Drug · FAERS side-effect profile with label screen
Nebivolol side effects: what 15,829 FDA adverse event reports show
Who reports
15,829 reports · 92% serious · 1,539 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
1. INDICATIONS AND USAGE Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
FDA label, Indications and Usage
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) 3Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 33
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.
- 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. 1,094 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cardiopulmonary exercise test abnormal | 13 | 1,414.5 645.5–3,099.5ROR 1,415.7 · χ² 8,148 / p <1e-300 | 339.5 EB05 211.2 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=13 | not reported in cached trials |
| Traumatic coma | 11 | 598.4 293.2–1,221.5ROR 598.9 · χ² 4,098 / p <1e-300 | 239.9 EB05 143.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Meniscopathy | 12 | 489.6 252.2–950.4ROR 490.0 · χ² 3,908 / p <1e-300 | 227.6 EB05 138.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Pelvic misalignment | 12 | 423.5 220.9–811.9ROR 423.8 · χ² 3,506 / p <1e-300 | 212.3 EB05 129.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Factor vii deficiency | 14 | 351.5 194.9–634.1ROR 351.8 · χ² 3,584 / p <1e-300 | 201.4 EB05 127.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Peroneal nerve injury | 13 | 171.5 96.2–305.6ROR 171.6 · χ² 1,799 / p <1e-300 | 124.4 EB05 77.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Sacroiliac joint dysfunction | 13 | 145.1 81.8–257.3ROR 145.2 · χ² 1,547 / p <1e-300 | 110.0 EB05 68.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Neurofibroma | 14 | 138.5 79.8–240.2ROR 138.6 · χ² 1,605 / p <1e-300 | 107.4 EB05 68.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Cerebellar ischaemia | 15 | 117.3 69.2–198.9ROR 117.4 · χ² 1,482 / p <1e-300 | 95.0 EB05 61.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Acute motor-sensory axonal neuropathy | 17 | 106.2 64.8–174.1ROR 106.3 · χ² 1,542 / p <1e-300 | 88.8 EB05 58.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Therapeutic drug monitoring analysis not performed | 19 | 90.2 56.7–143.6ROR 90.3 · χ² 1,486 / p <1e-300 | 78.1 EB05 52.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Enterobacter pneumonia | 10 | 88.8 46.8–168.5ROR 88.9 · χ² 733 / p 1e-161 | 72.2 EB05 41.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Cardiac myxoma | 12 | 77.2 43.1–138.1ROR 77.2 · χ² 782 / p 3e-172 | 65.7 EB05 40.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Merycism | 14 | 69.8 40.8–119.4ROR 69.8 · χ² 837 / p 3e-184 | 61.0 EB05 38.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Renal artery thrombosis | 13 | 59.3 34.1–103.4ROR 59.4 · χ² 659 / p 2e-145 | 52.7 EB05 32.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Hypoparathyroidism | 29 | 52.2 36.0–75.6ROR 52.2 · χ² 1,350 / p 6e-296 | 48.7 EB05 35.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 0% (drug 50%) · 100% clinician | not reported in cached trials |
| Fungal endocarditis | 11 | 51.5 28.2–94.0ROR 51.5 · χ² 476 / p 7e-106 | 45.9 EB05 27.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Orthostatic intolerance | 26 | 50.1 33.9–74.1ROR 50.2 · χ² 1,157 / p 6e-254 | 46.7 EB05 33.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 50%) | not reported in cached trials |
| Myosclerosis | 12 | 44.3 24.9–78.7ROR 44.3 · χ² 450 / p 4e-100 | 40.3 EB05 24.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Cervicobrachial syndrome | 18 | 39.5 24.7–63.1ROR 39.5 · χ² 619 / p 7e-137 | 37.0 EB05 24.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Patellofemoral pain syndrome | 14 | 36.9 21.7–62.8ROR 37.0 · χ² 442 / p 2e-98 | 34.4 EB05 21.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Helicobacter test positive | 15 | 36.5 21.9–61.0ROR 36.6 · χ² 470 / p 1e-104 | 34.2 EB05 22.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Joint hyperextension | 10 | 34.5 18.4–64.5ROR 34.5 · χ² 285 / p 4e-64 | 31.7 EB05 18.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Vestibular neuronitis | 13 | 33.2 19.1–57.5ROR 33.2 · χ² 365 / p 1e-81 | 31.0 EB05 19.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Renal ischaemia | 13 | 32.5 18.7–56.3ROR 32.5 · χ² 357 / p 8e-80 | 30.4 EB05 18.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Neurogenic shock | 13 | 32.4 18.7–56.2ROR 32.4 · χ² 356 / p 1e-79 | 30.4 EB05 18.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Product monitoring error | 33 | 31.2 22.1–44.0ROR 31.2 · χ² 912 / p 2e-200 | 30.0 EB05 22.3 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=33 · ♀ 19% (drug 50%) · 100% clinician | not reported in cached trials |
| Sinus rhythm | 10 | 30.9 16.5–57.8ROR 30.9 · χ² 254 / p 2e-57 | 28.6 EB05 16.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | not reported in cached trials |
| Infective exacerbation of chronic obstructive airways disease | 14 | 29.4 17.3–50.0ROR 29.5 · χ² 349 / p 4e-78 | 27.8 EB05 17.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | not reported in cached trials |
| Vascular purpura | 30 | 29.2 20.3–41.9ROR 29.2 · χ² 771 / p 6e-170 | 28.1 EB05 20.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 0% (drug 50%) | not reported in cached trials |
| Burnout syndrome | 12 | 28.4 16.1–50.4ROR 28.5 · χ² 285 / p 4e-64 | 26.7 EB05 16.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Stasis dermatitis | 14 | 27.6 16.2–46.8ROR 27.6 · χ² 326 / p 4e-73 | 26.1 EB05 16.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Systemic infection | 29 | 23.5 16.3–33.9ROR 23.5 · χ² 591 / p 7e-131 | 22.8 EB05 16.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 50%) · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 24 | 23.1 15.5–34.6ROR 23.2 · χ² 478 / p 3e-106 | 22.4 EB05 15.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 50%) | not reported in cached trials |
| Osteochondrosis | 20 | 23.0 14.8–35.8ROR 23.0 · χ² 392 / p 1e-87 | 22.2 EB05 15.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Resting tremor | 11 | 22.8 12.6–41.4ROR 22.8 · χ² 204 / p 1e-46 | 21.4 EB05 12.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Cerebellar ataxia | 16 | 22.4 13.6–36.7ROR 22.4 · χ² 300 / p 1e-67 | 21.4 EB05 13.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Cutaneous lupus erythematosus | 32 | 22.0 15.5–31.1ROR 22.0 · χ² 609 / p 9e-135 | 21.4 EB05 15.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=32 · 100% clinician | not reported in cached trials |
| Bladder transitional cell carcinoma | 23 | 21.6 14.3–32.6ROR 21.6 · χ² 424 / p 2e-94 | 20.9 EB05 14.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 50%) | not reported in cached trials |
| N-terminal prohormone brain natriuretic peptide increased | 22 | 21.1 13.8–32.1ROR 21.1 · χ² 395 / p 4e-88 | 20.4 EB05 14.1 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=22 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Nebivolol 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).
- NCT01218100 — Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monoth (N=664, PHASE4; 19 AE terms posted; arms: Placebo; Nebivolol + Lisinopril (Combination); Nebivolol; Lisinopril)
- NCT01415531 — Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) (N=641, PHASE4; 11 AE terms posted; arms: Placebo; Nebivolol)
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 |
|---|---|---|---|---|---|---|
| Acute kidney injury (sudden kidney damage) | 945 | 8.3 7.8–8.8ROR 8.7 · χ² 6,030 / p <1e-300 | 8.2 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 93% clinician | not reported in cached trials |
| Dyspnoea (shortness of breath) | 803 | 1.9 1.8–2.0ROR 1.9 · χ² 339 / p 5e-76 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 752 | 1.5 1.4–1.7ROR 1.6 · χ² 150 / p 8e-35 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | not reported in cached trials |
| Hypotension (low blood pressure) | 636 | 4.2 3.9–4.5ROR 4.3 · χ² 1,566 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | not reported in cached trials |
| Drug interaction | 633 | 5.3 4.9–5.7ROR 5.5 · χ² 2,212 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | not reported in cached trials |
| Anaemia (low red blood cells) | 614 | 4.3 4.0–4.6ROR 4.4 · χ² 1,544 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | not reported in cached trials |
| Nausea | 605 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.358 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 582 | 0.6 0.5–0.6ROR 0.6 · χ² 182 / p 8e-42 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | not reported in cached trials |
| Off label use (used outside approved label) | 574 | 0.9 0.8–0.9ROR 0.9 · χ² 10 / p 6e-4 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Fatigue (tiredness) | 554 | 0.9 0.9–1.0ROR 0.9 · χ² 2 / p 0.088 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | not reported in cached trials |
| Fall | 553 | 2.2 2.0–2.4ROR 2.2 · χ² 368 / p 3e-82 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | NCT01415531: 1/214 (0.5%) control (serious AE) |
| Dizziness | 511 | 1.4 1.2–1.5ROR 1.4 · χ² 49 / p 1e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Asthenia (weakness) | 488 | 1.7 1.6–1.9ROR 1.7 · χ² 149 / p 2e-34 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Headache | 476 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.451 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 · ♀ 71% (drug 50%) | NCT01218100: 10/188 (5.3%) on Nebivolol; 8/95 (8.4%) control |
| Vomiting | 434 | 1.2 1.1–1.3ROR 1.2 · χ² 18 / p 1e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.1 | 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.
- Hypoparathyroidism — n=29, PRR 52.2
- Orthostatic intolerance — n=26, PRR 50.1
- Vascular purpura — n=30, PRR 29.2
- Systemic infection — n=29, PRR 23.5
- Obstructive sleep apnoea syndrome — n=24, PRR 23.1
- Osteochondrosis — n=20, PRR 23.0
- Cutaneous lupus erythematosus — n=32, PRR 22.0
- Bladder transitional cell carcinoma — n=23, PRR 21.6
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 Nebivolol?
In FDA FAERS, the most frequently co-reported reaction terms for Nebivolol are acute kidney injury, dyspnoea, diarrhoea, hypotension, anaemia, nausea. 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 Nebivolol have an FDA boxed warning?
No. The FDA label retrieved for Nebivolol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nebivolol 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 126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f, effective 20250327; matched on
openfda.generic_name.exact:"NEBIVOLOL") - 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, 1,134 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
NEBIVOLOL, results-bearing studies sorted by enrollment)
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.