Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group

They may recommend lifestyle changes, such as more rest to help ease your headache.

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* To learn more about the clinical trials of sildenafil, refer to the drug’s prescribing information for erectile dysfunction and pulmonary arterial hypertension (PAH). No, sildenafil isn’t known to cause different side effects in females. * Sildenafil is approved to treat PAH in most adults, including females. If you’re female and concerned about side effects with sildenafil, talk with your doctor. Note: If you’re male, priapism may occur during sildenafil treatment.

How were differences between studies investigated?

With priapism, you experience a continued (4 hours or longer) erection that’s often painful. For more information about this side effect, see the “Sildenafil: Side effect specifics” section below. Use of the term “female” and “male” in this article refers to sex assigned at birth. It’s possible to develop long-term side effects from sildenafil treatment. In clinical trials,* long-term side effects, such as vision loss and hearing loss,† occurred at any time during treatment. Your doctor may also recommend pain medications to help treat your headache. These may include ibuprofen (Advil, Motrin) or acetaminophen (Tylenol).

Severe cardiovascular problems may occur during sildenafil treatment. This side effect was reported* in people taking sildenafil for ED after the drug was approved.

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If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported and their symptoms include: Symptoms can include:tinnitus (ringing in your ear)dizzinessdecrease in hearing Symptoms can include:trouble seeing in either eyeblurry visionseeing eye floaters * To learn more about this side effect, see the “Sildenafil: Side effect specifics” section below. Sildenafil is not approved by the Food and Drug Administration (FDA) for use in children. In clinical trials, children who were given sildenafil long term to treat pulmonary arterial hypertension had an increased risk of fatality. However, your child’s doctor may recommend taking sildenafil off-label in some cases.

Study of Flexible Dose Escalation, Efficacy, and Safety with a Long-Term, Open-Label Extension

(With off-label use, a doctor prescribes an FDA-approved drug for a purpose other than what it’s approved for.) Talk with your child’s doctor to determine if sildenafil is right for your child. They can help compare the risks and benefits of the drug. Sildenafil oral tablets come in different strengths: 20 milligrams (mg), 25 mg, 50 mg, and 100 mg. The dosage you’re prescribed will depend on what condition you’re taking sildenafil for. It also depends on how the dosage is working for you. Cardiovascular problems, such as heart attack, stroke, irregular heartbeat, lung bleeding, and brain bleeding were rarely reported.

• Take sildenafil on an empty stomach for faster absorption.
• High-fat meals may delay the effectiveness of the medication.
• Do not crush or chew sildenafil tablets; swallow whole.

Many of these reported side effects occurred during or shortly after sexual activity. Most of the people who experienced cardiovascular problems during sildenafil treatment already had other heart-related conditions. So it’s unknown if sildenafil was the direct cause of these side effects. They may be due to other factors, such as preexisting heart disease, sexual activity, or a combination of these factors. Before you sildenafil premature ejaculation start sildenafil treatment, be sure to tell your doctor if you have any heart conditions. Depending on your heart health, sildenafil may not be safe for you to take.

How should I take sildenafil?

For more information, you can refer to sildenafil’s prescribing information for erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). Mild side effects that have been reported with sildenafil include: These side effects may be temporary, lasting a few days to weeks. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking sildenafil and want to tell the FDA about it, visit MedWatch. * For more information about this side effect, see “Sildenafil: Side effect specifics” below.

Flexible, Fast-Acting Alternative to Oral Tablets for Sexual Health and Vasodilation Therapy

† An allergic reaction is possible after taking sildenafil. However, this side effect was rarely reported in clinical trials of sildenafil for ED and PAH. To learn more, see the “Sildenafil: Side effect specifics” section below. The list below may not include all possible serious side effects of the drug. If you develop serious side effects while taking sildenafil, call your doctor right away. Your doctor can review the risks and benefits of taking sildenafil to determine the right treatment plan for you. If you’re interested in having sex while taking sildenafil for ED or PAH, talk with your doctor before starting treatment.

It’s important to talk with your doctor about your heart health before having sex. Engaging in sexual activity when you have heart problems may increase your risk of severe cardiovascular problems, including heart attack. This risk may increase further if you take sildenafil, have heart problems, and have sex. Your doctor can review the risks and benefits of having sex during sildenafil treatment. Nosebleeds are a common side effect of sildenafil, and they’re typically mild. In clinical trials,* people who were taking warfarin (Jantoven) had an increased risk of nosebleeds.

