Vardenafil FAQs
In a report from 2010, researchers discussed a patient who experienced a sudden loss of hearing after using vardenafil to treat erectile dysfunction.
- 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.
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. This makes hearing loss one of the rarest potential side effects of vardenafil. If you experience hearing loss (with or without tinnitus and dizziness) after taking vardenafil, seek immediate medical treatment.
| Condition | Caution | Reason |
|---|---|---|
| Use with Nitrates | Contraindicated | Risk of severe hypotension |
| Severe Liver Impairment | Use with caution | Metabolism may be affected |
| Heart Disease | Consult doctor before use | Potential cardiovascular risks |
| Retinitis Pigmentosa | Avoid | Possible risk of vision loss |
| Hypotension or Hypertension | Caution or avoid | Blood pressure effects |
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.
Generic Vardenafil: Availability and Manufacturers
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. There have been rare reports of priapism from all medications used to treat erectile dysfunction, including vardenafil. Still, levitra price list priapism is a serious medical issue.
What are common drug interactions for vardenafil and tadalafil?
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. 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. 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. 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Soft Tabs | 20mg | 360 + 20 Pills | 682.21€ 649.72€ | |
| Levitra Professional | 20mg | 180 + 4 Pills | 502.31€ 478.39€ | |
| Levitra Generic | 20mg | 120 + 10 Pills | 224.15€ 213.48€ | |
| Levitra Generic | 40mg | 20 Pills | 67.56€ 64.34€ | |
| Levitra Generic | 10mg | 120 + 10 Pills | 178.59€ 170.09€ | |
| Levitra Professional | 20mg | 20 Pills | 101.00€ 96.19€ | |
| Levitra Generic | 10mg | 60 + 6 Pills | 112.98€ 107.60€ | |
| Levitra Original | 20mg | 120 + 8 Pills | 528.19€ 503.04€ | |
| Levitra Generic | 10mg | 180 + 10 Pills | 246.74€ 234.99€ | |
| Levitra Generic | 10mg | 10 Pills | 28.93€ 27.55€ | |
| Levitra Original | 20mg | 12 Pills | 81.99€ 78.09€ | |
| Levitra Generic | 20mg | 30 + 4 Pills | 70.59€ 67.23€ | |
| Levitra Generic | 40mg | 120 + 8 Pills | 302.37€ 287.97€ | |
| Levitra Generic | 20mg | 180 + 10 Pills | 293.10€ 279.14€ |
Since the medication has a moderate half-life, it’s rare for this side effect to last more than five hours.
- 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.
If you get severe headaches, it’s best to talk to your healthcare provider.
Implications of the review for practice and research
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. 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.
Other Medical Problems
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®. 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.
Possible Side Effects of Vardenafil
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. 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. They may suggest adjusting your dosage or using over-the-counter medication to reduce the severity of your headaches.
| 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 |
Our guide to dealing with headaches from ED medications has more tips.
- 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.
Flushing is the second-most common side effect of vardenafil. In clinical trials, 11 percent of men who used the medication experienced it, compared to just one percent of those who got a placebo.
Prescription Status: Rx-Only vs. OTC
FDA-2022-P-2060), under 21 CFR 10.30, requesting that the Agency determine whether Levitra (vardenafil hydrochloride) oral tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the 5 mg and 10 mg strengths, those strengths have also been discontinued. On our own initiative, we have also determined whether those strengths were withdrawn for safety or effectiveness reasons. 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.
Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy
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. 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.
Study designs of evaluations included in the review
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. 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. Flushing may develop due to the medication’s effects on blood vessels.
Warnings & Precautions
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs.
Vardenafil Levitra ®️
FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, are ( printed page 27902) the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially approved on August 19, 2003.
How were differences between studies investigated?
Levitra is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. In letters dated September 26, 2019, September 24, 2020, and September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc. notified FDA that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, respectively, were being discontinued, and FDA moved the drug products to the “Discontinued Drug Product List” section of the Orange Book. Respira Therapeutics, Inc. submitted a citizen petition dated August 29, 2022 (Docket No. 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.
Section snippets
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. 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.