Aliskiren

Aliskiren is a prescription medication used to treat High Blood Pressure (Hypertension). 

• Aliskiren is available under the following different brand names: Tekturna 

Common side effects of Aliskiren include:

• Diarrhea

Serious side effects of Aliskiren include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Itching,
• Vomiting,
• Severe stomach pain,
• Dizziness,
• Chest tightness,
• Lightheadedness,
• Little or no urination,
• Weakness,
• Tingly feeling,
• Irregular heartbeats,
• Loss of movement,
• Headache,
• Confusion,
• Slurred speech,
• Severe weakness,
• Loss of coordination, and
• Feeling unsteady

Rare side effects of Aliskiren include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 150 mg
• 300 mg

Oral pellets in capsules

• 37.5 mg

Hypertension

Adult dosage

• 150 mg orally once a day, may increase to 300 mg once a day based on response and tolerability

Pediatric dosage

• Below 2 years: Contraindicated
• 2 to below 6 years: Safety and efficacy not established
• 6 to 17 years
  • Below 20 kg: Not recommended
  • 20 to below 50 kg: Starting dose is 75 mg orally once a day; not to exceed 150 mg orally once a day
  • Above 50 kg: 150 mg orally once a day; may increase to 300 mg orally once a day based on response and tolerability

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Aliskiren has severe interactions with the following drugs:
  • azilsartan
  • benazepril
  • candesartan
  • captopril
  • enalapril
  • eprosartan
  • fosinopril
  • irbesartan
  • lisinopril
  • losartan
  • moexipril
  • olmesartan
  • perindopril
  • quinapril
  • ramipril
  • sacubitril/valsartan
  • telmisartan
  • trandolapril
  • valsartan
• Aliskiren has serious interactions with the following drugs:
  • azilsartan
  • captopril
  • cyclosporine
  • erdafitinib
  • itraconazole
  • lasmiditan
  • nirmatrelvir/ritonavir
  • potassium phosphates, IV
  • sotorasib
  • tepotinib
• Aliskiren has moderate interactions with at least 65 other drugs.
• Aliskiren has minor interactions with at least 29 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Coadministration with ARBs or ACE inhibitors in patients with diabetes mellitus
• Children below 2 years

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aliskiren?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aliskiren?”

Cautions

• Symptomatic hypotension may occur after initiation of treatment in patients with marked volume depletion, patients with salt depletion, or with the combined use of other agents acting on the renin-angiotensin-aldosterone system (RAAS); the volume or salt depletion should be corrected before administration of treatment, or the treatment should start under close medical supervision; transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
• Monitor renal function periodically; changes in renal function, including acute renal failure, can be caused by drugs that affect the RAAS; patients whose renal function may depend in part on the activity of the RAAS (.g, patients with renal artery stenosis, severe heart failure, post-myocardial infarction or volume depletion) or patients receiving ARB, ACE inhibitors or nonsteroidal anti-inflammatory drug (NSAID), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors)], therapy may be at particular risk of developing acute renal failure; monitor renal function periodically (see Black Box Warnings)
• Anaphylactic reactions
• Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis, and/or larynx reported with patients requiring hospitalization and intubation; this may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACEIs or angiotensin receptor antagonists
• Anaphylactic reactions reported post-marketing with unknown frequency; if angioedema involves the throat, tongue, glottis, or larynx, or if the patient has a history of upper respiratory surgery, airway obstruction may occur and be fatal; patients who experience these effects, even without respiratory distress, require prolonged observation and appropriate monitoring measures since treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement
• 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; discontinue therapy immediately in patients who develop anaphylactic reactions or angioedema, and do not readminister
• Drugs interactions overview
  • Cyclosporine or itraconazole increase aliskiren levels; avoid concomitant use
  • Oral coadministration of aliskiren and furosemide reduced exposure to furosemide
  • Coadministration of the nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors with aliskiren, may result in deterioration of renal function, including possible acute renal failure; effects are usually reversible; monitor renal function periodically in patients receiving aliskiren and NSAID therapy
• Coadministration with ACE inhibitors or ARBs
  • Concomitant use of aliskiren with other agents acting on the RAAS (.g, ACEIs or ARBs) is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared with monotherapy)
  • Coadministration of 2 drugs that inhibit the renin-angiotensin system does not obtain any additional benefit compared to monotherapy (see Contraindications)

Pregnancy and Lactation

• Fetal harm may occur when administered to a pregnant woman
• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (. g, need for cesarean section, and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
• Fetal or neonatal adverse reactions
  • Use of drugs that act on the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death
  • Perform serial ultrasound examinations to assess the intra-amniotic environment
  • Observe infants with histories of in-utero exposure to aliskiren for hypotension, oliguria, and hyperkalemia; if oliguria or hypotension occurs in neonates with a history of in-utero exposure to aliskiren, support blood pressure and renal perfusion
• Lactation
  • There is no information regarding the presence of aliskiren in human milk, the effects on the breastfed infant, or the effects on milk production
  • Owing to the potential for serious adverse reactions, including hypotension, hypercalcemia, and renal impairment in nursing infants
  • Advise a nursing woman that breastfeeding is not recommended during therapy