ADVERSE REACTIONS
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 (see Table 5).
Table 5: Adverse Events Reported By ≥2% of Patients Treated with LEVITRA and More Frequent on Drug than Placebo in Fixed and Flexible
Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil | Adverse Event | Percentage of Patients Reporting Event |
| Placebo
N = 1199 | LEVITRA
N = 2203 |
| 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)
POST-MARKETING EXPERIENCE
Ophthalmologic
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA. 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. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients).
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 post-marketing experience. It is not possible to determine whether these events are related directly to the use of LEVITRA.
Neurologic
Seizure and seizure recurrence have been reported post-marketing in temporal association with Levitra.
Otologic
Cases of sudden decrease or loss of hearing have been reported post-marketing in temporal association with the use of PDE5 inhibitors, including LEVITRA. 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 LEVITRA, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients).
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