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Angiotensin II receptor blocker (ARB) Pregnancy: SPC section 4.6: The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4). Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with AIIRAs, similar risks may exist for this class of drugs. Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started. AIIRAs therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken AIIRAs should be closely observed for hypotension. Breast-feeding: because no information is available regarding the use of valsartan during breastfeeding, valsartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Valsartan

Brand names: Diovan

Valsartan is an angiotensin II receptor blocker (ARB) used in hypertension, heart failure, and following myocardial infarction with left ventricular dysfunction.

Adult dose

Dose: Hypertension (essential hypertension in adults): starting dose 80 mg once daily; if blood pressure is not adequately controlled the dose can be increased to 160 mg and to a maximum of 320 mg. Recent myocardial infarction (clinically stable adults, therapy may start as early as 12 hours after the infarction): initial dose 20 mg twice daily, titrated to 40 mg, 80 mg and 160 mg twice daily over the next few weeks; target maximum dose 160 mg twice daily; in general patients should reach 80 mg twice daily by two weeks and 160 mg twice daily by three months, as tolerated. Heart failure (adults): starting dose 40 mg twice daily, up-titrated to 80 mg and 160 mg twice daily at intervals of at least two weeks to the highest dose tolerated.
Route: Oral (tablet), with water; may be taken independently of a meal.
Frequency: Hypertension: once daily. Recent myocardial infarction and heart failure: twice daily.
Max: Hypertension: 320 mg (printed as 'a maximum of 320 mg' in the once-daily regimen). Recent myocardial infarction: target maximum 160 mg twice daily. Heart failure: highest titration step printed is 160 mg twice daily, as tolerated (the maximum daily dose administered in clinical trials is 320 mg in divided doses).
Strength of the SPC pinned for this card: valsartan 80 mg film-coated tablets (SPC section 2). The post-myocardial-infarction and heart-failure starting steps (20 mg and 40 mg twice daily) are lower than 80 mg; the SPC text refers to 'the 40 mg divisible tablet' for the post-MI starting dose, so check the strength being prescribed. Hypertension: antihypertensive effect is substantially present within 2 weeks and maximal effects are attained within 4 weeks; may be given with other antihypertensives, and adding a diuretic such as hydrochlorothiazide decreases blood pressure further. Recent myocardial infarction: if symptomatic hypotension or renal dysfunction occurs, consider a dosage reduction; the combination with ACE inhibitors is not recommended; evaluation should always include assessment of renal function. Heart failure: consider reducing concomitant diuretic doses; the triple combination of an ACE inhibitor, valsartan and a beta-blocker or a potassium-sparing diuretic is not recommended; evaluation should always include assessment of renal function. Elderly: no dose adjustment required. Indications in section 4.1: essential hypertension in adults (and hypertension in children and adolescents 6 to less than 18 years); stable adults with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours-10 days) myocardial infarction; adults with symptomatic heart failure when ACE inhibitors are not tolerated, or as add-on to ACE inhibitors in beta-blocker intolerant patients when mineralocorticoid receptor antagonists cannot be used. Brand Diovan: this card is drawn from a generic valsartan 80 mg tablet SPC, not the Diovan SPC.

Paediatric dose

Dose: Hypertension, children and adolescents 6 to less than 18 years (valsartan tablets): initial dose 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more; adjust to blood pressure response and tolerability. Maximum doses studied in clinical trials (tablet): 18 kg to below 35 kg, 80 mg; 35 kg to below 80 kg, 160 mg; 80 kg to 160 kg, 320 mg. Doses higher than those listed have not been studied and are not recommended.
Route: Oral (tablet)
Frequency: Once daily
As printed in SPC section 4.2 (paediatric hypertension, 6 to less than 18 years) - not scaled from the adult dose. Children who cannot swallow tablets, and children aged 1 to 5 years: the SPC recommends the valsartan oral solution, which gives about 1.7-fold higher systemic exposure and 2.2-fold higher peak plasma concentration than the tablets - do not interchange milligram doses without the SPC switching advice. Safety and efficacy below 1 year of age have not been established. Not recommended in paediatric heart failure or recent myocardial infarction (below 18 years) due to lack of data. Paediatric renal impairment: not recommended with creatinine clearance below 30 ml/min or on dialysis (not studied); no dose adjustment with creatinine clearance above 30 ml/min. Paediatric hepatic impairment: contraindicated in severe hepatic impairment, biliary cirrhosis and cholestasis; the dose should not exceed 80 mg in mild to moderate impairment.

Dose adjustments

Renal

SPC section 4.2: no dose adjustment is required for adult patients with a creatinine clearance above 10 ml/min. Section 4.4: no experience in patients with creatinine clearance below 10 ml/min or on dialysis - use with caution. Concomitant use of valsartan with aliskiren is contraindicated in patients with renal impairment (GFR below 60 ml/min/1.73 m2).

Hepatic

SPC section 4.2: valsartan is contraindicated in severe hepatic impairment, biliary cirrhosis and cholestasis. In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg (use with caution, section 4.4).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (section 4.3)
  • Severe hepatic impairment, biliary cirrhosis and cholestasis (section 4.3)
  • Second and third trimester of pregnancy (section 4.3)
  • Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR below 60 ml/min/1.73 m2) (section 4.3)

Side effects

  • Uncommon (hypertension studies): vertigo, cough, abdominal pain, fatigue (section 4.8)
  • Very rare: intestinal angioedema (section 4.8)
  • Frequency not known: decrease in haemoglobin and haematocrit, neutropenia, thrombocytopenia; hypersensitivity including serum sickness; increase of serum potassium, hyponatraemia; vasculitis; elevation of liver function values including serum bilirubin; angioedema, bullous dermatitis, rash, pruritus; myalgia; renal failure and impairment, elevation of serum creatinine (section 4.8)
  • Symptomatic hypotension may occur in rare cases in severely sodium- and/or volume-depleted patients, such as those on high-dose diuretics, after initiation (section 4.4)
  • Paediatric hypertension: no relevant differences from adults apart from isolated gastrointestinal disorders (abdominal pain, nausea, vomiting) and dizziness (section 4.8)
  • This side-effect list may be incomplete — check the full SPC.

Interactions

  • Dual blockade of the renin-angiotensin-aldosterone system (ACE inhibitors, angiotensin II receptor blockers or aliskiren) is associated with more hypotension, hyperkalaemia and decreased renal function (including acute renal failure) (sections 4.4, 4.5)
  • Aliskiren: contraindicated in patients with diabetes mellitus or renal impairment (GFR below 60 ml/min/1.73 m2) (sections 4.3, 4.5)
  • Lithium: reversible increases in serum lithium concentrations and toxicity reported; if the combination is necessary monitor serum lithium carefully (concomitant use not recommended) (section 4.5)
  • Potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes and other agents that may raise potassium (e.g. heparin): monitor plasma potassium; concomitant use not recommended (sections 4.4, 4.5)
  • NSAIDs including selective COX-2 inhibitors and acetylsalicylic acid above 3 g/day: attenuated antihypertensive effect and increased risk of worsening renal function and raised serum potassium; monitor renal function at the start and ensure adequate hydration (section 4.5)
  • Hepatic uptake (OATP1B1/OATP1B3) or efflux (MRP2) transporter inhibitors such as rifampicin, ciclosporin or ritonavir may increase systemic exposure to valsartan (section 4.5)
  • ACE inhibitor combinations in recent myocardial infarction and heart failure: not recommended (section 4.4)
  • This interaction list may be incomplete — check the full SPC.

Monitoring

  • Potassium, as appropriate, especially with agents that raise potassium (section 4.4)
  • Renal function: assessment should always be included in post-myocardial infarction and heart failure patients; monitoring recommended in renal artery stenosis and when started with NSAIDs (sections 4.2, 4.4, 4.5)
  • Serum lithium levels if lithium is co-administered (section 4.5)
  • Correct sodium and/or volume depletion before starting treatment (section 4.4)
  • Paediatric patients: renal function and serum potassium closely monitored (section 4.2)
  • Ultrasound check of renal function and skull if exposure occurred from the second trimester of pregnancy; infants of mothers who took AIIRAs closely observed for hypotension (section 4.6)

Clinical monograph

How it works

It selectively antagonises the angiotensin II type 1 (AT1) receptor, blocking angiotensin II-mediated vasoconstriction and aldosterone release to reduce blood pressure and cardiac afterload.

Prescribing in practice

  • Contraindicated in pregnancy and should be stopped if pregnancy is planned or confirmed, as ARBs are foetotoxic in the second and third trimesters.
  • Avoid combining with an ACE inhibitor or aliskiren because dual renin-angiotensin blockade increases the risk of hyperkalaemia, hypotension and renal impairment.
  • Use cautiously in renal artery stenosis, volume depletion, and severe heart failure where renal function depends on the renin-angiotensin system.

Monitoring

Monitor blood pressure, renal function and serum potassium before starting and after dose changes.

Counselling the patient

  • Report planned or suspected pregnancy promptly so the medicine can be reviewed.
  • Rise slowly from sitting or lying, especially with the first doses, to limit dizziness.
  • Avoid potassium-containing salt substitutes unless advised otherwise.

Evidence & guidelines

NICE recommends ARBs such as valsartan as alternatives to ACE inhibitors for hypertension and heart failure, and the Val-HeFT and VALIANT trials support its use in heart failure and post-infarction LV dysfunction.

Reference: NICE NG136/NG106; ESC; 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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