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Prescription medicine

Metolazone First approved as Zaroxolyn

Metolazone (Zaroxolyn) is a prescription medicine with an FDA approval on record since 1973. FDA's NDC Directory lists it from 19 generic labelers, and pharmacies paid $0.233 per metolazone 2.5 mg tablet in the October 7, 2026 NADAC survey.

  • Generic listed

Check it at the source: the metolazone FDA label on DailyMed (effective December 11, 2025, Unichem Pharmaceuticals (USA), Inc.); the NDA 17386 record on Drugs@FDA; every metolazone label on DailyMed.

Highlights of the record

FDA label of December 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

Metolazone tablets, USP, are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure;

Forms and strengths

  • 2.5 mg
  • 5 mg
  • 10 mg

Tablet.

On the market

Earliest approval on file
November 27, 1973 Zaroxolyn, I3 Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
14 first December 19, 2003; 11 with a marketed status in Drugs@FDA
Labelers listed (NDC)
19 of which 19 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.233 per tablet Metolazone 2.5 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
11,175 through July 30, 2026

What is metolazone used for?

From the label: indications and usage

Metolazone tablets, USP, are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for metolazone tablets, USP, in the treatment of hypertension. […]

Conditions named in the indications of metolazone's FDA labels, with every medicine labeled for each:

From other metolazone labels

Edema (fluid retention): Metolazone tablets, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS).

FDA pharmacologic class: Thiazide-like Diuretic.

Source: FDA drug label (Metolazone), Unichem Pharmaceuticals (USA), Inc., effective December 11, 2025 (SPL set c6fe5426-a184-44b8-a555-621d72aa5b9f), via openFDA; the full label on DailyMed

Is there a generic for metolazone (Zaroxolyn)?

The FDA approved the first generic metolazone on December 19, 2003. 14 generic applications are approved; 11 of them carry 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 metolazone from 19 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

  • 1973 earliest approval on file
  • 2003 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for metolazone (Zaroxolyn)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.233 per Metolazone 2.5 mg tablet, up 8% from $0.216 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.

  • Metolazone 2.5 mg tablet (generic)
$0.305
$0.183
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Metolazone 10 mg tabletGeneric$0.381 per tablet$11.44-12%
Metolazone 2.5 mg tabletGeneric$0.233 per tablet$6.98+8%
Metolazone 5 mg tabletGeneric$0.239 per tablet$7.18-16%

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 metolazone label say about other medicines?

The metolazone label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Furosemidedrug interactionsDrug Interactions Diuretics Furosemide and probably other loop diuretics given concomitantly with metolazone can cause unusually large or prolonged losses of fluid and electrolytes (see WARNINGS).
Lithiumdrug interactionsLithium Serum lithium levels may increase (see WARNINGS).
Methenaminedrug interactionsMethenamine Efficacy may be decreased due to urinary alkalizing effect of metolazone.

Check metolazone against other medicines

Source: FDA drug label (Metolazone), Unichem Pharmaceuticals (USA), Inc., effective December 11, 2025 (SPL set c6fe5426-a184-44b8-a555-621d72aa5b9f), via openFDA; the full label on DailyMed

What do FAERS reports show for metolazone?

The FDA Adverse Event Reporting System holds 11,175 reports that list metolazone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,203 are coded as a death and 5,777 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

  • Dyspnoea1,247
  • Death (an outcome recorded in the report)879
  • Acute Kidney Injury799
  • Nausea (named in the label)761
  • Renal Failure716
  • Cardiac Failure Congestive683
  • Fatigue (named in the label)662
  • Diarrhoea (named in the label)659

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as metolazone?

79 other medicines are given the same way (oral) and in the same FDA class as metolazone 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.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
ChlorthalidoneHigh blood pressure, Heart failure, Edema (fluid retention)36 labelers$0.0743 per tablet 25 mg tabletNo current entry
IndapamideHigh blood pressure, Heart failure, Edema (fluid retention)8 labelers$0.109 per tablet 1.25 mg tabletNo current entry
Atenolol and chlorthalidoneHigh blood pressure10 labelers$0.335 per unit 100-25No current entry
Amlodipine and indapamide and telmisartanHigh blood pressurenone listedn/aNo current entry
Azilsartan and chlorthalidoneHigh blood pressurenone listed$8.49 per tablet 40-12.5 mg tabletNo current entry
MetoprololHigh blood pressure, Heart failure64 labelers$0.085 per tablet 100 mg tabletA presentation being discontinued
DiltiazemHigh blood pressure42 labelers$0.144 per capsule 24h ER(cd) 120 mg capsuleA presentation being discontinued
LisinoprilHigh blood pressure, Heart failure36 labelers$0.0254 per tablet 20 mg tabletNo current entry

Every medicine labeled for the same conditions as metolazone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does metolazone compare with medicines for the same use?

7 side-by-side pages set metolazone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to metolazone
79 medicines for the same use
Other thiazide-like diuretics
the pharmacologic class, with prices and generics
Metolazone side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other