Levitra Side Effects
Generic name: vardenafil
Please note - some side effects for Levitra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional By body system
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Side Effects of Levitra - for the consumer
Levitra
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Levitra:
Seek medical attention right away if any of these SEVERE side effects occur when using Levitra:Dizziness; flushing; headache; heartburn; stuffy or runny nose; upset stomach.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or muscle pain; chest pain; fainting; fast, slow, or irregular heartbeat; memory loss; prolonged, painful erection; ringing in the ears; severe or persistent dizziness; severe or persistent vision changes or vision loss; sudden hearing loss.
For the professional
Levitra
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 events were reported.
| Adverse Event | Percentage of Patients Reporting Event | |
| Placebo N = 1199 |
Levitra N = 2203 |
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| Headache | 4% | 15% |
| Flushing | 1% | 11% |
| Rhinitis | 3% | 9% |
| Dyspepsia | 1% | 4% |
| Accidental Injury† | 2% | 3% |
| Sinusitis | 1% | 3% |
| Flu Syndrome | 2% | 3% |
| Dizziness | 1% | 2% |
| Increased Creatine Kinase | 1% | 2% |
| Nausea | 1% | 2% |
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 events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of Levitra. The following section identifies additional, less frequent events (<2%) reported during the clinical development of Levitra. Excluded from this list are those events 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: anaphylactic reaction (including laryngeal edema),
asthenia, face edema, pain
AUDITORY: sudden decrease or loss of hearing, tinnitus
CARDIOVASCULAR: angina pectoris, chest pain, hypertension,
hypotension, myocardial ischemia, myocardial infarction, palpitation,
postural hypotension, syncope, tachycardia
DIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, dry
mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTP
increased, vomiting
MUSCULOSKELETAL: arthralgia, back pain, myalgia, neck pain
NERVOUS: hypertonia, hypesthesia, insomnia, paresthesia, somnolence,
vertigo
RESPIRATORY: dyspnea, epistaxis, pharyngitis
SKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash,
sweating
OPHTHALMOLOGIC: abnormal vision, blurred vision, chromatopsia,
changes in color vision, conjunctivitis (increased redness of the eye), dim
vision, eye pain, glaucoma, photophobia, watery eyes
UROGENITAL: abnormal ejaculation, priapism (including prolonged or
painful erections)
By body system
Cardiovascular side effects
Cardiovascular side effects have included flushing (vasodilation) in 11% and dizziness in 2% of patients. Consistent with its known effects on the nitric oxide/cGMP pathway, use of sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently taking organic nitrates is considered contraindicated. The following cardiovascular side effects have been associated with the use of sildenafil in less than 2% of patients: angina pectoris, chest pain, hypertension, hypotension, myocardial ischemia, palpitation, postural hypotension, syncope, and tachycardia. Congenital or Acquired QT Prolongation: In a study on the effect of vardenafil on QT interval in 59 healthy males, therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.
Dermatologic side effects
Dermatologic side effects have been reported in less than 2% of patients and include photosensitivity reaction, pruritus, rash, and sweating,
Gastrointestinal side effects
Gastrointestinal side effects have included dyspepsia (4%) and nausea (2%). Less common gastrointestinal complaints have included abdominal pain, diarrhea, dry mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux and vomiting (less than 2% of patients).
Hepatic side effects
Hepatic side effects have included increased creatine kinase (2%). Other hepatic side effects (less than 2%) have included other abnormal liver function tests.
Genitourinary side effects
Genitourinary side effects have been reported in less than 2% of patients and included abnormal ejaculation and priapism (including prolonged or painful erections). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Musculoskeletal side effects
Musculoskeletal side effects have been reported in less than 2% of patients. They include arthralgia, back pain, myalgia, and neck pain.
Nervous system side effects
Nervous system side effects have included headache (16%) and dizziness (2%). Other nervous system side effects reported in less than 2% of patients have included hypertonia, hypesthesia, insomnia, paresthesia, somnolence, and vertigo. Seizure and seizure recurrence have been reported postmarketing in temporal association with vardenafil. Transient global amnesia has also been reported postmarketing in temporal association with vardenafil.
Ocular side effects
Ocular side effects have been reported in less than 2% of patients and have included abnormal vision, blurred vision, chromatopsia, changes in color vision, conjunctivitis, dim vision, eye pain, glaucoma, photophobia, and watery eyes.
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 phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil.
Respiratory side effects
Respiratory system side effects have included rhinitis (9%) and sinusitis (3%). Other respiratory system side effects that occurred in more than 2% of patients have included dyspnea, epistaxis, and pharyngitis.
Other side effects
Other side effects have included tinnitus. Cases of sudden decrease or loss of hearing 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.
General side effects
General side effects have included accidental injury (3%) and flu syndrome (3%). Other side effects occurring in less than 2% of patients include: anaphylactic reaction (including laryngeal edema), asthenia, face edema and pain.
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