Udenafil

Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukemia).

Udenafil is not indicated for use in women.

Udenafil is not indicated for use in women.

As adverse effects such as dizziness, blurred vision were reported in clinical trials, patients should be careful when driving and operating machinery.

Udenafil was administered to 923 patients during Korean nationwide clinical trials. In general, most adverse events were temporal and its severity was mild to moderate. The most common adverse events were flushing and headache.

The following adverse events were reported in clinical trials:

In additional clinical studies, drug related adverse events unconfirmed before marketing are head discomfort, feeling cold, feeling dim, palpitation, postural dizziness, somnosis, ear daze, eye discomfort, rash, erythema, diarrhea, dyspnea, respiratory distress in exercise, cough, nasal hemorrhage, increase erection, and hypotension.

In clinical trials of single doses up to 200 mg per day, the types of adverse events and incidence rates were significantly increased from those seen at 100 mg dose level.

Not reported in the clinical studies, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely in post-marketing surveillance (PMS) studies of PDE5 inhibitors. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing 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.

A sudden hearing loss or deafness in one or both ears, which might be in temporal association with the use of PDE5 inhibitors, has been rarely reported in post-marketing surveillance (PMS). Even though, it is reported that the disease status and other factors will be related to adverse events about hearing in a few cases, medical tracing data which can be aware of that relationship are not confirmed in major cases. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying deafness risk factors, to a combination of these factors, or to other factors.