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Riociguat

Riociguat is a prescription tablet used to treat two serious forms of high blood pressure in the lungs: chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).

Brand name Adempas
Drug class Soluble Guanylate Cyclase Stimulator
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Riociguat at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Riociguat (Adempas) is a specialist medicine for CTEPH or PAH, two serious forms of high blood pressure in the lung arteries, and widens those vessels by helping nitric oxide (the body’s natural relaxing signal) work better while also switching on that same pathway by itself; it dates to about 2013 and is available as a generic. Headache, indigestion and dizziness are what most people notice, and the dose is raised gradually based on blood pressure. Its boxed warning is serious harm to an unborn baby, so pregnancy is ruled out before, monthly during and for a month after treatment, and every female patient must enroll in the REMS safety program.

Clinical pearls

  • Never combine it with nitrates like nitroglycerin or with sildenafil, tadalafil or vardenafil, because blood pressure can drop dangerously.
  • Tell your prescriber if you smoke or plan to quit, since smoking lowers riociguat levels and quitting may need a dose change.
  • Food does not matter, but keep aluminum or magnesium antacids at least an hour away from each dose.
  • It is taken three times a day, and a break of three days or more means restarting the slow dose build-up.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

WARNING: This medicine can cause serious harm or death to an unborn baby and must never be used during pregnancy. Before starting riociguat, a pregnancy test is required. Monthly pregnancy tests are required throughout treatment, and for one month after stopping. Reliable birth control must be used during treatment and for one month after the last dose. Because of this risk, all female patients must be enrolled in a special safety program called the riociguat REMS Program before they can receive this medicine — this applies to all women, not just those who could become pregnant.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2013
Companies listing it with the FDA2
FDA label last updatedAug 13, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Riociguat, written from its FDA label.

What Riociguat is used for

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Riociguat is an oral tablet approved to treat two serious forms of high blood pressure in the lungs in adults.

  • Chronic Thromboembolic Pulmonary Hypertension (CTEPH): Both Adempas and Riociguat tablets are approved for adults with CTEPH that persists or returns after surgical treatment, or for those who cannot have surgery. The goal is to improve exercise capacity and WHO functional class (a measure of how much the disease limits daily activity).
  • Pulmonary Arterial Hypertension (PAH): Both Adempas and Riociguat tablets are approved to improve exercise capacity and WHO functional class, and to delay clinical worsening in adults with PAH. They can be used alone or with other PAH medicines such as endothelin receptor antagonists or prostanoids.

How Riociguat works

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Riociguat targets an enzyme called soluble guanylate cyclase (sGC), which is activated by nitric oxide — a natural signal that tells blood vessels to relax. In pulmonary hypertension, nitric oxide signaling is impaired. Riociguat works in two ways: it makes sGC more sensitive to whatever nitric oxide is present, and it also directly activates sGC on its own. Both actions boost production of a molecule called cGMP, which causes the walls of pulmonary blood vessels to relax and widen, reducing the pressure the heart has to pump against.

Because riociguat amplifies the same pathway as nitrates and PDE-5 inhibitors (like sildenafil), combining these drugs can cause a dangerous and potentially life-threatening drop in blood pressure — which is why those combinations are strictly off-limits.

Riociguat dosage

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Riociguat tablets are taken by mouth three times a day. Food does not affect absorption, so they can be taken with or without a meal. For patients who cannot swallow whole tablets, Adempas or Riociguat tablets may be crushed and mixed with water or soft food like applesauce — but only right before taking, not stored ahead of time.

  • The dose is started low and increased gradually over several weeks, based on blood pressure and tolerability — always under a prescriber's guidance.
  • If you miss a dose, simply take the next one at the regular time; do not take a double dose.
  • If treatment is stopped for 3 or more days, the dose must be restarted at the lowest level and slowly increased again.
  • Smokers may need different dosing adjustments; talk to your prescriber if your smoking status changes.

