Zydena Adverse Reactions

The following are adverse drug reactions that occurred in clinical trials of 923 patients where Zydena 100 mg or 200 mg was administered on demand before sexual activity. In general, the adverse drug reactions were transient and their severity was mostly mild to moderate. The most common adverse drug reactions were headache and facial flushing. (See table.)

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The following adverse reactions whose causality could not be excluded and that were not identified in pre-marketing clinical studies were reported in additionally conducted clinical trials - heaviness in head, feeling cold and drowsy, palpitation, orthostatic dizziness, lethargy, ear numbness, ocular discomfort, rash, erythema, vomiting, diarrhea, dyspnea with exercise, cough, epistaxis, erection increased and hypotension.
Patients have been administered up to 200 mg once daily, and in this case, the type and frequency of adverse reactions significantly increased compared to 100 mg.
Although not reported in clinical trials of Zydena, 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 in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including Zydena. 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/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.
During post-marketing surveillance in patients taking PDE5 inhibitors including Zydena, cases of sudden decrease or loss of hearing have been reported. In some of the 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 Zydena, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Post-marketing surveillance study result of Zydena 100 mg and 200 mg: In the post-marketing surveillance study in 3,542 patients for 6 years for reexamination in Korea, the incidence of adverse reactions, regardless of causality, was 2.20% (78/3,542 patients) [90 cases], and the incidence of adverse drug reactions which the causal relationship with Zydena could not be excluded was 2.03% (72/3,542 patients) [82 cases].
Reported adverse drug reactions were flushing 1.04% (37/3,542 patients) [39 cases], headache 0.76% (27/3,542 patients) [27 cases], dizziness 0.11% (4/3,542 patients) [4 cases], nasal congestion 0.11% (4/3,542 patients) [5 cases], dyspepsia, eye redness, 0.06% each (2/3,542 patients), [2 cases], visual disorders, gastroesophageal reflux (GERD), palpitations, 0.03% each (1/3,542 patients) [1 case]. Of these events, GERD was the unexpected adverse drug reaction.