Pioglitazone Hydrochloride side effects: what 1,238 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,238 reports · 85% serious · 111 with death outcome · 42% female
Used for
Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [ see Clinical Studies ( 14 ) ]. Important Limitations of Use Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin.
What it is
Pioglitazone Tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Piogli.
Boxed warning
CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone hydrochloride, cause or exacerbate congestive heart failure in some patients [ see Warnings and Precautions ( 5.1 ) ]. After initiation of pioglitaz.
Causality screen of the 38 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 15 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vasculitis | 44 | 64.2 48.0–85.8ROR 66.5 · χ² 2,664 / p <1e-300 | 62.3 EB05 48.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.3 · ♀ 0% (drug 42%) | no trial data cached |
| Arteriosclerosis | 35 | 63.1 45.5–87.5ROR 64.9 · χ² 2,071 / p <1e-300 | 60.9 EB05 45.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.8 · ♀ 3% (drug 42%) | no trial data cached |
| Full blood count abnormal | 34 | 54.8 39.3–76.4ROR 56.3 · χ² 1,737 / p <1e-300 | 53.1 EB05 39.7 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 47.5 · ♀ 0% (drug 42%) | no trial data cached |
| Obstructive airways disorder | 32 | 48.7 34.6–68.6ROR 50.0 · χ² 1,444 / p <1e-300 | 47.3 EB05 35.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 34.0 · ♀ 0% (drug 42%) | no trial data cached |
| Nodule | 36 | 46.8 33.9–64.7ROR 48.2 · χ² 1,566 / p <1e-300 | 45.7 EB05 34.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 46.1 · ♀ 4% (drug 42%) | no trial data cached |
| Sleep disorder due to a general medical condition | 43 | 45.2 33.6–60.6ROR 46.7 · χ² 1,809 / p <1e-300 | 44.2 EB05 34.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 60.1 · ♀ 0% (drug 42%) | no trial data cached |
| Pulmonary fibrosis | 32 | 28.4 20.2–40.0ROR 29.1 · χ² 818 / p 3e-180 | 27.9 EB05 20.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 · ♀ 0% (drug 42%) | no trial data cached |
| Clostridium difficile colitis | 14 | 22.4 13.3–37.7ROR 22.6 · χ² 264 / p 9e-60 | 21.6 EB05 13.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Haemoptysis | 35 | 21.2 15.3–29.4ROR 21.8 · χ² 655 / p 1e-144 | 21.0 EB05 15.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 · ♀ 3% (drug 42%) | no trial data cached |
| Hypoglycaemia (low blood sugar) | 60 | 21.0 16.4–26.8ROR 22.0 · χ² 1,122 / p 3e-246 | 20.8 EB05 16.8 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.3 | no trial data cached |
| Hypothyroidism | 35 | 18.6 13.4–25.8ROR 19.1 · χ² 567 / p 1e-125 | 18.4 EB05 13.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · ♀ 0% (drug 42%) | no trial data cached |
| Cardiomegaly | 13 | 17.8 10.3–30.5ROR 17.9 · χ² 189 / p 2e-43 | 16.9 EB05 9.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Diabetes mellitus inadequate control | 18 | 17.2 10.9–27.3ROR 17.5 · χ² 259 / p 1e-58 | 16.7 EB05 10.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.6 | no trial data cached |
| Hypoxia (low oxygen) | 35 | 16.9 12.2–23.5ROR 17.4 · χ² 509 / p 6e-113 | 16.7 EB05 12.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 3% (drug 42%) | no trial data cached |
| Glycosylated haemoglobin increased | 22 | 14.8 9.8–22.4ROR 15.1 · χ² 270 / p 7e-61 | 14.3 EB05 9.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 16.5 | no trial data cached |
| Productive cough (cough with phlegm) | 38 | 13.6 9.9–18.6ROR 14.0 · χ² 432 / p 3e-96 | 13.3 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 6% (drug 42%) | no trial data cached |
