Prescription medicine
Aliskiren Brand names: Tekturna
Aliskiren (Tekturna) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $3.94 per aliskiren 150 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the aliskiren FDA label on DailyMed (effective March 7, 2024, LXO US Inc.); the NDA 21985 record on Drugs@FDA; every aliskiren label on DailyMed.
Highlights of the record
FDA label of March 7, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Tekturna as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Tekturna as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageTekturna 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.
Forms and strengths
- 150 mg
- 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 5, 2007 Tekturna, Lxo Ireland; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 22, 2019; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 19, 2026 Tekturna tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $3.94 per tablet Aliskiren 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,999 through July 30, 2026
What is aliskiren used for?
From the label: indications and usageTekturna 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. ( 1.1 ) 1.1 Hypertension Tekturna is 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 and older to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]
Conditions named in the indications of aliskiren's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Renin Inhibitor.
Source: FDA drug label (Tekturna), NDA021985 (Lxo Ireland), as published by LXO US Inc., effective March 7, 2024 (SPL set 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2), via openFDA; the full label on DailyMed
What does the patient leaflet for aliskiren say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Tekturna?Tekturna can cause harm or death to your unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you become pregnant during treatment with Tekturna, stop taking Tekturna and tell your doctor right away.
From the patient leaflet: How should I store Tekturna tablets?Store Tekturna at room temperature between 68°F to 77°F (20°C to 25°C). Keep Tekturna in the original container it comes in. Do not remove the desiccant (drying agent) from the bottle. Protect Tekturna from moisture. Keep Tekturna and all medicines out of the reach of children.
Source: FDA drug label (Tekturna), NDA021985 (Lxo Ireland), as published by LXO US Inc., effective March 7, 2024 (SPL set 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2), via openFDA; the full label on DailyMed
Is there a generic for aliskiren (Tekturna)?
The FDA approved the first generic aliskiren on March 22, 2019. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists aliskiren from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Tekturna tablets, the last expiring on August 19, 2026. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2019 first generic approved
- 2026 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for aliskiren (Tekturna)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.94 per Aliskiren 150 mg tablet, down 2% from $4.00 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Aliskiren 150 mg tablet (generic)
- Tekturna 300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aliskiren 150 mg tablet | Generic | $3.94 per tablet | $118.12 | -2% |
| Aliskiren 300 mg tablet | Generic | $5.86 per tablet | $175.75 | +15% |
| Tekturna 300 mg tablet | Brand | $15.09 per tablet | $452.83 | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the aliskiren label say about other medicines?
The aliskiren label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name aliskiren. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | DRUG INTERACTIONS Cyclosporine: Avoid coadministration of cyclosporine with aliskiren [see Warnings and Precautions ( 5.7 ) and Clinical Pharmacology ( 12.3 )]. |
| Epinephrine | warnings and precautions | Prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and measures to ensure a patent airway may be necessary. |
| Furosemide | drug interactions | Oral coadministration of aliskiren and furosemide reduced exposure to furosemide. |
| Itraconazole | drug interactions | Itraconazole: Avoid coadministration of itraconazole with aliskiren [see Warnings and Precautions ( 5.7 ) and Clinical Pharmacology ( 12.3 )]. |
Other labels that name aliskiren
Source: FDA drug label (Tekturna), NDA021985 (Lxo Ireland), as published by LXO US Inc., effective March 7, 2024 (SPL set 3dd61fa5-1620-4ebf-bbdb-ede29b92fce2), via openFDA; the full label on DailyMed
What do FAERS reports show for aliskiren?
The FDA Adverse Event Reporting System holds 5,999 reports that list aliskiren among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 744 are coded as a death and 1,918 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as aliskiren?
72 other medicines are given the same way (oral) and in the same FDA class as aliskiren or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Amlodipine | High blood pressure | 42 labelers | $0.0102 per tablet 5 mg tablet | No current entry |
| Clonidine | High blood pressure | 37 labelers | $0.0241 per tablet 0.1 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does aliskiren compare with medicines for the same use?
3 side-by-side pages set aliskiren beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to aliskiren
- 72 medicines for the same use
- Aliskiren side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other