What the label lists and what reports show
Nebivolol side effects
Nebivolol's FDA label: “Most common adverse reactions ( 6.1 ): Headache, fatigue To report SUSPECTED ADVERSE REACTIONS, Contact AbbVie Inc.” FAERS holds 33,555 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (1,861 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the nebivolol FDA label on DailyMed (effective August 1, 2024, Allergan, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions ( 6.1 ): Headache, fatigue To report SUSPECTED ADVERSE REACTIONS, Contact AbbVie Inc.
Table 1. Treatment-Emergent Adverse Reactions with an Incidence (over 6 weeks) ≥ 1% in BYSTOLIC-Treated Patients and at a Higher Frequency than Placebo-Treated Patients
| System Organ Class – Preferred Term | Placebo (n = 205) (%) | Nebivolol 5 mg (n = 459) (%) | Nebivolol 10 mg (n = 461) (%) | Nebivolol 20-40 mg (n = 677) (%) |
|---|---|---|---|---|
| Bradycardia | 0 | 0 | 0 | 1 |
| Diarrhea | 2 | 2 | 2 | 3 |
| Nausea | 0 | 1 | 3 | 2 |
| Fatigue | 1 | 2 | 2 | 5 |
| Chest pain | 0 | 0 | 1 | 1 |
| Peripheral edema | 0 | 1 | 1 | 1 |
| Headache | 6 | 9 | 6 | 7 |
| Dizziness | 2 | 2 | 3 | 4 |
| Insomnia | 0 | 1 | 1 | 1 |
| Dyspnea | 0 | 0 | 1 | 1 |
| Rash | 0 | 0 | 1 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedADVERSE REACTIONS Most common adverse reactions ( 6.1 ): Headache, fatigue To report SUSPECTED ADVERSE REACTIONS, Contact AbbVie Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience BYSTOLIC has been evaluated for safety in patients with hypertension and in patients with heart failure. The observed adverse reaction profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be informative and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. The data described below reflect worldwide clinical trial exposure to BYSTOLIC in 6545 patients, including 5038 patients treated for hypertension and the remaining 1507 subjects treated for other cardiovascular diseases. Doses ranged from 0.5 mg to 40 mg. Patients received BYSTOLIC for up to 24 months, with over 1900 patients treated for at least 6 months, and approximately 1300 patients for more than one year. …
Source: FDA drug label, Allergan, Inc., effective August 1, 2024 (SPL set 8b8ad213-1dc8-454e-a524-075685c0e1a8), via openFDA; the full label on DailyMed
What do FAERS reports show?
33,555 reports list nebivolol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,385 are coded as a death and 13,128 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nebivolol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions