HIGH-VOLUME · HOSP-HEAVY
spironolactone Side Effects
spironolactone (also sold as Aldactone) is HIGH-VOLUME in this FAERS book #49 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 47.8% mention hospitalization (64,112 reports).
Data updated 2026-05-15
- 133,996
- FAERS reports
FAERS voluntary reports, 2001 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
spironolactone: 47.8% mention hospitalization (64,112 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #49 of 524 by FAERS report count.
High-report extract for spironolactone (Aldactone): 133,996 FAERS rows (2001-2025). Top named reactions: DYSPNOEA, FATIGUE, NAUSEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2001–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
DYSPNOEA leads 10,389 of 133,996 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (30,035 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (17,638 reports, 13.2%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 4,908 |
| DYSPNOEA | 1,370 |
| CARDIAC FAILURE | 1,292 |
| PNEUMONIA | 1,228 |
| RENAL FAILURE | 1,041 |
| ACUTE KIDNEY INJURY | 949 |
| HYPOTENSION | 869 |
| CARDIAC ARREST | 866 |
| DIARRHOEA | 858 |
| RESPIRATORY FAILURE | 793 |
| CARDIAC FAILURE CONGESTIVE | 790 |
| SEPSIS | 771 |
| NAUSEA | 756 |
| FALL | 731 |
| ASTHENIA | 709 |
| FATIGUE | 707 |
| ANAEMIA | 655 |
| HEPATIC FAILURE | 621 |
| CONDITION AGGRAVATED | 617 |
| VOMITING | 612 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (64,112, 47.8% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| DYSPNOEA | 6,650 |
| ACUTE KIDNEY INJURY | 5,029 |
| HYPOTENSION | 3,873 |
| NAUSEA | 3,844 |
| DIARRHOEA | 3,795 |
| HYPERKALAEMIA | 3,785 |
| FALL | 3,726 |
| PNEUMONIA | 3,558 |
| FATIGUE | 3,542 |
| CARDIAC FAILURE | 3,258 |
| ASTHENIA | 3,070 |
| VOMITING | 3,044 |
| ANAEMIA | 2,957 |
| DIZZINESS | 2,919 |
| DEHYDRATION | 2,717 |
| DRUG INTERACTION | 2,689 |
| CARDIAC FAILURE CONGESTIVE | 2,444 |
| OEDEMA PERIPHERAL | 2,428 |
| MALAISE | 2,427 |
| HEADACHE | 2,426 |
How to read spironolactone FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 133,996 voluntary reports linked to spironolactone (Aldactone), 2001-2025. Death is listed on 17,638 (13.2%). Hospitalization appears on 64,112 (47.8%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with spironolactone
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 134,198 FAERS cases (Δ 202 heavier vs spironolactone); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 133,513 FAERS cases (Δ 483 lighter vs spironolactone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 134,536 FAERS cases (Δ 540 heavier vs spironolactone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 133,227 FAERS cases (Δ 769 lighter vs spironolactone); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 48.9 pp vs spironolactone's DEATH-HEAVY): CASELOAD · HOSP-MID.
spironolactone stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.