Quick answers
- What is Amiloride hydrochloride and hydrochlorothiazide used for?
- The FDA-approved label (Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., December 27, 2022) says: “Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Amiloride hydrochloride and hydrochlorothiazide?
- The “Adverse Reactions” section of the FDA label (Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., December 27, 2022) begins: “Amiloride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with amiloride hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Amiloride hydrochloride and hydrochlorothiazide?
- The “Drug Interactions” section of the FDA label (Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., December 27, 2022) begins: “In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when amiloride and hydrochlorothiazide plus non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Amiloride hydrochloride and hydrochlorothiazide have a boxed warning?
- Yes. The FDA label for Amiloride Hydrochloride and Hydrochlorothiazide has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Amiloride hydrochloride and hydrochlorothiazide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Amiloride hydrochloride and hydrochlorothiazide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Amiloride hydrochloride and hydrochlorothiazide?
- 1 company lists prescription products of Amiloride hydrochloride and hydrochlorothiazide in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc.
What Amiloride hydrochloride and hydrochlorothiazide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Amiloride hydrochloride and hydrochlorothiazide tablets are indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. …
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Amiloride hydrochloride and hydrochlorothiazide boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
Like other potassium-conserving diuretic combinations, amiloride and hydrochlorothiazide may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter). In patients without renal impairment or diabetes mellitus, the risk of hyperkalemia with this combination product is about 1 to 2 percent. This risk is higher in patients with renal impairment or diabetes mellitus (even without recognized diabetic nephropathy).
Read more of this section
Since hyperkalemia, if uncorrected, is potentially fatal, it is essential to monitor serum potassium levels carefully in any patient receiving amiloride hydrochloride and hydrochlorothiazide, particularly when it is first introduced, at the time of dosage adjustments, and during any illness that could affect renal function.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
Amiloride hydrochloride and hydrochlorothiazide side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Amiloride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with amiloride hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS).
Read more of this section
Minor adverse reactions to amiloride hydrochloride have been reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar to hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride and hydrochlorothiazide are generally those known to be associated with diuresis, thiazide therapy, or with the underlying disease being treated. Clinical trials have not demonstrated that combining amiloride and hydrochlorothiazide increases the risk of adverse reactions over those seen with the individual components. The adverse reactions for amiloride and hydrochlorothiazide listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (607 patients treated with amiloride and hydrochlorothiazide). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride and hydrochlorothiazide and these adverse reactions, some of which have been reported only rarely. Incidence > 1% Incidence ≤ 1% Body as a Whole Headache 1 Weakness 1 Fatigue/tiredness Malaise Chest pain Back pain Syncope Cardiovascular Arrhythmia Tachycardia Digitalis toxicity Orthostatic hypotension Angina pectoris Digestive Nausea/anorexia 1 Diarrhea Gastrointestinal pain Abdominal pain Constipation GI bleeding GI disturbance Appetite changes Abdominal fullness Hiccups Thirst Vomiting Anorexia Flatulence Metabolic Elevated serum potassium levels (> 5.5 mEq per liter) 2 Gout Dehydration Symptomatic hyponatremia 3 Musculoskeletal Leg ache Muscle cramps/spasm Joint pain Nervous Dizziness 1 Paresthesia/numbness Stupor Vertigo Psychiatric None Insomnia Nervousness Depression Sleepiness Mental confusion Respiratory Dyspnea None Skin Rash 1 Pruritus Flushing Diaphoresis Erythema multiforme including Stevens- Johnson syndrome Exfoliative dermatitis including toxic epidermal necrolysis Alopecia Special Senses None Bad taste Visual disturbance Nasal congestion Urogenital None Impotence Nocturia Dysuria Incontinence Renal dysfunction including renal failure Gynecomastia 1. Reactions occurring in 3% to 8% of patients treated with amiloride hydrochloride and hydrochlorothiazide. (Those reactions occurring in less than 3% of the patients are unmarked.) 2. See WARNINGS 3.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. This is part of the section. Read the full label on DailyMed →
Amiloride hydrochloride and hydrochlorothiazide drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when amiloride and hydrochlorothiazide plus non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Read more of this section
Since indomethacin and potassium-sparing diuretics, including this product, 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. Amiloride HCl When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. 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). Hydrochlorothiazide When given concurrently the following drugs may interact with thiazide diuretics. Alcohol, Barbiturates, or Narcotics Potentiation of orthostatic hypotension may occur. Antidiabetic Drugs (Oral Agents and Insulin) Dosage adjustment of the antidiabetic drug may be required. Other Antihypertensive Drugs Additive effect or potentiation. Cholestyramine and Colestipol Resins Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of cholestyramine and colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia. Pressor Amines (e.g., norepinephrine) Possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal Muscle Relaxants, Nondepolarizing (e.g., tubocurarine) Possible increased responsiveness to the muscle relaxant. Lithium Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with this combination product.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
Amiloride hydrochloride and hydrochlorothiazide dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Amiloride hydrochloride and hydrochlorothiazide tablets should be administered with food. The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of amiloride hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses. Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone.
Read more of this section
Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents. The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
Amiloride hydrochloride and hydrochlorothiazide and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Studies in rats have shown that amiloride is excreted in milk in concentrations higher than those found in blood, but it is not known whether amiloride HCl is excreted in human milk. However, thiazides appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
When Amiloride hydrochloride and hydrochlorothiazide should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Hyperkalemia Amiloride hydrochloride and hydrochlorothiazide tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter). Antikaliuretic Therapy or Potassium Supplementation Amiloride hydrochloride and hydrochlorothiazide should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene.
Read more of this section
Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet should not be used with this product except in severe and/or refractory cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary. Impaired Renal Function Anuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of amiloride hydrochloride and hydrochlorothiazide. Patients with evidence of renal function impairment (blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or diabetes mellitus should not receive the drug without careful, frequent and continuing monitoring of serum electrolytes, creatinine, and BUN levels. Potassium retention associated with the use of an antikaliuretic agent is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia. Hypersensitivity Amiloride hydrochloride and hydrochlorothiazide tablets is contraindicated in patients who are hypersensitive to this product, or to other sulfonamide-derived drugs.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
Amiloride hydrochloride and hydrochlorothiazide overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
No data are available in regard to overdosage in humans. The oral LD 50 of the combination drug is 189 and 422 mg/kg for female mice and female rats, respectively. It is not known whether the drug is dialyzable. No specific information is available on the treatment of overdosage with amiloride and hydrochlorothiazide and no specific antidote is available. Treatment is symptomatic and supportive.
Read more of this section
Therapy with amiloride and hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include the induction of emesis and/or gastric lavage. Amiloride Hydrochloride No data are available in regard to overdosage in humans. The oral LD 50 of amiloride hydrochloride (calculated as the base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the strain. The most common signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. If hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels. Hydrochlorothiazide The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
— FDA label: Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| amiloride hydrochloride 5 mg · hydrochlorothiazide 50 mg tablet | Generic | $0.4423 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Teva Pharmaceuticals USA, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA071111Barr · May 10, 1988
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 977883 |
|---|---|
| SPL set ID of the quoted label | 8b2c581a-f955-4a8e-bf85-e768e903fd10 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | AMILORIDE / HYDROCHLOROTHIAZIDE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Teva Pharmaceuticals USA, Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amiloride Hydrochloride and Hydrochlorothiazide, Teva Pharmaceuticals USA, Inc., effective December 27, 2022; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →