Sildenafil oral suspension is a liquid oral dosage form containing sildenafil. In the current U.S. market, however, the term can refer to more than one product design: REVATIO and several generic products are supplied as powder that becomes a 10 mg/mL suspension after reconstitution, while LIQREV is supplied as a ready-to-use 10 mg/mL oral suspension.
These products contain the same active moiety but differ in presentation, inactive ingredients, preparation requirements, storage conditions, labeled populations and regulatory pathway. Oral suspension should therefore be interpreted as a dosage-form category rather than as one universal sildenafil product.
This page focuses on those formulation-specific characteristics. Current U.S. sildenafil oral suspensions are associated with pulmonary arterial hypertension labeling; detailed dosage selection and comparisons with tablets belong on their dedicated pages.
An oral suspension is a liquid dosage form in which the drug is dispersed rather than completely dissolved as a uniform molecular solution. Maintaining appropriate dispersion is therefore an important formulation and handling consideration.
For sildenafil, current U.S. products include both powder-for-suspension presentations that become liquid after labeled reconstitution and a separate finished suspension that is supplied ready to use.
The active drug remains sildenafil in either case. Terms such as powder for oral suspension, reconstituted suspension and ready-to-use oral suspension describe different pharmaceutical presentations rather than different active drugs.
| Term | Meaning |
|---|---|
| Sildenafil | Active drug moiety |
| Oral suspension | Liquid oral dosage form containing dispersed drug |
| Powder for oral suspension | Dry product converted into the finished suspension before use |
| Reconstituted suspension | Liquid product produced after the labeled amount of water is added to the powder |
| Ready-to-use suspension | Finished liquid suspension supplied without a reconstitution step |
Tablets and oral suspensions can deliver the same active drug by the oral route, but their pharmaceutical designs are different. A tablet contains a defined amount of sildenafil in a solid unit, while a suspension expresses drug content as a concentration per volume.
A suspension also requires formulation components that maintain the liquid system and support properties such as viscosity, preservation, flavor and dispersion. Those components differ from the excipients used in sildenafil tablets.
The dosage form itself should not be used to assume that products have identical approved indications, populations or handling instructions.
| Feature | Tablet | Oral Suspension |
|---|---|---|
| Physical form | Solid unit | Liquid dispersion |
| Product strength expression | Usually mg per tablet | Usually mg per mL |
| Before-use handling | No suspension redispersion | Product-specific shaking requirements apply |
| Formulation ingredients | Solid-tablet excipients | Liquid or powder-for-suspension excipients |
| Route | Oral | Oral |
| Active drug | Sildenafil | Sildenafil |
REVATIO for oral suspension is supplied as a powder rather than as a ready-to-use liquid. Current labeling describes a white to slight pink powder containing sildenafil citrate that is reconstituted before dispensing or use.
After labeled reconstitution with a total of 90 mL of water, the resulting volume is 112 mL and the suspension contains 10 mg of sildenafil per mL. The product is grape flavored and is supplied with a bottle adaptor and oral dosing syringe.
REVATIO belongs to the pulmonary arterial hypertension product family rather than the conventional ED sildenafil-tablet framework. Its current U.S. labeling includes PAH use in adults and pediatric patients 1 to 17 years old.
REVATIO should also not be treated as the only U.S. sildenafil suspension product. Generic powder-for-suspension products and the separately approved ready-to-use LIQREV suspension also exist.
| REVATIO Suspension Feature | Current Label Context |
|---|---|
| Presentation | Powder for oral suspension |
| Active ingredient | Sildenafil citrate, expressed as sildenafil |
| Concentration after reconstitution | 10 mg/mL |
| Final volume | 112 mL after labeled reconstitution |
| Flavor | Grape |
| Indication context | Pulmonary arterial hypertension |
| Separate ready-to-use product? | Yes — LIQREV is a distinct sildenafil oral suspension product |
The principal current U.S. sildenafil oral-suspension concentration is 10 mg/mL. REVATIO reaches that concentration after reconstitution, while LIQREV is supplied as a finished 10 mg/mL suspension.
