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Aliskiren

Rasilez · ATC code C09XA02

Key facts
Active substance
Aliskiren
Drug class
Renin inhibitor
ATC code
C09XA02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Rasilez 150 mg film-coated tablets / Rasilez 300 mg film-coated tablets
Marketing authorisation holder
Lxo Ireland Designated Activity Company
Information as of
2026-10-28

Key facts

Aliskiren (Rasilez) is a direct renin inhibitor that blocks the renin-angiotensin-aldosterone system (RAAS) and is used to treat high blood pressure.

What it is used for

  • Essential hypertension in adults.

Dosing

  • Recommended dose 150 mg once daily; if blood pressure is not adequately controlled, it may be increased to 300 mg once daily.
  • The antihypertensive effect is substantially present (85-90%) within two weeks.
  • Elderly patients aged 65 years and over: starting dose 150 mg.
  • Mild to moderate renal impairment and any degree of hepatic impairment: no adjustment of the initial dose; not recommended in severe renal impairment (GFR < 30 ml/min/1.73 m2).
  • Taken once a day, always with or always without food, preferably at the same time; tablets swallowed whole with water. Fruit juice and drinks containing plant extracts (including herbal teas) should be avoided.
  • Should not be used in children aged 2 to less than 6 years; not recommended at 6 to 17 years.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • History of angioedema with aliskiren; hereditary or idiopathic angioedema.
  • Second and third trimesters of pregnancy.
  • Concomitant use with ciclosporin, itraconazole and other potent P-gp inhibitors (e.g. quinidine).
  • Combination with ACE inhibitors or angiotensin II receptor blockers in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
  • Children from birth to less than 2 years.

Important warnings

  • Therapy should be stopped in the event of severe and persistent diarrhoea.
  • Dual RAAS blockade with ACE inhibitors or angiotensin II receptor blockers is not recommended (hypotension, syncope, stroke, hyperkalaemia, decreased renal function including acute renal failure); if absolutely necessary, only under specialist supervision with close monitoring.
  • Symptomatic hypotension may occur with volume or salt depletion (e.g. high-dose diuretics); depletion should be corrected first.
  • Caution in serious congestive heart failure (NYHA class III-IV) and in heart failure treated with furosemide or torasemide.

Side effects

  • The most common adverse reaction is diarrhoea.
  • Common: dizziness, arthralgia, hyperkalaemia.
  • Uncommon: hypotension, cough, peripheral oedema, acute renal failure, severe cutaneous adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Rare but serious: anaphylactic reactions and angioedema.

Interactions

  • Ciclosporin and itraconazole strongly increase aliskiren exposure (AUC approximately 5-fold and 6.5-fold) - contraindicated.
  • Grapefruit juice decreased aliskiren AUC by 61% (150 mg) and 38% (300 mg); fruit juices are not recommended.
  • Dual RAAS blockade with ACE inhibitors or angiotensin II receptor blockers increases the frequency of adverse events.

Pregnancy and breastfeeding

  • Should not be used in the first trimester or in women planning pregnancy, and is contraindicated in the second and third trimesters; discontinue if pregnancy is detected.
  • 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)

  • RasilezLxo Ireland Designated Activity Company · EMEA/H/C/000780

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Rasilez
Liechtenstein
Rasilez
Norway
Rasilez

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

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Sources

  1. European Medicines Agency. Rasilez – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/rasilez-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC C09XA.

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.