HIGH-VOLUME · HOSP-MID
pioglitazone Side Effects
pioglitazone (also sold as Actos) is HIGH-VOLUME in this FAERS book #156 of 524 by FAERS report count. Signature opener: HOSP-MID - 27.1% mention hospitalization (11,530 reports).
Data updated 2026-05-15
- 42,504
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
pioglitazone: 27.1% mention hospitalization (11,530 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #156 of 524 by FAERS report count.
High-report extract for pioglitazone (Actos): 42,504 FAERS rows (2004-2025). Top named reactions: BLADDER CANCER, BLOOD GLUCOSE INCREASED, NAUSEA. Outcome stamps DEATH-HEAVY · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
BLADDER CANCER leads 8,736 of 42,504 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (9,898 reports)
Reporting taper since 2004 peak
Reactions in Death Reports
Death-mentioned subset is HEAVY here (4,296 reports, 10.1%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| BLADDER CANCER | 1,732 |
| DEATH | 1,539 |
| RENAL FAILURE | 204 |
| MYOCARDIAL INFARCTION | 180 |
| CARDIAC FAILURE CONGESTIVE | 142 |
| PNEUMONIA | 139 |
| DYSPNOEA | 137 |
| COMPLETED SUICIDE | 120 |
| CHRONIC KIDNEY DISEASE | 119 |
| SEPSIS | 116 |
| PAIN | 103 |
| NAUSEA | 102 |
| ASTHENIA | 100 |
| ANXIETY | 98 |
| CARDIAC ARREST | 98 |
| ACUTE KIDNEY INJURY | 97 |
| DIARRHOEA | 97 |
| HYPERTENSION | 96 |
| ANAEMIA | 92 |
| RESPIRATORY FAILURE | 92 |
Reactions in Hospitalization Reports
Hospitalization mid-share (11,530, 27.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| NAUSEA | 751 |
| DYSPNOEA | 736 |
| FALL | 672 |
| CARDIAC FAILURE CONGESTIVE | 645 |
| BLOOD GLUCOSE INCREASED | 616 |
| VOMITING | 576 |
| MYOCARDIAL INFARCTION | 546 |
| ASTHENIA | 531 |
| PNEUMONIA | 530 |
| DIARRHOEA | 512 |
| OEDEMA PERIPHERAL | 458 |
| RENAL FAILURE | 453 |
| HYPOGLYCAEMIA | 447 |
| FATIGUE | 442 |
| WEIGHT DECREASED | 428 |
| CHEST PAIN | 423 |
| DEHYDRATION | 419 |
| DIZZINESS | 410 |
| WEIGHT INCREASED | 407 |
| ACUTE KIDNEY INJURY | 405 |
How to read pioglitazone FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 42,504 voluntary reports linked to pioglitazone (Actos), 2004-2025. Death is listed on 4,296 (10.1%). Hospitalization appears on 11,530 (27.1%). Top co-reported indication: Type 2 Diabetes Mellitus.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-MID is the page opener, not a per-patient risk.
Read with pioglitazone
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 42,665 FAERS cases (Δ 161 heavier vs pioglitazone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 43,004 FAERS cases (Δ 500 heavier vs pioglitazone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 41,778 FAERS cases (Δ 726 lighter vs pioglitazone); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 41,632 FAERS cases (Δ 872 lighter vs pioglitazone); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.0 pp vs pioglitazone's DEATH-HEAVY): CASELOAD · HOSP-MID.
pioglitazone stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.