A concentration of 10 mg/mL means that each milliliter of the finished suspension contains sildenafil equivalent to 10 mg of the active moiety. The citrate salt is the drug substance used in these products, while labeled strength is expressed in terms of sildenafil.
Concentration identifies the amount of active drug per liquid volume. It should not be confused with an individual prescribed dose or with the milligram strength printed on a tablet.
| Product Context | Concentration | Presentation |
|---|---|---|
| REVATIO for oral suspension | 10 mg/mL after reconstitution | Powder before reconstitution |
| Generic sildenafil for oral suspension | Commonly 10 mg/mL after reconstitution | Powder before reconstitution |
| LIQREV | 10 mg/mL | Ready-to-use suspension |
Tablet strength and liquid concentration express drug content in different ways. A 20 mg tablet contains 20 mg of sildenafil in one solid unit, while a 10 mg/mL suspension contains 10 mg in each milliliter of finished liquid.
The numbers cannot be compared without keeping the unit attached. Milligrams identify an amount of drug; milligrams per milliliter identify a concentration.
This terminology matters when reading labels because the concentration does not by itself specify how much liquid is used for an individual administration. General strength information is covered on the sildenafil strengths page.
| Expression | What It Describes | Example |
|---|---|---|
| 20 mg | Amount of sildenafil in a defined unit | REVATIO tablet strength |
| 10 mg/mL | Amount of sildenafil per milliliter of liquid | Oral-suspension concentration |
| 112 mL | Total finished volume | REVATIO suspension after reconstitution |
| 122 mL | Bottle content | LIQREV ready-to-use product |
Sildenafil oral suspensions contain sildenafil citrate as the active drug substance, but the inactive ingredients depend on the specific formulation.
Current REVATIO powder for oral suspension contains citric acid anhydrous, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide and xanthan gum.
LIQREV uses a different ready-to-use formulation containing acesulfame potassium, citric acid monohydrate, glycerin, simethicone emulsion, sodium benzoate, sucralose, strawberry flavor, trisodium citrate dihydrate, xanthan gum and water.
These differences illustrate why 'sildenafil oral suspension' should not be treated as one universal excipient formula. The broader ingredient topic is covered on the sildenafil ingredients page.
| Product | Formulation Characteristics |
|---|---|
| REVATIO | Powder-for-suspension system; grape flavored; contains sorbitol, xanthan gum, sodium benzoate and other formulation excipients |
| Generic REVATIO-reference suspensions | Ingredient lists are product-specific and should be checked on the individual label |
| LIQREV | Ready-to-use suspension; strawberry flavored; contains glycerin, xanthan gum, simethicone emulsion, sodium benzoate and other excipients |
| Detailed ingredient reference | Sildenafil Ingredients |
Storage requirements differ materially between reconstituted REVATIO-type suspensions and ready-to-use LIQREV, so one generic storage statement is not sufficient.
Current REVATIO labeling states that the powder should be stored below 30°C (86°F) in its original package to protect it from moisture. After reconstitution, the suspension may be stored below 30°C or refrigerated at 2°C to 8°C (36°F to 46°F), should not be frozen and has a 60-day shelf life after reconstitution.
LIQREV uses a different storage framework. Current labeling specifies controlled room temperature at 20°C to 25°C (68°F to 77°F), with permitted excursions from 15°C to 30°C (59°F to 86°F). It should not be frozen and the bottle should be used within 90 days after first opening.
These are product-specific label conditions rather than general rules for every compounded or commercially supplied sildenafil liquid.
| Product / Stage | Storage | Use / Discard Limit |
|---|---|---|
| REVATIO powder before reconstitution | Below 30°C (86°F); original package; protect from moisture | Use according to labeled expiration |
| REVATIO after reconstitution | Below 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze | Discard remaining suspension 60 days after reconstitution |
| Generic powder-for-suspension products | Check the specific product label; many reference the same reconstituted storage framework | Product-specific label controls |
| LIQREV | 20°C to 25°C (68°F to 77°F); permitted excursions 15°C to 30°C; do not freeze | Use within 90 days after first opening |
| General storage topic | Sildenafil Storage | Broader sildenafil storage guidance |
Handling depends on whether the product begins as a powder or as a finished suspension. REVATIO and similar powder-for-suspension products require labeled reconstitution before they become the 10 mg/mL finished liquid.
For REVATIO, current labeling specifies reconstitution with a total of 90 mL of water and a final suspension volume of 112 mL. The detailed preparation sequence should follow the official Instructions for Use and pharmacy procedures rather than informal home recipes.
The reconstituted REVATIO suspension is labeled to be shaken well before each use and should not be mixed with another medication or additional flavoring agent.
LIQREV does not require reconstitution. It is supplied ready to use and current labeling instructs that the suspension be shaken well for at least 10 seconds before use.
| Handling Feature | REVATIO / Powder for Suspension | LIQREV |
|---|---|---|
| Initial presentation | Dry powder | Finished liquid suspension |
| Reconstitution required | Yes | No |
| Finished concentration | 10 mg/mL | 10 mg/mL |
| Shake before use | Yes | Yes; current LIQREV labeling specifies at least 10 seconds |
| Additional medication / flavoring | REVATIO label states not to mix with other medication or additional flavoring | Follow LIQREV-specific labeling |
| Official instructions | Product Instructions for Use / pharmacy labeling | LIQREV labeling and Instructions for Use |
Commercial sildenafil suspension products should be distinguished from extemporaneously compounded liquids. REVATIO powder for oral suspension is a manufactured prescription product specifically designed for labeled reconstitution; that is not the same process as creating a formulation from tablets or raw drug.
LIQREV further demonstrates the distinction because it is supplied as a finished ready-to-use suspension manufactured to its own approved specifications.
This page therefore reports labeled formulation and handling characteristics but does not provide recipes for crushing tablets, selecting vehicles or preparing unapproved home suspensions.
| Topic | Covered Here |
|---|---|
| Commercial suspension characteristics | Yes |
| REVATIO labeled reconstitution concept | Yes |
| LIQREV ready-to-use formulation | Yes |
| Product-specific storage | Yes |
| Tablet-crushing recipes | No |
| DIY compounding formulas | No |
Oral suspension and tablets are different dosage forms, but formulation differences do not necessarily imply different systemic exposure when specific products have been demonstrated to be bioequivalent.
Current REVATIO labeling states that bioequivalence was established between its 20 mg tablet and the 10 mg/mL oral suspension when each was administered as a single 20 mg oral dose of sildenafil.
That finding is product- and study-specific. It should not be interpreted to mean that every sildenafil liquid is automatically interchangeable with every sildenafil tablet or that dosage-form differences can be ignored.
The complete formulation comparison belongs on the sildenafil tablets vs oral suspension page.
| Feature | Oral Suspension | Tablet |
|---|---|---|
| Physical form | Liquid dispersion | Solid unit |
| Strength expression | mg/mL | mg per tablet |
| Before-use handling | Shaking and product-specific liquid handling | No suspension redispersion |
| REVATIO bioequivalence evidence | 10 mg/mL suspension | 20 mg tablet |
| Study comparison | Bioequivalent when administered as a single 20 mg dose in the labeled study | Reference tablet in that comparison |
| Full comparison | Sildenafil Tablets vs Oral Suspension | Sildenafil Tablets vs Oral Suspension |
Oral suspension is one part of a wider U.S. sildenafil formulation landscape that now includes several distinct oral and parenteral presentations.
Current formulations include conventional tablets, VYBRIQUE oral film, powder-for-oral-suspension products, LIQREV ready-to-use oral suspension and REVATIO injection. These dosage forms do not all share the same labeled indication.
