Prescription medicine
Riociguat Brand names: Adempas
Riociguat (Adempas) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the riociguat FDA label on DailyMed (effective August 13, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 204819 record on Drugs@FDA; every riociguat label on DailyMed.
Highlights of the record
FDA label of August 13, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY.
Adempas is contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1) ]. 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 [see Dosage and Administration (2.3), Warnings and Precautions (5.1), and Use in Specific Populations (8.3) ]. If pregnancy is detected, discontinue Adempas as soon as possible [see Warnings and Precautions (5.1) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning Based on animal data, Adempas may cause fetal harm if used during pregnancy. ( 4.1 , 5.1 , 8.1 ) Exclude pregnancy before start of treatment Use effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with Adempas. ( 2.3 , 5.1 , 8.6 ) When pregnancy is detected, discontinue Adempas as soon as possible.
Used for
From the label: indications and usageAdempas 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.
Forms and strengths
- 0.5 mg
- 1 mg
- 1.5 mg
- 2 mg
- 2.5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- October 8, 2013 Adempas, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first September 1, 2022; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 18, 2034 Adempas tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 32,415 through July 30, 2026
What is riociguat used for?
From the label: indications and usageAdempas 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. ( 1.1 )
Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. […]
Conditions named in the indications of riociguat's FDA labels, with every medicine labeled for each:
From other riociguat labelsPulmonary arterial hypertension: Adempas 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.
FDA pharmacologic class: Soluble Guanylate Cyclase Stimulator.
Source: FDA drug label (Adempas), Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026 (SPL set 7b57509a-3d5d-41d4-8fed-1471e26372a3), via openFDA; the full label on DailyMed
What does the patient leaflet for riociguat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Adempas?Serious birth defects. Adempas may cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking Adempas or become pregnant during treatment with Adempas. Females who are able to get pregnant should have a negative pregnancy status before beginning treatment with Adempas. Females who are able to get pregnant are females who: Have entered puberty, even if they have not started their period, and Have a uterus, and Have not gone through menopause (have not had a period for at least 12 months for natural reasons, or who have had their ovaries removed) Females who are not able to get pregnant are females who: Have not yet entered puberty, or Do not have a uterus, or Have gone through menopause (have not had a period for at least 12 months for natural reasons, or who have had their ovaries removed) Females who are able to get pregnant should use effective birth control before starting treatment with Adempas, during treatment with Adempas and for 1 month after stopping Adempas because the medicine may still be in the body. Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy during treatment with Adempas. If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another effective form of birth control. Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may talk with you about using emergency birth control. […]
From the patient leaflet: What should I avoid while taking Adempas?Do not get pregnant while taking Adempas. (See serious birth defects section of the Medication Guide above called "What is the most important information I should know about Adempas?") If you miss a menstrual period, or think you might be pregnant, call your doctor right away. • It is not known if Adempas passes into your breast milk. You should not breastfeed if you take Adempas. Talk to your doctor about the best way to feed your baby if you take Adempas. • Adempas may make you feel dizzy. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Adempas affects you. Talk with your doctor if you are concerned about when it is safe for you to do these activities. • Smoking. Adempas may not work as well if you smoke during treatment. […]
From the patient leaflet: How should I store Adempas?Store Adempas at room temperature between 59° F to 86° F (15° C to 30° C) Keep Adempas and all medicines out of the reach of children. General Information about Adempas Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adempas for a condition for which it is not prescribed. Do not give Adempas to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about Adempas. If you would like more information about Adempas, talk with your doctor. You can ask your doctor or pharmacist for information about Adempas that is written for health professionals. For more information go to www.Adempas-us.com or call 1-888-842-2937.
Source: FDA drug label (Adempas), Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026 (SPL set 7b57509a-3d5d-41d4-8fed-1471e26372a3), via openFDA; the full label on DailyMed
Is there a generic for riociguat (Adempas)?
The FDA approved the first generic riociguat on September 1, 2022. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists riociguat from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Adempas tablets: the compound patent runs to February 18, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2022 first generic approved
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the riociguat label say about other medicines?
