Most frequently reported adverse events, adverse events of special interest and serious adverse events
| Adverse event | Riociguat up to 2.5 mg t.i.d. (n=61) |
| Most frequently reported adverse events# | |
| Any | 58 (95) |
| Dyspepsia | 14 (23) |
| Headache | 12 (20) |
| Diarrhoea | 11 (18) |
| Dizziness | 10 (16) |
| Hypotension | 10 (16) |
| Nasopharyngitis | 9 (15) |
| Vomiting | 9 (15) |
| Peripheral oedema | 8 (13) |
| Right ventricular failure | 7 (11) |
| Adverse events of special interest | |
| Hypotension | 10 (16) |
| Symptomatic hypotension | 7 (11) |
| Haemoptysis | 1 (2) |
| Syncope | 0 (0) |
| Study drug-related adverse events# | |
| Any | 32 (52) |
| Headache | 10 (16) |
| Dyspepsia | 9 (15) |
| Hypotension | 7 (11) |
| Dizziness | 7 (11) |
| Adverse events resulting in discontinuation of study drug | |
| Any | 4 (7) |
| Right ventricular failure | 2 (3) |
| Dyspnoea | 2 (3) |
| Hypotension | 2 (3) |
| Renal failure | 1 (2) |
| Asthenia | 1 (2) |
| Serious adverse events | |
| Any | 10 (16) |
| Right ventricular failure¶,+,§ | 3 (5) |
| Abdominal pain lower | 1 (2) |
| Dyspepsia | 1 (2) |
| Asthenia | 1 (2) |
| Cholecystitis¶ | 1 (2) |
| Pneumonia | 1 (2) |
| Subdural haematoma | 1 (2) |
| Depression | 1 (2) |
| Renal failure¶ | 1 (2) |
| Interventional procedure+ | 1 (2) |
| Hypotension§ | 1 (2) |
| Study drug-related serious adverse events | |
| Any | 2 (3) |
| Right ventricular failure | 1 (2) |
| Asthenia | 1 (2) |
Data are presented as n (%). #: in >10% of patients; ¶: patient experienced three serious adverse events (right ventricular failure, cholecystitis and renal failure); +: patient experienced two serious adverse events (right ventricular failure and interventional procedure); §: patient experienced two serious adverse events (right ventricular failure and hypotension).