Medication-info.com Search Menu

Bystolic: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
5 mg, 10 mg
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Bystolic

WHAT IS BYSTOLIC?

BYSTOLIC is a kind of prescription medicine called a “beta-blocker”. BYSTOLIC treats:

  • High blood pressure (hypertension)

BYSTOLIC can lower blood pressure when used by itself and with other medicines.

BYSTOLIC is not approved for children less than 18 years of age.

WHO SHOULD NOT TAKE BYSTOLIC?

Do not take BYSTOLIC if you:

  • Have heart failure and are in the ICU or need medicines to keep up your blood circulation
  • Have a slow heartbeat or your heart skips beats (irregular heartbeat)
  • Have severe liver damage
  • Are allergic to any ingredient in BYSTOLIC. The active ingredient is nebivolol. See the end of this leaflet for a list of ingredients.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING BYSTOLIC?

Tell your doctor about all of your medical problems, including if you:

  • Have asthma or other lung problems (such as bronchitis or emphysema)
  • Have problems with blood flow in your feet and legs (peripheral vascular disease) BYSTOLIC can make symptoms of blood flow problems worse.
  • Have diabetes and take medicine to control blood sugar
  • Have thyroid problems
  • Have liver or kidney problems
  • Had allergic reactions to medications or have allergies
  • Have a condition called pheochromocytoma
  • Are pregnant or trying to become pregnant. It is not known if BYSTOLIC is safe for your unborn baby. Talk with your doctor about the best way to treat high blood pressure while you are pregnant.
  • Are breastfeeding. It is not known if BYSTOLIC passes into your breast milk. You should not breastfeed while using BYSTOLIC.
  • Are scheduled for surgery and will be given anesthetic agents

Tell your doctor about all the medicines you take. Include prescription and non-prescription medicines, vitamins, and herbal products. BYSTOLIC and certain other medicines can affect each other and cause serious side effects.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

HOW SHOULD I TAKE BYSTOLIC?

  • Do not suddenly stop taking BYSTOLIC. You could have chest pain or a heart attack. If your doctor decides to stop BYSTOLIC, your doctor may slowly lower your dose over time before stopping it completely.
  • Take BYSTOLIC every day exactly as your doctor tells you. Your doctor will tell you how much BYSTOLIC to take and how often. Your doctor may start with a low dose and raise it over time.
  • Do not stop taking BYSTOLIC or change your dose without talking with your doctor.

  • Take BYSTOLIC with or without food.

  • If you miss a dose, take your dose as soon as you remember, unless it is close to the time to take your next dose. Do not take 2 doses at the same time. Take your next dose at the usual time.
  • If you take too much BYSTOLIC, call your doctor or poison control center right away.

WHAT ARE POSSIBLE SIDE EFFECTS OF BYSTOLIC?

  • Low blood pressure and feeling dizzy. If you feel dizzy, sit or lie down and tell your doctor right away.
  • Tiredness
  • Slow heartbeat
  • Headache
  • Leg swelling due to fluid retention (edema). Tell your doctor if you gain weight or have trouble breathing while taking BYSTOLIC.

Tell your doctor if you have any side effects that bother you or don't go away.

HOW SHOULD I STORE BYSTOLIC?

  • Store BYSTOLIC between 68° to 77°F (20° - 25°C).
  • Safely throw away BYSTOLIC that is out of date or no longer needed.
  • Keep BYSTOLIC and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT BYSTOLIC

Doctors sometimes prescribe medicines for conditions not included in the patient information leaflets.

  • Only use BYSTOLIC for the medical problem it was prescribed for.
  • Do not give BYSTOLIC to other people, even if they have the same symptoms. It may harm them.

This leaflet summarizes the most important information about BYSTOLIC. For more information:

  • Talk with your doctor.
  • Ask your doctor or pharmacist for information about BYSTOLIC that is written for healthcare professionals.
  • Visit www.BYSTOLIC.com on the web or call 1-800-678-1605.

WHAT IS IN BYSTOLIC?

Active Ingredient: Nebivolol

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate

WHAT IS HIGH BLOOD PRESSURE (HYPERTENSION)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too great.

High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. BYSTOLIC tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

Rev. June 2011

Distributed by:

Forest Pharmaceuticals, Inc.

Subsidiary of Forest Laboratories, Inc.

St. Louis, MO 63045, USA

Licensed from Mylan Laboratories, Inc.

Under license from Janssen Pharmaceutica N.V., Beerse, Belgium

Actidose-Aqua® is a registered trademark of Paddock Laboratories, Inc.

© 2010 Forest Laboratories, Inc.

Relabeling and Repackaging by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021742 · View the label on DailyMed

Revision date stated in the text: June 2011

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Bystolic

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class beta-Adrenergic Blocker
Active ingredient Nebivolol hydrochloride
Dosage form Tablet
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) ALLERGAN
FDA approval NDA 021742New Drug Application (NDA) Approved December 17, 2007
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Nebivolol with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg – 30 in 1 bottle NDC 54868-5944-0
5 mg – 90 in 1 bottle NDC 54868-5944-1
10 mg – 90 in 1 bottle NDC 54868-6018-0
10 mg – 30 in 1 bottle NDC 54868-6018-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.