Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Riociguat
Drug ID BADD_D01948
Description Riociguat is a soluble guanylate cyclase (sGC) agonist approved in the USA, Europe and several other regions for patients with group I PAH (pulmonary arterial hypertension) in WHO FC II or III; and for the treatment of patients with inoperable CTEPH (chronic thromboembolic pulmonary hypertension), or persistent/recurrent PH (pulmonary hypertension) after pulmonary endarterectomy in WHO FC II or III. Riociguat is marketed under the brand Adempas® by Bayer HealthCare Pharmaceuticals. Treatment with riociguat costs USD $7,500 for 30 days of treatment.
Indications and Usage Riociguat is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class. Riociguat is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening. Efficacy was shown in patients on Riociguat monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%).
Marketing Status approved
ATC Code C02KX05
DrugBank ID DB08931
KEGG ID D09572
MeSH ID C542595
PubChem ID 11304743
TTD Drug ID D04UKC
NDC Product Code 12527-0254; 12527-0252; 50419-253; 69766-021; 50419-252; 12527-0253; 12527-0251; 50419-250; 50419-254; 12527-0250; 50419-251
UNII RU3FE2Y4XI
Synonyms riociguat | BAY 63-2521 | BAY-63-2521 | Adempas
Chemical Information
Molecular Formula C20H19FN8O2
CAS Registry Number 625115-55-1
SMILES CN(C1=C(N=C(N=C1N)C2=NN(C3=C2C=CC=N3)CC4=CC=CC=C4F)N)C(=O)OC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Localised oedema02.05.04.006; 08.01.07.011; 14.05.06.0090.000361%
Weight fluctuation14.03.02.0020.000120%-
Nocturnal dyspnoea02.11.05.009; 22.02.01.0190.000120%-
General physical health deterioration08.01.03.0180.001372%-
Balance disorder08.01.03.081; 17.02.02.0070.000806%-
Musculoskeletal chest pain15.03.04.012; 22.09.01.0010.000120%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000265%
Exercise tolerance decreased08.01.03.0360.000566%-
Ear discomfort04.03.01.005---
Respiratory tract congestion22.02.07.0030.000181%-
Musculoskeletal discomfort15.03.04.001---
Cardiac discomfort02.11.04.0010.000120%-
Increased viscosity of bronchial secretion22.12.01.0030.000120%-
Haemorrhoidal haemorrhage07.15.03.002; 24.10.02.0010.000120%
Haemorrhage24.07.01.002---
Pulmonary mass22.02.07.004---
Paranasal sinus hypersecretion22.04.06.0040.000409%-
Ocular icterus01.06.04.007; 06.08.03.009; 09.01.01.0070.000120%-
Angiopathy24.03.02.007---
Jugular vein distension02.11.04.011; 24.03.04.0050.000325%-
Adverse event08.06.01.0100.002250%-
Cardiac disorder02.11.01.0030.000963%-
Feeding disorder14.03.02.003; 19.09.01.0030.000445%-
Embolism24.01.01.0090.000301%
Infestation11.09.01.001; 23.11.01.002---
Intra-abdominal haemorrhage07.12.02.008; 12.01.17.011; 24.07.02.0350.000120%
Mediastinal disorder22.09.03.001---
Spinal disorder15.02.04.0230.000120%-
Decreased appetite08.01.09.028; 14.03.01.005--
Gastrointestinal ulcer07.04.04.0020.000120%-
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