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What the label lists and what reports show

Indapamide side effects

Indapamide's FDA label lists its adverse reactions in its own words. FAERS holds 17,817 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hyponatraemia (1,318 reports).

  • Generic listed

Check it at the source: the indapamide FDA label on DailyMed (effective October 1, 2022, Actavis Pharma, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most adverse effects have been mild and transient. The Clinical Adverse Reactions listed in Table 1 represent data from Phase II/III placebo-controlled studies (306 patients given indapamide 1.25 mg). The Clinical Adverse Reactions listed in Table 2 represent data from Phase II placebo-controlled studies and long-term controlled clinical trials (426 patients given indapamide 2.5 mg or 5 mg). The reactions are arranged into two groups: 1) a cumulative incidence equal to or greater than 5%; 2) a cumulative incidence less than 5%. Reactions are counted regardless of relation to drug. …

Source: FDA drug label, Actavis Pharma, Inc., effective October 1, 2022 (SPL set a8a4ec2c-9d4b-482b-ad29-88185c96db74), via openFDA; the full label on DailyMed

What do FAERS reports show?

17,817 reports list indapamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,137 are coded as a death and 8,336 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Hyponatraemia (named in the label)1,318
  • Acute Kidney Injury949
  • Dyspnoea920
  • Dizziness (named in the label)899
  • Nausea (named in the label)881
  • Diarrhoea (named in the label)879
  • Fatigue (named in the label)816
  • Drug Interaction (a use or a product term, not a reaction)782
  • Hypokalaemia (named in the label)758
  • Vomiting (named in the label)718
  • Malaise (named in the label)710
  • Drug Ineffective (a use or a product term, not a reaction)697
  • Headache (named in the label)676
  • Fall672
  • Asthenia (named in the label)665
  • Off Label Use (a use or a product term, not a reaction)644
  • Arthralgia626
  • Hypotension (named in the label)610
  • Confusional State592
  • Cough (named in the label)580
  • Pain555
  • Hypertension (a use or a product term, not a reaction)533
  • Rash (named in the label)506
  • Blood Pressure Increased479
  • Abdominal Pain (named in the label)444

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Indapamide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions