Riociguat is a soluble guanylate cyclase stimulator 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. MedsAcross supplies Riociguat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Adempas is a soluble guanylate cyclase (sGC) stimulator 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. • Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.
Source: US FDA prescribing information
Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO). When NO binds to sGC, the enzyme catalyzes synthesis of the signaling molecule cyclic guanosine monophosphate (cGMP). Intracellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis and inflammation. Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of nitric oxide and insufficient stimulation of the NO-sGC-cGMP pathway. Riociguat has a dual mode of action. It sensitizes sGC to endogenous NO by stabilizing the NO-sGC binding. Riociguat also directly stimulates sGC via a different binding site, independently of NO. Riociguat stimulates the NO-sGC-cGMP pathway and leads to increased generation of cGMP with subsequent vasodilation.
Source: US FDA prescribing information
• Initiate treatment at 1 mg taken three times a day. • For patients who may not tolerate the hypotensive effect of Adempas, consider a starting dose of 0.5 mg, three times a day. • Increase dosage by 0.5 mg at intervals of no sooner than 2-weeks as tolerated to a maximum of 2.5 mg three times a day. • Tablets may be crushed and mixed with water or soft foods for patients who have difficulty swallowing.
Source: US FDA prescribing information
• Pregnancy. • Use with nitrates or nitric oxide donors in any form. • Use with PDE inhibitors. • Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. • Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Source: US FDA prescribing information
Boxed warning (embryo-fetal toxicity): Adempas is contraindicated for use during pregnancy because it may cause fetal harm based on animal data. Exclude pregnancy prior to the start of treatment with Adempas. Advise use of effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with Adempas. If pregnancy is detected, discontinue Adempas as soon as possible. • Symptomatic hypotension. • Bleeding. • Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment
Source: US FDA prescribing information
The following serious adverse reactions are discussed elsewhere in the labeling: • Embryo-Fetal Toxicity • Hypotension • Bleeding Adverse reactions occurring more frequently (≥3%) on Adempas compared to placebo are headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux, and constipation.
Source: US FDA prescribing information
• Strong CYP and P-gp/BCRP inhibitors: For patients receiving strong CYP and P-gp/BCRP inhibitors, consider a starting dose of 0.5 mg three times a day. Monitor for hypotension. • Antacids: Separate administration by at least 1 hour.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
10 presentations of Riociguat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Adempas 0.5 mg tabletOral | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Adempas 1 mg tabletOral | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Adempas 1.5 mg tabletOral | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Adempas 2 mg tabletOral | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Adempas 2.5 mg tabletOral | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
| Riociguat 0.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Riociguat 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Riociguat 1.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Riociguat 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Riociguat 2.5 mg tabletOralGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Riociguat in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 10 presentations of Riociguat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Riociguat, including Adempas.
Yes. The US FDA first approved Riociguat on 8 October 2013, according to Drugs@FDA.
Yes. Riociguat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Riociguat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Riociguat is classified under ATC code C02KX05 (Riociguat).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.