Avetra Adverse Reactions

The adverse reactions reported with Vardenafil tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in ≥10% of patients is headache.
Adverse reactions are listed 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) and not known (can not be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The following adverse reactions have been reported: See table.

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Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
At the 20 mg dose Vardenafil tablets, elderly (≥65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years old). In general, the incidence of adverse reactions (especially "dizziness") has been shown to be slightly higher in patients with a history of hypertension.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.