The sildenafil formulations page provides the broader dosage-form map.
| Formulation | Presentation | Dedicated Page |
|---|---|---|
| Tablet | Solid oral dosage form | Sildenafil Tablets |
| Oral film | Solid flexible oral film | Sildenafil Formulations |
| Powder for oral suspension | Reconstituted liquid dosage form | Current page |
| Ready-to-use oral suspension | Finished liquid dosage form | Current page |
| Injection | Intravenous dosage form | Sildenafil Injection |
FDA approval applies to specific products and dosage forms rather than to the abstract idea of a sildenafil liquid. The regulatory histories of REVATIO for oral suspension and LIQREV illustrate this distinction.
FDA approved REVATIO for oral suspension under NDA 203109 on August 30, 2012 as a new 10 mg/mL dosage form within the PAH product family. Current REVATIO labeling now includes adult and pediatric PAH information.
FDA approved LIQREV under NDA 214952 on April 28, 2023. LIQREV is a separate 505(b)(2) product supplied as a ready-to-use 10 mg/mL oral suspension and is labeled for adult WHO Group I pulmonary arterial hypertension.
Multiple generic sildenafil powder-for-oral-suspension products are also listed in the U.S. market. Their labels can differ in manufacturer details and, in some cases, in protected pediatric information, so the label for the exact dispensed product matters.
The broader chronology is covered on the sildenafil FDA approval page.
| Product | Regulatory Context | Formulation |
|---|---|---|
| REVATIO for oral suspension | NDA 203109; new dosage form approved August 30, 2012 | Powder reconstituted to 10 mg/mL |
| REVATIO current label | PAH product family with adult and pediatric labeling | 10 mg/mL after reconstitution |
| LIQREV | NDA 214952; 505(b)(2) approval April 28, 2023; adult PAH | Ready-to-use 10 mg/mL suspension |
| Generic sildenafil for oral suspension | Approved generic products with product-specific labeling | Usually powder reconstituted to 10 mg/mL |
| Approval timeline | Sildenafil FDA Approval History | Broader regulatory chronology |
Liquid-product terminology becomes important because powder-for-suspension and ready-to-use suspension products can share the same 10 mg/mL concentration while requiring different handling.
Keeping product identity attached to the terminology prevents assumptions about preparation, storage or labeled population based only on the words oral suspension.
| Term | Definition |
|---|---|
| Oral suspension | Liquid dosage form containing dispersed sildenafil |
| Powder for oral suspension | Manufactured dry dosage form intended for labeled reconstitution |
| Reconstitution | Conversion of the commercial powder into the finished suspension using the labeled procedure |
| Ready-to-use suspension | Finished suspension that does not require reconstitution |
| Concentration | Amount of sildenafil per defined liquid volume |
| 10 mg/mL | Current concentration used by the U.S. suspension products discussed on this page |
| Beyond-use after reconstitution / opening | Product-specific period after preparation or first opening during which the labeled product is retained |
Sildenafil oral suspension is a liquid oral dosage form containing sildenafil. Current U.S. products include powders that become a suspension after labeled reconstitution and the ready-to-use LIQREV suspension.
The current U.S. products discussed on this page use a concentration of 10 mg/mL. REVATIO and many generic products reach 10 mg/mL after reconstitution, while LIQREV is supplied ready to use at 10 mg/mL.
No. REVATIO for oral suspension is supplied as a powder and becomes a 10 mg/mL suspension after labeled reconstitution. The resulting total volume is 112 mL.
LIQREV is a separately FDA-approved ready-to-use sildenafil oral suspension containing 10 mg/mL. It does not require the reconstitution step used for REVATIO powder for oral suspension.
Current REVATIO labeling states that the reconstituted suspension can be stored below 30°C or refrigerated at 2°C to 8°C, must not be frozen and should be discarded 60 days after reconstitution.
No. LIQREV is stored at controlled room temperature, should not be frozen and should be used within 90 days after the bottle is first opened. This differs from the 60-day post-reconstitution framework for REVATIO.