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riociguat

Adempas · ATC code C02KX05

Also known as: Riosiguat

Key facts
Active substance
riociguat
ATC code
C02KX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Adempas 0.5 mg film-coated tablets / Adempas 1 mg film-coated tablets / Adempas 1.5 mg film-coated tablets · Adempas 0.15 mg/mL granules for oral suspension
Marketing authorisation holder
Bayer AG
Information as of
2026-10-28

Key facts

Riociguat is a soluble guanylate cyclase stimulator used to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) (Adempas).

What it is used for

  • Adempas film-coated tablets: adults in WHO Functional Class II to III with inoperable CTEPH or persistent or recurrent CTEPH after surgery, to improve exercise capacity.
  • PAH in WHO Functional Class II to III in adults (monotherapy or with endothelin receptor antagonists) and in children aged 6 to less than 18 years in combination with endothelin receptor antagonists.
  • Adempas granules for oral suspension: PAH in children aged 6 to less than 18 years in combination with endothelin receptor antagonists.

Dosing

  • Tablets: starting dose 1 mg 3 times daily for 2 weeks, approximately 6 to 8 hours apart.
  • Adults: increase every 2 weeks by 0.5 mg 3 times daily to a maximum of 2.5 mg 3 times daily if systolic blood pressure is ≥95 mmHg without signs of hypotension; if hypotension occurs, decrease by 0.5 mg 3 times daily.
  • Children ≥ 50 kg: tablets, titration by systolic blood pressure (≥ 90 mmHg at 6 to < 12 years, ≥ 95 mmHg from 12 years) to a maximum of 2.5 mg 3 times daily; children < 50 kg: granules, see the full text.
  • Maximum daily dose 7.5 mg. After an interruption of 3 days or more, restart at 1 mg 3 times daily.
  • In patients on stable strong multi-pathway CYP and P-gp/BCRP inhibitors, consider a starting dose of 0.5 mg 3 times a day; smokers may need the maximum dose.
  • Elderly: higher risk of hypotension; severe renal impairment (creatinine clearance < 30 mL/min) or dialysis: not recommended.

Contraindications

  • Co-administration with PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil), nitrates or nitric oxide donors (including 'poppers') or other soluble guanylate cyclase stimulators.
  • Severe hepatic impairment (Child Pugh C); pregnancy; hypersensitivity.
  • Treatment initiation with systolic blood pressure < 90 mmHg (6 to < 12 years) or < 95 mmHg (12 years and older).
  • Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP).

Important warnings

  • Not recommended in pulmonary veno-occlusive disease; discontinue if pulmonary oedema occurs.
  • Increased risk of serious and fatal respiratory tract bleeding, particularly with anticoagulation; avoid with a history of serious haemoptysis.
  • In CTEPH, operability should be assessed by experts beforehand.
  • Smokers should be advised to stop smoking (lower response).

Side effects

  • Very common (≥ 10%): headache, dizziness, dyspepsia, peripheral oedema, nausea, diarrhoea and vomiting.
  • Serious haemoptysis and pulmonary haemorrhage, including fatal cases, have been observed.

Interactions

  • Nitrates, nitric oxide donors and PDE5 inhibitors: increased blood pressure lowering; contraindicated.
  • Antacids should be taken at least 2 hours before or 1 hour after riociguat.
  • CYP3A4 inducers (e.g. bosentan) decrease riociguat levels.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; women and adolescents of childbearing potential must use effective contraception; monthly pregnancy tests recommended.
  • Should not be used during breast-feeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • PahrilanG.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AdempasBAYER TÜRK KİMYA SAN. LTD. ŞTİ. · 10 register entries
  • DuophealPHEALX İLAÇ SAN. VE TİC. LTD. ŞTİ. · 10 register entries
  • RioneraHUMANİS SAĞLIK A.Ş. · 10 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 9 more European countries
Cyprus
Ridecia
Finland
Midive, Riociguat
Greece
Ridecia, Riociguat Win Medica
Iceland
Adempas, Riociguat Accord
Liechtenstein
Adempas, Riociguat Accord
Malta
Midive, Riociguat
Netherlands
Pahrilan
Norway
Adempas, Riociguat Accord
Sweden
Pahrilan, Ridecia, Riociguat Elpen, Riociguat Win Medica

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Adempas – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/adempas-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.