Sildenafil Citrate Oral tablet

What is this medicine?

SILDENAFIL (sil DEN a fil) is used to treat erection problems in men.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • bleeding disorders

  • eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa

  • anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)

  • heart disease, angina, a history of heart attack, irregular heart beats, or other heart problems

  • high or low blood pressure

  • history of blood diseases, like sickle cell anemia or leukemia

  • history of stomach bleeding

  • kidney disease

  • liver disease

  • stroke

  • an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. The dose is usually taken 1 hour before sexual activity. You should not take the dose more than once per day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not used in children for this condition.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • cisapride

  • methscopolamine nitrate

  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

  • nitroprusside

  • other medicines for erectile dysfunction like avanafil, tadalafil, vardenafil

  • other sildenafil products (Revatio)

This medicine may also interact with the following medications:

  • certain drugs for high blood pressure

  • certain drugs for the treatment of HIV infection or AIDS

  • certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole

  • cimetidine

  • erythromycin

  • rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Stop using this medicine and call your health care provider right away if you have a loss of sight in one or both eyes.

Contact your doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking this medicine. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Using this medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in hearing

  • changes in vision

  • chest pain

  • fast, irregular heartbeat

  • prolonged or painful erection

  • seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • back pain

  • dizziness

  • flushing

  • headache

  • indigestion

  • muscle aches

  • nausea

  • stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.


Sildenafil Citrate Oral tablet [Pulmonary Hypertension]

What is this medicine?

SILDENAFIL (sil DEN a fil) is used to treat pulmonary arterial hypertension. This is a serious heart and lung condition. This medicine helps to improve symptoms and quality of life.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)

  • bleeding disorders

  • eye disease, vision problems

  • heart disease

  • high or low blood pressure

  • history of blood diseases, like sickle cell anemia or leukemia

  • kidney disease

  • liver disease

  • pulmonary veno-occlusive disease (PVOD)

  • stomach ulcer

  • an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your doses at regular intervals about 4 to 6 hours apart. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • cisapride

  • cobicistat; elvitegravir; emtricitabine; tenofovir

  • methscopolamine nitrate

  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

  • nitroprusside

  • other sildenafil products (Viagra)

  • telaprevir

This medicine may also interact with the following medications:

  • antiviral medicines for HIV or AIDS

  • bosentan

  • certain medicines for benign prostatic hyperplasia (BPH)

  • certain medicines for blood pressure

  • certain medicines for fungal infections like ketoconazole and itraconazole

  • cimetidine

  • erythromcyin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Tell your doctor or health care professional right away if you have any change in your eyesight or hearing.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcoholic drinks; they can make you more dizzy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in vision

  • chest pain

  • decreased hearing

  • fast, irregular heartbeat

  • men: prolonged or painful erection (lasting more than 4 hours)

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • facial flushing

  • headache

  • nosebleed

  • trouble sleeping

  • upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.


Sildenafil Citrate Solution for injection [Pulmonary Hypertension]

What is this medicine?

SILDENAFIL (sil DEN a fil) is used to treat pulmonary arterial hypertension. This is a serious heart and lung condition. This medicine helps to improve symptoms and quality of life.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)

  • bleeding disorders

  • eye disease, vision problems

  • heart disease

  • high or low blood pressure

  • history of blood diseases, like sickle cell anemia or leukemia

  • kidney disease

  • liver disease

  • pulmonary veno-occlusive disease (PVOD)

  • stomach ulcer

  • an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • cisapride

  • cobicistat; elvitegravir; emtricitabine; tenofovir

  • methscopolamine nitrate

  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

  • nitroprusside

  • other sildenafil products (Viagra)

  • telaprevir

This medicine may also interact with the following medications:

  • antiviral medicines for HIV or AIDS

  • bosentan

  • certain medicines for benign prostatic hyperplasia (BPH)

  • certain medicines for blood pressure

  • certain medicines for fungal infections like ketoconazole and itraconazole

  • cimetidine

  • erythromycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Tell your doctor or health care professional right away if you have any change in your eyesight or hearing.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcoholic drinks; they can make you more dizzy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in vision

  • chest pain

  • decreased hearing

  • fast, irregular heartbeat

  • men: prolonged or painful erection (lasting more than 4 hours)

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • facial flushing

  • headache

  • nosebleed

  • trouble sleeping

  • upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.