Pindolol side effects: what 796 FDA adverse event reports show
Who reports
796 reports · 68% serious · 63 with death outcome · 67% female
Used for
Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.
What it is
DESCRIPTION Pindolol, a synthetic beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity is 1-(Indol-4-yloxy)-3-(isopropylamino)-2-propanol. Pindolol, USP is a white t.
Boxed warning
None in the current label
Causality screen of the 9 strongest signals
What the badges mean
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 6 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 |
|---|---|---|---|---|---|---|
| Oesophagitis | 24 | 57.9 39.0–85.9ROR 59.7 · χ² 1,284 / p 2e-281 | 55.4 EB05 39.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 28 | 17.7 12.3–25.5ROR 18.3 · χ² 426 / p 6e-95 | 17.5 EB05 12.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 100% (drug 67%) · 95% clinician | no trial data cached |
| Chromaturia | 15 | 17.5 10.6–28.9ROR 17.8 · χ² 217 / p 2e-49 | 16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 | no trial data cached |
| Blood pressure systolic increased | 10 | 13.5 7.3–24.9ROR 13.6 · χ² 103 / p 2e-24 | 11.5 EB05 5.8 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 12.4 | no trial data cached |
| Carpal tunnel syndrome | 6 | 11.3 5.1–25.0ROR 11.3 · χ² 46 / p 5e-12 | 7.8 EB05 3.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Drug toxicity | 5 | 9.5 4.0–22.9ROR 9.6 · χ² 30 / p 2e-8 | 6.1 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 7 | 6.5 3.1–13.5ROR 6.5 · χ² 27 / p 9e-8 | 4.8 EB05 2.5 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Drug exposure during pregnancy | 7 | 5.3 2.6–11.2ROR 5.4 · χ² 21 / p 3e-6 | 4.1 EB05 2.2 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Completed suicide (death by suicide) | 11 | 3.4 1.9–6.2ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Outcome field, not a reaction | serious PRR 2.9 | 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 |
|---|---|---|---|---|---|---|
| Rhabdomyolysis (muscle breakdown) | 28 | 17.7 12.3–25.5ROR 18.3 · χ² 426 / p 6e-95 | 17.5 EB05 12.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 100% (drug 67%) · 95% clinician | no trial data cached |
| Oesophagitis | 24 | 57.9 39.0–85.9ROR 59.7 · χ² 1,284 / p 2e-281 | 55.4 EB05 39.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · ♀ 100% (drug 67%) · 96% clinician | no trial data cached |
| Chromaturia | 15 | 17.5 10.6–28.9ROR 17.8 · χ² 217 / p 2e-49 | 16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 | no trial data cached |
| Completed suicide (death by suicide) | 11 | 3.4 1.9–6.2ROR 3.5 · χ² 17 / p 2e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Outcome field, not a reaction | serious PRR 2.9 | no trial data cached |
| Blood pressure systolic increased | 10 | 13.5 7.3–24.9ROR 13.6 · χ² 103 / p 2e-24 | 11.5 EB05 5.8 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 12.4 | no trial data cached |
| Drug exposure during pregnancy | 7 | 5.3 2.6–11.2ROR 5.4 · χ² 21 / p 3e-6 | 4.1 EB05 2.2 · IC025 +0.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 7 | 6.5 3.1–13.5ROR 6.5 · χ² 27 / p 9e-8 | 4.8 EB05 2.5 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Carpal tunnel syndrome | 6 | 11.3 5.1–25.0ROR 11.3 · χ² 46 / p 5e-12 | 7.8 EB05 3.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Drug toxicity | 5 | 9.5 4.0–22.9ROR 9.6 · χ² 30 / p 2e-8 | 6.1 EB05 2.6 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Malignant melanoma | 4 | 7.9 3.0–20.9ROR 7.9 · χ² 18 / p 1e-5 | 4.7 EB05 2.0 · IC025 +0.4 | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Breast cancer female | 3 | 2.9 0.9–9.1ROR 2.9 · χ² 2 / p 0.072 | 2.3 EB05 0.9 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Pharmaceutical product complaint | 3 | 3.0 1.0–9.3ROR 3.0 · χ² 2 / p 0.067 | 2.4 EB05 1.0 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Synovitis | 3 | 4.4 1.4–13.5ROR 4.4 · χ² 5 / p 0.014 | 3.0 EB05 1.2 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Hair texture abnormal | 3 | 5.9 1.9–18.1ROR 5.9 · χ² 8 / p 0.003 | 3.5 EB05 1.4 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious n=2 | no trial data cached |
| Hereditary angioedema | 3 | 7.5 2.4–23.3ROR 7.6 · χ² 11 / p 4e-4 | 4.1 EB05 1.6 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 7.6 | 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.
- Oesophagitis — n=24, PRR 57.9
- Rhabdomyolysis — n=28, PRR 17.7
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 Pindolol?
In FDA FAERS, the most frequently co-reported reaction terms for Pindolol are rhabdomyolysis, oesophagitis, chromaturia, blood pressure systolic increased, tardive dyskinesia, carpal tunnel syndrome. 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 Pindolol have an FDA boxed warning?
No. The FDA label retrieved for Pindolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pindolol 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 611be921-e9b6-4800-80b2-c2d4f677cdb2, effective 20250919; matched on
openfda.generic_name.exact:"PINDOLOL") - 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, 15 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.