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Before prescribing sildenafil, 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 [BP 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.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

5.1 Mortality with Pediatric Use

Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse sildenafil with caution in patients with anatomical deformation over the counter drugs containing sildenafil 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). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn 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 than by those randomized to placebo. The effectiveness and safety of sildenafil in the treatment of PAH secondary to sickle cell anemia has not been established. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed. Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)].

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When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥ 50 per year in the general population. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:• Mortality with pediatric use[see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]• Hypotension [see Warnings and Precautions (5.2)]• Vision loss [see Warnings and Precautions (5.5)]• Hearing loss [see Warnings and Precautions (5.6)]• Priapism [see Warnings and Precautions (5.8)]• Vaso-occlusive crisis [see Warnings and Precautions (5.9) ]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Safety data of sildenafil in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil-treated patients with PAH, WHO Group I [see Clinical Studies (14)].The overall frequency of discontinuation in sildenafil-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.In Study 1, the adverse reactions that were reported by at least 3% of sildenafil-treated patients (20 mg three times a day) and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.Table 1. Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil 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 is unknown in patients with bleeding disorders or active peptic ulceration.5.5 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 phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking.

8.2 Lactation

Before prescribing sildenafil, 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 [BP 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.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil 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 is unknown in patients with bleeding disorders or active peptic ulceration.5.5 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 phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking.

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Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥ 50 per year in the general population.An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2].Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil. Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe sildenafil with caution in these patients.5.6 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. It is not possible to determine whether these reported events are related directly to the use of sildenafil, 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.5.7 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA®. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥ 50 per year in the general population.An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period.

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Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2].Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil.

• Sildenafil tablets are classified as phosphodiesterase inhibitors.
• White sildenafil tablets are available by prescription only.
• They should not be used with nitrates due to risk of dangerous drops in blood pressure.
• Certain medications may interact with sildenafil, including antibiotics and antifungals.
• The tablets are designed to last approximately 4-6 hours.
• Overuse can lead to adverse effects like dizziness or vision changes.
• Sildenafil helps men with erectile dysfunction achieve and maintain erections.
• The medicine is not an aphrodisiac and requires sexual stimulation.
• The tablets should be stored in a cool, dry place away from children.
• Beware of counterfeit sildenafil tablets sold online.
• Always verify the legitimacy of the medication before use.

Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases.

• Sildenafil tablets are available in various generic versions.
• White sildenafil tablets are often easier to swallow due to their shape.
• The cost of sildenafil varies depending on the brand and dosage.
• Using sildenafil responsibly can improve quality of life for users.
• Not all erectile issues require medication; consult a doctor for underlying causes.
• Sildenafil is not suitable for women or children.
• The drug works by blocking PDE5, enhancing natural erections.
• Physical activity after taking sildenafil can enhance its effectiveness.
• Sildenafil is sometimes used off-label for pulmonary hypertension.
• Proper hydration may help reduce side effects like headaches.
• Patients should report any persistent or severe side effects to a healthcare professional.

Prescribe sildenafil with caution in these patients.5.6 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. It is not possible to determine whether these reported events are related directly to the use of sildenafil, 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.5.7 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA®. Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse sildenafil with caution in patients with anatomical deformation over the counter drugs containing sildenafil 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). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn 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 than by those randomized to placebo. The effectiveness and safety of sildenafil in the treatment of PAH secondary to sickle cell anemia has not been established.

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Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil-Treated Patients)At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and sildenafil 100mg lowest price transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.The incidence of retinal hemorrhage with sildenafil 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for sildenafil versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of sildenafil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].Table 2. Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Sildenafil + Epoprostenol group at least 6% greater than Epoprostenol group)6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction).

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It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.Nervous systemSeizure, seizure recurrenceOphthalmologicNAION [see Warnings and Precautions (5.5) and Patient Counseling Information (17)]. The following serious adverse events are discussed elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data of sildenafil in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil-treated patients with PAH, WHO Group I [see Clinical Studies (14)]. The overall frequency of discontinuation in sildenafil-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil-treated patients (20 mg three times a day) and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil dose was observed.

• Some sildenafil tablets are coated to improve taste and ease swallowing.
• Sildenafil should not be used if allergic to citrate compounds.
• Cost savings on generic sildenafil make it accessible to more users.
• The medication requires no special diet, but avoid fatty foods close to ingestion.
• Sildenafil may cause a modest drop in blood pressure temporarily.
• Do not share prescribed sildenafil with others; it is tailored to individual health.
• Inform your doctor of all medications and health conditions before use.
• Sildenafil may have different effects based on age and health status.
• The medication has been available in various formulations for convenience.
• The effectiveness may vary, and some users might need dose adjustments.
• Always keep sildenafil tablets out of reach of children and pets.

Use of sildenafil, particularly chronic use, is not recommended in children [see Use in Specific Populations (8.4)]. When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥ 50 per year in the general population. It is not possible to determine whether these reported events are related directly to the use of sildenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:• Mortality with pediatric use[see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]• Hypotension [see Warnings and Precautions (5.2)]• Vision loss [see Warnings and Precautions (5.5)]• Hearing loss [see Warnings and Precautions (5.6)]• Priapism [see Warnings and Precautions (5.8)]• Vaso-occlusive crisis [see Warnings and Precautions (5.9) ]6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Safety data of sildenafil in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil-treated patients with PAH, WHO Group I [see Clinical Studies (14)].The overall frequency of discontinuation in sildenafil-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.In Study 1, the adverse reactions that were reported by at least 3% of sildenafil-treated patients (20 mg three times a day) and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.Table 1. Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil-Treated Patients)At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and sildenafil 100mg lowest price transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.The incidence of retinal hemorrhage with sildenafil 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil doses studied was 1.9% versus 0% placebo.

What other information should I know?

The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for sildenafil versus 1.4% for placebo.

• White sildenafil tablets are used to treat erectile dysfunction.
• They are often sold under brand names like Viagra.
• The standard dose for sildenafil is 50 mg.
• White sildenafil tablets contain the active ingredient sildenafil citrate.
• These tablets typically come in 25 mg, 50 mg, and 100 mg doses.
• They work by increasing blood flow to the penis.
• Sildenafil tablets should be taken about 30-60 minutes before activity.
• They are most effective when taken on an empty stomach.
• Common side effects include headache, flushing, and upset stomach.
• Always consult a healthcare provider before using sildenafil.
• Purchasing from reputable sources ensures quality and safety.

The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of sildenafil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].Table 2.

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Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Sildenafil + Epoprostenol group at least 6% greater than Epoprostenol group)6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.Nervous systemSeizure, seizure recurrenceOphthalmologicNAION [see Warnings and Precautions (5.5) and Patient Counseling Information (17)]. The following serious adverse events are discussed elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data of sildenafil in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil-treated patients with PAH, WHO Group I [see Clinical Studies (14)]. The overall frequency of discontinuation in sildenafil-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil-treated patients (20 mg three times a day) and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1.