Drug · FAERS side-effect profile with label screen

Bisoprolol and Hydrochlorothiazide side effects: what 614 FDA adverse event reports show

Bisoprolol Fumarate And Hydrochlorothiazide · 26 reaction terms · 291 drug–reaction co-reports · data 2026-09-14

Drug class

Thiazide Diuretic

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Bisoprolol Fumarate And Hydrochlorothiazide (Bisoprolol Fumarate And Hydrochlorothiazide)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

614 reports · 72% serious · 53 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.

FDA label, Indications and Usage

What it is

DESCRIPTION Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic bet.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 16 strongest signals

Labeled adverse reaction 2Labeled (related wording) 3Reporting / coding artifact 2Lab value / disease marker 1Outcome field, not a reaction 1Not in label — unassessed 7

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Red blood cell sedimentation rate increased	14	43.2 25.7–72.5ROR 44.1 · χ² 535 / p 1e-118	40.9 EB05 25.9 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 39.2	no trial data cached
Hypercalcaemia	14	38.8 23.1–65.2ROR 39.7 · χ² 478 / p 3e-106	37.0 EB05 23.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 33.3	no trial data cached
Basal cell carcinoma	15	32.8 19.9–54.1ROR 33.6 · χ² 432 / p 4e-96	31.6 EB05 20.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.1	no trial data cached
Ulcer	15	32.2 19.5–53.1ROR 33.0 · χ² 422 / p 4e-94	31.0 EB05 19.9 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.5	no trial data cached
Drug eruption	15	29.1 17.6–48.0ROR 29.8 · χ² 379 / p 9e-85	28.1 EB05 18.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.8	no trial data cached
Pulmonary fibrosis	15	26.8 16.3–44.2ROR 27.5 · χ² 348 / p 7e-78	26.0 EB05 16.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 21.7	no trial data cached
Synovitis	13	24.6 14.4–42.2ROR 25.1 · χ² 271 / p 3e-61	23.7 EB05 14.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Prescribed underdose	13	22.3 13.0–38.1ROR 22.7 · χ² 243 / p 4e-55	21.5 EB05 13.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.5	no trial data cached
Skin ulcer	16	21.2 13.1–34.3ROR 21.7 · χ² 288 / p 7e-65	20.6 EB05 13.2 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.6	no trial data cached
Hepatitis (liver inflammation)	14	18.7 11.1–31.4ROR 19.1 · χ² 217 / p 2e-49	18.0 EB05 10.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Renal failure acute	20	15.9 10.3–24.4ROR 16.4 · χ² 265 / p 9e-60	15.4 EB05 10.1 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.8	no trial data cached
Deafness	12	15.7 8.9–27.4ROR 15.9 · χ² 150 / p 7e-35	14.5 EB05 7.9 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.0	no trial data cached
Rash pruritic	22	13.9 9.2–21.0ROR 14.4 · χ² 252 / p 5e-57	13.4 EB05 8.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.0 · ♀ 100% (drug 66%) · 90% clinician	no trial data cached
Contraindicated product administered	12	13.6 7.8–23.8ROR 13.8 · χ² 128 / p 6e-30	12.1 EB05 6.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6	no trial data cached
Therapeutic product effect decreased	14	10.8 6.4–18.1ROR 11.0 · χ² 115 / p 4e-27	9.3 EB05 5.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 15.8	no trial data cached
Completed suicide (death by suicide)	11	4.5 2.5–8.0ROR 4.5 · χ² 26 / p 1e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Outcome field, not a reaction	serious PRR 3.6	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Rash pruritic	22	13.9 9.2–21.0ROR 14.4 · χ² 252 / p 5e-57	13.4 EB05 8.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.0 · ♀ 100% (drug 66%) · 90% clinician	no trial data cached
Renal failure acute	20	15.9 10.3–24.4ROR 16.4 · χ² 265 / p 9e-60	15.4 EB05 10.1 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.8	no trial data cached
Skin ulcer	16	21.2 13.1–34.3ROR 21.7 · χ² 288 / p 7e-65	20.6 EB05 13.2 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.6	no trial data cached
Pulmonary fibrosis	15	26.8 16.3–44.2ROR 27.5 · χ² 348 / p 7e-78	26.0 EB05 16.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 21.7	no trial data cached
Drug eruption	15	29.1 17.6–48.0ROR 29.8 · χ² 379 / p 9e-85	28.1 EB05 18.1 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.8	no trial data cached
Ulcer	15	32.2 19.5–53.1ROR 33.0 · χ² 422 / p 4e-94	31.0 EB05 19.9 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 32.5	no trial data cached
Basal cell carcinoma	15	32.8 19.9–54.1ROR 33.6 · χ² 432 / p 4e-96	31.6 EB05 20.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.1	no trial data cached
Therapeutic product effect decreased	14	10.8 6.4–18.1ROR 11.0 · χ² 115 / p 4e-27	9.3 EB05 5.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 15.8	no trial data cached
Hepatitis (liver inflammation)	14	18.7 11.1–31.4ROR 19.1 · χ² 217 / p 2e-49	18.0 EB05 10.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Hypercalcaemia	14	38.8 23.1–65.2ROR 39.7 · χ² 478 / p 3e-106	37.0 EB05 23.4 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 33.3	no trial data cached
Red blood cell sedimentation rate increased	14	43.2 25.7–72.5ROR 44.1 · χ² 535 / p 1e-118	40.9 EB05 25.9 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 39.2	no trial data cached
Prescribed underdose	13	22.3 13.0–38.1ROR 22.7 · χ² 243 / p 4e-55	21.5 EB05 13.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.5	no trial data cached
Synovitis	13	24.6 14.4–42.2ROR 25.1 · χ² 271 / p 3e-61	23.7 EB05 14.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Contraindicated product administered	12	13.6 7.8–23.8ROR 13.8 · χ² 128 / p 6e-30	12.1 EB05 6.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6	no trial data cached
Deafness	12	15.7 8.9–27.4ROR 15.9 · χ² 150 / p 7e-35	14.5 EB05 7.9 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.0	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.

Rash pruritic — n=22, PRR 13.9

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.

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 Bisoprolol and Hydrochlorothiazide?

In FDA FAERS, the most frequently co-reported reaction terms for Bisoprolol and Hydrochlorothiazide are rash pruritic, renal failure acute, skin ulcer, pulmonary fibrosis, drug eruption, ulcer. 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 Bisoprolol and Hydrochlorothiazide have an FDA boxed warning?

No. The FDA label retrieved for Bisoprolol and Hydrochlorothiazide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bisoprolol and Hydrochlorothiazide 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 27d52b23-e3e2-4339-b00e-cd0fec43ffbb, effective 20260811; matched on openfda.generic_name.exact:"BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE")
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, field patient.drug.openfda.generic_name.exact, 26 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.