Direct renin inhibitor Pregnancy: Can cause fetal harm — drugs acting on the renin-angiotensin system in the 2nd/3rd trimester reduce fetal renal function and increase fetal/neonatal morbidity and death; discontinue as soon as pregnancy is detected

Aliskiren

Brand names: Rasilez, Tekturna

Aliskiren is a direct renin inhibitor used in the management of hypertension.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 150 mg once daily (starting dose); may be increased to 300 mg once daily if blood pressure remains uncontrolled

Route: oral

Frequency: once daily

Max: 300 mg once daily (doses above 300 mg gave no increased BP response, only more diarrhoea)

Establish a routine pattern with regard to meals; high-fat meals decrease absorption substantially. Majority (85–90%) of effect of a given dose attained by 2 weeks. Paediatric (US label): in patients 6 years and older weighing 50 kg or more, starting 150 mg once daily, may increase to 300 mg once daily — not a per-kg dose. Contraindicated under 2 years of age; not approved 6+ years weighing 20 to <50 kg (no suitable dosage form). Avoid combined use with ACE inhibitors or ARBs, particularly if CrCl <60 mL/min; contraindicated with ARBs/ACEIs in patients with diabetes.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Do not use with ARBs or ACE inhibitors in patients with diabetes
Known hypersensitivity to any of the components
Contraindicated in paediatric patients less than 2 years of age

Side effects

Diarrhoea (most common, 2.3%)
Anaphylactic reactions and head and neck angioedema
Hypotension
Hyperkalaemia
Impaired renal function

Interactions

Cyclosporine — avoid coadministration
Itraconazole — avoid coadministration
NSAIDs (including COX-2 inhibitors) — risk of renal deterioration in elderly/volume-depleted/renally impaired; antihypertensive effect may be attenuated
Dual RAAS blockade with ACE inhibitors or ARBs — increased risk of hypotension, hyperkalaemia and changes in renal function

Clinical monograph

How it works

It directly inhibits renin, reducing the conversion of angiotensinogen to angiotensin I and thereby lowering angiotensin II and aldosterone activity within the renin-angiotensin-aldosterone system.

Prescribing in practice

Combining aliskiren with an ACE inhibitor or angiotensin receptor blocker increases the risk of hyperkalaemia, hypotension and renal impairment and is contraindicated in patients with diabetes or moderate-to-severe renal impairment.
Contraindicated in pregnancy because of the risk of fetal harm from drugs acting on the renin-angiotensin system.
Use with caution in patients at risk of volume depletion, in whom first-dose hypotension may occur.

Monitoring

Monitor blood pressure, serum potassium and renal function, particularly in those with renal impairment or taking other renin-angiotensin system blockers.

Counselling the patient

Avoid this medicine if you are or may become pregnant, and tell your prescriber straight away if pregnancy occurs.
Avoid potassium-containing salt substitutes unless advised, and attend for blood tests as requested.

Evidence & guidelines

The ALTITUDE trial showed harm from adding aliskiren to other renin-angiotensin system blockers in high-risk patients, supporting current contraindications.

Reference: ALTITUDE NEJM 2012; 367:2204-13; MHRA Drug Safety Update Feb 2012; NICE NG136; ESC Hypertension Guidelines 2018; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways