Label: SILDENAFIL- sildenafil tablet, film coated

There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo.

Drug Label Information

Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil tablets was assessed sildenafil 100g for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Tablets and Placebo on 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-709-30Bottles of 500 tablets NDC 31722-709-05Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-710-30Bottles of 100 tablets NDC 31722-710-01Bottles of 500 tablets NDC 31722-710-05Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-711-30Bottles of 100 tablets NDC 31722-711-01Bottles of 500 tablets NDC 31722-711-05Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

• Side effects may include dizziness, nasal congestion, or upset stomach.
• Alcohol can reduce the effectiveness of sildenafil.
• If an erection lasts more than 4 hours, seek medical help.
• The pink pill is sometimes used recreationally, which is risky.
• Do not take the pill if you have severe heart issues.
• Always check for medical hash compatibility before use.

Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients.

Therefore, when sildenafil tablets are co-administered with alpha-blockers, 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 Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in sildenafil film tablet the event of a sudden loss of vision in one or both eyes.

6.2 Postmarketing Experience

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil tablets with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [see Contraindications(4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil tablets with use of guanylate cyclase stimulators such as riociguat [see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil tablets to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil tablets and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil tablets are co-administered with alpha-blockers, 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 Warnings and Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [see Warnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil tablets, and seek medical attention in sildenafil film tablet the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors.

Recreational use

Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases.

What should I know about sildenafil before taking it?

Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Manufactured for:Camber Pharmaceuticals, Inc.,Piscataway, NJ 08854by: HETERO TMHetero Labs LimitedJeedimetla, Hyderabad - 500 055, India.Revised: 12/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Patient Information Patient InformationSildenafil Tablets, USP(sil den' a fil)What is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas ®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil tablets, for this uncommon condition [see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

Is Addyi effective?

What are the serious side effects of sildenafil?

Who should not take sildenafil?

Sildenafil is also marketed as REVATIO for the treatment of PAH. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [see Warnings and Precautions(5.7)].Sexually Transmitted DiseaseThe use of sildenafil tablets offers no protection against sexually transmitted diseases.

Adverse effects

There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on sildenafil tablets compared to placebo. On a global improvement question, 57% of sildenafil tablets patients reported improved erections versus 10% on placebo. Diary data indicated that on sildenafil tablets, 48% of intercourse attempts were successful versus 12% on placebo.One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted. The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of sildenafil tablets. On a global improvement question, 83% of patients reported improved erections on sildenafil tablets versus 12% on placebo.

What is sildenafil used for?

Diary data indicated that on sildenafil tablets, 59% of attempts at sexual intercourse were successful compared to 13% on placebo.Across all trials, sildenafil tablets improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of sildenafil tablets patients reported improvement in erections compared with 26% of placebo. Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for sildenafil tablets and 29% for placebo.Efficacy Results in Subpopulations in Controlled Clinical StudiesA review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. sildenafil tablets was effective in a broad range of ED patients, including those with a history of coronary artery disease, hypertension, other cardiac disease, peripheral vascular disease, diabetes mellitus, depression, coronary artery bypass graft (CABG), radical prostatectomy, transurethral resection of the prostate (TURP) and spinal cord injury, and in patients taking antidepressants/antipsychotics and anti-hypertensives/diuretics. In clinical studies, sildenafil tablets was assessed sildenafil 100g for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.

Other Interactions

Effect of Placebo on Maintenance of Erection by Baseline Score Effect of Sildenafil Tablets and Placebo on 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-709-30Bottles of 500 tablets NDC 31722-709-05Sildenafil Tablets USP, 50 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '36'on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-710-30Bottles of 100 tablets NDC 31722-710-01Bottles of 500 tablets NDC 31722-710-05Sildenafil Tablets USP, 100 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '58' on the other side. They are available as follows:Bottles of 30 tablets NDC 31722-711-30Bottles of 100 tablets NDC 31722-711-01Bottles of 500 tablets NDC 31722-711-05Recommended Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 25 mg are white colored, round-shaped, biconvex, film coated tablets debossed with ' I ' on one side and '35'on the other side. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [see Warnings and Precautions (5.9)].Manufactured for:Camber Pharmaceuticals, Inc.,Piscataway, NJ 08854by: HETERO TMHetero Labs LimitedJeedimetla, Hyderabad - 500 055, India.Revised: 12/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Patient Information Patient InformationSildenafil Tablets, USP(sil den' a fil)What is the most important information I should know about sildenafil tablets?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take sildenafil tablets if you take any other medicines called “nitrates.” Nitrates are used to treat chest pain (angina).

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

2.1 Dosage Information

Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take medicines called ''nitrates” (such as nitroglycerin)• use street drugs called ''poppers'' such as amyl nitrate or amyl nitrite, and butyl nitrate• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets.

Does sildenafil interact with other medicines (drug interactions)?

Less common

Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include:• Riociguat (Adempas ®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

• Sildenafil pink pill may be contraindicated for some health conditions.
• Always inform your doctor of current medications before use.
• It can cause side effects like dizziness or stomach upset.
• Combining it with other ED medications is dangerous.
• Sildenafil should be taken on an empty stomach for best results.
• The medication is not a hormone and does not alter testosterone.

Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED).

• The pink sildenafil pill is often used recreationally.
• Overuse can lead to adverse health effects.
• It doesn't increase libido but improves erectile response.
• Food intake can delay the pill’s effectiveness.
• The medication should not be mixed with alcohol.
• It is possible to develop dependence with frequent use.

You will not get an erection just by taking this medicine. Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated).Sildenafil tablets are not for use in women or children.It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.Who should not take sildenafil tablets?Do not take sildenafil tablets if you:• take medicines called ''nitrates” (such as nitroglycerin)• use street drugs called ''poppers'' such as amyl nitrate or amyl nitrite, and butyl nitrate• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)• are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets.