Sildenafil Oral Film: Package Insert / Prescribing Info

Stop taking SILDENAFIL CITRATE TABLETS and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking SILDENAFIL CITRATE TABLETS and contact a doctor right away. The most common side effects of SILDENAFIL CITRATE TABLETS are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking SILDENAFIL CITRATE TABLETS. Most, but not all, of these men had heart problems before taking SILDENAFIL CITRATE TABLETS. It is not known if SILDENAFIL CITRATE TABLETS caused these problems. These are not all the possible side effects of SILDENAFIL CITRATE TABLETS. How should I store SILDENAFIL CITRATE TABLETS? Store SILDENAFIL CITRATE TABLETS at room temperature between 68°F to 77°F (20°C to 25°C). Keep SILDENAFIL CITRATE TABLETS and all medicines out of the reach of children. General information about the safe and effective use of SILDENAFIL CITRATE TABLETS.

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Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. 1 INDICATIONS AND USAGE AdultsSildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies ( 14) ].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies ( 14) ]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablets are 20 mg three times a day. [see Clinical Studies ( 14)]Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets.

2.2 DosageModificationsforDrug Interactions

The recommended dosage of sildenafil tablets are 20 mg three times a day. 4 CONTRAINDICATIONS Sildenafil citrate 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 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Sildenafil citrate 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)] . Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Do not use SILDENAFIL CITRATE TABLETS for a condition for which it was not prescribed. Do not give SILDENAFIL CITRATE TABLETS to other people, even if they have the same symptoms that you have. This Patient Information leaflet summarizes the most important information about SILDENAFIL CITRATE TABLETS.

You can ask your healthcare provider or pharmacist for information about SILDENAFIL CITRATE TABLETS that is written for health professionals. For more information, go to or call 1-800-438-1985 What are the ingredients in SILDENAFIL CITRATE TABLETS? This product's label may have been updated. For current full prescribing information, please visit Cardura (doxazosin mesylate), and Minipress (prazosin HCl) are registered trademarks of Pfizer Inc.

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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 DiseaseIn 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 sildenafil citrate than by those randomized to placebo. The effectiveness and safety of sildenafil citrate in the treatment of PH secondary to sickle cell disease has not been established. Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.

How sildenafil is used

The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration. The other brands listed are trademarks of their respective owners and are not trademarks of Pfizer Inc. The makers of these brands are not affiliated with and do not endorse Pfizer Inc or its products. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998INDICATIONS AND USAGEAdultsSildenafil citrate is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. ( 1)DOSAGE AND ADMINISTRATION• Adults: 20 mg three times a day. ( 2.1)DOSAGE FORMS AND STRENGTHSTablets :20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

• These tablets provide a discreet alternative to traditional pills.
• They are designed to dissolve quickly in the mouth or be swallowed.
• Suitable for people who have difficulty swallowing capsules.

( 5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. ( 5.8)ADVERSE REACTIONSDRUG INTERACTIONS• 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)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 1/2026 • Adults: 20 mg three times a day.

Pulmonary sildenafil citrate tablets 50 mg hypertension (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. • Use with strong CYP3A inhibitors: Not recommended. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. 1 INDICATIONS AND USAGE AdultsSildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies ( 14) ].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets.

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5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil tablets, 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 sildenafil citrate.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD.

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The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.5.4 Visual LossWhen 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 postmarketing 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 sildenafil citrate.There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended.5.5 Hearing LossCases 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 sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, 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 sildenafil tablets.5.6 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA ®. Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil citrate 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). Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies ( 14) ].

2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablets are 20 mg three times a day.

• Sildenafil film tablets are oral medications used to treat erectile dysfunction.
• These tablets are smooth, coated, and designed for quick swallowing.
• They contain sildenafil citrate as the active ingredient.

