Bystolic Tablets
- Generic Name: nebivolol tablets
- Brand Name: Bystolic Tablets
Bystolic Tablets (Nebivolol Tablets) side effects drug center
What Is Bystolic?
Bystolic (nebivolol) is a beta-blocker indicated for the treatment of high blood pressure (hypertension).
What Are Side Effects of Bystolic?
Side effects of Bystolic include:
- headache,
- dizziness,
- tiredness,
- fatigue,
- slow heartbeat,
- nausea,
- stomach pain,
- diarrhea,
- sleep problems (insomnia),
- numbness or a cold feeling in your hands and feet,
- shortness of breath,
- rash, or
- fluid retention in the legs.
Dosage for Bystolic?
The dose of Bystolic is individualized to the needs of the patient. For most patients, the recommended starting dose of Bystolic is 5 mg once daily, with or without food, as monotherapy or in combination with other agents.
What Drugs, Substances, or Supplements Interact with Bystolic?
Bystolic may interact with cimetidine, clonidine, digitalis, isoniazid, methimazole, reserpine, ropinirole, ticlopidine, other beta-blockers, antibiotics, antidepressants, anti-malaria medications, heart or blood pressure medicines, heart rhythm medicines, HIV or AIDS medicines, or medicines to treat psychiatric disorders. Tell your doctor all medications and supplements you use.
Bystolic During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant while using Bystolic; it is unknown if Bystolic will harm a fetus. It is unknown if Bystolic passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Bystolic Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- rapid weight gain;
- shortness of breath;
- slow or uneven heartbeats; or
- numbness or cold feeling in your hands and feet.
Common side effects may include:
- dizziness;
- swelling in your legs;
- slow heartbeats;
- tiredness; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Bystolic Tablets (Nebivolol Tablets)
SIDE EFFECTS
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.
HYPERTENSION
In placebo-controlled clinical trials comparing BYSTOLIC with placebo, discontinuation of therapy due to adverse reactions was reported in 2.8% of patients treated with nebivolol and 2.2% of patients given placebo. The most common adverse reactions that led to discontinuation of BYSTOLIC were headache (0.4%), nausea (0.2%) and bradycardia (0.2%).
Table 1 lists treatment-emergent adverse reactions that were reported in three 12-week, placebo-controlled monotherapy trials involving 1597 hypertensive patients treated with either 5 mg, 10 mg, or 20-40 mg of BYSTOLIC and 205 patients given placebo and for which the rate of occurrence was at least 1% of patients treated with nebivolol and greater than the rate for those treated with placebo in at least one dose group.
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) (%) |
| Cardiac Disorders | ||||
| Bradycardia | 0 | 0 | 0 | 1 |
| Gastrointestinal Disorders | ||||
| Diarrhea | 2 | 2 | 2 | 3 |
| Nausea | 0 | 1 | 3 | 2 |
| General Disorders | ||||
| Fatigue | 1 | 2 | 2 | 5 |
| Chest pain | 0 | 0 | 1 | 1 |
| Peripheral edema | 0 | 1 | 1 | 1 |
| Nervous System Disorders | ||||
| Headache | 6 | 9 | 6 | 7 |
| Dizziness | 2 | 2 | 3 | |
| Psychiatric Disorders | ||||
| Insomnia | 0 | 1 | 1 | 1 |
| Respiratory Disorders | ||||
| Dyspnea | 0 | 0 | 1 | 1 |
| Skin and subcutaneous Tissue Disorders | ||||
| Rash | 0 | 0 | 1 | 1 |
Listed below are other reported adverse reactions with an incidence of at least 1% in the more than 4300 patients treated with BYSTOLIC in controlled or open-label trials except for those already appearing in Table 1, terms too general to be informative, minor symptoms, or adverse reactions unlikely to be attributable to drug because they are common in the population. These adverse reactions were in most cases observed at a similar frequency in placebo-treated patients in the controlled studies.
Body as a Whole: asthenia.
Gastrointestinal System Disorders: abdominal pain
Metabolic and Nutritional Disorders: hypercholesterolemia
Nervous System Disorders: paraesthesia
Laboratory Abnormalities
In controlled monotherapy trials of hypertensive patients, BYSTOLIC was associated with an increase in BUN, uric acid, triglycerides and a decrease in HDL cholesterol and platelet count.
Postmarketing Experience
The following adverse reactions have been identified from spontaneous reports of BYSTOLIC received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to BYSTOLIC. Adverse reactions common in the population have generally been omitted. Because these adverse reactions were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to BYSTOLIC exposure: abnormal hepatic function (including increased AST, ALT and bilirubin), acute pulmonary edema, acute renal failure, atrioventricular block (both second and third degree), bronchospasm, erectile dysfunction, hypersensitivity (including urticaria, allergic vasculitis and rare reports of angioedema), hypotension, myocardial infarction, pruritus, psoriasis, Raynaud's phenomenon, peripheral ischemia/claudication, somnolence, syncope, thrombocytopenia, various rashes and skin disorders, vertigo, and vomiting.
Read the entire FDA prescribing information for Bystolic Tablets (Nebivolol Tablets)
© Bystolic Tablets Patient Information is supplied by Cerner Multum, Inc. and Bystolic Tablets Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.