Levitra Adverse Reactions
- abdominal pain
- anaphylactoid reactions
- angina
- arthralgia
- asthenia
- back pain
- blurred vision
- chest pain (unspecified)
- conjunctivitis
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dyspepsia
- dysphagia
- dyspnea
- ejaculation dysfunction
- epistaxis
- esophagitis
- flushing
- gastritis
- gastroesophageal reflux
- headache
- hypertension
- hypertonia
- hypotension
- insomnia
- lacrimation
- laryngeal edema
- myalgia
- myocardial infarction
- nausea/vomiting
- ocular pain
- orthostatic hypotension
- palpitations
- paresthesias
- pharyngitis
- photophobia
- photosensitivity
- priapism
- pruritus
- rash (unspecified)
- rhinitis
- sinus tachycardia
- sinusitis
- syncope
- tinnitus
- vertigo
- visual impairment
- xerostomia
Levitra Adverse Reactions
During controlled and uncontrolled clinical trials of vardenafil, over 4430 men (mean age 56, range 18 - 89 years) received vardenafil. Of these patients, 2200 were treated for 6 months or longer and 880 were treated for at least 1 year. Adverse reactions occurring in >= to 2% of patients taking vardenafil and more frequent than placebo included headache (15% vs 4%), flushing (11% vs 1%), rhinitis (9% vs 3%), dyspepsia (4% vs 1%), sinusitis (3% vs 1%), flu-like syndrome (3% vs 2%), dizziness (2% vs 1%), increased creatine kinase (2% vs 1%), nausea/vomiting (2% vs 1%). The incidences of headache, flushing, dyspepsia, nausea, and rhinitis appear to increase as the dose increases. Back pain was reported in 2% of patients compared to 1.7% for placebo. The discontinuation rate due to adverse reactions in placebo-controlled trials was 3.4% for vardenafil and 1.1% for placebo.
Adverse reactions that occurred less frequently (<2%) with vardenafil include anaphylactoid reactions (including laryngeal edema), asthenia, facial edema, pain (unspecified), tinnitus, angina pectoris, chest pain (unspecified), hypertension, hypotension, myocardial ischemia, myocardial infarction, orthostatic hypotension, palpitations, syncope, sinus tachycardia, abdominal pain, abnormal liver function tests, diarrhea, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTP increased, vomiting, xerostomia, arthralgia, myalgia, neck pain, hypertonia, hypesthesia, insomnia, paresthesias, somnolence (drowsiness), vertigo, dyspnea, epistaxis, pharyngitis, photosensitivity reaction, pruritus, rash (unspecified), sweating (diaphoresis), and ejaculation dysfunction. The effects of vardenafil on blood pressure were evaluated using single 20 mg doses of vardenafil in patients with erectile dysfunction. Vardenafil caused a mean maximum decrease in supine blood pressure of 7 mm Hg systolic and 8 mm Hg diastolic (compared to placebo), accompanied by a mean maximum increase in heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. After multiple dosing, the effects of vardenafil on blood pressure were similar on Day 31 as on Day 1. Vardenafil may add to the hypotensive effects of antihypertensive agents.
The effects of vardenafil on QT prolongation were evaluated in 59 healthy males using moxifloxacin (400 mg) as an active control. Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produced similar increases in QTc interval (e.g., 4 - 6 msec calculated by individual QT correction) as moxifloxacin (7 msec). The potential effect of vardenafil on the QT interval should be considered when prescribing the drug; the manufacturer recommends against drug use in certain patient groups with risk factors for QT prolongation (see Precautions).
Prolonged erections greater than 4 hours and priapism have been reported rarely with PDE5 inhibitors, including vardenafil.
Phosphodiesterase inhibitors, such as vardenafil, inhibit PDE6 in retinal rods and cones, which are involved in phototransduction in the retina. Changes in color vision were reported in < 2% of patients and occurred as a result of PDE6 inhibition. In single dose studies, dose-related impairment of color discrimination (blue/green) as well as reductions in electroretinogram (ERG) b-wave amplitudes were noted; peak effects were noted near the time of peak plasma levels (approximately 1 hour after dosing). These effects diminished but were still present 6 hours after administration. In a single dose study of 25 healthy males, vardenafil 40 mg did not alter visual acuity, intraocular pressure, or funduscopic and slit lamp findings. Other ophthalmic adverse reactions occurring in <2% of patients receiving vardenafil include blurred vision, chromatopsia, conjunctivitis (increased redness of the eye), dim vision, glaucoma, ocular pain, photophobia, visual impairment, and watery eyes (lacrimation). Post-marketing reports have included cases of visual disturbances including retinal vein occlusion, visual field defects, reduced visual acuity, and loss of vision (temporary or permanent). Nonarteritic ischemic optic neuropathy (NAION) has also been reported rarely in patients using phosphodiesterase type 5 (PDE5) inhibitors. It is thought that the vasoconstrictive effect of phosphodiesterase inhibitors may decrease blood flow to the optic nerve, especially in patients with a low cup to disk ratio. Symptoms, such as blurred vision and loss of visual field in one or both eyes, are usually reported within 24 hours of use. Most, but not all, of these patients who reported this adverse effect had underlying anatomic or vascular risk factors for development of NAION. These risk factors include, but are not limited to: low cup to disc ratio (’crowded disc’), age over 50 years, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. Additionally, two patients had retinal detachment and one patient had hypoplastic optic neuropathy. It is not yet possible to determine if these adverse events are related directly to the use of PDE5 inhbitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors.
[ Last revised: 7/11/2005 9:45:00 AM ]
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