What the label lists and what reports show
Amiloride side effects
Amiloride's FDA label lists its adverse reactions in its own words. FAERS holds 849 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 dyspnoea (69 reports).
- Generic listed
- Boxed warning
Check it at the source: the amiloride FDA label on DailyMed (effective May 5, 2023, Padagis US LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAmiloride HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq per 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 HCl 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 HCl listed in the following table have been arranged into two groups: (1) incidence greater than one percent; …
Source: FDA drug label, Padagis US LLC, effective May 5, 2023 (SPL set 2b70cf0c-45be-428f-b396-5001ed4e30fc), via openFDA; the full label on DailyMed
What do FAERS reports show?
849 reports list amiloride among the medicines taken, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 390 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 22 reactions below, 12 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amiloride: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions