Irbesartan

DRUG INFORMATION

  ADULT
    - DOSAGE & ADMINISTRATION Indication Dose Hypertension ( 2.2 ) 150 mg 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.
      Source: US FDA label for irbesartan (Irbesartan), section 'dosage and
      administration', retrieved 2026-08-29
    - 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 )].
      Source: US FDA label for irbesartan (Irbesartan), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - In infants with histories of in utero exposure to an angiotensin II receptor
      antagonist observe for hypotension, oliguria, and hyperkalemia. If oliguria
      occurs, support blood pressure and renal perfusion. Exchange transfusion or
      dialysis may be required as means of reversing hypotension and/or substituting for
      disordered renal function.
      Source: US FDA label for irbesartan (Irbesartan), section 'pediatric use',
      retrieved 2026-08-29
    - Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not
      appear to lower blood pressure effectively in pediatric patients ages 6 to 16
      years.
      Source: US FDA label for irbesartan (Irbesartan), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Exchange transfusion or dialysis may be required as means of reversing hypotension
      and/or substituting for disordered renal function.
      Source: US FDA label for irbesartan (Irbesartan), section 'use in specific
      populations', retrieved 2026-08-29
    - Patients whose renal function may depend in part on the activity of the renin-
      angiotensin system (e.g., patients with renal artery stenosis, chronic kidney
      disease, severe heart failure, or volume depletion) may be at particular risk of
      developing acute renal failure or death on irbesartan.
      Source: US FDA label for irbesartan (Irbesartan), section 'warnings and cautions',
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for irbesartan (Irbesartan),
      retrieved 2026-08-29

  PREGNANCY
    - Teratogenic effects Pregnancy Category D Use of drugs that act on the renin-
      angiotensin system during the second and third trimesters of pregnancy reduces
      fetal renal function and increases fetal and neonatal morbidity and death.
      Source: US FDA label for irbesartan (Irbesartan), section 'pregnancy', retrieved
      2026-08-29
    - Resulting oligohydramnios can be associated with fetal lung hypoplasia and
      skeletal deformations.
      Source: US FDA label for irbesartan (Irbesartan), section 'pregnancy', retrieved
      2026-08-29
    - Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension,
      renal failure, and death.
      Source: US FDA label for irbesartan (Irbesartan), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - It is not known whether irbesartan is excreted in human milk, but irbesartan or
      some metabolite of irbesartan is secreted at low concentration in the milk of
      lactating rats.
      Source: US FDA label for irbesartan (Irbesartan), section 'nursing mothers',
      retrieved 2026-08-29
    - Because of the potential for adverse effects on the nursing infant, discontinue
      nursing or discontinue irbesartan.
      Source: US FDA label for irbesartan (Irbesartan), section 'nursing mothers',
      retrieved 2026-08-29
    - • Nursing Mothers: Potential for adverse effects in infant.
      Source: US FDA label for irbesartan (Irbesartan), section 'use in specific
      populations', retrieved 2026-08-29