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 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 Prescription
ATC Code C02KX05
DrugBank ID DB08931
KEGG ID D09572
MeSH ID C542595
PubChem ID 11304743
TTD Drug ID D04UKC
NDC Product Code 50419-251; 50419-250; 12527-0253; 69766-021; 12527-0254; 12527-0251; 46708-894; 50419-253; 12527-0250; 50419-254; 50419-252; 12527-0252
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cor pulmonale24.08.03.001; 22.06.01.003; 02.05.03.0010.000151%Not Available
Cough22.02.03.0010.011836%
Crying12.02.11.001; 08.01.03.005; 19.04.02.002; 17.02.05.013--Not Available
Cystitis20.03.02.002; 11.01.14.0010.000866%
Death08.04.01.0010.044581%
Decreased activity08.01.01.006; 19.11.01.0020.001155%Not Available
Dehydration14.05.05.0010.005773%
Depressed mood19.15.02.0010.001443%Not Available
Depression19.15.01.001--
Diarrhoea07.02.01.0010.019919%
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Diverticulitis11.01.07.003; 07.10.02.0010.000577%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.040414%
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.0050.001443%Not Available
Dry mouth07.06.01.0020.001732%
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.0010.012124%
Dysphagia07.01.06.0030.003175%
Dysphonia17.02.08.004; 22.02.05.005; 19.19.03.002--
Dyspnoea22.02.01.004; 02.01.03.0020.042146%
Dyspnoea at rest22.02.01.025; 02.01.03.0070.000866%Not Available
Dyspnoea exertional22.02.01.005; 02.01.03.0030.007794%Not Available
Dysuria20.02.02.0020.001155%
Eating disorder19.09.01.008; 14.03.01.0080.000577%Not Available
Emotional disorder19.04.02.0050.000577%Not Available
Epilepsy17.12.03.002--Not Available
Epistaxis24.07.01.005; 22.04.03.0010.005485%
Erythema23.03.06.001--Not Available
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.0020.001155%
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