[see Clinical Studies ( 14)]Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. The recommended dosage of sildenafil tablets are 20 mg three times a day. 4 CONTRAINDICATIONS Sildenafil citrate 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 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Sildenafil citrate 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)] . Phosphodiesterase-5 (PDE5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil tablets, 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 sildenafil citrate.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

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Do not use SILDENAFIL CITRATE TABLETS for a condition for which it was not prescribed. Do not give SILDENAFIL CITRATE TABLETS to other people, even if they have the same symptoms that you have. This Patient Information leaflet summarizes the most important information about SILDENAFIL CITRATE TABLETS. You can ask your healthcare provider or pharmacist for information about SILDENAFIL CITRATE TABLETS that is written for health professionals. For more information, go to or call 1-800-438-1985 What are the ingredients in SILDENAFIL CITRATE TABLETS?

Sildenafil Oral Film for ED

This product's label may have been updated. For current full prescribing information, please visit Cardura (doxazosin mesylate), and Minipress (prazosin HCl) are registered trademarks of Pfizer Inc. The other brands listed are trademarks of their respective owners and are not trademarks of Pfizer Inc. The makers of these brands are not affiliated with and do not endorse Pfizer Inc or its products. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Since there are no clinical data on administration of sildenafil citrate to patients with veno-occlusive disease, administration of sildenafil citrate to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. The incidence of epistaxis was also higher in sildenafil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.5.4 Visual LossWhen 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 postmarketing 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 sildenafil citrate.There are no controlled clinical data on the safety or efficacy of sildenafil citrate in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases. Therefore, use of sildenafil citrate in patients with retinitis pigmentosa is not recommended.5.5 Hearing LossCases 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 sildenafil citrate. It is not possible to determine whether these reported events are related directly to the use of sildenafil citrate, 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 sildenafil tablets.5.6 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA ®.

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Approval: 1998INDICATIONS AND USAGEAdultsSildenafil citrate is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. ( 1)DOSAGE AND ADMINISTRATION• Adults: 20 mg three times a day. ( 2.1)DOSAGE FORMS AND STRENGTHSTablets :20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. ( 5.8)ADVERSE REACTIONSDRUG INTERACTIONS• Use with strong CYP3A inhibitors: Not recommended.

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( 7, 12.3)• Concomitant PDE-5 inhibitors: Avoid use with Viagra ®or other PDE-5 inhibitors. ( 5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 1/2026 • Adults: 20 mg three times a day. Pulmonary sildenafil citrate tablets 50 mg hypertension (PH) secondary to sickle cell disease: Sildenafil citrate may cause serious vaso-occlusive crises. • Use with strong CYP3A inhibitors: Not recommended. Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil citrate 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).

• Sildenafil film tablets are available by prescription only.
• They may interact with nitrates, causing dangerous blood pressure drops.
• Alcohol can impair the effectiveness of these tablets.

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 DiseaseIn 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 sildenafil citrate than by those randomized to placebo.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

Stop taking SILDENAFIL CITRATE TABLETS and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking SILDENAFIL CITRATE TABLETS and contact a doctor right away. The most common side effects of SILDENAFIL CITRATE TABLETS are: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking SILDENAFIL CITRATE TABLETS. Most, but not all, of these men had heart problems before taking SILDENAFIL CITRATE TABLETS. It is not known if SILDENAFIL CITRATE TABLETS caused these problems.

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These are not all the possible side effects of SILDENAFIL CITRATE TABLETS. How should I store SILDENAFIL CITRATE TABLETS? Store SILDENAFIL CITRATE TABLETS at room temperature between 68°F to 77°F (20°C to 25°C). Keep SILDENAFIL CITRATE TABLETS and all medicines out of the reach of children. General information about the safe and effective use of SILDENAFIL CITRATE TABLETS. The effectiveness and safety of sildenafil citrate in the treatment of PH secondary to sickle cell disease has not been established.

• Sildenafil tablets should not be combined with certain medications like alpha-blockers.
• A healthcare provider will determine the appropriate dosage.
• Follow prescribed instructions precisely for safety.

Sildenafil citrate has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate. Should signs of pulmonary edema occur when sildenafil citrate is administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking sildenafil citrate with PAH secondary to CTD. The safety of sildenafil citrate is unknown in patients with bleeding disorders or active peptic ulceration.

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4.1 Nitrates