Version July 2025
When pregnancy is detected, discontinue aliskiren as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.
Hypertension (alternative agent): Initial: 150 mg once daily; may increase to 300 mg once daily (maximum: 300 mg/day) (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: No initial dosage adjustment necessary.
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, limited data suggests no dosage adjustment is necessary (Ref). Risk of hyperkalemia is increased and progressive renal impairment may occur; use with caution.
ESRD (requiring hemodialysis): No dosage adjustment necessary. Risk of hyperkalemia is increased with chronic therapy; use with extreme caution. Note: Hemodialysis eliminates a minimal fraction; does not significantly alter overall aliskiren exposure.
No initial dosage adjustment necessary.
Refer to adult dosing. No initial dosage adjustment required.
(For additional information see "Aliskiren: Pediatric drug information")
Note: Prior to initiation, correct hypovolemia and/or closely monitor volume status in patients on concurrent diuretics during treatment initiation.
Hypertension:
Children ≥6 years and Adolescents: Oral:
20 to 50 kg: Limited data available: Initial: 75 mg once daily; if blood pressure not adequately controlled, may increase to 150 mg once daily; maximum daily dose: 150 mg/day (Ref).
≥50 kg: Initial: 150 mg once daily; if blood pressure not adequately controlled, may increase to 300 mg once daily; maximum daily dose: 300 mg/day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥6 years and Adolescents: Oral:
CrCl ≥30 mL/minute: No initial dosage adjustment necessary
CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, limited data in adults suggests no dosage adjustment is necessary (Ref). Risk of hyperkalemia is increased and progressive renal impairment may occur; use with caution, monitor serum potassium closely.
ESRD (requiring hemodialysis): No dosage adjustment necessary. Hemodialysis eliminates a minimal fraction; does not significantly alter overall aliskiren exposure. Risk of hyperkalemia is increased with chronic therapy; use with extreme caution, monitor serum potassium closely.
Children ≥6 years and Adolescents: Oral: No initial dosage adjustment necessary.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Skin rash (1%)
Gastrointestinal: Diarrhea (2%)
Neuromuscular & skeletal: Increased creatine phosphokinase (>300% increase: 1%)
Renal: Increased blood urea nitrogen (≤7%), increased serum creatinine (≤7%)
Respiratory: Cough (1%)
<1%, postmarketing, and/or case reports: Abdominal pain, anaphylaxis, anemia, angioedema, decreased hematocrit, decreased hemoglobin, dyspepsia, erythema, gastroesophageal reflux disease, gout, hepatic insufficiency, hyperkalemia, hyponatremia, increased liver enzymes, increased uric acid, myositis, nausea, nephrolithiasis, periorbital edema, peripheral edema, pruritus, rhabdomyolysis, seizure, severe hypotension, Stevens-Johnson syndrome, tonic-clonic seizures, toxic epidermal necrolysis, urticaria, vomiting
Hypersensitivity to aliskiren or any component of the formulation; concomitant use with an ACE inhibitor or ARB in patients with diabetes; children <2 years of age
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): History of angioedema with aliskiren, ACE inhibitors, or ARBs; hereditary or idiopathic angioedema; pregnancy, breastfeeding; concomitant use with ACE inhibitors or ARBs in patients with GFR <60 mL/minute/1.73 m2
Concerns related to adverse effects:
• Hyperkalemia: May occur; risk increased in patients with renal impairment or diabetes, or concomitant use with ACE inhibitors, ARBs, NSAIDs, potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts.
• Hypersensitivity: Anaphylaxis and angioedema have been reported. Since the effect of aliskiren on bradykinin levels is unknown, the risk of kinin-mediated etiologies of angioedema occurring is also unknown. Use with caution in any patient with a history of angioedema (of any etiology) as angioedema, some cases necessitating hospitalization and intubation, has been observed with aliskiren use. Discontinue immediately following the occurrence of anaphylaxis or angioedema; do not readminister. Prolonged frequent monitoring may be required especially if tongue, glottis, or larynx are involved as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Early, aggressive, and appropriate management is critical.
• Hypotension: During the initiation of therapy, symptomatic hypotension may occur, particularly in volume or salt-depleted patients or with concomitant use of other agents acting on the renin-angiotensin-aldosterone system. Prior to initiation, correct hypovolemia or salt depletion, or closely monitor during treatment initiation. If hypotension does occur, this is not a contraindication for further use; once blood pressure has been stabilized, aliskiren usually can be continued without difficulty.
• Renal effects: Changes in renal function, including acute renal failure, may occur; risk is increased in patients with renal artery stenosis, severe heart failure, post-myocardial infarction, volume depletion, or patients receiving ARB, ACEI or NSAIDs. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.
Disease-related concerns:
• Diabetes: Use in patients with diabetes has demonstrated an increased incidence of renal impairment, hypotension, and hyperkalemia; use is contraindicated in patients with diabetes who are taking an ACE inhibitor or ARB.
• Renal impairment: Use with caution in patients with renal impairment; risk of developing acute renal failure and hyperkalemia is increased. Avoid concomitant use with an ACE inhibitor or ARB in patients with CrCl <60 mL/minute.
Special populations:
• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.
Preclinical studies show increased exposure in pediatric patients compared to adults; use is not recommended in children <6 years of age and is contraindicated for use in children <2 years of age.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Tekturna: 150 mg, 300 mg
Generic: 150 mg, 300 mg
Yes
Tablets (Aliskiren Fumarate Oral)
150 mg (per each): $7.48 - $7.81
300 mg (per each): $9.44 - $9.86
Tablets (Tekturna Oral)
150 mg (per each): $13.81
300 mg (per each): $17.43
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Rasilez: 150 mg [DSC], 300 mg [DSC]
Oral: Administer at the same time daily with or without a meal, but consistent administration with regards to meals is recommended; high-fat meal reduces absorption.
Oral: Administer at the same time daily with or without a meal, but consistent administration with regards to meals is recommended; high-fat meal reduces absorption.
Hypertension: Management of hypertension in adults and pediatric patients ≥50 kg and ≥6 years of age.
Note: Not recommended for the initial treatment of hypertension (ACC/AHA [Whelton 2017]).
Tekturna may be confused with Valturna
Substrate of CYP3A4 (Minor), P-glycoprotein (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification
Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor
Angiotensin II Receptor Blockers: Aliskiren may increase nephrotoxic effects of Angiotensin II Receptor Blockers. Aliskiren may increase hyperkalemic effects of Angiotensin II Receptor Blockers. Aliskiren may increase hypotensive effects of Angiotensin II Receptor Blockers. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider Therapy Modification
Angiotensin-Converting Enzyme Inhibitors: Aliskiren may increase hyperkalemic effects of Angiotensin-Converting Enzyme Inhibitors. Aliskiren may increase nephrotoxic effects of Angiotensin-Converting Enzyme Inhibitors. Aliskiren may increase hypotensive effects of Angiotensin-Converting Enzyme Inhibitors. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider Therapy Modification
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor
Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor
Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid
CycloSPORINE (Systemic): May increase serum concentration of Aliskiren. Risk X: Avoid
Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor
Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Drospirenone-Containing Products: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor
DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor
Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor
Furosemide: Aliskiren may decrease serum concentration of Furosemide. Risk C: Monitor
Grapefruit Juice: May decrease serum concentration of Aliskiren. Risk C: Monitor
Heparins (Low Molecular Weight): May increase hyperkalemic effects of Aliskiren. Risk C: Monitor
Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor
Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor
Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid
Itraconazole: May increase serum concentration of Aliskiren. Risk X: Avoid
Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor
Lonafarnib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors). Risk C: Monitor
Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor
Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Lumacaftor and Ivacaftor: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor
Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor
Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor
Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicorandil: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor
Nirmatrelvir and Ritonavir: May increase serum concentration of Aliskiren. Risk X: Avoid
Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents: May increase nephrotoxic effects of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may decrease antihypertensive effects of Aliskiren. Risk C: Monitor
Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification
P-glycoprotein/ABCB1 Inducers: May decrease serum concentration of Aliskiren. Risk C: Monitor
P-glycoprotein/ABCB1 Inhibitors: May increase serum concentration of Aliskiren. Risk C: Monitor
Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor
Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor
Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Potassium Salts: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor
Potassium-Sparing Diuretics: May increase hyperkalemic effects of Aliskiren. Risk C: Monitor
Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor
Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Sparsentan: May increase adverse/toxic effects of Aliskiren. Risk X: Avoid
Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor
Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor
Vimseltinib: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors). Management: Avoid concomitant use of vimseltinib and P-gp substrates when possible. If combined, administer vimseltinib at least 4 hours before the P-gp substrate. Risk D: Consider Therapy Modification
High-fat meals decrease absorption. Grapefruit juice may decrease the serum concentration of aliskiren. Management: Administer at the same time each day; administer with or without a meal, but consistent administration with regards to meals is recommended. Avoid concomitant use of aliskiren and grapefruit juice.
[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. The use of drugs which act on the renin-angiotensin system are associated with oligohydramnios. Oligohydramnios, due to decreased fetal renal function, may lead to fetal lung hypoplasia and skeletal malformations. Use is also associated with anuria, hypotension, renal failure, skull hypoplasia, and death in the fetus/neonate. The exposed fetus should be monitored for fetal growth, amniotic fluid volume, and organ formation. Infants exposed in utero should be monitored for hyperkalemia, hypotension, and oliguria.
It is not known if aliskiren is present in breast milk. Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended by the manufacturer.
Blood pressure; serum potassium, BUN, serum creatinine
The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2017]):
Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended
Confirmed hypertension without markers of increased ASCVD risk: Target blood pressure <130/80 mm Hg may be reasonable
Decreases plasma renin activity and inhibits conversion of angiotensinogen to angiotensin I.
Note: Reported pharmacokinetic data in pediatric patients 6 to 17 years is similar to that of adults.
Onset of action: Maximum antihypertensive effect: Within 2 weeks
Absorption: Poor; absorption decreased by high-fat meal. Aliskiren is a substrate of P-glycoprotein; concurrent use of P-glycoprotein inhibitors may increase absorption.
Metabolism: Extent of metabolism unknown; in vitro studies indicate metabolism via CYP3A4
Bioavailability: ~3%
Half-life elimination: ~24 hours (range: 16 to 32 hours)
Time to peak, plasma: 1 to 3 hours
Excretion: Urine (~25% of absorbed dose excreted unchanged in urine); feces (unchanged via biliary excretion)
Older adult: AUC is increased in patients ≥65 years.
