Indapamide

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Indapamide
Generic name
INDAPAMIDE
Manufacturer
Bryant Ranch Prepack
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
8a16fc49-7a36-4873-9652-194ebb0bac68
SPL ID
4bc3f68d-e26e-4adb-e063-6294a90aa57f
Version
101
Effective date
2026-02-26
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:33:06
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Severe cases of hyponatremia, accompanied by hypokalemia have been reported with recommended doses of indapamide. This occurred primarily in elderly females. (See PRECAUTIONS, Geriatric Use .) This appears to be dose related. Also, a large case-controlled pharmacoepidemiology study indicates that there is an increased risk of hyponatremia with indapamide 2.5 mg and 5 mg doses. Hyponatremia considered possibly clinically significant (< 125 mEq/L) has not been observed in clinical trials with the 1.25 mg dosage (see PRECAUTIONS ). Thus, patients should be started at the 1.25 mg dose and maintained at the lowest possible dose. (See DOSAGE AND ADMINISTRATION .) Hypokalemia occurs commonly with diuretics (see ADVERSE REACTIONS, Hypokalemia ), and electrolyte monitoring is essential, particularly in patients who would be at increased risk from hypokalemia, such as those with cardiac arrhythmias or who are receiving concomitant cardiac glycosides. In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy.

Adverse reactions cross-check#

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Adverse reactions sections page 2 of 2 · 5 matching rows.

adverse reactions table

<table width="100%"><col width="23%"/><col width="15%"/><col width="15%"/><col width="15%"/><col width="21%"/><col width="11%"/><thead><tr><th align="center" colspan="6" styleCode="Botrule Toprule " valign="top"><content styleCode="bold">Mean Changes from Baseline after 40 Weeks of Treatment - 2.5 mg and 5 mg</content></th></tr><tr><th align="left" rowspan="2" styleCode="Rrule Botrule " valign="top"/><th align="center" colspan="3" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">Serum Electrolytes (mEq/L)</content></th><th align="center" rowspan="2" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">Serum Uric Acid</content> <content styleCode="bold">(mg/dL)</content></th><th align="center" rowspan="2" valign="top"><content styleCode="bold">BUN</content> <content styleCode="bold">(mg/dL)</content></th></tr><tr><th align="center" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">Potassium</content></th><th align="center" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">Sodium</content></th><th align="center" styleCode="Rrule Botrule " valign="top"><content styleCode="bold">Chloride</content></th></tr></thead><tbody><tr><td styleCode="Rrule Toprule Botrule " valign="top"><paragraph>Indapamide 2.5 mg (n=76) </paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>-0.4</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>-0.6</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>-3.6</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="middle"><paragraph>0.7</paragraph></td><td align="center" styleCode="Toprule Botrule " valign="middle"><paragraph>-0.1</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>Indapamide 5 mg (n=81) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>-0.6</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>-0.7</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>-5.1</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>1.1</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>1.4</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.