Dosing details from the FDA-approved label

From the Riociguat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults - recommended starting dosage
    • 1 mg taken 3 times a day
    • Up-titrate by 0.5 mg taken three times a day if systolic blood pressure remains greater than 95 mmHg and the patient has no signs or symptoms of hypotension
    • Dose increases no sooner than 2 weeks apart
    • Maximum: 2.5 mg taken three times a day
    • Tablets may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration if unable to swallow whole tablets
  • Patients who may not tolerate the hypotensive effect
    • Consider a starting dose of 0.5 mg taken three times a day
    • Maximum: 2.5 mg taken three times a day
    • If symptoms of hypotension occur at any time, decrease the dosage by 0.5 mg taken three times a day
  • Patients who smoke
    • Consider titrating to dosages higher than 2.5 mg three times a day, if tolerated
    • A dose decrease may be required in patients who stop smoking
  • Patients receiving strong CYP and P-gp/BCRP inhibitors
    • Consider a starting dose of 0.5 mg, three times a day
    • Monitor for signs and symptoms of hypotension on initiation and on treatment
  • Transitioning from sildenafil or tadalafil
    • Discontinue sildenafil at least 24 hours, or tadalafil at least 48 hours, prior to administering riociguat
    • Consider a starting dose of 0.5 mg in patients at risk of hypotension
    • Monitor for signs and symptoms of hypotension on initiation
  • Transitioning from riociguat to a PDE5 inhibitor
    • Discontinue riociguat at least 24 hours prior to administering a PDE5-inhibitor
    • Monitor for signs and symptoms of hypotension on initiation
  • Interrupted dosing
    • If a dose is missed, continue with the next regularly scheduled dose
    • If interrupted for 3 days or more, re-titrate
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Initiate treatment at 1 mg taken three times a day. ( 2.1 ) For patients who may not tolerate the hypotensive effect of riociguat tablets, consider a starting dose of 0.5 mg, three times a day. ( 2.1 ) 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. (2.1 ) Tablets may be crushed and mixed with water or soft foods for patients who have difficulty swallowing. ( 2.1 ) 2.1 Recommended Dosage in Adult Patients The recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of riociguat tablets, consider a starting dose of 0.5 mg taken three times a day. If systolic blood pressure remains greater than 95 mmHg and the patient has no signs or symptoms of hypotension, up-titrate the dose by 0.5 mg taken three times a day. Dose increases should be no sooner than 2 weeks apart. The dose can be increased to the highest tolerated dosage, up to a maximum of 2.5 mg taken three times a day. If at any time, the patient has symptoms of hypotension, decrease the dosage by 0.5 mg taken three times a day. Crushed Tablets For patients who are unable to swallow whole tablets, riociguat tablets may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration [ see Clinical Pharmacology (12.3)]. 2.2 Dosage Interruption If a dose is missed, advise patients to continue with the next regularly scheduled dose. In case riociguat tablets are interrupted for 3 days or more, re-titrate riociguat tablets. 2.3 Pregnancy Testing in Females of Reproductive Potential Obtain pregnancy tests prior to start of treatment and monthly during treatment [see Use in Specific Populations (8.3) ]. 2.4 Use in Patients who Smoke Consider titrating to dosages higher than 2.5 mg three times a day, if tolerated, in patients who smoke. A dose decrease may be required in patients who stop smoking [ see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Riociguat side effects

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The most common side effects with riociguat — most of which relate to its blood-vessel-relaxing effect — include:

Common side effects

  • Headache
  • Indigestion or stomach irritation
  • Dizziness
  • Nausea
  • Diarrhea
  • Low blood pressure (hypotension)
  • Vomiting
  • Acid reflux
  • Anemia (low red blood cell count)
  • Constipation

When to get medical help

  • Call your doctor right away if you feel faint, lightheaded, or have a sudden drop in blood pressure
  • Seek emergency help for any unusual or heavy bleeding — including coughing up blood, vomiting blood, or heavy vaginal bleeding
  • Tell your doctor immediately if you develop sudden shortness of breath or fluid buildup (possible signs of pulmonary edema)
  • If you are pregnant or become pregnant while taking this medication, contact your prescriber immediately — it can cause serious harm to an unborn baby

More serious reactions — including significant bleeding (such as coughing up blood), dangerously low blood pressure, and fluid buildup in the lungs — have been reported. Contact your doctor or seek emergency care right away if you experience any of these.

