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
- 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 |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 074299 | derived:openfda.application_number |
| application number | ANDA074299 | openfda.application_number | |
| brand name | Indapamide | openfda.brand_name | |
| generic name | INDAPAMIDE | openfda.generic_name | |
| manufacturer name | Bryant Ranch Prepack | openfda.manufacturer_name | |
| ndc | package | 72162-1766-1 | openfda.package_ndc |
| ndc | product | 72162-1766 | openfda.product_ndc |
| ndc11 | package | 72162176601 | derived:openfda.package_ndc |
| rxcui | 197815 | openfda.rxcui | |
| spl id | 4bc3f68d-e26e-4adb-e063-6294a90aa57f | id | |
| spl set id | 8a16fc49-7a36-4873-9652-194ebb0bac68 | set_id | |
| unii | F089I0511L | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.