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Aliskiren

Published: July 26, 2026Updated: July 26, 2026

Aliskiren is a direct renin inhibitor used to treat high blood pressure (hypertension). It works by blocking the renin enzyme in the renin-angiotensin-aldosterone system (RAAS), preventing the conversion of angiotensinogen to angiotensin I, which reduces angiotensin II levels and lowers blood pressure. It may be used alone or in combination with other antihypertensive agents.

Quick summary

Aliskiren is an antihypertensive medication that works by directly inhibiting renin to reduce blood pressure.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
C09XA02
RxNorm
325646
Generic
Aliskiren
Class
atc-c09
Brands
Tekturna HCT, Tekturna
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
150mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
not established
Maximum
consult physician
Frequency
not applicable
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
150mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses above 600 mg may cause significant hypotension and renal impairment
Chronic overdose: Prolonged use above recommended 300 mg daily may lead to cumulative renal and cardiovascular toxicity
Immediate actions
Supportive care, IV fluids, vasopressors if needed, monitor renal function and electrolytes
Antidote
No specific antidote exists(Treatment is supportive and symptomatic)
Poison Control: 1-800-222-1222

Special Populations

8 groups
✗

pregnancy

overall
unsafe
FDA Category
D
Dose Adjustment

avoid use

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks. Aliskiren acts on the renin-angiotensin system which is critical for fetal development

Monitor

regular fetal monitoring including ultrasound

Use of this medication in this population requires careful consideration of risks and benefits.

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

avoid use

Key Recommendations

discontinue breastfeeding or discontinue the drug

Monitor

monitor infant for hypotension and renal function

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

start at low end of dosing range

Key Recommendations

use with caution in patients over 65 years. Monitor renal function and blood pressure closely

Monitor

regular monitoring of blood pressure and renal function

Use with caution and monitor for adverse effects.

✗

pediatric_age

children adolescents
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not recommended for use in children and adolescents under 18 years of age. Safety and efficacy not established

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

✗

renal_impairment

severe
contraindicated
FDA Category
N
Dose Adjustment

avoid in severe impairment

Key Recommendations

contraindicated in patients with severe renal impairment (CrCl <30 mL/min). Use with caution in moderate impairment

Monitor

monitor renal function and serum potassium regularly

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

moderate
caution
FDA Category
N
Dose Adjustment

reduce dose if needed

Key Recommendations

use with caution in patients with moderate renal impairment (CrCl 30-60 mL/min). Start at lower dose

Monitor

monitor renal function and potassium levels

Use with caution and monitor for adverse effects.

✓

hepatic_impairment

mild moderate
safe
FDA Category
N
Dose Adjustment

no adjustment needed

Key Recommendations

no dose adjustment required for mild to moderate hepatic impairment

Monitor

standard monitoring

⚠

hepatic_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use with caution in severe hepatic impairment due to limited data

Monitor

monitor liver function tests

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2007

FDA approval date for Aliskiren

drug_classWHO
2023

Drug class

Value:Direct renin inhibitor

Pharmacological classification

usageMedical guidelines
2023

Common uses

Value:Treatment of hypertension

Primary therapeutic indication

mechanismFDA
2023

Mechanism of action

Value:Renin-angiotensin system inhibition

Pharmacodynamic properties

Treatment of essential hypertension (high blood pressure) in adults. It may be prescribed alone or combined with other blood pressure medications such as thiazide diuretics or calcium channel blockers.

Aliskiren is a direct renin inhibitor that binds to the active site of renin, blocking the conversion of angiotensinogen to angiotensin I. This reduces the production of angiotensin II, a potent vasoconstrictor, leading to decreased vascular resistance and lower blood pressure.

Contraindicated during pregnancy due to risk of fetal harm. Not recommended in combination with ACE inhibitors or ARBs in patients with diabetes. May cause hyperkalemia, especially when used with other RAAS inhibitors. Common side effects include diarrhea, dizziness, and headache. Not typically used as first-line therapy.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy