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)
Intervertebral disc disorder15.10.01.0030.000469%-
Sensation of foreign body08.01.09.0020.000325%-
Drug intolerance08.06.01.0130.002599%-
Obstructive airways disorder22.03.01.0110.000181%-
Renal impairment20.01.03.010---
Sinus disorder22.04.06.002--
Poor quality sleep17.15.04.002; 19.02.05.0050.000120%-
Gastrointestinal inflammation07.08.03.0070.000181%-
Chronic kidney disease20.01.03.0170.000361%
Pulmonary arterial hypertension22.06.01.002; 24.08.03.0030.002166%-
Adverse reaction08.06.01.0180.000120%-
Gastrointestinal sounds abnormal07.01.01.0020.000265%-
Oropharyngeal discomfort07.05.05.008; 22.12.03.0150.000120%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Acute kidney injury20.01.03.016--
Toxicity to various agents12.03.01.046---
Frustration tolerance decreased19.04.02.0160.000120%-
Abnormal loss of weight14.03.02.019---
Cardiac failure chronic02.05.01.0090.000241%-
Chronic respiratory failure14.01.04.005; 22.02.06.0050.000181%-
Mesenteric vein thrombosis07.15.02.013; 24.01.08.0040.000120%-
Urinary bladder haemorrhage20.03.01.023; 24.07.01.0860.000181%-
Terminal state08.01.03.0790.000120%-
Diastolic hypotension24.06.03.012---
Heart valve incompetence02.07.02.0030.000120%-
Seizure like phenomena17.12.03.0300.000120%-
Pulmonary pain22.12.01.0100.000181%-
Internal haemorrhage24.07.01.0720.000301%-
Hemianaesthesia17.02.06.0430.000120%-
Critical illness08.01.03.0650.000241%-
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