MID-VOLUME · HOSP-HEAVY
hydralazine Side Effects
hydralazine (also sold as Apresoline) sits MID-VOLUME #197 of 524 by FAERS report count. Lead signal: HOSP-HEAVY - 42.8% mention hospitalization (12,190 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 28,498
- FAERS reports
FDA Adverse Event Reporting System extract for hydralazine. Stamp set CASELOAD · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
hydralazine: 42.8% mention hospitalization (12,190 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #197 of 524 by FAERS report count.
Mid-book FAERS page for hydralazine (Apresoline) (28,498 reports). Signature HOSP-HEAVY. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (1995–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
CHRONIC KIDNEY DISEASE leads 2,819 of 28,498 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (6,121 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (3,510 reports, 12.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 1,309 |
| CHRONIC KIDNEY DISEASE | 530 |
| ACUTE KIDNEY INJURY | 449 |
| RENAL FAILURE | 409 |
| END STAGE RENAL DISEASE | 403 |
| COMPLETED SUICIDE | 255 |
| CARDIAC ARREST | 182 |
| CARDIAC FAILURE CONGESTIVE | 160 |
| NEPHROGENIC ANAEMIA | 157 |
| PNEUMONIA | 144 |
| DYSPNOEA | 129 |
| SEPSIS | 126 |
| RESPIRATORY FAILURE | 121 |
| TOXICITY TO VARIOUS AGENTS | 115 |
| ANAEMIA | 102 |
| HYPERTENSION | 99 |
| RENAL INJURY | 98 |
| ATRIAL FIBRILLATION | 94 |
| CEREBROVASCULAR ACCIDENT | 93 |
| ASTHENIA | 92 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (12,190, 42.8% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 1,201 |
| DYSPNOEA | 895 |
| RENAL FAILURE | 836 |
| HYPERTENSION | 767 |
| CHRONIC KIDNEY DISEASE | 753 |
| PNEUMONIA | 708 |
| CARDIAC FAILURE CONGESTIVE | 704 |
| ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS | 671 |
| FATIGUE | 599 |
| NAUSEA | 595 |
| FALL | 553 |
| DIARRHOEA | 541 |
| ASTHENIA | 537 |
| END STAGE RENAL DISEASE | 480 |
| ANAEMIA | 476 |
| VOMITING | 446 |
| HYPOTENSION | 444 |
| DIZZINESS | 433 |
How to read hydralazine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 28,498 voluntary reports linked to hydralazine (Apresoline), 1995-2025. Death is listed on 3,510 (12.3%). Hospitalization appears on 12,190 (42.8%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 42.8% mention hospitalization (12,190 reports).
Read with hydralazine
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 28,502 FAERS cases (Δ 4 heavier vs hydralazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 28,434 FAERS cases (Δ 64 lighter vs hydralazine); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 28,128 FAERS cases (Δ 370 lighter vs hydralazine); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 28,005 FAERS cases (Δ 493 lighter vs hydralazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 49.8 pp vs hydralazine's DEATH-HEAVY): CASELOAD · HOSP-MID.
hydralazine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.