Bisoprolol side effects: what 135,055 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Bisoprolol Fumarate (Bisoprolol Fumarate)
Who reports
135,055 reports · 97% serious · 14,918 with death outcome · 48% female
Used for
Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
What it is
DESCRIPTION Bisoprolol fumarate USP is a synthetic, beta 1 -selective (cardioselective) adrenoceptor blocking agent.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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, 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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Right atrial hypertrophy | 90 | 684.9 421.9–1,111.9ROR 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% consumer | not reported in cached trials |
| Cardiospasm | 404 | 418.3 346.4–505.2ROR 419.6 · calibrated p 5e-13 ✓ | 111.8 EB05 102.9 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=404 | not reported in cached trials |
| Fractional exhaled nitric oxide increased | 109 | 267.6 195.9–365.5ROR 267.8 · calibrated p 8e-11 ✓ | 96.1 EB05 81.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=109 · ♀ 0% (drug 48%) | not reported in cached trials |
| Immunisation | 264 | 245.0 201.7–297.7ROR 245.5 · calibrated p 9e-11 ✓ | 93.9 EB05 84.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=264 | not reported in cached trials |
| Palmoplantar keratoderma | 396 | 191.3 165.0–221.8ROR 191.9 · calibrated p 7e-10 ✓ | 85.0 EB05 78.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=396 | not reported in cached trials |
| Neurologic neglect syndrome | 204 | 89.0 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 — unassessed | serious n=204 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Vital capacity decreased | 125 | 59.5 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 — unassessed | serious n=125 · ♀ 100% (drug 48%) | not reported in cached trials |
| Amaurosis fugax | 264 | 50.7 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 — unassessed | serious n=264 · 93% clinician | not reported in cached trials |
| Carotid artery thrombosis | 208 | 49.9 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 — unassessed | serious n=208 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Atrial tachycardia | 503 | 48.5 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 — unassessed | serious n=502 | not reported in cached trials |
| Systemic infection | 338 | 39.5 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 — unassessed | serious n=338 · 100% clinician | not reported in cached trials |
| Reversible airways obstruction | 103 | 38.7 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 — unassessed | serious n=103 · ♀ 100% (drug 48%) | not reported in cached trials |
| Pruritus genital | 423 | 34.3 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 — unassessed | serious n=421 | not reported in cached trials |
| Steroid dependence | 146 | 32.1 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 — unassessed | serious n=146 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Catarrh | 148 | 30.9 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 — unassessed | serious n=148 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| N-terminal prohormone brain natriuretic peptide increased | 221 | 28.9 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 marker | serious n=217 · ♀ 28% (drug 48%) | not reported in cached trials |
| Bronchial secretion retention | 197 | 28.5 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 — unassessed | serious n=197 | not reported in cached trials |
| Adjustment disorder | 193 | 26.8 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 — unassessed | serious n=192 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Product monitoring error | 190 | 23.6 20.2–27.5ROR 23.6 · calibrated p 1e-3 ✓ | 20.5 EB05 18.2 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=189 · 100% clinician | not reported in cached trials |
| Bronchial wall thickening | 96 | 23.6 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 — unassessed | serious n=96 · ♀ 0% (drug 48%) · 100% consumer | not reported in cached trials |
| Sputum culture positive | 104 | 22.3 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 marker | serious n=104 · ♀ 100% (drug 48%) | not reported in cached trials |
| Cardiac failure chronic | 514 | 21.2 19.4–23.3ROR 21.3 · calibrated p 0.001 ✓ | 18.7 EB05 17.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=514 · 92% clinician | not reported in cached trials |
| Carotid arteriosclerosis | 123 | 21.1 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 — unassessed | serious n=123 · ♀ 0% (drug 48%) | not reported in cached trials |
| Bradyarrhythmia | 196 | 21.0 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 — unassessed | serious n=195 · 100% clinician | not reported in cached trials |
| Carotid artery occlusion | 433 | 20.7 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 — unassessed | serious n=433 | not reported in cached trials |
| Aortic valve stenosis | 187 | 18.0 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 — unassessed | serious n=186 | not reported in cached trials |
| Myoglobin blood increased | 160 | 18.0 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 marker | serious n=160 · ♀ 0% (drug 48%) | not reported in cached trials |
| Right ventricular hypertrophy | 95 | 18.0 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% consumer | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 142 | 17.5 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 — unassessed | serious n=142 · ♀ 0% (drug 48%) | not reported in cached trials |
| Tension headache | 431 | 17.2 15.6–19.0ROR 17.3 · calibrated p 0.004 ✓ | 15.6 EB05 14.4 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=430 | not reported in cached trials |
| Systolic dysfunction | 104 | 16.9 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 — unassessed | serious n=104 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Sleep terror | 400 | 16.2 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 — unassessed | serious n=400 | not reported in cached trials |
| Pulmonary function test abnormal | 148 | 16.2 13.6–19.1ROR 16.2 · calibrated p 0.005 ✓ | 14.7 EB05 12.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=148 · ♀ 0% (drug 48%) | not reported in cached trials |
| Bloody discharge | 108 | 16.0 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 — unassessed | serious n=108 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Diastolic dysfunction | 285 | 15.6 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 — unassessed | serious n=283 · ♀ 22% (drug 48%) | not reported in cached trials |
| Left ventricular dysfunction | 595 | 15.1 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 — unassessed | serious n=595 | not reported in cached trials |
| Brain natriuretic peptide increased | 275 | 15.1 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 marker | serious n=272 · ♀ 20% (drug 48%) | not reported in cached trials |
| International normalised ratio fluctuation | 186 | 15.0 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 marker | serious n=186 · ♀ 100% (drug 48%) | not reported in cached trials |
| Sinus node dysfunction | 154 | 14.2 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 — unassessed | serious n=154 · 100% clinician | not reported in cached trials |
| Tachyarrhythmia | 208 | 14.0 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 — unassessed | serious n=207 | not 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.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Arrhythmia / qt | 7,390 | 6.16.0–6.3 | signal |
| Hyponatraemia | 3,059 | 6.15.9–6.3 | signal |
| Heart failure | 5,550 | 4.94.8–5.1 | signal |
| Kidney injury | 13,323 | 4.64.6–4.7 | signal |
| Rhabdomyolysis / myopathy | 2,320 | 4.54.4–4.7 | signal |
| Gi bleeding | 4,674 | 4.03.9–4.2 | signal |
| Interstitial lung disease | 1,892 | 3.13.0–3.2 | signal |
| Anaemia | 5,642 | 3.02.9–3.0 | signal |
| Severe cutaneous reaction | 1,274 | 2.72.5–2.8 | signal |
| Myocardial infarction | 3,225 | 2.52.4–2.6 | signal |
| Stroke | 3,877 | 2.42.4–2.5 | signal |
| Fall / fracture | 5,652 | 2.32.3–2.4 | signal |
| Hypoglycaemia | 1,341 | 2.22.1–2.3 | signal |
| Liver injury | 4,150 | 2.22.1–2.2 | signal |
| Tendon disorder | 518 | 2.11.9–2.3 | raised |
| Anaphylaxis / angioedema | 1,686 | 2.12.0–2.2 | signal |
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).
- NCT03730116 — Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril (N=1909, phase n/a; 8 AE terms posted; arms: the Patients With HT and Concomitant Sta)
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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 9,172 | 2.5 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 2.1 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 7,220 | 7.7 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 — unassessed | age-adj. PRR 5.3 · serious PRR 4.4 · 94% clinician | not reported in cached trials |
| Fatigue (tiredness) | 7,142 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.612 | 1.4 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 6,637 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.732 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.6 | not reported in cached trials |
| Nausea | 6,432 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.495 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 1.4 | not reported in cached trials |
| Dizziness | 6,198 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.939 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 2.0 | NCT03730116: 2/1,909 (0.1%) on Bisoprolol (serious AE) |
| Drug interaction | 5,779 | 5.8 5.7–6.0ROR 6.0 · calibrated p 0.147 | 5.7 EB05 5.5 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.2 · serious PRR 3.7 | not reported in cached trials |
| Off label use (used outside approved label) | 5,707 | 1.0 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 artifact | age-adj. PRR 0.9 · serious PRR 1.1 | not reported in cached trials |
| Hypotension (low blood pressure) | 5,454 | 4.3 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 2.9 | NCT03730116: 2/1,909 (0.1%) on Bisoprolol (serious AE) |
| Fall | 5,398 | 2.5 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 — unassessed | age-adj. PRR 1.5 · serious PRR 1.8 | not reported in cached trials |
| Vomiting | 5,008 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.764 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.4 | not reported in cached trials |
| Malaise (feeling unwell) | 4,930 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.817 | 1.7 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.7 | not reported in cached trials |
| Asthenia (weakness) | 4,856 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.974 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.7 | not reported in cached trials |
| Drug ineffective (drug did not work) | 4,786 | 0.6 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 artifact | age-adj. PRR 0.7 · serious PRR 0.9 | not reported in cached trials |
| Headache | 4,461 | 1.1 1.1–1.1ROR 1.1 · calibrated p 0.380 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.3 | not 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.
- Cardiospasm — n=404, PRR 418.3
- Fractional exhaled nitric oxide increased — n=109, PRR 267.6
- Immunisation — n=264, PRR 245.0
- Palmoplantar keratoderma — n=396, PRR 191.3
- Neurologic neglect syndrome — n=204, PRR 89.0
- Vital capacity decreased — n=125, PRR 59.5
- Amaurosis fugax — n=264, PRR 50.7
- Carotid artery thrombosis — n=208, PRR 49.9
- Atrial tachycardia — n=503, PRR 48.5
- Systemic infection — n=338, PRR 39.5
✓ 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
- FDA label via openFDA (set ID 200ab93b-6ad3-46cb-8f57-db056a14de16, effective 20250516; matched on
openfda.generic_name.exact:"BISOPROLOL FUMARATE") - 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, 1,251 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 - ClinicalTrials.gov API v2 (query
BISOPROLOL, results-bearing studies sorted by enrollment)
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.