day
- 45 kg and greater: 20 mg three times a day
- Maximum: 40 mg three times a day for patients >45 kg based on experience in adults; a maximum dose in pediatric patients has not been identified
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets 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 ) 2.1 Dosage Information For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets 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 toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. 2.2 Use with Food Sildenafil tablets may be taken with or without food. 2.3 Dosage Adjustments in Specific Situations Sildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [see Contraindications (4.1) , Drug Interactions (7.1) , and Clinical Pharmacology (12.2) ]. When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at 25 mg [see Warnings and Precautions (5.5) , Drug Interactions (7.2) , and Clinical Pharmacology (12.2) ]. 2.4 Dosage Adjustments Due to Drug Interactions Ritonavir The recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25mg within a 48hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [see Warnings and Precautions (5.6) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3) ]. CYP3A4 Inhibitors Consider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 3 fold [see Drug Interactions (7.4) and Clinical Pharmacology (12.3) ].
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Sildenafil side effects
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Most side effects are mild. The ones reported most often were:
Common side effects
- Headache
- Flushing (warmth and redness of the face)
- Indigestion (dyspepsia)
- Abnormal vision, such as a color tinge, light sensitivity or blurred vision
- Stuffy nose
- Back pain
- Muscle aches
- Nausea and dizziness
When to get medical help
- Get emergency help if an erection lasts more than 4 hours.
- Stop the medicine and get medical care right away if you suddenly lose vision in one or both eyes.
- Stop the medicine and get prompt medical care if your hearing suddenly drops or is lost, which may come with ringing in the ears or dizziness.
- Call your doctor if you have dizziness, lightheadedness or fainting from low blood pressure.
- Seek help for rash or hives, which can be signs of an allergic reaction.
Seek help for an erection over 4 hours, sudden vision loss, sudden hearing loss, or fainting.
Sildenafil warnings and precautions
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- Low blood pressure: sildenafil widens blood vessels, and the effect is stronger with nitrates, alpha-blockers and other blood pressure drugs.
- Heart health: sexual activity strains the heart. Do not use it if sex is unsafe for you because of heart disease.
- Prolonged erection (priapism): can permanently damage penile tissue if not treated right away.
- Eyes: rare sudden vision loss (NAION) has been reported with PDE5 inhibitors.
- Hearing: sudden hearing loss has been reported.
- Bleeding: bleeding events have been reported, but a cause has not been established.
- It offers no protection against sexually transmitted infections.
Sildenafil interactions
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Several medicines change how sildenafil works or how safe it is.
- Nitrates: contraindicated, because blood pressure can drop dangerously.
- Riociguat: not to be used together, for the same reason.
- Alpha-blockers: can lower blood pressure too much. Start sildenafil at the lowest dose once stable.
- Amlodipine and other blood pressure drugs: additional blood pressure drop.
- Ritonavir: raises sildenafil levels about 11-fold, so a lower dose is needed.
- Ketoconazole, itraconazole, saquinavir, erythromycin: raise sildenafil levels.
- Other PDE5 inhibitors: not recommended together.
- Alcohol: sildenafil did not add to alcohol’s blood-pressure-lowering effect in a study.
Interactions listed in the FDA-approved label
From the Sildenafil prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Nitrates (nitric oxide donors, organic nitrates or nitrites in any form): Sildenafil was shown to potentiate the hypotensive effects of nitrates. Concomitant use is contraindicated.
- Alpha-blockers: Potential additive blood pressure-lowering effects. Use caution; patients should be stable on alpha-blocker therapy before starting sildenafil, and sildenafil should be initiated at the lowest dose (25 mg).
- Amlodipine: With sildenafil 100 mg and amlodipine (5 mg or 10 mg) in hypertensive patients, the mean additional reduction in supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.
- Ritonavir: A strong CYP3A4 inhibitor that greatly increased systemic exposure of sildenafil (11-fold increase in AUC). Do not exceed a maximum single dose of 25 mg in a 48 hour period.
- Erythromycin: A moderate CYP3A4 inhibitor; resulted in 160% and 182% increases in sildenafil Cmax and AUC, respectively. Consider a starting dose of 25 mg.
- Saquinavir: A strong CYP3A4 inhibitor; resulted in 140% and 210% increases in sildenafil Cmax and AUC, respectively. Consider a starting dose of 25 mg.
- Ketoconazole or itraconazole: Stronger CYP3A4 inhibitors expected to have greater effects than seen with saquinavir. Consider a starting dose of 25 mg.
- Alcohol: Sildenafil 50 mg given with alcohol 0.5 g/kg (mean maximum blood alcohol 0.08%) did not potentiate the hypotensive effect of alcohol in healthy volunteers.
- Anti-hypertensives: Sildenafil can potentiate the hypotensive effects of anti-hypertensives.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) • With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose ( 2.3 ) • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4 ) 7.1 Nitrates Administration of sildenafil tablets 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 tablets were shown to potentiate the hypotensive effects of nitrates [see Dosage and Administration (2.3) , Contraindications (4.1) , Clinical Pharmacology (12.2) ]. 7.2 Alpha-blockers Use caution when co-administering alpha-blockers with sildenafil tablets because of potential additive blood pressure-lowering effects. When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets treatment and sildenafil tablets should be initiated at the lowest dose [see Dosage and Administration (2.3) , Warnings and Precautions (5.5) , Clinical Pharmacology (12.2) ]. 7.3 Amlodipine When sildenafil tablets 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).
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sildenafil
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- Do not use with nitrates or riociguat, or if allergic to sildenafil.
- Tell your prescriber about heart disease, recent heart attack, stroke or arrhythmia, heart failure, or high or low blood pressure.
- Tell them about penis shape problems or conditions like sickle cell anemia, multiple myeloma or leukemia.
- Tell them about past sudden vision loss, retinitis pigmentosa, bleeding disorders or stomach ulcers.
- Pregnancy: limited data show no clear link to birth defects, while untreated PAH poses risks. Discuss with your doctor.
- Breastfeeding: sildenafil appears in breast milk and infant effects are unknown.
- Children: long-term use for PAH is not recommended.
- Older adults: doses are chosen cautiously.
- No dose change is needed for mild to moderate liver impairment or for kidney impairment. Severe liver impairment has not been studied.
Sildenafil overdose
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In healthy volunteers given single doses up to 800 mg, side effects were similar to those at lower doses but more frequent and more severe. Treatment is standard supportive care. Dialysis is not expected to help clear sildenafil.
What Sildenafil does in the body
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In studies of men with erectile dysfunction, sildenafil improved the hardness and duration of erections with sexual stimulation compared with placebo. The effect lasted up to 4 hours, but was weaker than at 2 hours. Sildenafil also lowers blood pressure slightly, most noticeably 1 to 2 hours after a dose, with larger effects in people taking nitrates.
How to store Sildenafil
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for Sildenafil Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) . for sildenafil for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Sildenafil
160 supplements and herbal products have documented interactions with Sildenafil in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 114
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Sildenafil: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sildenafil — the kind of thing our pharmacy team would talk through with you at the counter.
What is sildenafil used for?
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How do I take it for erectile dysfunction?
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What side effects should I expect?
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When should I get urgent help?
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Can I take it with my other medicines?
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Is it safe in pregnancy?
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Is Sildenafil available over the counter?
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When was Sildenafil first available?
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Who makes Sildenafil?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Sildenafil on HelloPharmacist
Sildenafil forms and strengths (how it comes)
Sildenafil is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Viagra is used to treat erectile dysfunction.
- Revatio and many sildenafil tablets are used to treat pulmonary arterial hypertension in adults.
- Some sildenafil tablet products are labeled for erectile dysfunction.
- Viagra is taken as needed, about 1 hour before sexual activity, up to once per day, with or without food.
- Revatio and sildenafil tablets for pulmonary arterial hypertension are taken by mouth three times a day.
Oral suspension
How this form is used
- Revatio and sildenafil for oral suspension are used to treat pulmonary arterial hypertension in adults.
- Revatio and some sildenafil oral suspension products list use in children 1 to 17 years old with pulmonary arterial hypertension.
- Revatio and sildenafil oral suspension for pulmonary arterial hypertension are taken by mouth three times a day.
Dissolving oral film
How this form is used
- Vybrique and sildenafil oral film are used to treat erectile dysfunction.
- Vybrique and sildenafil oral film are placed directly on the tongue, where they dissolve and are swallowed with saliva, with no water needed.
- Do not cut or chew Vybrique or sildenafil oral film.
- Vybrique and sildenafil oral film can be taken with or without food, about 1 hour before sexual activity, up to once per day.
Injection
How this form is used
- Revatio and sildenafil injection are used to treat pulmonary arterial hypertension in adults.
- Revatio and sildenafil injection also list use in children 1 to 17 years old with pulmonary arterial hypertension.
- Revatio injection for adults is given three times a day as an intravenous bolus injection.
Sildenafil on the U.S. market: products, makers and brands
How Sildenafil appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
61 companies list 233 Sildenafil product records with the FDA, mostly as tablet, oral suspension, dissolving oral film; the earliest marketing or approval year on record is 1998. Brand names on the directory include Revatio, Viagra, Liqrev and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (40) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Sildenafil is used (Medicaid data)
A general measure of how commonly Sildenafil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sildenafil is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sildenafil prescribed? Of the 1,601 medications we measure, Sildenafil ranks #591 by Medicaid prescriptions — more than 63% of them.
Utilization by Sildenafil product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
sildenafil 20 MG Oral Tablet Most dispensed
Summed across the 17 of 273 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 577033
sildenafil 10 MG/ML Oral Suspension
Summed across the 8 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1307427
sildenafil 100 MG Oral Tablet
Summed across the 7 of 257 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314229
sildenafil 50 MG Oral Tablet
Summed across the 3 of 158 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312950
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sildenafil, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 35 of 712 listed Sildenafil NDCs with Medicaid activity.
Compare Sildenafil products
A representative set of FDA-listed product records for Sildenafil — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Dissolving oral film | ||||
| 25 mg | Oral | IBSA Pharma Inc. | NDA | View NDC → |
| 50 mg | Oral | IBSA Pharma Inc. | NDA | View NDC → |
| 75 mg | Oral | IBSA Pharma Inc. | NDA | View NDC → |
| 100 mg | Oral | IBSA Pharma Inc. | NDA | View NDC → |
| 25 mg | Oral | Yaral Pharma Inc. | NDA | View NDC → |
| 50 mg | Oral | Yaral Pharma Inc. | NDA | View NDC → |
| 75 mg | Oral | Yaral Pharma Inc. | NDA | View NDC → |
| 100 mg | Oral | Yaral Pharma Inc. | NDA | View NDC → |
| 💊Injection | ||||
| 10 mg/12.5 mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 0.8 mg/mL | Intravenous | Viatris Specialty LLC | NDA | View NDC → |
| 💊Oral suspension | ||||
| 10 mg/mL | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 10 mg/mL | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 10 mg/mL | Oral | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg/mL | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 10 mg/mL | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg/mL | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg/mL | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg/mL | Oral | Viatris Specialty LLC | NDA | View label ↗ |
| 10 mg/mL | Oral | Virtus Pharmaceuticals, LLC | ANDA | View NDC → |
| 10 mg/mL | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 10 mg/mL | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 20 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 25 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 50 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 100 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 25 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 50 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 100 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 100 mg | Oral | Advanced Rx of Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 20 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 25 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 50 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 100 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 20 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 20 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 25 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 50 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 100 mg | Oral | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 20 mg | Oral | Amneal Pharmaceuticals of New York LLC | ANDA | View NDC → |
| 25 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 100 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 25 mg | Oral | Appco Pharma LLC | ANDA | View NDC → |
| 50 mg | Oral | Appco Pharma LLC | ANDA | View NDC → |
| 100 mg | Oral | Appco Pharma LLC | ANDA | View NDC → |
| 20 mg | Oral | Asclemed USA, Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 20 mg | Oral | AvKARE | ANDA | View NDC → |
| 20 mg | Oral | AvPAK | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 25 mg | Oral | Cipla Usa Inc., | ANDA | View NDC → |
| 50 mg | Oral | Cipla Usa Inc., | ANDA | View NDC → |
| 100 mg | Oral | Cipla Usa Inc., | ANDA | View NDC → |
| 20 mg | Oral | DirectRx | ANDA | View NDC → |
| 25 mg | Oral | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 25 mg | Oral | Nivagen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | Nivagen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Nivagen Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 50 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 100 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 20 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 20 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 50 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 50 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Quallent Pharmaceuticals Health LLC | ANDA | View NDC → |
| 20 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
Showing 102 of 233 products — FDA National Drug Code Directory. See every product, package size and price: browse all 233 Sildenafil NDCs →
Sildenafil side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sildenafil — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sildenafil in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sildenafil FDA approval history
How Sildenafil went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sildenafil recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Sildenafil recalls since July 2021.
✅No Sildenafil recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 136411 4 dose forms · 11 strengths
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Dose form (SCDF) Injection RxCUI 1658939In current FDA listingsClinical drug / strength (SCD) 12.5 ML sildenafil 0.8 MG/MLRxCUI 882527 -
Dose form (SCDF) Oral Film RxCUI 2735814In current FDA listings -
Dose form (SCDF) Oral Suspension RxCUI 1307426In current FDA listings -
Dose form (SCDF) Oral Tablet RxCUI 373871In current FDA listings
Look up RxCUI 136411 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sildenafil supply and shortage status
Whether Sildenafil is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sildenafil brand names
Sildenafil is sold under 4 brand names in the FDA directory — Revatio, Viagra, Liqrev, Vybrique. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Sildenafil: manufacturers and labelers
61 companies list Sildenafil products with the FDA. By number of product records, the largest are NuCare Pharmaceuticals,Inc., Proficient Rx LP, Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 37 more on the FDA NDC directory.
Sildenafil drug class (RxNorm)
Sildenafil belongs to the Phosphodiesterase 5 Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Sildenafil page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Greenstone LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →