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Angiotensin II receptor antagonist (ARB) Pregnancy: Not recommended in the first trimester; contraindicated in the second and third trimesters (known human foetotoxicity and neonatal toxicity). Breast-feeding not recommended.

Irbesartan

Brand names: Aprovel

Irbesartan is an angiotensin-II receptor blocker (ARB) used for hypertension and for nephropathy in type-2 diabetes.

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 (usual initial and maintenance dose); may be increased to 300 mg once daily if insufficiently controlled
Route: Oral
Frequency: Once daily, with or without food
Max: 300 mg once daily
150 mg once daily generally gives better 24-hour BP control than 75 mg. Starting at 75 mg may be considered, particularly in haemodialysed patients and in patients over 75 years. Hypertensive type 2 diabetics with renal disease: initiate 150 mg once daily and titrate up to 300 mg once daily as the preferred maintenance dose. Adding a diuretic (e.g. hydrochlorothiazide) has an additive effect. Mild-to-moderate hepatic impairment: no adjustment; no experience in severe hepatic impairment. Paediatric (0-18 years): safety and efficacy not established, no posology recommendation.

Dose adjustments

Renal

No dosage adjustment necessary in impaired renal function; a lower starting dose (75 mg) should be considered for patients undergoing haemodialysis. Monitor serum potassium and creatinine.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily 2.1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies (14.1) ]. 2.3 Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ]. 2.4 Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2026-01-27. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to irbesartan or to any of the excipients
  • Second and third trimesters of pregnancy
  • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73m2)

Side effects

  • Dizziness / orthostatic dizziness (common)
  • Orthostatic hypotension (common)
  • Nausea / vomiting (common)
  • Musculoskeletal pain (common)
  • Fatigue (common)

Interactions

  • Aliskiren - contraindicated in diabetes mellitus or renal impairment; dual RAAS blockade not recommended
  • ACE inhibitors / other angiotensin II receptor blockers - dual RAAS blockade increases risk of hypotension, hyperkalaemia and decreased renal function; not recommended (must not be combined in diabetic nephropathy)
  • Diuretics such as hydrochlorothiazide - additive antihypertensive effect
  • Insulin / antidiabetic agents - risk of hypoglycaemia; blood glucose monitoring and dose adjustment may be needed

Clinical monograph

How it works

It blocks the angiotensin-II type-1 receptor, reducing vasoconstriction and aldosterone-driven sodium and water retention without inhibiting ACE.

Prescribing in practice

  • Do not combine an ARB with an ACE inhibitor, as dual blockade increases the risk of hyperkalaemia, hypotension and renal impairment.
  • Hyperkalaemia and reductions in renal function can occur; check renal function and potassium before starting and after dose changes.
  • Avoid in pregnancy and in bilateral renal artery stenosis; ARBs are a useful alternative when ACE-inhibitor cough is a problem, as cough is much less common.

Monitoring

Monitor renal function, serum potassium and blood pressure before treatment, after dose adjustments and periodically during therapy.

Counselling the patient

  • Tell your clinician at once if you think you may be pregnant, as this medicine must be stopped.
  • Report swelling of the face, lips or throat, and avoid potassium-based salt substitutes.

Evidence & guidelines

Guideline-recommended for hypertension and diabetic kidney disease (NICE NG136, NG203).

Reference: NICE NG136; 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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