Fixed-dose combination: angiotensin II receptor blocker plus thiazide diuretic
ATC code: C09DA03 (Valsartan and diuretics)
Valsartan blocks AT1 receptors of angiotensin II – stopping vasoconstriction and aldosterone secretion. Hydrochlorothiazide excretes sodium and water via distal tubules. Combined BP reduction of 14-21/8-11 mmHg from baseline at 160/12.5 mg.
Second line
Essential hypertension when BP is not normalized on valsartan monotherapy. Per ESH/ 2023 and SEH-LELHA 2023 – second-line. Dose: 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 mg once daily. Full effect at 2-4 weeks. Do not combine with aliskiren in diabetes or CrCl <60 (AKI and hyperkalemia risk).
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Contraindicated from the 2nd trimester. ARBs and ACE inhibitors cause fetopathy: oligohydramnios, fetal renal failure, skull hypoplasia, limb contractures. In women of reproductive age planning pregnancy, switch in advance to methyldopa, labetalol, or slow-release nifedipine (ACOG 222 (2020), SEGO 2023).
Milk excretion data for the fixed combination are limited. For breastfeeding ESH 2023 and ACOG 2020 recommend switching to enalapril (RID 0.2%), captopril (RID 0.02%), methyldopa, or labetalol.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Valsartan + Hydrochlorothiazide is evaluated for the following indications with varying evidence strength: Hypertension (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Valsartan + Hydrochlorothiazide (≥ 1 in 100): Dizziness, Hypotension, Hyperkalemia, Hyponatremia, Hyperuricemia, Elevated creatinine. See the Safety section for uncommon and serious reactions.
FDA category D. Contraindicated from the 2nd trimester. ARBs and ACE inhibitors cause fetopathy: oligohydramnios, fetal renal failure, skull hypoplasia, limb contractures. In women of reproductive age planning pregnancy, switch in advance to methyldopa, labetalol, or slow-release nifedipine (ACOG 222 (2020), SEGO 2023).
Milk excretion data for the fixed combination are limited. For breastfeeding ESH 2023 and ACOG 2020 recommend switching to enalapril (RID 0.2%), captopril (RID 0.02%), methyldopa, or labetalol.
Valsartan + Hydrochlorothiazide is contraindicated in: Hypersensitivity to sartan, thiazides, or sulfonamides; Pregnancy (2nd-3rd trimester); Bilateral renal artery stenosis; Severe renal impairment (CrCl <30 for the thiazide component); Severe hepatic impairment, cholestasis. Full list in the Safety section.