Medical Editor: John P. Cunha, DO, FACOEP
What Is Levitra?
Levitra (vardenafil hydrochloride) is an erectile dysfunction agent that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction (impotence).
What Are Side Effects of Levitra?
Levitra may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- chest pain or pressure,
- pain spreading to your jaw or shoulder,
- nausea,
- sweating,
- vision changes,
- sudden vision loss,
- erection that is painful or lasts longer then 4 hours,
- ringing in your ears,
- sudden hearing loss,
- irregular heartbeat,
- swelling in your hands, ankles, or feet,
- shortness of breath,
- lightheadedness,
- seizure
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Levitra include:
- headache,
- flushing (warmth or redness in your face, neck, or chest),
- runny or stuffy nose,
- stomach upset,
- heartburn,
- dizziness,
- back pain, or
- nausea.
In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using Levitra and get medical help right away, or permanent problems could occur. Tell your doctor if you have serious side effects of Levitra including sudden vision loss; ringing in your ears, or sudden hearing loss; chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; irregular heartbeat; swelling in your hands, ankles, or feet; shortness of breath; vision changes; lightheadedness, fainting; or seizures (convulsions).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Levitra
The recommended starting dose of Levitra is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day.
What Drugs, Substances, or Supplements Interact with Levitra?
Levitra may interact with nitrate drugs for chest pain or heart problems, other medications for erectile dysfunction, conivaptan, diclofenac, imatinib, isoniazid, antidepressants, antibiotics, antifungals, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, heart rhythm medicine, or HIV/AIDS medicine. Tell your doctor all medications you use.
Levitra During Pregnancy and Breastfeeding
This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have questions.
Additional Information
Our Levitra (vardenafil hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
SLIDESHOW
Erectile Dysfunction (ED) Causes and Treatment See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop taking vardenafil and get emergency medical help if you have:
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- vision changes or sudden vision loss; or
- erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis).
Stop using vardenafil and call your doctor at once if you have:
- ringing in your ears, or sudden hearing loss;
- irregular heartbeat;
- swelling in your hands, ankles, or feet;
- shortness of breath;
- a light-headed feeling, like you might pass out;
- penis erection that is painful or lasts 4 hours or longer; or
- seizure (convulsions).
Common side effects may include:
- flushing (warmth, redness, or tingly feeling);
- stuffy nose, sinus pain;
- headache, dizziness;
- 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.
QUESTION
Erectile dysfunction (ED) is… See AnswerSIDE EFFECTS
The following serious adverse reactions with the use of LEVITRA (vardenafil) are discussed elsewhere in the labeling:
- Cardiovascular Effects [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS ]
- Effects on Eye [see WARNINGS AND PRECAUTIONS ]
- Sudden Hearing Loss [see WARNINGS AND PRECAUTIONS]
- QT Prolongation [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.
In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo.
When LEVITRA was taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1).
Table 1: Adverse Reactions Reported By ≥2% of Patients Treated with LEVITRA and More Frequent on Drug
than Placebo in Fixed and Flexiblea Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil
| Adverse Reaction | Percentage of Patients Reporting Reactions | |
| Placebo N = 1199 |
LEVITRA N = 2203 |
|
| Headache | 4% | 15% |
| Flushing | 1% | 11% |
| Rhinitis | 3% | 9% |
| Dyspepsia | 1% | 4% |
| Accidental Injuryb | 2% | 3% |
| Sinusitis | 1% | 3% |
| Flu Syndrome | 2% | 3% |
| Dizziness | 1% | 2% |
| Increased Creatine Kinase | 1% | 2% |
| Nausea | 1% | 2% |
|
a) Flexible dose studies started all patients at LEVITRA 10 mg and allowed decrease in dose to 5 mg or increase in dose to 20 mg based on side effects and efficacy. b) All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury. |
||
Back pain was reported in 2.0% of patients treated with LEVITRA and 1.7% of patients on placebo
Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of LEVITRA.
All Vardenafil Studies
LEVITRA film-coated tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18.89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.
In the placebo-controlled clinical trials for LEVITRA film-coated tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.
The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of LEVITRA film-coated tablets and vardenafil orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:
Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain
Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension
Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases
Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia
Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure
Respiratory: dyspnea, sinus congestion
Skin and appendages: erythema, rash
Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis
Urogenital: increase in erection, priapism
Postmarketing Experience
The following adverse reactions have been identified during post approval use of LEVITRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Ophthalmologic
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of vardenafil.
Neurologic
Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.
Otologic
Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see PATIENT INFORMATION].
Read the entire FDA prescribing information for Levitra (Vardenafil HCl)
© Levitra Patient Information is supplied by Cerner Multum, Inc. and Levitra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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