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ethacrynic acid Side Effects

Also known as: Edecrin

Analysis of 520 adverse event reports submitted to the FDA from 1997 to 2025.

Total Reports

520

Death-Related

64

12.3% of reports

Hospitalizations

212

40.8% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS
59
OFF LABEL USE
50
NAUSEA
43
DYSPNOEA
42
DRUG INEFFECTIVE
35
ACUTE KIDNEY INJURY
33
FATIGUE
32
DIARRHOEA
31
VOMITING
31
DRUG HYPERSENSITIVITY
28
ASTHENIA
25
DEATH
24
WEIGHT DECREASED
24
DIZZINESS
23
HEADACHE
23
MALAISE
23
HYPOTENSION
21
PNEUMONIA
21
PRURITUS
21
RASH
21

Who Reports Side Effects

Gender Distribution

Female 295 (61%)
Male 188 (39%)
Unknown 1

Age Distribution

0-17 17 (4%)
18-44 41 (11%)
45-64 85 (22%)
65-74 132 (35%)
75+ 106 (28%)

Reporting Trend by Year

1997 2025

Reactions in Death Reports

Top reactions reported in 64 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 24
FATIGUE 9
PYREXIA 9
CONSTIPATION 6
RESPIRATORY DISTRESS 6
TOXIC EPIDERMAL NECROLYSIS 6
VOMITING 6
ACUTE KIDNEY INJURY 5
APLASIA PURE RED CELL 5
ASPIRATION 5
CARDIAC FAILURE 5
DEVELOPMENTAL DELAY 5
ENTEROCOCCAL INFECTION 5
HAEMOGLOBIN DECREASED 5
LYMPHOCYTOSIS 5
NO THERAPEUTIC RESPONSE 5
RASH 5
STAPHYLOCOCCAL INFECTION 5
TRANSPLANT REJECTION 5
WHEEZING 5

Reactions in Hospitalization Reports

Top reactions in 212 reports where hospitalization was an outcome.

Reaction Reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 46
OFF LABEL USE 30
PNEUMONIA 19
ACUTE KIDNEY INJURY 18
DIARRHOEA 18
DYSPNOEA 18
DRUG HYPERSENSITIVITY 17
FATIGUE 16
NAUSEA 14
MALAISE 13
ASTHENIA 12
DRUG INEFFECTIVE 11
HYPOTENSION 11
PYREXIA 11
WEIGHT DECREASED 11
PRODUCT USE IN UNAPPROVED INDICATION 10
SEPSIS 10
VOMITING 10
ANAEMIA 9
CARDIAC FAILURE 9

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What the FAERS Data Reveals About ethacrynic acid Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 520 voluntary reports linked to ethacrynic acid and its brand equivalents (Edecrin), spanning 1997 through 2025. Of those, 64 (12.3%) listed death as an outcome and 212 (40.8%) 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, 61% were female and 39% male; age distribution skews toward 65-74, with 132 reports in that bracket. The single most reported reaction is drug reaction with eosinophilia and systemic symptoms with 59 submissions, followed by off label use 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.