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At a glance

Aliskiren Hemifumarate + Hydrochlorothiazide is a fixed-dose combination medicine used for the treatment of essential hypertension in adults. Aliskiren is a direct renin inhibitor, and hydrochlorothiazide is a thiazide diuretic.

Indications

Essential hypertension in adults, particularly in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide alone [citation:1][citation:4][citation:5].

Pharmacology

Aliskiren is a potent, selective, orally active direct renin inhibitor that inhibits the enzyme renin, preventing the conversion of angiotensinogen to angiotensin I [citation:2][citation:3]. This reduces angiotensin II (a potent vasoconstrictor) and aldosterone levels, lowering blood pressure [citation:1][citation:2][citation:5]. Unlike ACE inhibitors or ARBs, aliskiren decreases plasma renin activity (PRA) [citation:2][citation:3][citation:6]. Hydrochlorothiazide is a thiazide diuretic that inhibits the Na+-Cl- symporter in the distal convoluted tubule, increasing sodium and chloride excretion [citation:2][citation:3][citation:6]. This reduces plasma volume and lowers blood pressure [citation:1][citation:3][citation:5].

Dosage

Adults:

  • Usual starting dose: 150/12.5 mg once daily [citation:4]
  • May be titrated up to maximum 300/25 mg once daily as needed [citation:4]
Side effects

Common side effects:

  • Diarrhea – most common side effect of aliskiren [citation:1][citation:5]
  • Dizziness
  • Joint pain
  • Cough [citation:1][citation:5]
  • Fatigue
  • Increased blood potassium levels
  • Gastrointestinal irritation, weakness, headache (from hydrochlorothiazide) [citation:1][citation:5]

Serious (rare): Angioedema (rare with aliskiren) [citation:1][citation:5]

Use in pregnancy

Pregnancy Category: D

Aliskiren + Hydrochlorothiazide is highly unsafe during pregnancy. Drugs acting on the renin-angiotensin system can cause fetal and neonatal morbidity and death [citation:6]. Discontinue immediately if pregnancy is detected [citation:3][citation:4][citation:6].

Pregnancy Category: D — always consult a doctor before taking during pregnancy.

Precautions & warnings
  • Pregnancy: Highly unsafe (Category D). Discontinue immediately if pregnancy is detected [citation:3][citation:4][citation:6]
  • Severe renal impairment: Not recommended [citation:3]
  • Diabetes with renal impairment (GFR <60 mL/min): Avoid concomitant use with ACE inhibitors or ARBs
  • History of angioedema: Caution required
  • Volume depletion/dehydration: Not recommended as initial therapy [citation:4]
  • Electrolyte imbalance: Regular monitoring required
Overdose effects

Overdose symptoms: electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration from excessive diuresis [citation:6]. Treatment: symptomatic and supportive measures.

Storage conditions

Store below 30°C in a cool and dry place, protected from light. Keep out of reach of children.

Aliskiren Hemifumarate + Hydrochlorothiazide — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.