WARNINGS AND PRECAUTIONS

Sildenafil > 200mg sildenafil citrate


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.

Side Effect Incidence (%) Severity Notes
Headache 25 Mild to moderate Common, usually temporary
Flushing 18 Mild Reddening of face
Nasal Congestion 12 Mild Stuffy nose
Dizziness 10 Mild to moderate Especially when standing up quickly
Vision Changes 8 Mild Blue tint, blurred vision

Sildenafil is also marketed as REVATIO for the treatment of PAH.

  • Regular monitoring may be necessary when using high doses of sildenafil citrate.
  • Sildenafil citrate can cause side effects like low blood pressure and headache.
  • Discontinue use and seek medical attention if adverse reactions are severe or persistent.

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.

Frequently asked questions

Does sildenafil interact with foods or drinks?

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)].Product of IndiaManufactured by:Ajanta Pharma LimitedIndiaManufactured for:Quallent Pharmaceuticals Health LLCGrand Cayman, Cayman IslandsRevised: 11/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Concomitant Use with Drugs Which Lower Blood Pressure Patient Information Sildenafil (sil den' a fil )tablets, USPWhat 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.

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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 chronic-thromboembolic 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 do not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. Sildenafil tablet 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 is 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 nitratetake 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.

Storage Condition Details Shelf Life Precautions
Temperature Store below 30°C (86°F), in a dry place 2 years Protect from moisture and heat
Packaging Keep in original container, tight seal Keep out of reach of children
Light Exposure Store in a dark place Prevent degradation from light
Handling Avoid crushing or splitting tablets Use with clean, dry hands

See the end of this leaflet for a complete list of ingredients in sildenafil tablets.What should I tell my healthcare provider before taking sildenafil tablets?Before you take sildenafil tablets, tell your healthcare provider if you:have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell your healthcare provider about all the medicines you take*, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets works causing side effects.

Call to Action

You will not get an erection just by taking this medicine. Sildenafil tablet 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 is 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 nitratetake 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. See the end of this leaflet for a complete list of ingredients in sildenafil tablets.What should I tell my healthcare provider before taking sildenafil tablets?Before you take sildenafil tablets, tell your healthcare provider if you:have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell your healthcare provider about all the medicines you take*, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablets works causing side effects. Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see “What is the most important information I should know about sildenafil tablets?”)medicines called guanylate cyclase stimulators, such as riociguat (Adempas)medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure.

2. Custom Packaging & Private Labeling

In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting.medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSildenafil tablets contain sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary sildenafil pink pill arterial hypertension (PAH). Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.Your healthcare provider may change your dose if needed.Take sildenafil tablets about 1 hour before sexual activity. You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed.Sildenafil tablets can be taken with or without food. Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see “What is the most important information I should know about sildenafil tablets?”)medicines called guanylate cyclase stimulators, such as riociguat (Adempas)medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin).

  • Grapefruit and grapefruit juice can increase sildenafil blood levels by 20-30%.
  • High-fat meals (e.g., cheeseburger) delay absorption and reduce peak effect.
  • Alcohol may worsen side effects like dizziness and headache with 200mg.
  • Caffeine can slightly potentiate cardiovascular effects; use caution.
  • No known interaction with chocolate, but moderation is advisable.
  • Herbal supplements like St. John's Wort reduce drug efficacy.
  • Ginkgo biloba may increase bleeding risk; avoid concurrent use.
  • Licorice can affect blood pressure; limit intake when on 200mg.
  • Always inform your doctor about your full diet and supplement regimen.

Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting.medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSildenafil tablets contain sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary sildenafil pink pill arterial hypertension (PAH). Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.Your healthcare provider may change your dose if needed.Take sildenafil tablets about 1 hour before sexual activity.

More about sildenafil

You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed.Sildenafil tablets can be taken with or without food.

  • 200mg sildenafil citrate is rarely prescribed; usually, lower doses are effective.
  • Ensure adequate hydration when taking sildenafil citrate to prevent dehydration side effects.
  • Avoid fatty meals, which can delay sildenafil citrate's effectiveness.

If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start workingDo not take sildenafil tablets more than 1 time a day.If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of sildenafil tablets?Sildenafil tablets can cause serious side effects.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

Incidence not known

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)].Product of IndiaManufactured by:Ajanta Pharma LimitedIndiaManufactured for:Quallent Pharmaceuticals Health LLCGrand Cayman, Cayman IslandsRevised: 11/2025 Advise the patient to read the FDA-approved patient labeling (Patient Information) Concomitant Use with Drugs Which Lower Blood Pressure Patient Information Sildenafil (sil den' a fil )tablets, USPWhat 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 chronic-thromboembolic 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 do not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED). Rarely reported side effects include:an erection that will not go away (priapism).

5.9 Counseling Patients About Sexually Transmitted Diseases

If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start workingDo not take sildenafil tablets more than 1 time a day.If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of sildenafil tablets?Sildenafil tablets can cause serious side effects. Rarely reported side effects include:an erection that will not go away (priapism). If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss.

Usage of Cenforce 200

If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.The most common side effects of sildenafil tablets are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. Most, but not all, of these men had heart problems before taking sildenafil tablets. It is not known if sildenafil tablets caused these problems.Tell your healthcare provider if you have any side effect that bothers you or does not go away.These are not all the possible side effects of sildenafil tablets. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store sildenafil tablets?Sildenafil tablets comes in a child-resistant package.Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).Keep sildenafil tablets and all medicines out of the reach of children.General information about the safe and effective use of sildenafil tablets.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.The most common side effects of sildenafil tablets are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. Most, but not all, of these men had heart problems before taking sildenafil tablets.

Country Approved Use Prescription Required Maximum Allowed Dose Notes
United States Erectile Dysfunction Yes 100mg tablet max 200mg often not approved OTC
European Union Erectile Dysfunction Yes 100mg per dose 200mg used only under medical supervision
Australia Pulmonary Hypertension Yes Up to 200mg daily Under special prescription
India Both Uses Yes 200mg dose Commonly available in pharmacies

It is not known if sildenafil tablets caused these problems.Tell your healthcare provider if you have any side effect that bothers you or does not go away.These are not all the possible side effects of sildenafil tablets. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects.

  • At 200mg, visual side effects like blue-green tint are more pronounced.
  • This occurs because PDE6 in retinal rods is also inhibited at high doses.
  • Transient light sensitivity and blurred vision may last several hours.
  • Risk increases with dose; 200mg has higher incidence than 50mg or 100mg.
  • In most cases, visual changes are reversible upon drug elimination.
  • Patients with retinitis pigmentosa should avoid sildenafil altogether.
  • NAION (non-arteritic ischemic optic neuropathy) risk is dose-independent.
  • Annual eye exams may be advised for patients using high-dose sildenafil.
  • Report any sudden vision loss immediately; it may be permanent.

You may report side effects to FDA at 1-800-FDA-1088.How should I store sildenafil tablets?Sildenafil tablets comes in a child-resistant package.Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).Keep sildenafil tablets and all medicines out of the reach of children.General information about the safe and effective use of sildenafil tablets.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.