nebivolol Side Effects
Also known as: Bystolic
Analysis of 14,997 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
14,997
Death-Related
1,464
9.8% of reports
Hospitalizations
8,438
56.3% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,464 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 184 |
| ACUTE KIDNEY INJURY | 165 |
| COMPLETED SUICIDE | 123 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 91 |
| PNEUMONIA | 88 |
| DYSPNOEA | 75 |
| ANAEMIA | 72 |
| CARDIAC FAILURE | 72 |
| DIARRHOEA | 67 |
| CARDIAC ARREST | 60 |
| LACTIC ACIDOSIS | 58 |
| RESPIRATORY FAILURE | 54 |
| TOXICITY TO VARIOUS AGENTS | 54 |
| SEPSIS | 53 |
| PYREXIA | 52 |
| RENAL FAILURE | 52 |
| OFF LABEL USE | 51 |
| ASTHENIA | 50 |
| COMA | 50 |
| HYPOTENSION | 46 |
Reactions in Hospitalization Reports
Top reactions in 8,438 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 710 |
| DYSPNOEA | 494 |
| ANAEMIA | 469 |
| DIARRHOEA | 441 |
| HYPOTENSION | 423 |
| FALL | 417 |
| DRUG INTERACTION | 358 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 343 |
| OFF LABEL USE | 310 |
| NAUSEA | 304 |
| VOMITING | 289 |
| ASTHENIA | 284 |
| HYPONATRAEMIA | 281 |
| PYREXIA | 280 |
| PNEUMONIA | 267 |
| BRADYCARDIA | 247 |
| DIZZINESS | 246 |
| DRUG INEFFECTIVE | 243 |
| FATIGUE | 235 |
| SYNCOPE | 231 |
Nearby — Related Medications
What the FAERS Data Reveals About nebivolol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 14,997 voluntary reports linked to nebivolol and its brand equivalents (Bystolic), spanning 2004 through 2025. Of those, 1,464 (9.8%) listed death as an outcome and 8,438 (56.3%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 49% were female and 50% male; age distribution skews toward 75+, with 4,405 reports in that bracket. The single most reported reaction is acute kidney injury with 922 submissions, followed by dyspnoea and diarrhoea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.