Riociguat 0.5mg Tablets — Generic Adempas® 0.5mg | Order Online

Riociguat 0.5mg Tablets are a prescription medicine containing riociguat 0.5mg as the active ingredient and the generic equivalent of Adempas® 0.5mg, the reference brand developed by Bayer. Riociguat is a first-in-class soluble guanylate cyclase (sGC) stimulator — a novel mechanism of action distinct from all other PAH therapies — approved for the treatment of both pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The 0.5mg strength is the lowest available dose of riociguat, used as a starting dose specifically for patients at higher risk of hypotension who cannot begin on the standard 1mg initiation dose. Generic riociguat 0.5mg tablets are available internationally across the USA, UK, Australia, UAE, Germany, France, Russia, South Korea and worldwide.

Product Information

What Is Riociguat 0.5mg Used For?

Riociguat is approved for two distinct pulmonary hypertension indications — making it the only oral medicine approved across both PAH and CTEPH. The 0.5mg strength serves a specific role in the titration schedule for patients at elevated hypotension risk.

Pulmonary Arterial Hypertension (PAH — WHO Group 1)
Riociguat is indicated for the treatment of PAH in adult patients with WHO functional class II–III, to improve exercise capacity, WHO functional class and delay clinical worsening. Clinical evidence comes from the PATENT-1 trial, a Phase 3 randomised controlled study demonstrating significant improvement in 6-minute walk distance and secondary endpoints including pulmonary vascular resistance and WHO functional class.

Chronic Thromboembolic Pulmonary Hypertension (CTEPH — WHO Group 4)
Riociguat is the only oral medicine approved for CTEPH — a form of pulmonary hypertension caused by organised thrombi obstructing the pulmonary arteries. It is indicated for:

• Inoperable CTEPH — patients who are not surgical candidates
• Persistent or recurrent CTEPH — patients with residual pulmonary hypertension after pulmonary endarterectomy (PEA surgery)

Clinical evidence comes from the CHEST-1 trial, demonstrating significant improvements in 6-minute walk distance, pulmonary vascular resistance and WHO functional class in CTEPH patients.

When is the 0.5mg dose used?
The standard riociguat starting dose is 1mg three times daily. The 0.5mg three times daily starting dose is used specifically for patients at higher risk of hypotension, including those with:

• Low systolic blood pressure at baseline
• Volume-depleted patients
• Patients on antihypertensive medicines or vasodilatory therapies
• Patients where the physician determines a lower initiation dose is clinically appropriate

After 2 weeks on 0.5mg TID, the dose may be uptitrated to 1mg TID if systolic blood pressure remains above 95 mmHg and the medicine is tolerated.

United States: Adempas® (riociguat) is FDA-approved for PAH and CTEPH. Available only through the Adempas REMS programme due to teratogenicity. Generic riociguat 0.5mg is available from multiple manufacturers.

United Kingdom / EU: Riociguat (Adempas®) is EMA-approved for PAH (WHO FC II–III) and inoperable or post-PEA persistent/recurrent CTEPH.

Australia: Riociguat 0.5mg Australia — subject to TGA registration and ARTG listing. PBS subsidisation for PAH and CTEPH — confirm with your specialist.

UAE / Gulf: Subject to UAE Ministry of Health registration. Consult a UAE-licensed specialist for current riociguat 0.5mg UAE availability.

Germany: Riociguat 0,5mg Filmtabletten are available as Adempas® 0,5mg and as generic riociguat 0,5mg products. All prescription-only (rezeptpflichtig).

France: Riociguat 0,5mg comprimés pelliculés are available as Adempas® and as generics, subject to HAS reimbursement.

Russia: Риоцигуат 0,5 мг is available as Адемпас® 0,5 мг in Russia, requiring a valid prescription.

South Korea: 리오시구아트 0.5mg is registered for prescription use per MFDS-approved labeling.

Always follow the prescribing information applicable to your country and the guidance of your licensed PAH/CTEPH specialist.

How Riociguat 0.5mg Works

Riociguat has a unique dual mechanism of action that distinguishes it from all other pulmonary hypertension therapies:

1. Direct sGC stimulation
Riociguat directly stimulates soluble guanylate cyclase (sGC) — the receptor for nitric oxide (NO) in vascular smooth muscle cells — independently of nitric oxide. This means riociguat can activate sGC even when endogenous nitric oxide production is impaired, as occurs in PAH and CTEPH.

2. Sensitisation of sGC to nitric oxide
Riociguat also increases the sensitivity of sGC to available endogenous nitric oxide, amplifying the vasodilatory signalling even at low NO concentrations.

Both mechanisms lead to increased production of cyclic guanosine monophosphate (cGMP), which:

• Relaxes pulmonary vascular smooth muscle — causing vasodilation
• Reduces pulmonary vascular resistance (PVR)
• Inhibits vascular smooth muscle cell proliferation
• Has anti-fibrotic and anti-inflammatory effects on pulmonary vessel walls
• Reduces right ventricular afterload — relieving strain on the right heart

Why riociguat is distinct from PDE-5 inhibitors (sildenafil, tadalafil):
PDE-5 inhibitors prevent the breakdown of cGMP, whereas riociguat stimulates the production of cGMP. Both increase cGMP levels but through different mechanisms — which is why they must never be combined (dangerous additive hypotension risk).

Riociguat Titration Schedule — Where 0.5mg Fits

Riociguat is titrated every 2 weeks based on systolic blood pressure and tolerability:

Uptitration proceeds every 2 weeks if systolic BP remains above 95 mmHg and the patient is not experiencing hypotension symptoms. Dose reduction follows if systolic BP drops below 95 mmHg with hypotension symptoms.

Generic Riociguat 0.5mg vs Adempas® 0.5mg

Adempas® 0.5mg is the originator brand containing riociguat 0.5mg. Generic riociguat 0.5mg tablets contain the same active ingredient at the same strength but may differ in inactive ingredients, tablet appearance, packaging and manufacturer. PAH and CTEPH are specialist-managed conditions — consult your specialist before switching between branded and generic riociguat products.

Key Safety Information — Riociguat 0.5mg

Teratogenicity — Absolute Pregnancy Contraindication
Riociguat is highly teratogenic and absolutely contraindicated in pregnancy. Animal studies demonstrated embryo-foetal toxicity and teratogenicity at clinically relevant exposures. In women of childbearing potential:

• Negative pregnancy test required before starting
• Reliable contraception required throughout treatment and for one month after stopping
• Monthly pregnancy tests required during treatment
• In the USA, the Adempas REMS programme enforces these requirements — prescribers, pharmacies and female patients must be enrolled

Hypotension
Riociguat causes vasodilation and can produce significant hypotension, particularly:

• At initiation and during uptitration
• In volume-depleted patients
• When combined with antihypertensive agents, vasodilators or PDE-5 inhibitors

The 0.5mg TID starting dose is specifically designed to minimise hypotension risk during initiation. Blood pressure must be monitored at each dose level.

Absolute Contraindications

• Pregnancy (absolute)
• Concurrent use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil) — serious hypotension risk; this combination is contraindicated
• Concurrent use of nitrates or nitric oxide donors
• Concurrent use of riociguat with macitentan — not contraindicated but monitor closely
• Severe hepatic impairment (Child-Pugh C)
• Severe renal impairment (creatinine clearance <15 ml/min) or dialysis patients
• Known hypersensitivity to riociguat or excipients
• Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)

Drug Interactions

• PDE-5 inhibitors — absolutely contraindicated (additive hypotension)
• Nitrates and nitric oxide donors — contraindicated
• Strong CYP3A4 and P-gp inhibitors (ketoconazole, itraconazole, ritonavir) — significantly increase riociguat exposure; avoid
• CYP3A4 inducers (rifampicin, carbamazepine, phenytoin) — reduce riociguat efficacy
• Antacids (aluminium/magnesium hydroxide) — reduce riociguat absorption; take riociguat at least 1 hour before antacids
• Smoking — significantly reduces riociguat exposure; smokers may require higher doses and dose reduction may be needed on cessation

Pulmonary Oedema
If pulmonary oedema develops, consider pulmonary veno-occlusive disease (PVOD) — riociguat is not indicated for PH associated with PVOD and should be discontinued if PVOD is confirmed.

Always read the patient information leaflet and prescribing information applicable to your country.

Riociguat 0.5mg — Availability by Country

Frequently Asked Questions — Riociguat 0.5mg

What is Riociguat 0.5mg used for?
Riociguat 0.5mg is the lowest available starting dose of riociguat, used in patients with PAH or CTEPH who are at higher risk of hypotension and cannot begin on the standard 1mg three-times-daily starting dose. After 2 weeks, the dose is uptitrated to 1mg TID if blood pressure and tolerability allow.

Is Riociguat 0.5mg the generic for Adempas® 0.5mg?
Yes. Adempas® 0.5mg is the originator brand. Generic riociguat 0.5mg film-coated tablets contain the same active ingredient and strength. Inactive ingredients, appearance and manufacturer may differ.

What is the difference between Riociguat 0.5mg and 1mg?
Riociguat 0.5mg is the reduced starting dose for hypotension-risk patients. Riociguat 1mg is the standard starting dose for most patients. After 2 weeks on either starting dose, uptitration proceeds every 2 weeks up to the maximum dose of 2.5mg three times daily, based on systolic blood pressure and tolerability.

Why can’t Riociguat be taken with Sildenafil or Tadalafil?
Riociguat and PDE-5 inhibitors both increase cGMP levels in vascular smooth muscle — riociguat by stimulating cGMP production and PDE-5 inhibitors by preventing cGMP breakdown. Combining them produces dangerous additive hypotension and is absolutely contraindicated. This applies to all PDE-5 inhibitors including sildenafil, tadalafil, vardenafil and avanafil.

What is the Adempas REMS programme?
In the USA, Adempas® and generic riociguat are only available through the REMS programme due to teratogenicity risk. Prescribers, pharmacies and female patients must all be enrolled. Monthly pregnancy testing and reliable contraception are mandatory for women of childbearing potential.

Is Riociguat the only medicine approved for both PAH and CTEPH?
Yes. Riociguat is currently the only oral medicine approved for both pulmonary arterial hypertension (WHO Group 1) and chronic thromboembolic pulmonary hypertension (WHO Group 4 — inoperable or post-PEA persistent/recurrent CTEPH).

How does Riociguat differ from Macitentan and Sildenafil?
Riociguat (sGC stimulator), macitentan (ERA) and sildenafil (PDE-5 inhibitor) all target different pathways in PAH. Riociguat and macitentan can be combined. Riociguat and sildenafil cannot be combined — the combination is contraindicated due to serious hypotension risk.

Does smoking affect Riociguat 0.5mg?
Yes. Smoking significantly reduces riociguat plasma concentrations. Smokers may require higher doses during titration. If a patient stops smoking during treatment, dose reduction may be needed as riociguat exposure increases.

Can I buy Riociguat 0.5mg tablets online?
Riociguat 0.5mg is prescription-only in all major markets. In the USA it is only available through the Adempas REMS programme. PAH and CTEPH are specialist-managed conditions — riociguat must be prescribed by a licensed specialist.

Is Riociguat 0.5mg available in Australia?
Riociguat 0.5mg products are registered on the ARTG. PBS subsidisation depends on indication and eligibility. Confirm current PBS status with your PAH/CTEPH specialist or pharmacist.

Medical Disclaimer

This information is provided for educational and commercial reference purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Riociguat 0.5mg is a prescription-only medicine for serious conditions — pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension — and carries important risks including teratogenicity, hypotension and dangerous interactions with PDE-5 inhibitors and nitrates. In the USA it is only available through the Adempas REMS programme. It must be prescribed and managed by a qualified PAH/CTEPH specialist. Always use according to the applicable prescribing information and the advice of a licensed healthcare professional in your country.

Last Updated: September 25, 2026