Quick answers
- What is Riociguat used for?
- The FDA-approved label (Adempas, Bayer HealthCare Pharmaceuticals Inc., August 13, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Riociguat have a boxed warning?
- Yes. The FDA label for Adempas has a boxed warning (“WARNING: EMBRYO-FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Riociguat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Riociguat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Riociguat?
- 2 companies list prescription products of Riociguat in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc. and Zydus Pharmaceuticals USA Inc..
What Riociguat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Adempas, Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: EMBRYO-FETAL TOXICITY
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Adempas |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bayer HealthCare Pharmaceuticals Inc.5 products
- Zydus Pharmaceuticals USA Inc.5 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204819 ADEMPAS | Bayer Hlthcare | October 8, 2013 | 14, latest August 4, 2026 2026: REMS · 2026: REMS · 2021: Labeling |
Generic approvals (1)
- ANDA211135Msn · September 1, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Adempas, Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →