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Two medicines, side by side

Aliskiren vs amiodarone

Aliskiren is labeled for high blood pressure; amiodarone has no indication this site maps. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of aliskiren since 2007 and of amiodarone since 1985. Pharmacies paid $3.94 per aliskiren 150 mg tablet and $0.122 per amiodarone HCl 200 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, aliskiren is a renin inhibitor and amiodarone an antiarrhythmic.

Check it at the source: the aliskiren FDA label on DailyMed (effective March 7, 2024); the amiodarone FDA label on DailyMed (effective December 9, 2025).

Highlights of the aliskiren record

Aliskiren (Tekturna) · label of March 7, 2024

Boxed warning

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

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. […]

On the market

Earliest approval on file
March 5, 2007
Generic labelers
1 labeler
Pharmacy cost
$3.94 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the amiodarone record

Amiodarone (Pacerone) · label of December 9, 2025

Boxed warning

PULMONARY, HEPATIC AND CARDIAC TOXICITY Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ]. Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients.

Used for

From the label: indications

Amiodarone hydrochloride is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Amiodarone hydrochloride is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. […]

On the market

Earliest approval on file
December 24, 1985
Generic labelers
32 labelers
Pharmacy cost
$0.122 per tablet

Supply and safety

Shortage
No current entry
Recalls
7

Source: FDA drug labels via openFDA (Aliskiren label of March 7, 2024, Amiodarone label of December 9, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do aliskiren and amiodarone differ on the record?

In FDA's classes, aliskiren is a renin inhibitor and amiodarone an antiarrhythmic.

How each works, in its label's words: Aliskiren, “Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion.”; Amiodarone, “Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes.”

Half-life, in each label's words: Aliskiren, “12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation …”; Amiodarone, “Elimination Following single dose administration in 12 healthy subjects, amiodarone exhibited multi- compartmental …”

Both labels carry a boxed warning; the records quote them.

Generics: aliskiren since 2019; amiodarone since 1998 (Drugs@FDA).

AliskirenAmiodarone
Labeled forHigh blood pressuren/a
Pharmacologic classRenin InhibitorAntiarrhythmic
How it works (label)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).Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes.
Half-life (label)12.3 Pharmacokinetics Aliskiren is poorly absorbed (bioavailability about 2.5%) with an approximate accumulation half-life of 24 hours.Elimination Following single dose administration in 12 healthy subjects, amiodarone exhibited multi- compartmental pharmacokinetics with a mean apparent plasma terminal elimination half-life of 58 days (range 15 to 142 …
Earliest approval on file (Drugs@FDA)March 5, 2007December 24, 1985
First generic approvedMarch 22, 2019April 30, 1998
Generic labelers (NDC)1 labeler32 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$3.94 per tablet (Aliskiren 150 mg tablet)$0.122 per tablet (Amiodarone HCl 200 mg tablet)
12-month price change-2%+4%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded07
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)5,99911,139
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

Alternatives to aliskiren
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