Symptoms of nosebleeds include bleeding from one or both nostrils. It also includes feeling as if you have to swallow a lot. If you start to experience nosebleeds often or if they don’t stop, talk with your doctor.

Further information

However, the exact reason why these side effects occurred is not fully known. If you have any sudden changes in your vision or hearing, talk with your doctor right away. Also talk with them if you’re concerned about long-term side effects with sildenafil treatment. * To learn more about the clinical trials of sildenafil, refer to the drug’s prescribing information for erectile dysfunction and pulmonary arterial hypertension. † For more details about these side effects, including their symptoms, see the “Sildenafil: Serious side effects” section above.

Incidence not known

Learn more about some of the side effects that sildenafil may cause. To find out how often side effects occurred in clinical trials, see the drug’s prescribing information for erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). However, this side effect was rare in clinical trials. * Sildenafil is a vasodilator, meaning it widens the blood vessels and makes it easier for blood to flow. When this happens, your blood pressure may drop. They may recommend applying a cold cloth to the bridge of your nose briefly or pinching your nostrils for a short period of time.

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This is because your heart doesn’t have to work as hard to move blood around your body. Signs and symptoms of low blood pressure include tiredness, lightheadedness, or blurry vision. They may also include nausea, dizziness, fainting, and confusion. Low blood pressure can be mild or severe depending on how much your blood pressure drops. You may have an increased risk of severe low blood pressure if you: already take drugs to lower your blood pressure have a blood pressure less than 90/50 before taking sildenafil If you take blood pressure drugs during sildenafil treatment, your doctor will recommend monitoring your blood pressure regularly.

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If you notice any signs or symptoms of low blood pressure while taking sildenafil, talk with your doctor. They’ll review your symptoms and other medications to make sure it’s safe for you to keep taking the drug. * To learn more about the clinical trials of sildenafil, refer to the drug’s prescribing information for ED and PAH. Headache is a possible side effect while taking sildenafil. Headaches were common and typically mild in clinical trials of the drug.* If you start to experience headaches often or if they affect your daily life, talk with your doctor. Your doctor may also recommend medications to help with nosebleeds, such as oxymetazoline (Afrin). It usually happens without sexual stimulation or continues long after sex.

• Sildenafil should not be used with certain medications like alpha-blockers.
• Avoid alcohol consumption when taking sildenafil to reduce side effects.
• Discuss all medications with your doctor to prevent interactions.

Priapism was a rare side effect in clinical trials of sildenafil.* Priapism can become a serious side effect if your erection lasts longer than 4 hours. If you’ve ever had sickle cell anemia, multiple myeloma, or leukemia, you may have an increased risk of developing severe priapism. Call 911 (or your local emergency number) and go to the emergency room if you experience an erection that lasts longer than 4 hours. You may experience permanent damage to your penis if this is not treated right away.

• Common side effects include headache, flushing, and nasal congestion.
• Serious side effects are rare but can include vision changes and priapism.
• Report any severe reactions to your doctor immediately.

If your erections are lasting longer than usual, but less than 4 hours, talk with your doctor. They may recommend decreasing your sildenafil dosage.

Medical uses

You can experience mild or severe side effects from sildenafil with any dosage. However, you may have an increased risk of side effects with higher dosages. If you start to experience side effects that become bothersome or severe while taking sildenafil, talk with your doctor. Here are some frequently asked questions about the drug’s side effects and their answers. No, there aren’t any reviews from people who’ve taken 50-milligram (mg) or 100-mg sildenafil tablets.

Erectile dysfunction

However, you may experience mild or severe side effects from sildenafil with any prescribed dose. In clinical trials,* a similar number of people reported certain side effects with both 50-mg and 100-mg doses. These side effects included mild to moderate headaches, flushing, and back pain. However, people taking the 100-mg dose sildenafil citrate 120 mg had an increased risk of upset stomach, vision changes, and runny nose. If you have questions about the side effects of your prescribed sildenafil dose, talk with your doctor or pharmacist. As with most drugs, sildenafil can cause an allergic reaction in some people. However, these reactions were rarely reported in clinical trials.* Symptoms can be mild or serious and can include: For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and help determine whether you should keep taking sildenafil. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.