Levitra was administered to over 9500 patients during clinical trials worldwide (Status: March 2004). It was generally very well tolerated.
Adverse events were generally transient and mild to moderate in nature.
Placebo-Controlled Clinical Trials: When Levitra was taken as recommended, the following adverse drug reactions were reported in placebo-controlled clinical trials: Adverse Drug Reactions (ADRs) reported by ≥1% of patients treated with Levitra and more frequent on drug than placebo in all placebo-controlled trials of 5, 10 and 20 mg Levitra. (See table).
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All Clinical Trials: The following adverse drug reactions were reported in patients given Levitra which are WHO critical terms (special attention warranted because of possible association with serious disease states) or ADRs of otherwise clinical relevance are listed: Category of Frequency: Very Common (≥10%): Nervous: Headache. Vascular: Flushing.
Common (≥1% to <10%): Gastrointestinal: Dyspepsia, nausea. Nervous: Dizziness. Respiratory: Rhinitis.
Uncommon (≥0.1% to <1%): Nervous: Somnolence. Vascular: Hypertension, hypotension. Eye: Increased lacrimation, visual disturbances.
Rare (≥0.01% to <0.1%): Nervous: Syncope. Reproductive: Increased erection.
Post-Marketing: Myocardial infarction (MI) has been reported in temporal association with the use of vardenafil and sexual activity, but it is not possible to determine whether MI is related directly to vardenafil, or to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these factors.
Non-arteric 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 PDE type 5 inhibitors, including Levitra. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including: low cup to disc ratio ("crowded disc"), age >50 years, 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.
Visual disturbances including vision loss (temporary or permanent) have been reported rarely post-marketing in temporal association with the use of PDE type 5 inhibitors, including Levitra. 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 to other factors.
From the post-marketing experience with another drug of this class, the following serious adverse events have been reported in temporal association with the use of this other PDE5 inhibitor:
Cardiovascular System: Cerebrovascular hemorrhage, pulmonary hemorrhage, subarachnoid and intracerebral hemorrhages, sudden cardiac death, transient ischemic attack, ventricular arrhythmia.
Nervous System: Seizure.
Urogenital System: Hematuria.
Special Senses: Decreased vision/temporary loss of vision.