Home FDA labels 220503b7-b1bf-4ea3-8b3c-990fa4edc123 FDA label 220503b7-b1bf-4ea3-8b3c-990fa4edc123 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID 89107b20-5437-45b6-958d-9880202edd87
SPL ID 220503b7-b1bf-4ea3-8b3c-990fa4edc123
Version 2
Effective date 2018-01-11
Source export date 2026-10-12
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
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Import run 20261013T011858Z
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boxed warning Hyperkalemia 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 is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1 to 2%. 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.
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warnings WARNINGS
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adverse reactions ADVERSE REACTIONS Amiloride hydrochloride is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq liter – see WARNINGS ), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride hydrochloride is uncertain and the overall frequency was similar in 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 are generally those known to be associated with diuresis, or with the underlying disease being treated. The adverse reactions for amiloride hydrochloride 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 (837 patients treated with amiloride hydrochloride). 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 hydrochloride and these adverse reactions, some of which have been reported only rarely. * Reactions occurring in 3% to 8% of patients treated with amiloride hydrochloride. (Those reactions occurring in less than 3% of the patients are unmarked.) ** See WARNINGS . Incidence > 1 % Incidence ≤ 1 % Body as a Whole Headache * Back pain Weakness Chest pain Fatigability Neck/shoulder ache Pain, extremities Cardiovascular None Angina pectoris Orthostatic hypotension Arrhythmia Palpitation Digestive Nausea/anorexia * Jaundice Diarrhea * GI bleeding Vomiting * Abdominal fullness Abdominal pain GI disturbance Gas pain Thirst Appetite changes Heartburn Constipation Flatulence Dyspepsia Metabolic Elevated serum potassium levels (>5.5 mEq per liter) * * None Skin None Skin rash Itching Dryness of mouth Pruritus Alopecia Musculoskeletal Muscle cramps Joint pain Leg ache Nervous Dizziness Paresthesia Encephalopathy Tremors Vertigo Psychiatric None Nervousness Mental confusion Insomnia Decreased libido Depression Somnolence Respiratory Cough Shortness of Breath Dyspnea Special Senses None Visual disturbances Nasal congestion Tinnitus Increased intraocular pressure Urogenital Impotence Polyuria Dysuria Urinary frequency Bladder spasms Gynecomastia Causal Relationship Unknown Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians. Activation of probable pre-existing peptic ulcer Aplastic anemia Neutropenia Abnormal liver function
adverse reactions table <table ID="ID40" width="100%"> <col width="50%"/> <col width="50%"/> <tfoot> <tr> <td align="left" colspan="2"> <paragraph styleCode="Footnote"> <sup>*</sup>Reactions occurring in 3% to 8% of patients treated with amiloride hydrochloride. </paragraph> </td> </tr> <tr> <td align="left" colspan="2"> <paragraph styleCode="Footnote">(Those reactions occurring in less than 3% of the patients are unmarked.) </paragraph> </td> </tr> <tr> <td align="left" colspan="2"> <paragraph styleCode="Footnote">**<linkHtml href="#ID20">See WARNINGS</linkHtml>. </paragraph> </td> </tr> </tfoot> <tbody> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Incidence </content> <content styleCode="bold">> </content> <content styleCode="bold">1</content> <content styleCode="bold">% </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold">Incidence </content> <content styleCode="bold">≤ </content> <content styleCode="bold">1</content> <content styleCode="bold">%</content> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Body </content> <content styleCode="bold italics">as </content> <content styleCode="bold italics">a </content> <content styleCode="bold italics">Whole</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Headache<sup>*</sup> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Back pain </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Weakness </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Chest pain </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Fatigability<content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Neck/shoulder ache </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Pain, extremities </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Cardiovascular</content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">None </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Angina pectoris </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Orthostatic hypotension </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Arrhythmia </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Palpitation </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Digestive</content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Nausea/anorexia<sup>*</sup> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Jaundice </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Diarrhea<sup>*</sup> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">GI bleeding </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Vomiting<sup>*</sup> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Abdominal fullness </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Abdominal pain </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">GI disturbance </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Gas pain </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Thirst </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Appetite changes </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Heartburn </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Constipation </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Flatulence </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Dyspepsia </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Metabolic </content>Elevated serum potassium levels (>5.5 mEq per liter)<sup>*</sup> <sup>*</sup> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">None </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Skin</content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">None </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Skin rash </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Itching </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Dryness of mouth </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Pruritus </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Alopecia </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Musculoskeletal</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Muscle cramps </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Joint pain </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Leg ache </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Nervous</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Dizziness </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Paresthesia </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Encephalopathy </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Tremors </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Vertigo </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Psychiatric</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">None </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Nervousness </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Mental confusion </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Insomnia </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Decreased libido </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Depression </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Somnolence </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Respiratory</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Cough </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Shortness of Breath </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Dyspnea </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Special </content> <content styleCode="bold italics">Senses</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">None </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Visual disturbances </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Nasal congestion </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Tinnitus </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Increased intraocular pressure </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> <content styleCode="bold italics">Urogenital</content> <content styleCode="bold italics"> </content> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule"> </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Impotence </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Polyuria </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Toprule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Dysuria </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Urinary frequency </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Bladder spasms </td> </tr> <tr> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule"> </td> <td align="justify" valign="top" styleCode=" Lrule Rrule Botrule Toprule">Gynecomastia </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.