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Aliskiren (Tekturna): Uses, Side Effects and Dosage

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Prescription (Rx) Boxed warning
Strength:
150 mg, 300 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Aliskiren

What is the most important information I should know about aliskiren tablets?

Aliskiren tablets 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 aliskiren tablets, stop taking aliskiren tablets and tell your doctor right away.

What are aliskiren tablets?

Aliskiren tablet are a prescription medicine used to treat high blood pressure (hypertension) in adults and children weighing 50 kg or greater who are at least 6 years of age to lower blood pressure.

It is not known if aliskiren tablets are safe and effective in children under 6 years of age.

Do not take aliskiren tablet if:

  • you have diabetes and are taking a kind of medicine called an angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI).
  • you are allergic to any of the ingredients in aliskiren tablets. See the end of this leaflet for a complete list of the ingredients in aliskiren tablets.

Do not give aliskiren tablets to children less than 2 years of age.

Before taking aliskiren tablets, tell your doctor about all of your medical conditions, including if you:

  • have kidney or heart problems.
  • have diabetes.
  • have ever had an allergic reaction to another blood pressure medicine.

  • are pregnant or plan to become pregnant. See “What is the most important information I should know about aliskiren tablets?”

  • are breastfeeding or plan to breastfeed. It is not known if aliskiren passes into your breast milk. You should not breastfeed during treatment with aliskiren tablets.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

  • a kind of medicine to control blood pressure called angiotensin receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEI).
  • water pills (also called “diuretics”).
  • cyclosporine (Gengraf® , Neoral® , Sandimmune®)
  • itraconazole (Onmel®, Sporanox®).
  • potassium-containing medicines, potassium supplements, or salt substitutes containing potassium.
  • nonsteroidal anti-inflammatory drugs (NSAIDs).

Ask your doctor if you are not sure if you are taking one of the medicines listed above.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

How should I take aliskiren tablets?

  • Take aliskiren tablets exactly as your doctor tells you to take it.
  • Take aliskiren tablets 1 time a day, about the same time each day.
  • Your doctor may change your dose if needed.

What are possible side effects of aliskiren tablets?

Aliskiren tablets may cause serious side effects, including:

  • See “What is the most important information I should know about aliskiren tablets?”
  • Serious allergic reactions that can be life threatening. Stop taking aliskiren tablets and get emergency medical help right away and if you get any of these symptoms of a serious reactions during treatment with aliskiren tablets:
  • trouble breathing or swallowing
  • chest tightness
  • raised bumps (hives)
  • rash
  • swelling of the face, lips, tongue, throat, arms, legs or the whole body
  • itching
  • dizziness
  • vomiting
  • stomach (abdomen) pain
  • Low blood pressure (hypotension). Your blood pressure may get too low if you also take water pills, are on a low-salt diet, sweat more than normal, receive dialysis treatments, have heart problems, or have vomiting or diarrhea. Lie down if you feel faint or dizzy and call your doctor right away.
  • Kidney problems, including kidney failure. Tell your doctor if you urinate less.
  • Increased potassium blood levels (hyperkalemia). Your doctor will check your potassium blood level during treatment with aliskiren tablets.

The most common side effect of aliskiren tablets is diarrhea.

These are not all of the possible side effects of aliskiren tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store aliskiren tablets?

  • Store aliskiren tablets at room temperature between 68° to 77°F (20° to 25°C).
  • Keep aliskiren tablets in the original container it comes in. Do not remove the desiccant (drying agent) from the bottle.
  • Protect aliskiren tablets from moisture.

Keep aliskiren tablets and all medicines out of the reach of children.

General information about the safe and effective use of aliskiren tablets.

Medicines are sometimes prescribed for purpose other than those listed in the Patient Information leaflet. Do not take aliskiren tablets for a condition for which it was not prescribed. Do not give aliskiren tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

What is high blood pressure (hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great. High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Aliskiren tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

What are the ingredients in aliskiren tablets?

Aliskiren is available as film-coated tablets, which contains 165.765 mg or 331.530 mg aliskiren hemifumarate (equivalent to 150 mg or 300 mg aliskiren).

Active ingredient: aliskiren hemifumarate

Inactive ingredients: calcium stearate, colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, microcrystalline cellulose, polyethylene glycol, talc and titanium dioxide. In addition, the 150 mg strength contains iron oxide black.

For more information about aliskiren tablets, call Par Health at 1-800-828-9393.

This Patient Information has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Par Health.

Manufactured for:

Par Health USA

Rochester, MI 48307 U.S.A.

Made in India

Neutral Code: TN/DRUGS/TN00002121

© 2026 Par Health, Inc. or one of its affiliates.

OS424-01-74-06

Revised: 04/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 206665 · View the label on DailyMed

Revision date stated in the text: April 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Aliskiren

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Renin Inhibitor
Active ingredient Aliskiren hemifumarate
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) PH HEALTH
FDA approval ANDA 206665Abbreviated New Drug Application (ANDA) – generic drug Approved March 22, 2019
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Tekturna with the same TE code
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
150 mg – 30 in 1 bottle NDC 49884-424-11
300 mg – 30 in 1 bottle NDC 49884-425-11

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.