The riociguat label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name riociguat. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Strong CYP3A inducers: Strong inducers of CYP3A (for example, rifampin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may significantly reduce riociguat exposure. |
| Dipyridamole | contraindications | Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE-5 inhibitors (such as dipyridamole or theophylline) is contraindicated [see Dosage and Administration (2.6), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]. |
| Itraconazole | drug interactions | Strong CYP and P-gp/BCRP inhibitors: Concomitant use of riociguat with strong cytochrome CYP inhibitors and P-gp/BCRP inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat exposure and may result in hypotension. |
| Ketoconazole | drug interactions | Strong CYP and P-gp/BCRP inhibitors: Concomitant use of riociguat with strong cytochrome CYP inhibitors and P-gp/BCRP inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat exposure and may result in hypotension. |
| Magnesium hydroxide | drug interactions | Antacids such as aluminum hydroxide/magnesium hydroxide decrease riociguat absorption and should not be taken within 1 hour of taking Adempas [see Clinical Pharmacology (12.3) ]. |
| Milrinone | drug interactions | Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited. |
| Nitric oxide | contraindications | Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated [see Drug Interactions (7.1) and Clinical Pharmacology (12.2) ]. |
| Phenobarbital | drug interactions | Strong CYP3A inducers: Strong inducers of CYP3A (for example, rifampin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may significantly reduce riociguat exposure. |
| Phenytoin | drug interactions | Strong CYP3A inducers: Strong inducers of CYP3A (for example, rifampin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may significantly reduce riociguat exposure. |
| Rifampin | drug interactions | Strong CYP3A inducers: Strong inducers of CYP3A (for example, rifampin, phenytoin, carbamazepine, phenobarbital or St. John's Wort) may significantly reduce riociguat exposure. |
| Ritonavir | drug interactions | Strong CYP and P-gp/BCRP inhibitors: Concomitant use of riociguat with strong cytochrome CYP inhibitors and P-gp/BCRP inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat exposure and may result in hypotension. |
| Roflumilast | drug interactions | Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited. |
| Sildenafil | contraindications | Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE-5 inhibitors (such as dipyridamole or theophylline) is contraindicated [see Dosage and Administration (2.6), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]. |
| Tadalafil | contraindications | Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE-5 inhibitors (such as dipyridamole or theophylline) is contraindicated [see Dosage and Administration (2.6), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]. |
Every other medicine the riociguat label names
| Medicine named | Section | What the label says |
|---|---|---|
| Theophylline | contraindications | … vardenafil) or nonspecific PDE-5 inhibitors (such as dipyridamole or theophylline) is contraindicated [see Dosage and Administration (2.6), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 … |
| Vardenafil | contraindications | Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE-5 inhibitors (such as dipyridamole or theophylline) is … |
Other labels that name riociguat
Source: FDA drug label (Adempas), Bayer HealthCare Pharmaceuticals Inc., effective August 13, 2026 (SPL set 7b57509a-3d5d-41d4-8fed-1471e26372a3), via openFDA; the full label on DailyMed
What do FAERS reports show for riociguat?
The FDA Adverse Event Reporting System holds 32,415 reports that list riociguat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,092 are coded as a death and 15,294 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as riociguat?
6 other medicines are given the same way (oral) and in the same FDA class as riociguat or labeled mainly for the same use (pulmonary arterial hypertension), the same class first. Pulmonary arterial hypertension lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ambrisentan | Pulmonary arterial hypertension | 12 labelers | $8.02 per tablet 10 mg tablet | No current entry |
| Selexipag | Pulmonary arterial hypertension | 2 labelers | n/a | No current entry |
| Treprostinil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
| Bosentan | Pulmonary arterial hypertension | 5 labelers | n/a | No current entry |
| Macitentan | Pulmonary arterial hypertension | 13 labelers | n/a | No current entry |
| Macitentan and tadalafil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to riociguat
- 6 medicines for the same use
- Other soluble guanylate cyclase stimulators
- the pharmacologic class, with prices and generics
- Riociguat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other