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amiloride Side Effects

Also known as: Midamor

Analysis of 834 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

834

Death-Related

62

7.4% of reports

Hospitalizations

384

46.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DYSPNOEA
69
DIARRHOEA
57
NAUSEA
49
VOMITING
39
FATIGUE
37
MALAISE
37
FALL
36
CONFUSIONAL STATE
33
DRUG INTERACTION
33
HEADACHE
32
HYPERKALAEMIA
31
PRURITUS
29
RENAL FAILURE ACUTE
29
ABDOMINAL PAIN
28
ASTHENIA
27
PYREXIA
27
DIZZINESS
26
DRUG INEFFECTIVE
26
ARTHRALGIA
25
OFF LABEL USE
25

Who Reports Side Effects

Gender Distribution

Female 440 (56%)
Male 341 (44%)
Unknown 1

Age Distribution

0-17 13 (2%)
18-44 47 (9%)
45-64 183 (33%)
65-74 156 (28%)
75+ 150 (27%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 62 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
RENAL FAILURE 8
DEATH 7
DIARRHOEA 7
CARDIAC ARREST 6
HYPOTENSION 6
ABDOMINAL PAIN 5
CARDIAC FAILURE 5
CARDIAC FAILURE CONGESTIVE 5
DYSPNOEA 5
GENERAL PHYSICAL HEALTH DETERIORATION 5
LOSS OF CONSCIOUSNESS 5
DRUG INTERACTION 4
MULTI-ORGAN FAILURE 4
MYOCARDIAL INFARCTION 4
NAUSEA 4
NEUTROPENIA 4
PULMONARY HYPERTENSION 4
PYREXIA 4
SEPSIS 4
ASTHENIA 3

Reactions in Hospitalization Reports

Top reactions in 384 reports where hospitalization was an outcome.

Reaction Reports
DIARRHOEA 35
HYPERKALAEMIA 25
RENAL FAILURE ACUTE 25
NAUSEA 24
DYSPNOEA 23
OFF LABEL USE 23
PYREXIA 23
VOMITING 22
ASTHENIA 20
ANAEMIA 19
HYPONATRAEMIA 19
DEHYDRATION 17
MALAISE 17
ABDOMINAL PAIN 16
ACUTE KIDNEY INJURY 14
HYPOKALAEMIA 14
SOMNOLENCE 14
CONFUSIONAL STATE 13
DRUG INTERACTION 13
FALL 13

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What the FAERS Data Reveals About amiloride Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 834 voluntary reports linked to amiloride and its brand equivalents (Midamor), spanning 2004 through 2025. Of those, 62 (7.4%) listed death as an outcome and 384 (46.0%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 56% were female and 44% male; age distribution skews toward 45-64, with 183 reports in that bracket. The single most reported reaction is dyspnoea with 69 submissions, followed by diarrhoea and nausea.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.