LEVITRA is a prescription medicine used for the treatment of erectile dysfunction (ED) in men.
Important Safety Information
- LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.
Do not take LEVITRA if you:
- Take any medications called “nitrates” (often used to control chest pain, also known as angina), or if you use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. Nitrates may cause abnormally low blood pressure and LEVITRA may increase that risk
- Take riociguat (Adempas®), a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension
- Have been told by your healthcare provider not to have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease
- Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA.
- LEVITRA does not protect a man or his partner from sexually transmitted diseases, including HIV.
Before taking LEVITRA, tell your doctor about all your medical problems, including if you:
- have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack—ask your doctor if it is safe for you to have sexual activity
- have low blood pressure or have high blood pressure that is not controlled
- have pulmonary hypertension
- have had a stroke
- have had a seizure
- or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
- have liver problems
- have kidney problems and require dialysis
- have retinitis pigmentosa, a rare genetic (runs in families) eye disease
- have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION)
- have stomach ulcers
- have a bleeding problem
- have a deformed penis shape or Peyronie’s disease
- have had an erection that lasted more than 4 hours
- have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
- have hearing problems
- Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. LEVITRA and other medicines may affect each other. Especially tell your doctor if you take any of the following:
- Ritonavir (Norvir®) or indinavir sulfate (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®), or other HIV protease inhibitors
- Ketoconazole or itraconazole (such as Nizoral® or Sporanox®)
- Erythromycin or clarithromycin
- Tell your doctor if you take alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly, leading to fainting.
- Contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider
- Tell your doctor if you take medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. Patients taking these drugs should not use LEVITRA.
- Do not use LEVITRA with other medicines or treatments for ED.
- Take LEVITRA exactly as your doctor prescribes. LEVITRA comes in different doses (2.5 mg, 5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. Do not take more than one tablet of LEVITRA per day. Doses should be taken at least 24 hours apart. Some men can take only a low dose of LEVITRA because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you.
- If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA
- If you have prostate problems or high blood pressure for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of LEVITRA
- If you are taking certain other medicines, your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3-day) period
- The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain.
LEVITRA may uncommonly cause:
- An erection that lasts more than 4 hours. Get medical help right away to avoid lasting damage to your penis
- Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green
- In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes or a sudden decrease or loss in hearing, sometimes with ringing in the ears and dizziness. It is uncertain whether PDE5 inhibitors directly cause these events, or if it can be attributed to other diseases or medications, to other factors, or to a combination of factors. If you experience sudden decrease or loss of vision or hearing, stop taking LEVITRA and contact a doctor right away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the Patient Information and discuss it with your doctor.
The physician Prescribing Information is also available.