Safety Information

In clinical trials, only 3.4 percent of participants stopped taking the medication due to side effects (compared to 1.1 percent for a placebo). Headaches are by far the most common side effect of vardenafil and other oral medications used to treat ED. According to the FDA, around 15 percent of men who use vardenafil get one. Headaches typically fade away on their own as the drug exits your system. Since the medication has a moderate half-life, it’s rare for this side effect to last more than five hours. If you get severe headaches, it’s best to talk to your healthcare provider. They may suggest adjusting your dosage or using over-the-counter medication to reduce the severity of your headaches. Our guide to dealing with headaches from ED medications has more tips. Flushing is the second-most common side effect of vardenafil.

Key Takeaways

There have been rare reports of priapism from all medications used to treat erectile dysfunction, including vardenafil. Still, priapism is a serious medical issue. If you get an erection that lasts four or more hours after using vardenafil, seek medical assistance immediately. Priapism can be treated successfully in a hospital, helping you avoid lasting damage to the erectile tissues of your penis. Vardenafil and other ED medications are linked to cases of optic nerve damage causing decreased vision.

Less common

Vision changes are a very uncommon side effect of PDE5 inhibitors. If you experience sudden vision loss in one or both eyes after using vardenafil, seek medical attention immediately. Vision loss could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). That’s when optic nerve damage causes permanent vision loss in one or both eyes. Although research hasn’t established a direct link between PDE5 inhibitor use and damage to the optic nerve, some studies suggest an association. In clinical trials, 11 percent of men who used the medication experienced it, compared to just one percent of those who got a placebo. Flushing may develop due to the medication’s effects on blood vessels. You might notice that your cheeks, nose, chin, and forehead take on an inflamed, red appearance. Like other side effects, flushing typically improves over a few hours as the active ingredient exits your system. Irritation and inflammation inside the nostrils can also happen with vardenafil.

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Known medically as rhinitis, this side effect can result in a blocked airway or a runny nose.

Continue Learning

Vardenafil (generic for Levitra®) improves erectile dysfunction (ED) by making it easier for blood to flow to the penis. It’s in the same class of drugs as Viagra®, Cialis®, and Stendra®, and like these other medications for ED, vardenafil is safe and effective when taken as prescribed. However, there are potential vardenafil side effects to consider, like headaches and nausea. While most adverse effects are mild, some may be more serious. We’ll list the common and uncommon side effects of vardenafil and what you can do to deal with them and improve your experience while using this medication for ED.

More common

These drugs increase blood flow to erectile tissues in the penis, making it easier to get and keep an erection with sexual stimulation. It’s one of several medications for ED. Others include sildenafil (the active ingredient in Viagra), tadalafil (Cialis), and avanafil (Stendra). Vardenafil is available as 2.5mg, 5mg, 10mg, or 20mg (milligrams) oral tablets. It’s also sold as disintegrating tablets under the brand name Staxyn®. In clinical trials with vardenafil, nine percent of men who used the medication to treat ED developed symptoms of rhinitis. This side effect may be more common with vardenafil than other ED treatments. For example, only two to four percent of men prescribed Cialis in clinical trials reported nasal congestion.

• Levitra is available in 10 mg and 20 mg tablets.
• The medication is not an aphrodisiac; it enhances ability when sexually stimulated.
• Vardenafil is a PDE5 inhibitor class drug.
• It can be used by men with diabetes-related erectile issues.
• Levitra may cause dizziness; avoid driving after taking.
• The medication is approved by the FDA for ED treatment.
• Do not use if you have severe liver or kidney problems.
• Vardenafil should be stored at room temperature, away from moisture.
• It is not suitable for women or children.
• Consult your doctor for potential drug interactions.

About three percent of men who use vardenafil also report sinusitis, another form of nasal irritation and congestion. And general flu-like symptoms affect around three percent of users.

Parameter	Value	Notes
Onset of Action	25-60 minutes	Typically 30-45 minutes
Duration of Effect	Up to 5 hours	Varies with dose and individual
Half-life	Approximately 4-5 hours	Determines dosing frequency
Time to Peak Concentration	About 60 minutes	After oral administration

Like the other common side effects of vardenafil, nasal congestion usually fades gradually as the medication leaves your body. Indigestion is a fairly common side effect reported by about four percent of men who use vardenafil.

• Levitra is manufactured by Bayer Pharmaceuticals.
• It is available in both tablet and generic forms.
• The drug can be prescribed for men aged 18 and above.
• Levitra's active ingredient is vardenafil hydrochloride.
• It helps achieve erections suitable for sexual activity.
• Taking fatty meals may delay the drug's onset.
• Levitra does not protect against sexually transmitted diseases.
• Use with caution if you have heart conditions.
• It is essential to inform your doctor of all medications.
• Vardenafil does not cure ED; it manages symptoms.

You can usually treat indigestion (and resulting heartburn) from vardenafil and other oral ED drugs with over-the-counter medications and antacids. If you have frequent or severe indigestion from vardenafil, talk to your healthcare provider for medical advice. Nausea is a common side effect of many medications — and it can happen with ED drugs like vardenafil. In clinical trials, two percent of men who used Levitra to treat erectile dysfunction developed nausea.

• Vardenafil Levitra is a prescription medication for erectile dysfunction.
• It works by increasing blood flow to the penis.
• Vardenafil is marketed under the brand name Levitra.
• It typically takes about 25-60 minutes to work.
• The effects of vardenafil last up to 4-5 hours.
• It should be taken on an empty stomach for faster results.
• Common side effects include headache and flushing.
• Vardenafil is contraindicated with nitrates.
• Do not consume alcohol with vardenafil.
• Always follow your doctor's dosage instructions.

Like other vardenafil side effects, nausea is generally mild and temporary. If you feel nauseous after taking the medication, your healthcare provider may adjust your dosage, recommend taking your dose with a small amount of food, or suggest using anti-nausea medicine. Alternatively, they may suggest switching to a different type of medication to treat erectile dysfunction.

Study design

If you have a history of vision issues or any underlying NAION risk factors, tell your healthcare provider before using medications to treat ED. Vardenafil and other PDE5 inhibitors have been linked to hearing issues, including some cases of sudden hearing loss. In a report from 2010, researchers discussed a patient who experienced a sudden loss of hearing after using vardenafil to treat erectile dysfunction. This was only the second known case of hearing loss associated with vardenafil at the time the study came out — roughly seven years after the FDA (U.S. Food and Drug Administration) initially approved the medication. A small percentage of men who use vardenafil experience some degree of dizziness after taking the medication.

• Vardenafil requires a prescription; self-medicating is unsafe.
• Take Levitra approximately 60 minutes before intimacy.
• Do not take more than one dose per 24 hours.
• Symptoms like priapism need immediate medical attention.
• Levitra may cause nasal congestion or upset stomach.
• Combining vardenafil with other ED drugs increases risks.
• Alcohol can hinder the effectiveness of Levitra.
• Levitra is designed for occasional use, not daily.
• Precautions include monitoring for vision changes.
• Seek medical advice if you experience allergic reactions.

In clinical trials, around two percent of men given a typical dose of Levitra noted that they felt dizzy while the medication was active.

Side Effect	Frequency	Severity	Notes
Headache	Common	Mild to Moderate	Usually subsides over time
Flushing	Common	Mild	Occasionally persistent
Nasal Congestion	Common	Mild	Temporary
Dizziness	Less Common	Mild	Especially when standing up
Dyspepsia	Less Common	Mild	Stomach upset

Several PDE5 inhibitor medications are linked to visual disturbances.

Bibliographic details

Vardenafil pills are designed to be taken about an hour before sexual activity. You can take it with or without food, but it might work more quickly if you take it on an empty stomach. The effects can last five to seven hours, making vardenafil a great choice for single-night use compared to longer-acting ED medications. Our blog on Levitra versus Viagra compares vardenafil to another single-night-use ED medication. Serious side effects from vardenafil and other ED medications are uncommon, only affecting a small percentage of men who use them.

Does vardenafil interact with foods or drinks?

However, they can still happen, and some may require urgent medical attention when they occur. Let’s go over the more serious potential side effects and drug interactions of vardenafil, including those that call for medical help. Priapism is a painful, prolonged erection lasting four hours or longer. It happens when blood can’t flow out of the penis after an erection. When untreated, priapism can damage erectile tissues inside the penis. These may include a noticeable color tinge to your eyesight, increased sensitivity to light, or blurred vision.

Medication	Active Ingredient	Onset of Action	Duration	Typical Dose	Cost
Vardenafil (Levitra)	Vardenafil	25-60 min	Up to 5 hours	10 mg	Moderate
Sildenafil (Viagra)	Sildenafil	30-60 min	4-6 hours	50 mg	Moderate
Tadalafil (Cialis)	Tadalafil	30-60 min	Up to 36 hours	10-20 mg	Higher

Though visual disturbances are more common with other ED medications than with vardenafil, a small percentage of users report ocular side effects.

How do costs compare for vardenafil and tadalafil?

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness.

How to Take Vardenafil

Accordingly, the Agency will continue to list Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. In a small 2019 study, men who took a 40mg dose of vardenafil temporarily made more errors in a vision test (the Farnsworth–Munsell D100 color vision test) than those given a placebo. But 24 hours later, their vision was back to normal.

Pros and Cons

This makes hearing loss one of the rarest potential side effects of vardenafil. If you experience hearing loss (with or without tinnitus and dizziness) cost levitra uk after taking vardenafil, seek immediate medical treatment. Vardenafil can cause several common side effects, most of which are mild and temporary: These side effects are similar to those of other ED medications. So switching to Viagra or Cialis may not be much better. Most men who use brand-name or generic vardenafil don’t have significant issues. If you have noticeable or persistent visual disturbances while using vardenafil, contact your healthcare provider. Since vardenafil dilates blood vessels throughout the body, it can cause a temporary decrease in blood pressure. This drop is usually mild and won’t negatively affect your health if you don’t already have cardiovascular issues. If you have cardiovascular disease or currently take medication to treat high blood pressure (hypertension), using vardenafil could potentially lead to more serious health problems.