Drug · FAERS side-effect profile with label screen
Indapamide side effects: what 17,816 FDA adverse event reports show
Who reports
17,816 reports · 93% serious · 1,137 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS ).
FDA label, Indications and Usage
What it is
DESCRIPTION Indapamide is an oral antihypertensive/diuretic. Its molecule contains both a polar sulfamoyl chlorobenzamide moiety and a lipid-soluble methylindoline moiety. It differs chemically from the thiazides in that it does not possess the thiazide ring system and contains only one sulfonamide group.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 2Lab value / disease marker 6Not in label — unassessed 30
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,139 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Persistent cloaca | 17 | 939.3 495.6–1,780.0ROR 940.2 · χ² 8,294 / p <1e-300 | 327.7 EB05 216.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Conjoined twins | 35 | 644.6 426.5–974.2ROR 645.9 · χ² 14,047 / p <1e-300 | 338.0 EB05 254.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 100% (drug 58%) · 91% clinician | no trial arm names this drug |
| Urachal abnormality | 15 | 580.1 312.2–1,078.0ROR 580.6 · χ² 5,401 / p <1e-300 | 259.3 EB05 166.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Central nervous system lupus | 68 | 540.4 405.4–720.3ROR 542.5 · χ² 24,611 / p <1e-300 | 334.3 EB05 272.7 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=68 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Congenital bladder anomaly | 17 | 173.0 104.0–288.0ROR 173.2 · χ² 2,383 / p <1e-300 | 129.2 EB05 85.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Hyponatraemic seizure | 29 | 151.6 103.0–223.1ROR 151.8 · χ² 3,704 / p <1e-300 | 123.4 EB05 90.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Labile hypertension | 20 | 92.5 58.6–145.7ROR 92.6 · χ² 1,592 / p <1e-300 | 79.4 EB05 54.3 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=20 | no trial arm names this drug |
| Intestinal malrotation | 19 | 90.0 56.4–143.5ROR 90.1 · χ² 1,470 / p <1e-300 | 77.3 EB05 52.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Butterfly rash | 66 | 83.0 64.7–106.5ROR 83.3 · χ² 4,912 / p <1e-300 | 75.9 EB05 61.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Postictal paralysis | 15 | 77.7 46.1–131.0ROR 77.8 · χ² 994 / p 2e-218 | 66.9 EB05 43.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Sensitisation | 43 | 70.0 51.5–95.2ROR 70.1 · χ² 2,693 / p <1e-300 | 64.3 EB05 49.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Hyperhomocysteinaemia | 14 | 65.8 38.4–112.7ROR 65.8 · χ² 785 / p 5e-173 | 57.7 EB05 36.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Lipoprotein (a) increased | 13 | 53.9 30.9–93.9ROR 53.9 · χ² 595 / p 1e-131 | 48.1 EB05 29.9 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Burning mouth syndrome | 23 | 50.0 32.9–75.8ROR 50.0 · χ² 1,012 / p 2e-222 | 46.2 EB05 32.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Herbal interaction | 13 | 45.8 26.3–79.8ROR 45.9 · χ² 506 / p 2e-112 | 41.7 EB05 25.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Rectal polyp | 36 | 44.0 31.5–61.3ROR 44.1 · χ² 1,415 / p <1e-300 | 41.5 EB05 31.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Hypochloraemia | 42 | 43.9 32.3–59.8ROR 44.0 · χ² 1,657 / p <1e-300 | 41.6 EB05 32.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=42 · 100% clinician | no trial arm names this drug |
| Lupus nephritis | 66 | 43.8 34.3–56.0ROR 44.0 · χ² 2,620 / p <1e-300 | 41.8 EB05 34.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Osmotic demyelination syndrome | 25 | 41.1 27.6–61.3ROR 41.2 · χ² 907 / p 1e-199 | 38.7 EB05 27.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial arm names this drug |
| Renal artery stenosis | 45 | 39.5 29.3–53.1ROR 39.6 · χ² 1,595 / p <1e-300 | 37.6 EB05 29.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 81% (drug 58%) | no trial arm names this drug |
| Blood uric acid abnormal | 13 | 39.1 22.5–67.9ROR 39.1 · χ² 430 / p 6e-96 | 36.0 EB05 22.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Urine albumin/creatinine ratio increased | 14 | 31.9 18.8–54.3ROR 31.9 · χ² 378 / p 1e-84 | 29.9 EB05 18.9 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Forced vital capacity decreased | 17 | 31.7 19.6–51.2ROR 31.7 · χ² 462 / p 9e-103 | 29.9 EB05 19.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Tachyarrhythmia | 59 | 28.4 22.0–36.8ROR 28.5 · χ² 1,498 / p <1e-300 | 27.6 EB05 22.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Hyponatraemia (low sodium) | 1,318 | 28.2 26.8–29.8ROR 30.4 · χ² 33,873 / p <1e-300 | 27.6 EB05 26.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.6 · 95% clinician | no trial arm names this drug |
| Bronchial wall thickening | 17 | 28.2 17.4–45.6ROR 28.2 · χ² 410 / p 2e-91 | 26.8 EB05 17.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Helicobacter test positive | 13 | 28.0 16.2–48.6ROR 28.1 · χ² 305 / p 1e-68 | 26.4 EB05 16.3 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Gingival hyperplasia | 14 | 27.7 16.3–47.1ROR 27.7 · χ² 327 / p 3e-73 | 26.2 EB05 16.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Upper airway obstruction | 20 | 27.0 17.4–42.1ROR 27.1 · χ² 465 / p 2e-103 | 25.9 EB05 17.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial arm names this drug |
| Carotid arteriosclerosis | 23 | 27.0 17.9–40.8ROR 27.0 · χ² 538 / p 3e-119 | 25.9 EB05 18.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Nasal mucosal disorder | 13 | 26.7 15.4–46.3ROR 26.8 · χ² 290 / p 2e-65 | 25.2 EB05 15.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Change of bowel habit | 44 | 25.8 19.2–34.8ROR 25.9 · χ² 1,002 / p 3e-220 | 25.0 EB05 19.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Left atrial dilatation | 27 | 25.2 17.2–37.0ROR 25.3 · χ² 592 / p 5e-131 | 24.4 EB05 17.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Angular cheilitis | 14 | 24.5 14.5–41.7ROR 24.6 · χ² 287 / p 1e-64 | 23.3 EB05 14.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Fungal oesophagitis | 14 | 24.3 14.3–41.2ROR 24.3 · χ² 284 / p 6e-64 | 23.1 EB05 14.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Gravitational oedema | 14 | 24.0 14.1–40.7ROR 24.0 · χ² 280 / p 4e-63 | 22.8 EB05 14.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Glomerular filtration rate increased | 15 | 22.1 13.3–36.9ROR 22.1 · χ² 276 / p 2e-62 | 21.1 EB05 13.4 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial arm names this drug |
| Inappropriate antidiuretic hormone secretion | 185 | 21.8 18.8–25.2ROR 22.0 · χ² 3,579 / p <1e-300 | 21.3 EB05 18.9 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.4 · 96% clinician | no trial arm names this drug |
| Blood pressure systolic abnormal | 45 | 21.6 16.1–29.0ROR 21.7 · χ² 850 / p 5e-187 | 21.1 EB05 16.4 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=45 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Croup infectious | 13 | 20.1 11.6–34.7ROR 20.1 · χ² 213 / p 1e-48 | 19.0 EB05 11.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Indapamide only as a background or rescue medication (NCT04518293, NCT03722524); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hyponatraemia (low sodium) | 1,318 | 28.2 26.8–29.8ROR 30.4 · χ² 33,873 / p <1e-300 | 27.6 EB05 26.4 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.6 · 95% clinician | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 949 | 7.4 6.9–7.8ROR 7.7 · χ² 5,226 / p <1e-300 | 7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 95% clinician | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 920 | 1.9 1.8–2.0ROR 2.0 · χ² 412 / p 6e-92 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.6 | no trial arm names this drug |
| Dizziness | 899 | 2.1 2.0–2.3ROR 2.2 · χ² 548 / p 2e-121 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial arm names this drug |
| Nausea | 881 | 1.3 1.2–1.4ROR 1.3 · χ² 68 / p 6e-17 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 · ♀ 79% (drug 58%) | no trial arm names this drug |
| Diarrhoea (diarrhea) | 879 | 1.6 1.5–1.7ROR 1.6 · χ² 208 / p 2e-47 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Fatigue (tiredness) | 816 | 1.2 1.2–1.3ROR 1.2 · χ² 38 / p 4e-10 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial arm names this drug |
| Drug interaction | 782 | 5.8 5.4–6.2ROR 6.0 · χ² 3,128 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial arm names this drug |
| Hypokalaemia (low potassium) | 758 | 19.7 18.4–21.2ROR 20.6 · χ² 13,277 / p <1e-300 | 19.4 EB05 18.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 · 93% clinician | no trial arm names this drug |
| Vomiting | 718 | 1.8 1.7–1.9ROR 1.8 · χ² 262 / p 4e-59 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Malaise (feeling unwell) | 710 | 1.9 1.8–2.0ROR 1.9 · χ² 309 / p 2e-69 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 697 | 0.6 0.6–0.7ROR 0.6 · χ² 169 / p 5e-39 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial arm names this drug |
| Headache | 676 | 1.3 1.2–1.4ROR 1.3 · χ² 40 / p 1e-10 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial arm names this drug |
| Fall | 672 | 2.4 2.2–2.6ROR 2.4 · χ² 545 / p 9e-121 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 | no trial arm names this drug |
| Asthenia (weakness) | 665 | 2.1 1.9–2.2ROR 2.1 · χ² 380 / p 8e-85 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Conjoined twins — n=35, PRR 644.6
- Hyponatraemic seizure — n=29, PRR 151.6
- Butterfly rash — n=66, PRR 83.0
- Sensitisation — n=43, PRR 70.0
- Burning mouth syndrome — n=23, PRR 50.0
- Rectal polyp — n=36, PRR 44.0
- Hypochloraemia — n=42, PRR 43.9
- Lupus nephritis — n=66, PRR 43.8
- Osmotic demyelination syndrome — n=25, PRR 41.1
- Renal artery stenosis — n=45, PRR 39.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Indapamide ↔ Hyponatraemia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Indapamide?
In FDA FAERS, the most frequently co-reported reaction terms for Indapamide are hyponatraemia, acute kidney injury, dyspnoea, dizziness, nausea, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Indapamide have an FDA boxed warning?
No. The FDA label retrieved for Indapamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Indapamide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 59cd3331-7afe-432a-8b50-39533fd5f392, effective 20260513; matched on
openfda.generic_name.exact:"INDAPAMIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,179 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
INDAPAMIDE, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.