Prescription medicine
Amiloride First approved as Midamor
Amiloride (Midamor) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $0.190 per amiloride HCl 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amiloride FDA label on DailyMed (effective May 5, 2023, Padagis US LLC); the NDA 18200 record on Drugs@FDA; every amiloride label on DailyMed.
Highlights of the record
FDA label of May 5, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic. This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly. When amiloride HCl is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2 percent. It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function.
Used for
From the label: indications and usageAmiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a.
Forms and strengths
- 5 mg
Tablet.
On the market
- Earliest approval on file
- October 5, 1981 Midamor, Padagis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first January 22, 1986; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.190 per tablet Amiloride HCl 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 849 through July 30, 2026
What is amiloride used for?
From the label: indications and usageAmiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. […]
Conditions named in the indications of amiloride's FDA labels, with every medicine labeled for each:
From other amiloride labelsHigh blood pressure and Heart failure: INDICATIONS AND USAGE Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to: a. …
FDA pharmacologic class: Potassium-sparing Diuretic.
Source: FDA drug label (amiloride hydrochloride), Padagis US LLC, effective May 5, 2023 (SPL set 2b70cf0c-45be-428f-b396-5001ed4e30fc), via openFDA; the full label on DailyMed
Is there a generic for amiloride (Midamor)?
The FDA approved the first generic amiloride on January 22, 1986. 3 generic applications are approved; 2 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 amiloride from 2 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.
- 1981 earliest approval on file
- 1986 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amiloride (Midamor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.190 per Amiloride HCl 5 mg tablet, down 2% from $0.195 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.
- Amiloride HCl 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amiloride HCl 5 mg tablet | Generic | $0.190 per tablet | $5.70 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amiloride been recalled?
The FDA's Enforcement Report lists 1 recall naming amiloride since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of amiloride and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amiloride label say about other medicines?
The amiloride label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name amiloride. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | Drug Interactions When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. |
| Indomethacin | drug interactions | Since indomethacin and potassium-sparing diuretics, including amiloride HCl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently. |
| Lithium | drug interactions | Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. (See WARNINGS .) Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium … |
| Sodium bicarbonate | warnings | Such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. |
| Sodium polystyrene sulfonate | warnings | If needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. |
| Spironolactone | contraindications | Antikaliuretic Therapy or Potassium Supplementation Amiloride HCl should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. |
| Tacrolimus | drug interactions | Drug Interactions When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. |
| Triamterene | contraindications | Antikaliuretic Therapy or Potassium Supplementation Amiloride HCl should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. |
Other labels that name amiloride
Source: FDA drug label (amiloride hydrochloride), Padagis US LLC, effective May 5, 2023 (SPL set 2b70cf0c-45be-428f-b396-5001ed4e30fc), via openFDA; the full label on DailyMed
What do FAERS reports show for amiloride?
The FDA Adverse Event Reporting System holds 849 reports that list amiloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 390 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amiloride?
80 other medicines are given the same way (oral) and in the same FDA class as amiloride 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.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Hydrochlorothiazide and triamterene | High blood pressure | 24 labelers | $0.0969 per tablet 37.5-25 mg tablet | No current entry |
| Triamterene | Heart failure | 3 labelers | $5.98 per capsule 50 mg capsule | No current entry |
| Metoprolol | High blood pressure, Heart failure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure, Heart failure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Carvedilol | High blood pressure, Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amiloride
- 80 medicines for the same use
- Other potassium-sparing diuretics
- the pharmacologic class, with prices and generics
- Amiloride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other