Drug · FAERS side-effect profile with label screen
Nebivolol Hydrochloride side effects: what 33,545 FDA adverse event reports show
Who reports
33,545 reports · 70% serious · 2,385 with death outcome · 56% 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) 1Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 31
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). 1,132 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 |
|---|---|---|---|---|---|---|
| Therapeutic drug monitoring analysis not performed | 21 | 47.4 30.4–73.8ROR 47.4 · calibrated p 4e-5 ✓ | 42.5 EB05 29.3 · IC025 +3.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.0 (6.4–22.3) | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Hypoparathyroidism | 29 | 24.6 17.0–35.6ROR 24.6 · calibrated p 0.001 ✓ | 23.4 EB05 17.0 · IC025 +3.5 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (6.5–18.1) | Not in label — unassessed | serious n=29 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Orthostatic intolerance | 27 | 24.6 16.7–36.1ROR 24.6 · calibrated p 0.001 ✓ | 23.3 EB05 16.8 · IC025 +3.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.2 (6.6–19.3) | Not in label — unassessed | serious n=27 · ♀ 0% (drug 56%) | not reported in cached trials |
| Product monitoring error | 34 | 15.1 10.8–21.3ROR 15.2 · calibrated p 0.008 ✓ | 14.5 EB05 10.7 · IC025 +3.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.2 (6.9–18.0) | Reporting / coding artifact | serious n=34 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Vascular purpura | 30 | 13.8 9.6–19.7ROR 13.8 · calibrated p 0.012 ✓ | 13.1 EB05 9.3 · IC025 +2.9 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (6.5–18.0) | Not in label — unassessed | serious n=30 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Nephrogenic anaemia | 92 | 12.5 10.2–15.4ROR 12.6 · calibrated p 0.015 ✓ | 12.2 EB05 10.2 · IC025 +3.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 1.9 (1.6–2.4) | Not in label — unassessed | serious n=92 · ♀ 33% (drug 56%) | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 21 | 12.4 8.1–19.1ROR 12.4 · calibrated p 0.019 ✓ | 11.4 EB05 7.4 · IC025 +2.5 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 4.7 (2.8–7.9) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 27 | 12.3 8.4–18.0ROR 12.3 · calibrated p 0.019 ✓ | 11.5 EB05 8.0 · IC025 +2.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.2 (7.0–21.1) | Not in label — unassessed | serious n=27 · ♀ 0% (drug 56%) | not reported in cached trials |
| Systemic infection | 31 | 11.8 8.3–16.9ROR 11.9 · calibrated p 0.021 ✓ | 11.1 EB05 7.9 · IC025 +2.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.6 (7.0–19.2) | Not in label — unassessed | serious n=31 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Hyperparathyroidism secondary | 44 | 11.0 8.2–14.9ROR 11.0 · calibrated p 0.026 ✓ | 10.5 EB05 8.0 · IC025 +2.8 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 1.8 (1.3–2.4) | Not in label — unassessed | serious n=44 | not reported in cached trials |
| N-terminal prohormone brain natriuretic peptide increased | 24 | 10.9 7.3–16.3ROR 10.9 · calibrated p 0.030 ✓ | 9.9 EB05 6.7 · IC025 +2.5 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.8 (6.6–21.1) | Lab value / disease marker | serious n=24 · 100% clinician | not reported in cached trials |
| Osteochondrosis | 20 | 10.8 7.0–16.9ROR 10.9 · calibrated p 0.031 ✓ | 9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (5.8–20.1) | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Bladder transitional cell carcinoma | 24 | 10.6 7.1–15.9ROR 10.6 · calibrated p 0.032 ✓ | 9.6 EB05 6.5 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.3 (6.4–20.0) | Not in label — unassessed | serious n=24 · ♀ 100% (drug 56%) | not reported in cached trials |
| Cutaneous lupus erythematosus | 32 | 10.4 7.3–14.7ROR 10.4 · calibrated p 0.033 ✓ | 9.6 EB05 6.9 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (6.6–17.7) | Not in label — unassessed | serious n=32 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Peripheral motor neuropathy | 21 | 9.5 6.2–14.7ROR 9.5 · calibrated p 0.047 ✓ | 8.4 EB05 5.6 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.4 (6.2–21.0) | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Normocytic anaemia | 21 | 9.3 6.0–14.2ROR 9.3 · calibrated p 0.051 | 8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.6 (6.7–23.7) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Cerebral haematoma | 48 | 9.1 6.8–12.0ROR 9.1 · calibrated p 0.049 ✓ | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.7 (2.7–5.2) | Not in label — unassessed | serious n=48 · ♀ 29% (drug 56%) · 100% clinician | not reported in cached trials |
