In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Tabulated list of adverse reactions: The table as follows lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See table.)
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Description of selected adverse reactions observed with other PDE5 inhibitors: Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported ina small number of post-marketing and clinical trial cases with other PDE5 inhibitors. No cases were reported during clinical trials of avanafil (see Precautions).
Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors. No cases were reported during clinical trials of avanafil.
Haematuria, haematospermia and penile haemorrhage has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
Hypotension has been reported post-marketing with other PDE5 inhibitors, and dizziness, a symptom commonly caused by lowered blood pressure, has been reported in clinical trials with avanafil (see Interactions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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