Vardenafilum is a prescription medication used to treat erectile dysfunction (ED). It belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. These drugs work by relaxing blood vessels and increasing blood flow to the penis during sexual arousal. Vardenafilum is available in tablet form and is taken orally. It is available in three strengths: 2.5 mg, 5 mg, and 10 mg. The recommended starting dose is 10 mg. Vardenafilum can be taken with or without food. Common side effects of Vardenafilum include headache, flushing, stuffy or runny nose, upset stomach, and back pain. Vardenafilum can also cause dizziness. This side effect may be worse if you take it with alcohol or other medications that can cause dizziness. Vardenafilum should not be used by women or children. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Vardenafilum can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine. Do not take Vardenafilum if you are also using a nitrate drug for chest pain or heart problems. Nitrates include nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates can also be found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Vardenafilum with a nitrate medicine can cause a sudden and serious decrease in blood pressure. If you are taking Vardenafilum for erectile dysfunction, your doctor will probably start you on an average dose of 10 mg and increase or decrease your dose depending on your response to the medication. If you are taking Vardenafilum for PAH, you should know that Vardenafilum may decrease the pressure in your lungs. This may worsen your condition if you have PAH. You should not use Vardenafilum if you are allergic to it, or: if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". If you have any of these other conditions, you may need a Vardenafilum dose adjustment or special tests: heart disease or heart rhythm problems; a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure; angina (chest pain), high or low blood pressure; pulmonary hypertension; a history of heart surgery within the last 6 months; kidney disease (or if you are on dialysis); liver disease; a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; a bleeding disorder such as hemophilia; a stomach ulcer; retinitis pigmentosa (an inherited condition of the eye); a physical deformity of the penis (such as Peyronie's disease); or if you have been told you should not have sexual intercourse for health reasons. Vardenafilum may cause a sudden decrease in vision in one or both eyes. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent vision loss. Call your doctor right away if you have any sudden vision loss. Sudden hearing loss has occurred in people taking Vardenafilum. Sometimes they also have ringing in their ears or dizziness. If you have these symptoms, stop taking Vardenafilum and contact a doctor right away. Do not take Vardenafilum more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if you have an erection that lasts more than 4 hours. A prolonged erection (priapism) can damage the penis. Vardenafilum may rarely cause a sudden decrease or loss of hearing. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent hearing loss. Stop taking Vardenafilum and contact your doctor right away if you have sudden hearing loss. Call your doctor at once if you have any of these serious side effects: changes in vision or sudden vision loss; ringing in your ears or sudden hearing loss; chest pain, pounding heartbeats or fluttering in your chest; pain, swelling, warmth, or redness in one or both legs; shortness of breath, swelling in your hands or feet; feeling light-headed, fainting; or penis erection that is painful or lasts 4 hours or longer. Less serious Vardenafilum side effects may include: warmth or redness in your face, neck, or chest; stuffy nose; headache; upset stomach; or back pain. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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