| Glomerular filtration rate abnormal | 20 | 9.0 5.8–14.0ROR 9.0 · calibrated p 0.056 | 7.8 EB05 5.2 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 18.0 (8.8–36.9) | Lab value / disease marker | serious n=20 | not reported in cached trials |
| Actinic keratosis | 36 | 8.7 6.3–12.1ROR 8.7 · calibrated p 0.057 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 14.4 (8.8–23.8) | Not in label — unassessed | serious n=34 · ♀ 0% (drug 56%) | not reported in cached trials |
| Hypomagnesaemia | 182 | 8.3 7.2–9.6ROR 8.3 · calibrated p 0.060 | 8.1 EB05 7.1 · IC025 +2.8 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.2 (2.7–3.7) | Not in label — unassessed | serious PRR 6.9 · 93% clinician | not reported in cached trials |
| Potentiating drug interaction | 43 | 8.3 6.1–11.2ROR 8.3 · calibrated p 0.065 | 7.7 EB05 5.9 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.0 (2.2–4.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=41 · 100% clinician | not reported in cached trials |
| Sinus arrest | 20 | 8.2 5.3–12.7ROR 8.2 · calibrated p 0.075 | 7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.0 (6.4–22.7) | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Sinus node dysfunction | 23 | 7.9 5.3–12.0ROR 7.9 · calibrated p 0.079 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.9 (6.6–21.4) | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Hypertensive crisis | 137 | 7.8 6.6–9.2ROR 7.8 · calibrated p 0.074 | 7.5 EB05 6.5 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.1 (2.6–3.8) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.3 | not reported in cached trials |
| Akinesia | 25 | 7.6 5.1–11.3ROR 7.6 · calibrated p 0.088 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (6.2–18.8) | Not in label — unassessed | serious n=25 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Haemorrhagic anaemia | 53 | 7.5 5.7–9.8ROR 7.5 · calibrated p 0.086 | 7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.5 (2.6–4.7) | Not in label — unassessed | serious n=53 | not reported in cached trials |
| Rebound acid hypersecretion | 36 | 7.4 5.3–10.3ROR 7.4 · calibrated p 0.092 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 2.2 (1.5–3.1) | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Aortic valve stenosis | 21 | 7.4 4.8–11.4ROR 7.4 · calibrated p 0.098 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.6 (6.7–23.7) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Renal tubular disorder | 33 | 7.4 5.2–10.4ROR 7.4 · calibrated p 0.094 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.9 (7.3–19.5) | Not in label — unassessed | serious n=33 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Monoparesis | 21 | 7.3 4.7–11.2ROR 7.3 · calibrated p 0.102 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.0 (6.4–22.3) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Sprue-like enteropathy | 57 | 7.3 5.6–9.4ROR 7.3 · calibrated p 0.094 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 29.4 (17.8–48.5) | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Labelled drug-drug interaction medication error | 100 | 7.1 5.8–8.6ROR 7.1 · calibrated p 0.098 | 6.8 EB05 5.8 · IC025 +2.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 12.7 (9.5–17.0) | Reporting / coding artifact | serious PRR 6.3 | not reported in cached trials |
| Hyperkalaemia (high potassium) | 376 | 6.8 6.1–7.5ROR 6.9 · calibrated p 0.105 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.0 (2.7–3.4) | Not in label — unassessed | serious PRR 5.6 · ♀ 30% (drug 56%) · 91% clinician | not reported in cached trials |
| Microcytic anaemia | 22 | 6.6 4.4–10.1ROR 6.6 · calibrated p 0.130 | 5.9 EB05 4.1 · IC025 +1.8 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (6.0–19.5) | Not in label — unassessed | serious n=22 · 100% clinician | not reported in cached trials |
| Diabetic nephropathy | 23 | 6.5 4.3–9.9ROR 6.6 · calibrated p 0.134 | 5.8 EB05 4.1 · IC025 +1.8 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 13.1 (7.1–24.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=23 | not reported in cached trials |
| Cardiac failure chronic | 44 | 6.5 4.8–8.8ROR 6.5 · calibrated p 0.128 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 11.9 (7.8–18.3) | Labeled (related wording) related wording | serious n=44 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Coronary artery stenosis | 51 | 6.4 4.8–8.4ROR 6.4 · calibrated p 0.135 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 2.5 (1.9–3.5) | Not in label — unassessed | serious n=51 · ♀ 23% (drug 56%) | not reported in cached trials |
| Essential hypertension | 26 | 6.3 4.3–9.3ROR 6.3 · calibrated p 0.144 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 2.5 (1.7–3.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=26 | not reported in cached trials |
| Retroperitoneal haematoma | 21 | 6.0 3.9–9.3ROR 6.0 · calibrated p 0.166 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 10.8 (5.9–19.8) | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Atrial tachycardia | 20 | 6.0 3.8–9.3ROR 6.0 · calibrated p 0.171 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 16.7 (8.3–33.5) | Not in label — unassessed | serious n=20 | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,862 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.660 | 1.5 EB05 1.4 · IC025 +0.5 vs other beta-Adrenergic Blockers: PRR 2.2 (2.1–2.3) | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,794 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.822 | 1.7 EB05 1.7 · IC025 +0.7 vs other beta-Adrenergic Blockers: PRR 2.2 (2.1–2.3) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,724 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.920 | 1.9 EB05 1.8 · IC025 +0.8 vs other beta-Adrenergic Blockers: PRR 2.3 (2.2–2.5) | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,628 | 0.8 0.7–0.8ROR 0.8 · calibrated p 0.162 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC vs other beta-Adrenergic Blockers: PRR 1.6 (1.5–1.7) | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Nausea | 1,616 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.505 | 1.3 EB05 1.2 · IC025 +0.3 vs other beta-Adrenergic Blockers: PRR 1.8 (1.7–1.9) | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Headache | 1,441 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.615 | 1.4 EB05 1.4 · IC025 +0.4 vs other beta-Adrenergic Blockers: PRR 2.1 (2.0–2.2) | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01218100: 10/188 (5.3%) on Nebivolol; 8/95 (8.4%) control |
| Dizziness | 1,405 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.829 | 1.8 EB05 1.7 · IC025 +0.7 vs other beta-Adrenergic Blockers: PRR 2.0 (1.9–2.1) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 1,293 | 5.3 5.1–5.6ROR 5.5 · calibrated p 0.186 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 3.3 (3.1–3.5) | Labeled (related wording) related wording | serious PRR 4.3 | not reported in cached trials |
| Off label use (used outside approved label) | 1,273 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.251 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other beta-Adrenergic Blockers: PRR 2.3 (2.2–2.5) | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Asthenia (weakness) | 1,099 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.863 | 1.8 EB05 1.7 · IC025 +0.8 vs other beta-Adrenergic Blockers: PRR 2.0 (1.8–2.1) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Fall | 1,056 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.955 | 2.0 EB05 1.9 · IC025 +0.9 vs other beta-Adrenergic Blockers: PRR 2.0 (1.9–2.1) | Not in label — unassessed | serious PRR 1.8 | NCT01415531: 1/214 (0.5%) control (serious AE) |
| Hypotension (low blood pressure) | 970 | 3.0 2.9–3.2ROR 3.1 · calibrated p 0.596 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 2.1 (2.0–2.3) | Labeled adverse reaction exact term | serious PRR 2.6 | not reported in cached trials |
| Hypertension (high blood pressure) | 938 | 2.8 2.6–3.0ROR 2.8 · calibrated p 0.687 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other beta-Adrenergic Blockers: PRR 1.9 (1.8–2.1) | Likely indication confounding term in indications; also in warnings | serious PRR 2.3 | NCT01218100: 1/95 (1.1%) control (serious AE) |
| Malaise (feeling unwell) | 902 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.502 | 1.3 EB05 1.2 · IC025 +0.2 vs other beta-Adrenergic Blockers: PRR 1.8 (1.7–2.0) | Not in label — unassessed | serious PRR 1.2 | not reported in cached trials |
| Vomiting | 889 | 1.2 1.1–1.3ROR 1.2 · calibrated p 0.434 | 1.2 EB05 1.1 · IC025 +0.1 vs other beta-Adrenergic Blockers: PRR 1.9 (1.8–2.1) | Labeled adverse reaction exact term | serious PRR 1.2 | 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.
- Therapeutic drug monitoring analysis not performed — n=21, PRR 47.4
- Hypoparathyroidism — n=29, PRR 24.6
- Orthostatic intolerance — n=27, PRR 24.6
- Vascular purpura — n=30, PRR 13.8
- Nephrogenic anaemia — n=92, PRR 12.5
- Chronic kidney disease-mineral and bone disorder — n=21, PRR 12.4
- Obstructive sleep apnoea syndrome — n=27, PRR 12.3
- Systemic infection — n=31, PRR 11.8
- Hyperparathyroidism secondary — n=44, PRR 11.0
- Osteochondrosis — n=20, PRR 10.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oxycodone Hydrochloride ↔ Drug Dependence.
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 fatigue, diarrhoea, dyspnoea, nausea, headache, 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 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, 1,172 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 2026-10-14. 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.