| Diabetic ketoacidosis | 19 | 13.4 8.6–21.0ROR 13.6 · χ² 207 / p 4e-47 | 12.7 EB05 8.1 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.1 | no trial data cached |
| Lactic acidosis | 25 | 13.2 9.0–19.5ROR 13.5 · χ² 270 / p 5e-61 | 12.7 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Loss of personal independence in daily activities | 37 | 13.2 9.6–18.1ROR 13.6 · χ² 405 / p 2e-90 | 12.9 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 3% (drug 42%) | no trial data cached |
| Wheezing | 46 | 13.2 9.9–17.5ROR 13.6 · χ² 507 / p 2e-112 | 12.9 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 5% (drug 42%) | no trial data cached |
| Haemorrhoids | 14 | 12.1 7.2–20.4ROR 12.3 · χ² 132 / p 7e-31 | 10.8 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 26 | 12.1 8.3–17.7ROR 12.4 · χ² 255 / p 1e-57 | 11.5 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Lung disorder | 34 | 11.8 8.4–16.4ROR 12.1 · χ² 325 / p 6e-73 | 11.3 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 0% (drug 42%) | no trial data cached |
| Therapeutic product effect incomplete | 47 | 11.3 8.5–14.9ROR 11.7 · χ² 431 / p 6e-96 | 10.9 EB05 8.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 14.3 · ♀ 0% (drug 42%) | no trial data cached |
| Blood glucose abnormal | 12 | 11.0 6.3–19.3ROR 11.1 · χ² 99 / p 1e-23 | 9.2 EB05 5.1 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 11.9 | no trial data cached |
| Thrombosis | 51 | 10.7 8.2–14.0ROR 11.1 · χ² 441 / p 4e-98 | 10.4 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 11% (drug 42%) | no trial data cached |
| Hyperkalaemia (high potassium) | 19 | 9.2 5.9–14.4ROR 9.4 · χ² 131 / p 1e-30 | 8.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Pancreatitis acute | 11 | 8.4 4.6–15.0ROR 8.4 · χ² 64 / p 6e-16 | 6.7 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Renal failure acute | 20 | 7.9 5.1–12.2ROR 8.0 · χ² 113 / p 9e-27 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Cardiac failure (heart failure) | 37 | 7.8 5.7–10.7ROR 8.0 · χ² 213 / p 1e-48 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.3 · ♀ 69% (drug 42%) | no trial data cached |
| Cerebral infarction | 11 | 7.6 4.2–13.7ROR 7.7 · χ² 57 / p 2e-14 | 6.1 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Acute myocardial infarction | 13 | 7.4 4.3–12.8ROR 7.5 · χ² 66 / p 2e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Hepatic function abnormal | 16 | 7.3 4.5–11.9ROR 7.4 · χ² 81 / p 1e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 14 | 7.0 4.2–11.8ROR 7.1 · χ² 66 / p 2e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Skin exfoliation | 29 | 5.9 4.1–8.5ROR 6.0 · χ² 114 / p 7e-27 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 7% (drug 42%) | no trial data cached |
| Blood glucose decreased | 15 | 5.3 3.2–8.7ROR 5.3 · χ² 48 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.4 | no trial data cached |
| Bladder cancer | 17 | 4.8 3.0–7.8ROR 4.9 · χ² 48 / p 2e-12 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.7 | no trial data cached |
| Blood glucose increased | 52 | 4.7 3.6–6.1ROR 4.8 · χ² 147 / p 4e-34 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 60 | 21.0 16.4–26.8ROR 22.0 · χ² 1,122 / p 3e-246 | 20.8 EB05 16.8 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.3 | no trial data cached |
| Blood glucose increased | 52 | 4.7 3.6–6.1ROR 4.8 · χ² 147 / p 4e-34 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Thrombosis | 51 | 10.7 8.2–14.0ROR 11.1 · χ² 441 / p 4e-98 | 10.4 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 11% (drug 42%) | no trial data cached |
| Therapeutic product effect incomplete | 47 | 11.3 8.5–14.9ROR 11.7 · χ² 431 / p 6e-96 | 10.9 EB05 8.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 14.3 · ♀ 0% (drug 42%) | no trial data cached |
| Wheezing | 46 | 13.2 9.9–17.5ROR 13.6 · χ² 507 / p 2e-112 | 12.9 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · ♀ 5% (drug 42%) | no trial data cached |
| Vasculitis | 44 | 64.2 48.0–85.8ROR 66.5 · χ² 2,664 / p <1e-300 | 62.3 EB05 48.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.3 · ♀ 0% (drug 42%) | no trial data cached |
| Sleep disorder due to a general medical condition | 43 | 45.2 33.6–60.6ROR 46.7 · χ² 1,809 / p <1e-300 | 44.2 EB05 34.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 60.1 · ♀ 0% (drug 42%) | no trial data cached |
| Productive cough (cough with phlegm) | 38 | 13.6 9.9–18.6ROR 14.0 · χ² 432 / p 3e-96 | 13.3 EB05 9.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 6% (drug 42%) | no trial data cached |
| Cardiac failure (heart failure) | 37 | 7.8 5.7–10.7ROR 8.0 · χ² 213 / p 1e-48 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.3 · ♀ 69% (drug 42%) | no trial data cached |
| Loss of personal independence in daily activities | 37 | 13.2 9.6–18.1ROR 13.6 · χ² 405 / p 2e-90 | 12.9 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 3% (drug 42%) | no trial data cached |
| Nodule | 36 | 46.8 33.9–64.7ROR 48.2 · χ² 1,566 / p <1e-300 | 45.7 EB05 34.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 46.1 · ♀ 4% (drug 42%) | no trial data cached |
| Hypoxia (low oxygen) | 35 | 16.9 12.2–23.5ROR 17.4 · χ² 509 / p 6e-113 | 16.7 EB05 12.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 3% (drug 42%) | no trial data cached |
| Hypothyroidism | 35 | 18.6 13.4–25.8ROR 19.1 · χ² 567 / p 1e-125 | 18.4 EB05 13.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · ♀ 0% (drug 42%) | no trial data cached |
| Haemoptysis | 35 | 21.2 15.3–29.4ROR 21.8 · χ² 655 / p 1e-144 | 21.0 EB05 15.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 · ♀ 3% (drug 42%) | no trial data cached |
| Arteriosclerosis | 35 | 63.1 45.5–87.5ROR 64.9 · χ² 2,071 / p <1e-300 | 60.9 EB05 45.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.8 · ♀ 3% (drug 42%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Vasculitis — n=44, PRR 64.2
- Arteriosclerosis — n=35, PRR 63.1
- Obstructive airways disorder — n=32, PRR 48.7
- Nodule — n=36, PRR 46.8
- Sleep disorder due to a general medical condition — n=43, PRR 45.2
- Pulmonary fibrosis — n=32, PRR 28.4
- Haemoptysis — n=35, PRR 21.2
- Hypothyroidism — n=35, PRR 18.6
- Hypoxia — n=35, PRR 16.9
- Productive cough — n=38, PRR 13.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Pioglitazone ↔ Bladder cancer.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pioglitazone?
In FDA FAERS, the most frequently co-reported reaction terms for Pioglitazone are hypoglycaemia, blood glucose increased, thrombosis, wheezing, vasculitis, sleep disorder due to a general medical condition. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pioglitazone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone hydrochloride, cause or exacerbate congestive heart failure in some patients [ see Warnings and Precautions ( 5.1 ) ]. After initiation of pioglitaz.
Do FAERS signals prove that Pioglitazone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 22569835-bc9f-7787-e063-6394a90a6232, effective 20260119; matched on
openfda.generic_name.exact:"PIOGLITAZONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 53 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.