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Bisoprolol side effects: what 135,055 FDA adverse event reports show

Bisoprolol Fumarate · 1,251 reaction terms · 552,781 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Label matched

Bisoprolol Fumarate (Bisoprolol Fumarate)

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

Who reports

135,055 reports · 97% serious · 14,918 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.

FDA label, Indications and Usage

What it is

DESCRIPTION Bisoprolol fumarate USP is a synthetic, beta 1 -selective (cardioselective) adrenoceptor blocking agent.

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 40 strongest signals

Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 5Not in label — unassessed 29
What the badges mean

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,211 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Right atrial hypertrophy90684.9
421.9–1,111.9ROR 685.4 · calibrated p 5e-14 ✓
122.2 EB05 102.4 · IC025 +5.9
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=90 · ♀ 0% (drug 48%) · 100% consumernot reported in cached trials
Cardiospasm404418.3
346.4–505.2ROR 419.6 · calibrated p 5e-13 ✓
111.8 EB05 102.9 · IC025 +6.5
3/3 methods agree
Not in label — unassessedserious n=404not reported in cached trials
Fractional exhaled nitric oxide increased109267.6
195.9–365.5ROR 267.8 · calibrated p 8e-11 ✓
96.1 EB05 81.9 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious n=109 · ♀ 0% (drug 48%)not reported in cached trials
Immunisation264245.0
201.7–297.7ROR 245.5 · calibrated p 9e-11 ✓
93.9 EB05 84.8 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious n=264not reported in cached trials
Palmoplantar keratoderma396191.3
165.0–221.8ROR 191.9 · calibrated p 7e-10 ✓
85.0 EB05 78.2 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious n=396not reported in cached trials
Neurologic neglect syndrome20489.0
74.9–105.7ROR 89.1 · calibrated p 3e-7 ✓
56.2 EB05 50.1 · IC025 +5.4
3/3 methods agree
Not in label — unassessedserious n=204 · ♀ 100% (drug 48%) · 100% cliniciannot reported in cached trials
Vital capacity decreased12559.5
48.4–73.1ROR 59.5 · calibrated p 5e-6 ✓
42.8 EB05 36.8 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=125 · ♀ 100% (drug 48%)not reported in cached trials
Amaurosis fugax26450.7
44.1–58.3ROR 50.8 · calibrated p 1e-5 ✓
38.2 EB05 34.5 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=264 · 93% cliniciannot reported in cached trials
Carotid artery thrombosis20849.9
42.6–58.3ROR 49.9 · calibrated p 2e-5 ✓
37.7 EB05 33.6 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=208 · ♀ 100% (drug 48%) · 100% cliniciannot reported in cached trials
Atrial tachycardia50348.5
43.9–53.6ROR 48.7 · calibrated p 2e-5 ✓
37.0 EB05 34.3 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=502not reported in cached trials
Systemic infection33839.5
35.0–44.5ROR 39.5 · calibrated p 6e-5 ✓
31.5 EB05 28.8 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=338 · 100% cliniciannot reported in cached trials
Reversible airways obstruction10338.7
31.2–48.1ROR 38.7 · calibrated p 8e-5 ✓
30.9 EB05 26.2 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=103 · ♀ 100% (drug 48%)not reported in cached trials
Pruritus genital42334.3
30.9–38.1ROR 34.4 · calibrated p 1e-4 ✓
28.2 EB05 26.0 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=421not reported in cached trials
Steroid dependence14632.1
26.8–38.3ROR 32.1 · calibrated p 2e-4 ✓
26.6 EB05 23.2 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=146 · ♀ 0% (drug 48%) · 100% cliniciannot reported in cached trials
Catarrh14830.9
25.9–36.8ROR 30.9 · calibrated p 2e-4 ✓
25.8 EB05 22.5 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=148 · ♀ 0% (drug 48%) · 100% cliniciannot reported in cached trials
N-terminal prohormone brain natriuretic peptide increased22128.9
25.1–33.4ROR 29.0 · calibrated p 3e-4 ✓
24.4 EB05 21.8 · IC025 +4.3
3/3 methods agree
Lab value / disease markerserious n=217 · ♀ 28% (drug 48%)not reported in cached trials
Bronchial secretion retention19728.5
24.5–33.2ROR 28.6 · calibrated p 4e-4 ✓
24.1 EB05 21.4 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=197not reported in cached trials
Adjustment disorder19326.8
23.0–31.3ROR 26.9 · calibrated p 5e-4 ✓
22.9 EB05 20.3 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=192 · ♀ 100% (drug 48%) · 100% cliniciannot reported in cached trials
Product monitoring error19023.6
20.2–27.5ROR 23.6 · calibrated p 1e-3 ✓
20.5 EB05 18.2 · IC025 +4.0
3/3 methods agree
Reporting / coding artifactserious n=189 · 100% cliniciannot reported in cached trials
Bronchial wall thickening9623.6
19.0–29.2ROR 23.6 · calibrated p 0.001 ✓
20.5 EB05 17.3 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=96 · ♀ 0% (drug 48%) · 100% consumernot reported in cached trials
Sputum culture positive10422.3
18.1–27.4ROR 22.3 · calibrated p 0.001 ✓
19.5 EB05 16.6 · IC025 +3.8
3/3 methods agree
Lab value / disease markerserious n=104 · ♀ 100% (drug 48%)not reported in cached trials
Carotid arteriosclerosis12321.1
17.5–25.5ROR 21.1 · calibrated p 0.002 ✓
18.6 EB05 16.0 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=123 · ♀ 0% (drug 48%)not reported in cached trials
Bradyarrhythmia19621.0
18.0–24.3ROR 21.0 · calibrated p 0.002 ✓
18.5 EB05 16.4 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=195 · 100% cliniciannot reported in cached trials
Carotid artery occlusion43320.7
18.8–22.9ROR 20.8 · calibrated p 0.002 ✓
18.4 EB05 16.9 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=433not reported in cached trials
Aortic valve stenosis18718.0
15.5–21.0ROR 18.0 · calibrated p 0.003 ✓
16.2 EB05 14.3 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=186not reported in cached trials
Myoglobin blood increased16018.0
15.3–21.2ROR 18.0 · calibrated p 0.003 ✓
16.2 EB05 14.2 · IC025 +3.7
3/3 methods agree
Lab value / disease markerserious n=160 · ♀ 0% (drug 48%)not reported in cached trials
Right ventricular hypertrophy9518.0
14.5–22.2ROR 18.0 · calibrated p 0.004 ✓
16.1 EB05 13.6 · IC025 +3.6
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=95 · ♀ 0% (drug 48%) · 100% consumernot reported in cached trials
Obstructive sleep apnoea syndrome14217.5
14.7–20.8ROR 17.5 · calibrated p 0.004 ✓
15.7 EB05 13.7 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=142 · ♀ 0% (drug 48%)not reported in cached trials
Systolic dysfunction10416.9
13.8–20.7ROR 16.9 · calibrated p 0.005 ✓
15.3 EB05 12.9 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=104 · ♀ 0% (drug 48%) · 100% cliniciannot reported in cached trials
Sleep terror40016.2
14.6–18.0ROR 16.3 · calibrated p 0.005 ✓
14.7 EB05 13.6 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=400not reported in cached trials
Pulmonary function test abnormal14816.2
13.6–19.1ROR 16.2 · calibrated p 0.005 ✓
14.7 EB05 12.8 · IC025 +3.5
3/3 methods agree
Reporting / coding artifactserious n=148 · ♀ 0% (drug 48%)not reported in cached trials
Bloody discharge10816.0
13.1–19.5ROR 16.0 · calibrated p 0.006 ✓
14.5 EB05 12.3 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=108 · ♀ 100% (drug 48%) · 100% cliniciannot reported in cached trials
Diastolic dysfunction28515.6
13.8–17.6ROR 15.7 · calibrated p 0.006 ✓
14.2 EB05 12.9 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=283 · ♀ 22% (drug 48%)not reported in cached trials
Left ventricular dysfunction59515.1
13.9–16.5ROR 15.2 · calibrated p 0.007 ✓
13.8 EB05 12.9 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=595not reported in cached trials
Brain natriuretic peptide increased27515.1
13.4–17.1ROR 15.2 · calibrated p 0.007 ✓
13.8 EB05 12.5 · IC025 +3.6
3/3 methods agree
Lab value / disease markerserious n=272 · ♀ 20% (drug 48%)not reported in cached trials
International normalised ratio fluctuation18615.0
12.9–17.5ROR 15.1 · calibrated p 0.007 ✓
13.7 EB05 12.1 · IC025 +3.5
3/3 methods agree
Lab value / disease markerserious n=186 · ♀ 100% (drug 48%)not reported in cached trials
Sinus node dysfunction15414.2
12.0–16.7ROR 14.2 · calibrated p 0.009 ✓
13.0 EB05 11.3 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=154 · 100% cliniciannot reported in cached trials
Tachyarrhythmia20814.0
12.2–16.2ROR 14.0 · calibrated p 0.009 ✓
12.9 EB05 11.5 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=207not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

ConceptReportsPRR 95% CIReading
Arrhythmia / qt7,3906.16.0–6.3signal
Hyponatraemia3,0596.15.9–6.3signal
Heart failure5,5504.94.8–5.1signal
Kidney injury13,3234.64.6–4.7signal
Rhabdomyolysis / myopathy2,3204.54.4–4.7signal
Gi bleeding4,6744.03.9–4.2signal
Interstitial lung disease1,8923.13.0–3.2signal
Anaemia5,6423.02.9–3.0signal
Severe cutaneous reaction1,2742.72.5–2.8signal
Myocardial infarction3,2252.52.4–2.6signal
Stroke3,8772.42.4–2.5signal
Fall / fracture5,6522.32.3–2.4signal
Hypoglycaemia1,3412.22.1–2.3signal
Liver injury4,1502.22.1–2.2signal
Tendon disorder5182.11.9–2.3raised
Anaphylaxis / angioedema1,6862.12.0–2.2signal

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Bisoprolol as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Dyspnoea (shortness of breath)9,1722.5
2.5–2.6ROR 2.7 · calibrated p 0.749
2.5 EB05 2.5 · IC025 +1.3
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 2.0 · serious PRR 2.1not reported in cached trials
Acute kidney injury (sudden kidney damage)7,2207.7
7.5–7.9ROR 8.1 · calibrated p 0.065
7.4 EB05 7.2 · IC025 +2.8
3/3 methods agree
Not in label — unassessedage-adj. PRR 5.3 · serious PRR 4.4 · 94% cliniciannot reported in cached trials
Fatigue (tiredness)7,1421.4
1.4–1.5ROR 1.5 · calibrated p 0.612
1.4 EB05 1.4 · IC025 +0.5Labeled adverse reaction
exact term
age-adj. PRR 1.2 · serious PRR 1.5not reported in cached trials
Diarrhoea (diarrhea)6,6371.6
1.6–1.6ROR 1.6 · calibrated p 0.732
1.6 EB05 1.6 · IC025 +0.6Labeled adverse reaction
exact term
age-adj. PRR 1.3 · serious PRR 1.6not reported in cached trials
Nausea6,4321.3
1.2–1.3ROR 1.3 · calibrated p 0.495
1.3 EB05 1.2 · IC025 +0.3Labeled adverse reaction
exact term
age-adj. PRR 1.2 · serious PRR 1.4not reported in cached trials
Dizziness6,1981.9
1.9–2.0ROR 2.0 · calibrated p 0.939
1.9 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
age-adj. PRR 1.5 · serious PRR 2.0NCT03730116: 2/1,909 (0.1%) on Bisoprolol (serious AE)
Drug interaction5,7795.8
5.7–6.0ROR 6.0 · calibrated p 0.147
5.7 EB05 5.5 · IC025 +2.5
3/3 methods agree
Reporting / coding artifactage-adj. PRR 4.2 · serious PRR 3.7not reported in cached trials
Off label use (used outside approved label)5,7071.0
1.0–1.0ROR 1.0 · calibrated p 0.321
1.0 EB05 1.0 · IC025 -0.0
PRR-only: not supported by EBGM or IC
Reporting / coding artifactage-adj. PRR 0.9 · serious PRR 1.1not reported in cached trials
Hypotension (low blood pressure)5,4544.3
4.2–4.4ROR 4.5 · calibrated p 0.302
4.2 EB05 4.1 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
age-adj. PRR 3.1 · serious PRR 2.9NCT03730116: 2/1,909 (0.1%) on Bisoprolol (serious AE)
Fall5,3982.5
2.5–2.6ROR 2.6 · calibrated p 0.767
2.5 EB05 2.5 · IC025 +1.3
3/3 methods agree
Not in label — unassessedage-adj. PRR 1.5 · serious PRR 1.8not reported in cached trials
Vomiting5,0081.7
1.6–1.7ROR 1.7 · calibrated p 0.764
1.7 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
age-adj. PRR 1.6 · serious PRR 1.4not reported in cached trials
Malaise (feeling unwell)4,9301.7
1.7–1.8ROR 1.8 · calibrated p 0.817
1.7 EB05 1.7 · IC025 +0.8Labeled adverse reaction
exact term
age-adj. PRR 1.5 · serious PRR 1.7not reported in cached trials
Asthenia (weakness)4,8562.0
2.0–2.1ROR 2.1 · calibrated p 0.974
2.0 EB05 2.0 · IC025 +1.0Labeled adverse reaction
exact term
age-adj. PRR 1.4 · serious PRR 1.7not reported in cached trials
Drug ineffective (drug did not work)4,7860.6
0.5–0.6ROR 0.5 · calibrated p 0.064
0.6 EB05 0.6 · IC025 -0.9
PRR-only: not supported by EBGM or IC
Reporting / coding artifactage-adj. PRR 0.7 · serious PRR 0.9not reported in cached trials
Headache4,4611.1
1.1–1.1ROR 1.1 · calibrated p 0.380
1.1 EB05 1.1 · IC025 +0.1Labeled adverse reaction
exact term
age-adj. PRR 1.1 · serious PRR 1.3not reported in cached trials

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.

✓ 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?

In FDA FAERS, the most frequently co-reported reaction terms for Bisoprolol are dyspnoea, acute kidney injury, fatigue, diarrhoea, nausea, dizziness. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Bisoprolol 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

Page generated 2026-10-14. 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.