Riociguat warnings and precautions

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  • Pregnancy — do not use: Riociguat can cause serious fetal harm and is completely off-limits during pregnancy. All women must be enrolled in the riociguat REMS Program, use reliable birth control throughout treatment and for one month after stopping, and have regular pregnancy tests.
  • Low blood pressure (hypotension): This medicine lowers blood pressure. If you feel faint, dizzy, or unusually weak — especially when standing up — contact your prescriber. The risk is higher if you are also taking blood pressure medicines, are dehydrated, or are on certain other medications.
  • Serious bleeding: Serious bleeding events, including fatal cases of coughing up blood, have occurred. Report any unusual bleeding to your doctor immediately.
  • Pulmonary veno-occlusive disease (PVOD): If you have blocked veins in the lungs (PVOD), riociguat can cause dangerous fluid buildup. This medicine should be stopped if PVOD is confirmed.

Riociguat interactions

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Riociguat has several critical drug interactions that can cause life-threatening low blood pressure or reduce the medicine's effectiveness:

  • Nitrates and nitric oxide donors (e.g., nitroglycerin, amyl nitrite) — completely contraindicated; combination can cause a severe, dangerous drop in blood pressure.
  • PDE-5 inhibitors (sildenafil, tadalafil, vardenafil) and nonspecific PDE inhibitors (dipyridamole, theophylline) — contraindicated; additive blood pressure lowering can be life-threatening.
  • Other sGC stimulators — must not be combined with riociguat.
  • Strong antifungals and HIV protease inhibitors (ketoconazole, itraconazole, ritonavir) — increase riociguat blood levels, raising the risk of low blood pressure.
  • Strong CYP3A inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) — can significantly lower riociguat levels and reduce its effectiveness.
  • Antacids (aluminum/magnesium hydroxide) — reduce riociguat absorption; take at least 1 hour apart.
  • Cigarette smoking — reduces riociguat blood levels by 50–60%; dose may need adjustment if you start or stop smoking.

Interactions listed in the FDA-approved label

From the Riociguat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Other soluble guanylate cyclase (sGC) stimulators: Co-administration of riociguat is contraindicated. Do not co-administer
  • Nitrates or nitric oxide donors (such as amyl nitrite): Co-administration in any form is contraindicated because of hypotension. Do not co-administer
  • Specific PDE-5 inhibitors (sildenafil, tadalafil, vardenafil) and nonspecific PDE inhibitors (dipyridamole, theophylline): Co-administration is contraindicated because of hypotension. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.
  • Other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast): Clinical experience with co-administration is limited.
  • Smoking: Plasma concentrations in smokers are reduced by 50% to 60% compared to nonsmokers. Doses higher than 2.5 mg three times a day may be considered; consider a dose reduction in patients who stop smoking. Safety and effectiveness of doses higher than 2.5 mg three times a day have not been established.
  • Strong CYP and P-gp/BCRP inhibitors (azole antimycotics such as ketoconazole, itraconazole; HIV protease inhibitors such as ritonavir): Increase riociguat exposure and may result in hypotension. Consider a starting dose of 0.5 mg 3 times a day; monitor for signs and symptoms of hypotension on initiation and during treatment; consider dose reduction if hypotensive effect not tolerated.
  • Strong CYP3A inducers (for example, rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort): May significantly reduce riociguat exposure. Data are not available to guide dosing when co-administered.
  • Antacids (such as aluminum hydroxide/magnesium hydroxide): Decrease riociguat absorption. Should not be taken within 1 hour of taking riociguat.
Read the label’s full interactions text

7 DRUG INTERACTIONS 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. ( 7.2 ) Antacids: Separate administration by at least 1 hour. ( 7.2 ) 7.1 Pharmacodynamic Interactions with Riociguat Other Soluble Guanylate Cyclase Stimulators: Co-administration of riociguat is contraindicated in patients with use of other soluble guanylate cyclase (sGC) stimulators [ see Contraindications (4.4) ]. Nitrates : Co-administration of riociguat with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated because of hypotension [ see Contraindications (4.2) and Clinical Pharmacology (12.2)]. PDE Inhibitors : Co-administration of riociguat with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) and nonspecific PDE inhibitors (such as dipyridamole or theophylline), is contraindicated because of hypotension. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil [ see Dosage and Administration (2.6)]. Clinical experience with co-administration of riociguat and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited. 7.2 Pharmacokinetic Interactions with Riociguat Smoking : Plasma concentrations in smokers are reduced by 50% to 60% compared to nonsmokers. Based on pharmacokinetic modeling, for patients who are smokers, doses higher than 2.5 mg three times a day may be considered in order to match exposure seen in nonsmoking patients. Safety and effectiveness of riociguat doses higher than 2.5 mg three times a day have not been established. A dose reduction should be considered in patients who stop smoking [ see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿230 supplements and herbs with documented Riociguat interactions, ranked by severity Check Riociguat against a supplement or herb →

