Verquvo Adverse Reactions

Summary of the safety profile: The most frequently reported adverse reaction under treatment with vericiguat was hypotension (16.4%).
Tabulated list of adverse reactions: The safety of vericiguat was evaluated in a phase III study (VICTORIA) which included a total of 2,519 patients treated with vericiguat (up to 10 mg once daily) (see Pharmacology: Pharmacodynamics under Actions). The mean duration of vericiguat exposure was 1 year and the maximum duration was 2.6 years.
The adverse reactions reported with vericiguat obtained from clinical studies are listed in the following table by MedDRA system organ class and by frequency. Frequencies are defined as 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 very rare (<1/10,000). (See Table 3.)

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Description of selected adverse reactions: Hypotension: Over the course of the VICTORIA study, the mean reduction in systolic blood pressure was approximately 1 to 2 mmHg greater in patients who received vericiguat compared with placebo. In VICTORIA, hypotension was reported in 16.4% of vericiguat-treated patients compared with 14.9% of placebo-treated patients. This includes also orthostatic hypotension that was reported in 1.3% of vericiguat-treated patients compared with 1.0% of placebo-treated patients. Symptomatic hypotension was reported in 9.1% of vericiguat-treated and 7.9% of placebo-treated patients, and was considered as a serious adverse event in 1.2% of vericiguat-treated patients and 1.5% of placebo-treated patients (see Precautions).
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.