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Molecule

Aliskiren

Also known as aliskiren hemifumarate
Available on requestCardiology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Aliskiren is a renin inhibitor indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. MedsAcross supplies Aliskiren for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Renin Inhibitor, Renin Inhibitors
ATC classification
C09XA02 Aliskiren · Renin inhibitor
US FDA first approval
5 March 2007
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 502FWN4Q32RxCUI 325646CAS 173334-57-1DrugBank DB09026Q414904

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Source: US FDA prescribing information

How it works

Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion. Renin cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by ACE and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits renin release, thus providing a negative feedback to the system. This cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS).

Source: US FDA prescribing information

Dosing overview

Starting dose (adults and pediatric patients): 150 mg once daily with a routine pattern with regard to meals. If blood pressure remains uncontrolled titrate up to 300 mg daily. Majority of effect of given dose attained in 2 weeks.

Source: US FDA prescribing information

Contraindications

Do not use Tekturna with ARBs or ACEIs in patients with diabetes. Tekturna is contraindicated in patients with known hypersensitivity to any of the components. Tekturna is contraindicated in pediatric patients less than 2 years of age because of the risk of high aliskiren exposures identified in juvenile animals due to immaturity of transporters and metabolic enzymes. Do not use with angiotensin receptor blockers (ARBs) or angiotensin- converting enzyme inhibitors (ACEIs) in patients with diabetes. Hypersensitivity to any of the components. Tekturna is contraindicated in pediatric patients less than 2 years of age.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue Tekturna as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Avoid concomitant use with ARBs or ACEIs particularly in patients with renal impairment [creatinine clearance (CrCl) <60 mL/min]. Anaphylactic Reactions and Head and Neck Angioedema. Hypotension: Correct imbalances in volume and/or salt depleted patients. Impaired Renal Function: Monitor serum creatinine periodically. Hyperkalemia: Monitor potassium levels periodically.

Source: US FDA prescribing information

Interactions

Cyclosporine: Avoid coadministration of cyclosporine with aliskiren. Itraconazole: Avoid coadministration of itraconazole with aliskiren. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors with agents that affect the RAAS, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy. The antihypertensive effect of aliskiren may be attenuated by NSAIDs.

Source: US FDA prescribing information

Storage

Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59 ºF to 86ºF). Protect from moisture.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Aliskiren, sorted by availability.

MedicineManufacturerRegisterAvailability
Aliskiren 150 mg tabletOralGeneric name—US FDAAvailable on request
Aliskiren 300 mg tabletOralGeneric name—US FDAAvailable on request
Tekturna 150 mg tabletOralLxoUS FDAAvailable on request
Tekturna 300 mg tabletOralLxoUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 5 March 2007Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Aliskiren in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Aliskiren available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Aliskiren and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Aliskiren have?

The catalogue lists 1 brand names for Aliskiren, including Tekturna.

Is Aliskiren approved by the US FDA?

Yes. The US FDA first approved Aliskiren on 5 March 2007, according to Drugs@FDA.

Is Aliskiren authorised in the European Union?

Yes. Aliskiren has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Aliskiren need cold chain shipping?

No listed presentation of Aliskiren is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Aliskiren in?

Aliskiren is classified under ATC code C09XA02 (Aliskiren).

References

  1. Tekturna prescribing information (Lxo). U.S. National Library of Medicine, DailyMed. Retrieved 7 March 2024
  2. Rasilez: European public assessment report (EPAR). European Medicines Agency. Retrieved 2 October 2026

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