Before taking Riociguat

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  • Pregnancy: Do not take riociguat if you are pregnant or planning to become pregnant — it can cause serious harm to an unborn baby.
  • Women of childbearing potential: Must use effective contraception during treatment and for one month after stopping, and must enroll in the riociguat REMS Program.
  • Breastfeeding: Do not breastfeed while taking riociguat.
  • Low blood pressure or dehydration: Tell your doctor if you have low blood pressure, are dehydrated, or have a condition affecting your nervous system's control of blood pressure.
  • Kidney problems: Riociguat is not recommended for patients with severely reduced kidney function — discuss with your prescriber.
  • Pulmonary hypertension from interstitial lung disease (PH-IIP): Riociguat is contraindicated in this specific type of pulmonary hypertension.
  • Smokers: Blood levels of riociguat are significantly lower in smokers; tell your prescriber and inform them if you quit.
  • Current medications: Share a full list of your medicines — especially anything for chest pain, erectile dysfunction, blood pressure, or infections — before starting riociguat.

Riociguat overdose

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If too much riociguat is taken, blood pressure may drop to a dangerous level. Blood pressure should be closely monitored and supported with appropriate treatment. Because riociguat binds tightly to proteins in the blood, dialysis is not expected to remove it effectively.

What Riociguat does in the body

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Riociguat directly reduces the resistance in the pulmonary blood vessels, lowering the pressure the heart must work against. In clinical studies, it measurably reduced pulmonary vascular resistance and pulmonary arterial pressure while improving cardiac output — the amount of blood the heart pumps per minute. It also reduced levels of NT-proBNP, a blood marker that rises when the heart is under strain, suggesting less cardiovascular stress. Because it also lowers overall blood pressure, careful monitoring for low blood pressure is important throughout treatment.

How your body processes Riociguat

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Riociguat is absorbed quickly after swallowing a tablet, reaching peak blood levels within about 1.5 hours, and food does not affect how much is absorbed. It is approximately 95% bound to proteins in the blood and has a half-life of about 12 hours in patients — meaning it takes roughly half a day for blood levels to drop by half. It is broken down mainly in the liver by CYP enzymes (including CYP1A1 and CYP3A4) and cleared through both urine and stool. Cigarette smoking speeds up its breakdown via CYP1A1, which is why smokers tend to have significantly lower drug levels.

How to store Riociguat

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Store at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

230

Supplements & herbs that interact with Riociguat

230 supplements and herbal products have documented interactions with Riociguat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 187
  • Minor · 37
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major GRAPEFRUIT Major ST. JOHN'S WORT Major TYRAMINE Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate +222 more
Every supplement checked against Riociguat — ranked by severity The full interaction hub: 6 major · 187 moderate · 37 minor · every one linked to its full report. Check Riociguat against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Riociguat has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Riociguat nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Riociguat: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Riociguat — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is riociguat treating — what's going wrong in my body?

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In both CTEPH and PAH, the blood vessels in your lungs have become narrowed or blocked, forcing your heart to pump much harder than normal to push blood through. Over time, this strains the heart and limits how much oxygen your body gets. Riociguat helps by relaxing and widening those narrowed lung blood vessels, which lowers the pressure and makes it easier for your heart to do its job. It won't cure the underlying disease, but it can meaningfully improve your ability to be active and slow things from getting worse.

How do I take it, and does it matter if I take it with food?

▾
You take riociguat three times a day — roughly evenly spaced throughout the day. The good news is that food doesn't affect how well it works, so you can take it with or without a meal, whichever is easier for you. If you have trouble swallowing tablets, you can crush the tablet and mix it into water or soft food like applesauce — just take it right away and don't save the mixture for later. If you ever miss a dose, just skip it and take your next dose at the regular time.

What side effects should I expect, and what should make me call the doctor?

▾
The most common side effects are related to the medicine lowering blood pressure — things like headaches, dizziness, and feeling lightheaded, especially when you first stand up. Stomach issues like nausea, heartburn, and diarrhea are also common. Most of these tend to be manageable. What you should call your doctor about right away: any sign of unusual bleeding (especially coughing up blood), fainting, or sudden worsening shortness of breath. Those can be signs of something more serious that needs prompt attention.

I've heard this medicine has a serious pregnancy warning — can you explain that?

▾
Yes, and this is one of the most important things to understand about riociguat. This medicine can cause serious birth defects and must never be taken during pregnancy. Because of that, all women — even those who don't think they can get pregnant — have to be enrolled in a special safety program called the REMS Program before they can receive it. If you're a woman who could become pregnant, you'll need to use reliable birth control the entire time you're on riociguat and for one month after you stop. You'll also need regular pregnancy tests while on it. If you ever think you might be pregnant, contact your doctor immediately.

Are there medicines or supplements I absolutely cannot take with riociguat?

▾
Yes — a few combinations are strictly off-limits because they can cause your blood pressure to drop to a dangerously low level. You cannot take nitrate medicines (like nitroglycerin for chest pain) or erectile dysfunction medicines like sildenafil (Viagra) or tadalafil (Cialis) at the same time. St. John's Wort and certain antifungal or HIV medications can also interfere with how riociguat works in your body. Always tell every prescriber and pharmacist you see that you're on riociguat, and don't start any new medicine — including supplements — without checking first.

I'm a smoker — does that affect my treatment?

▾
It does, actually. Smoking causes your body to break down riociguat faster, so smokers tend to have significantly lower levels of the drug in their blood compared to non-smokers. Your prescriber may account for this when setting your dose. If you quit smoking while on riociguat, your drug levels could rise, so let your doctor know right away — your dose may need to be adjusted to prevent side effects.

Is Riociguat available over the counter?

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No. Riociguat is a prescription medicine: every Riociguat product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Riociguat first available?

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The earliest FDA record we hold for Riociguat is from 2013: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Riociguat was first used.

Who makes Riociguat?

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2 companies currently list Riociguat products in the FDA's NDC Directory, including Bayer HealthCare Pharmaceuticals Inc., Zydus Pharmaceuticals USA Inc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Riociguat on HelloPharmacist

📊Riociguat supplement interactions230 checked — ranked by severity 🌿Drug & Supplement CheckerRiociguat vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Riociguat NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Riociguat Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Riociguat forms and strengths (how it comes)

Riociguat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Adempas
How this form is used
What it may be used for
  • Adempas tablets are used to treat persistent or recurring CTEPH in adults after surgery, or when surgery is not possible, to improve exercise capacity and functional class
  • Adempas tablets are used to treat PAH in adults to improve exercise capacity, functional class, and to delay clinical worsening
  • Riociguat tablets are used to treat persistent or recurring CTEPH in adults after surgery, or when surgery is not possible, to improve exercise capacity and functional class
  • Riociguat tablets are used to treat PAH in adults to improve exercise capacity, functional class, and to delay clinical worsening
Important instructions
  • Adempas and Riociguat tablets are taken by mouth three times a day, with or without food
  • Adempas and Riociguat tablets may be crushed and mixed with water or soft foods like applesauce immediately before swallowing — do not store the mixture
  • If a dose is missed, continue with the next regularly scheduled dose; do not double up
  • If Adempas or Riociguat tablets are stopped for 3 or more days, your prescriber will need to restart and retitrate the dose gradually
Available strengths 5 strengths
0.5 mg 1 mg 1.5 mg 2 mg 2.5 mg
40 FDA-listed product records ⓘ

Riociguat on the U.S. market: products, makers and brands

How Riociguat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2 companies list 10 Riociguat product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Adempas; the rest are generics.

1
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
2
Brand names
10
FDA-listed product records ⓘ
2013
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bayer HealthCare Pharmaceuticals Inc.50%
Zydus Pharmaceuticals USA Inc50%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Riociguat is used (Medicaid data)

A general measure of how commonly Riociguat is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Riociguat is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

6,299
Medicaid prescriptions filled (Q1–Q4 2025)
$87.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Riociguat prescribed? Of the 1,601 medications we measure, Riociguat ranks #1,011 by Medicaid prescriptions — more than 37% of them.

Where Riociguat ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,011 of 1,601
#1,006 Ado-trastuzumab Emtans... 6,495 Rx #1,007 Piroxicam 6,458 Rx #1,008 Pyridoxine 6,433 Rx #1,009 Pertuzumab, Trastuzuma... 6,412 Rx #1,010 Pemetrexed Disodium 6,336 Rx #1,011 Riociguat 6,299 Rx #1,012 Voriconazole 6,277 Rx #1,013 Technetium Tc-99M 6,225 Rx #1,014 Amoxicillin / Omeprazo... 6,073 Rx #1,015 Sapropterin 6,060 Rx #1,016 Urea 6,045 Rx

Utilization by Riociguat product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2.5 mg oral tablet is the most-dispensed Riociguat product — about 75% of these Medicaid prescriptions.

riociguat 2.5 MG Oral Tablet Most dispensed

4,746 Medicaid prescriptions (Q1–Q4 2025) 75% of Riociguat prescriptions shown $67M gross reimbursement (before rebates) ≈ $14,107 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439833

riociguat 2 MG Oral Tablet

578 Medicaid prescriptions (Q1–Q4 2025) 9% of Riociguat prescriptions shown $8M gross reimbursement (before rebates) ≈ $13,795 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439837

riociguat 1.5 MG Oral Tablet

484 Medicaid prescriptions (Q1–Q4 2025) 8% of Riociguat prescriptions shown $6.7M gross reimbursement (before rebates) ≈ $13,816 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439823

riociguat 1 MG Oral Tablet

305 Medicaid prescriptions (Q1–Q4 2025) 5% of Riociguat prescriptions shown $3.8M gross reimbursement (before rebates) ≈ $12,602 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439831

riociguat 0.5 MG Oral Tablet

186 Medicaid prescriptions (Q1–Q4 2025) 3% of Riociguat prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $13,204 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1439821

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Riociguat, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 27 listed Riociguat NDCs with Medicaid activity.

Compare Riociguat products

A representative set of FDA-listed product records for Riociguat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
0.5 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
1 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
1.5 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
2 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
2.5 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →
0.5 mg Oral Zydus Pharmaceuticals USA Inc ANDA View NDC →
1 mg Oral Zydus Pharmaceuticals USA Inc ANDA View NDC →
1.5 mg Oral Zydus Pharmaceuticals USA Inc ANDA View NDC →
2 mg Oral Zydus Pharmaceuticals USA Inc ANDA View NDC →
2.5 mg Oral Zydus Pharmaceuticals USA Inc ANDA View NDC →

Showing 10 of 10 products — FDA National Drug Code Directory. See every product, package size and price: browse all 10 Riociguat NDCs →

Riociguat recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Riociguat recalls since July 2021.

✅No Riociguat recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Riociguat RxCUI 1439816 1 dose form · 5 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1439820 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 1439821 1 MG RxCUI 1439831 1.5 MG RxCUI 1439823 2 MG RxCUI 1439837 2.5 MG RxCUI 1439833

Look up RxCUI 1439816 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Riociguat brand names

Riociguat is sold under one brand name in the FDA directory — Adempas. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Adempas

Who makes Riociguat: manufacturers and labelers

2 companies list Riociguat products with the FDA. By number of product records, the largest are Bayer HealthCare Pharmaceuticals Inc., Zydus Pharmaceuticals USA Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bayer HealthCare Pharmaceuticals Inc. 5 Zydus Pharmaceuticals USA Inc 5

Riociguat drug class (RxNorm)

Riociguat belongs to the Soluble Guanylate Cyclase Stimulator class.

Pharmacologic class Soluble Guanylate Cyclase Stimulator
Drug family (ATC) Antihypertensives for pulmonary arterial hypertension
How it works Guanylate Cyclase Stimulators

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Riociguat page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 13, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Riociguat.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Riociguat after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
10
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
Bayer HealthCare Pharmaceuticals Inc.
Linked label effective
Aug 13, 2026
Composite sections available
23
Linked SPL Set ID
7b57509a-3d5d-41d4-8fed-1471e26372a3
Linked SPL Document ID
21ffd9c9-204f-4809-af50-5e6f26e9d4ce
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bayer HealthCare Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →