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ARB Pregnancy: Not recommended in the 1st trimester; contraindicated in the 2nd and 3rd trimester (ARB fetotoxicity — decreased renal function, oligohydramnios, skull ossification retardation; neonatal renal failure, hypotension, hyperkalaemia). Not recommended during breast-feeding

Azilsartan medoxomil

Brand names: Edarbi

Azilsartan medoxomil is an angiotensin II receptor blocker (ARB) used in the treatment of essential 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: 40 mg once daily (recommended starting dose); may be increased to a maximum of 80 mg once daily if blood pressure not adequately controlled at the lower dose
Route: oral
Frequency: once daily
Max: 80 mg once daily
May be taken with or without food. Near-maximal antihypertensive effect at 2 weeks, maximal by 4 weeks. Very elderly (>=75 years): consider 20 mg starting dose (hypotension risk). Mild-to-moderate hepatic impairment: consider 20 mg starting dose with close monitoring; not recommended in severe hepatic impairment. Intravascular volume/salt depletion (e.g. high-dose diuretics, vomiting, diarrhoea): correct hypovolaemia first or initiate under close supervision, consider 20 mg starting dose. No dose adjustment for mild/moderate renal impairment; caution in severe renal impairment/ESRD (no experience); haemodialysis does not remove azilsartan. Not indicated for use under 18 years — no posology recommendation can be made.

Dose adjustments

Renal

No dose adjustment in mild or moderate renal impairment; caution in severe renal impairment and end-stage renal disease (no experience of use); haemodialysis does not remove azilsartan

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; 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

  • Hypersensitivity to the active substance or any excipient
  • Second and third trimester of pregnancy
  • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2)

Side effects

  • Dizziness (common)
  • Diarrhoea (common)
  • Blood creatine phosphokinase increased (common)
  • Hypotension (uncommon)
  • Nausea (uncommon)
  • Angioedema (uncommon)

Interactions

  • Dual RAAS blockade with ACE inhibitors, other ARBs or aliskiren — increased risk of hypotension, hyperkalaemia and decreased renal function; not recommended
  • NSAIDs (including COX-2 inhibitors) — risk of renal deterioration in elderly/volume-depleted/renally impaired; antihypertensive effect may be attenuated
  • Lithium — increases in serum lithium concentrations and lithium toxicity
  • Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes — risk of hyperkalaemia

Clinical monograph

How it works

Its active moiety selectively blocks the angiotensin II type-1 (AT1) receptor, producing vasodilatation and reducing aldosterone-mediated sodium and water retention.

Prescribing in practice

  • Contraindicated in pregnancy because angiotensin receptor blockers can cause fetal toxicity, particularly in the second and third trimesters.
  • Can cause hyperkalaemia and deterioration in renal function, especially in renal impairment, volume depletion or when combined with other renin-angiotensin system agents.
  • Avoid concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment.

Monitoring

Monitor blood pressure, renal function and serum potassium, particularly after initiation and dose changes.

Counselling the patient

  • Tell your prescriber immediately if you become pregnant, as this medicine should be stopped.
  • Rise slowly when starting, as dizziness can occur, and attend for blood tests as advised.

Evidence & guidelines

Azilsartan medoxomil's antihypertensive efficacy is established in clinical trials and supported by the SPC.

Reference: NICE NG136; ESC HT; 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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