Bystolic Side Effects: FDA Label Numbers vs Placebo
[Side effects · Bystolic]

Bystolic side effects

nebivolol · once-daily oral tablet, 2.5, 5, 10 or 20 mg · Label checked

Short answer: In three 12-week placebo-controlled trials, the most common Bystolic side effects were headache (9% on 5 mg vs 6% on placebo) and fatigue (5% on 20-40 mg vs 1%), with dizziness, nausea and diarrhea next. Few people stopped: 2.8% vs 2.2% on placebo. Bystolic has no boxed warning; its first listed risk is stopping it suddenly in coronary artery disease.

What Bystolic is approved for: Bystolic is a beta-blocker approved to treat high blood pressure, alone or with other blood pressure medicines (section 1.1). The label notes that no controlled trials have shown that Bystolic itself lowers the risk of heart events. It is not approved for children under 18.

Source
BYSTOLIC (nebivolol) tablets, for oral use, prescribing information and Patient Information. Allergan (AbbVie). DailyMed, version published December 31, 2025. DailyMed setid 8b8ad213-1dc8-454e-a524-075685c0e1a8

Does Bystolic have a boxed warning?

No. The current Bystolic label has no boxed warning.

What are the most common Bystolic side effects?

These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Bystolic.

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 [Section 6.1]
Adverse reactionPlacebo (n = 205) (%)Nebivolol 5 mg (n = 459) (%)Nebivolol 10 mg (n = 461) (%)Nebivolol 20-40 mg (n = 677) (%)
Bradycardia0001
Diarrhea2223
Nausea0132
Fatigue1225
Chest pain0011
Peripheral edema0111
Headache6967
Dizziness2234
Insomnia0111
Dyspnea0011
Rash0011

Three 12-week placebo-controlled trials of Bystolic alone in 1,597 people with high blood pressure and 205 on placebo. Bradycardia means a slow heart rate; dyspnea means shortness of breath.

Other numbers in the Adverse Reactions section

  • Section 6.1

    2.8% stopped Bystolic because of a side effect vs 2.2% on placebo, most often for headache (0.4%), nausea (0.2%) and slow heart rate (0.2%).

  • Section 6.1

    Other reactions in at least 1% of more than 4,300 people in controlled or open trials, mostly at similar rates on placebo: weakness, abdominal pain, high cholesterol and tingling.

  • Section 6.2

    In controlled trials, Bystolic was linked to increases in BUN, uric acid and triglycerides, and decreases in HDL cholesterol and platelet count.

  • Section 8.6

    In 2,128 people over 70 with chronic heart failure taking up to 10 mg a day for a median of 20 months, no worsening of heart failure was reported vs placebo.

  • Section 6.3

    Reported after approval: liver test changes, fluid on the lungs, acute kidney failure, heart block, wheezing (bronchospasm), erectile dysfunction, allergic reactions including rare angioedema, low blood pressure, heart attack, psoriasis, Raynaud's phenomenon, leg circulation problems and sleepiness.

What serious risks does the Bystolic label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 5.1

    Stopping suddenly. Severe worsening of angina, heart attack and dangerous heart rhythms have been reported after beta-blockers were stopped abruptly in people with coronary artery disease. When stopping is planned, Bystolic is tapered over 1 to 2 weeks when possible, and restarted promptly if angina worsens.

  • Section 5.3

    Lung disease. In general, people with bronchospastic diseases such as asthma should not receive beta-blockers.

  • Section 5.4

    Surgery and anesthesia. People already on beta-blockers generally continue them through surgery, with close monitoring when certain anesthetics are used.

  • Section 5.5

    Low blood sugar. Beta-blockers may hide early warning signs of low blood sugar, such as a fast heartbeat, and raise the risk of severe or prolonged low blood sugar, especially in diabetes, in children and in people who are fasting or vomiting.

  • Section 5.6

    Overactive thyroid. Beta-blockers may hide signs of an overactive thyroid, and stopping suddenly may worsen it or trigger thyroid storm.

  • Section 5.7

    Poor leg circulation. Beta-blockers can bring on or worsen symptoms of poor blood flow in people with peripheral vascular disease.

  • Section 5.9

    CYP2D6 inhibitors. Medicines such as fluoxetine, paroxetine, quinidine and propafenone raise nebivolol levels, and the Bystolic dose may need to be lowered (section 7.1).

  • Section 5.12

    Allergic reactions. People with a history of severe allergic reactions may react more strongly on a beta-blocker and may not respond to usual epinephrine doses.

  • Section 4

    Who should not take it. People with a severely slow heart rate, heart block beyond first degree, cardiogenic shock, decompensated heart failure, sick sinus syndrome without a pacemaker, severe liver impairment, or allergy to any ingredient.

When does the label say to call your doctor?

From the Patient Information that comes with Bystolic:

  • Feeling dizzy: sit or lie down and tell your doctor right away (possible low blood pressure).
  • Weight gain or trouble breathing while taking Bystolic: tell your doctor (possible fluid retention).
  • Any side effects that bother you or do not go away: tell your doctor.
  • Taking too much Bystolic: call your doctor or poison control center right away.

How do I keep track of side effects in Dose Track?

Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Side effects for similar medicines

Frequently asked questions

What are the most common side effects of Bystolic?+
Headache and fatigue. Headache was 9% on 5 mg vs 6% on placebo, and fatigue 5% on 20-40 mg vs 1%. Dizziness, nausea and diarrhea were next (section 6.1, Table 1).
Does Bystolic cause fatigue?+
Fatigue was 2% on 5 mg and 10 mg and 5% on 20-40 mg, vs 1% on placebo, in 12-week trials (section 6.1, Table 1).
Is it safe to stop Bystolic suddenly?+
The label says not to stop it abruptly in coronary artery disease, since severe angina, heart attack and dangerous rhythms have followed sudden beta-blocker withdrawal. When stopping is planned, it is tapered over 1 to 2 weeks when possible (section 5.1).
Can Bystolic hide low blood sugar?+
Yes. Beta-blockers may hide early signs such as a fast heartbeat and raise the risk of severe or prolonged low blood sugar, especially in diabetes or when fasting or vomiting (section 5.5).
Does Bystolic cause erectile dysfunction?+
Erectile dysfunction is listed among reports received after approval, where frequency and cause cannot be established. It is not in the label's placebo-controlled trial table (sections 6.1 and 6.3).