Summary of the safety profile: The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see Pharmacology: Pharmacodynamics under Actions).
Most of the adverse reactions are caused by relaxation of smooth muscle cells in vasculature or the gastrointestinal tract.
The most commonly reported adverse reactions, occurring in ≥10% of patients under Adempas treatment (up to 2.5 mg three times daily), were headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhoea and vomiting.
Serious haemoptysis and pulmonary haemorrhage, including cases with fatal outcome have been observed in patients with CTEPH or PAH treated with Adempas (see Precautions).
The safety profile of Adempas in patients with CTEPH and PAH appeared to be similar, therefore adverse reactions identified from placebo controlled 12 and 16 weeks clinical studies are presented as pooled frequency in the table listed as follows (see table 6).
Tabulated list of adverse reactions: The adverse reactions reported with Adempas 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) and uncommon (≥ 1/1,000 to < 1/100). (See Table 6.)
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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.