Byvalson Side Effects Center

Last updated on RxList: 6/15/2016
Byvalson Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/15/2016

Byvalson (nebivolol and valsartan) is a beta adrenergic blocker and an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension (high blood pressure), to lower blood pressure. Common side effects of Byvalson include:

As initial therapy and in patients not adequately controlled on valsartan 80 mg or nebivolol up to and including 10 mg, the recommended dose of Byvalson is 5 mg/80 mg taken orally once daily. Byvalson may interact with quinidine, propafenone, fluoxetine, paroxetine, other beta-blockers, reserpine, clonidine, digitalis, calcium channel blockers, potassium sparing diuretics, potassium supplements or salt substitutes, nonsteroidal anti-inflammatory drugs (NSAIDs), lithium, ACE inhibitors, or aliskiren. Tell your doctor all medications and supplements you use. Byvalson is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Byvalson passes into breast milk. Due to the possibility of unwanted effects on a nursing infant, breastfeeding is not recommended while taking Byvalson.

Our Byvalson (nebivolol and valsartan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Byvalson Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; trouble breathing or swallowing; stomach pain, vomiting; 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;
  • very slow heartbeats;
  • chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • shortness of breath (even with mild exertion);
  • swelling or numbness in your legs or feet;
  • rapid weight gain; or
  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement.

Common side effects may include:

  • slow heartbeats.

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 Byvalson (Nebivolol and Valsartan Tablets)

QUESTION

Salt and sodium are the same. See Answer
Byvalson Professional Information

SIDE EFFECTS

The following serious adverse reactions are included in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

BYVALSON

BYVALSON has been evaluated for safety in patients with hypertension. A total of 1,664 patients received at least 1 dose of a fixed-dose combination of nebivolol/valsartan in an 8-week trial. A total of 807 patients received at least 1 dose of nebivolol and valsartan in an open-label safety study; of these, 621 patients completed 180 days and 476 patients completed 360 days of open-label treatment with nebivolol and valsartan.

The safety of the 5 mg/ 80 mg dose of nebivolol/valsartan was evaluated during the first 4 weeks of an 8-week placebo-controlled trial. During the 4 week period, the overall incidence of adverse events on therapy with BYVALSON 5 mg/ 80 mg was similar to placebo and the individual components (nebivolol 5 mg and valsartan 80 mg). Discontinuation of therapy due to a clinical adverse event occurred in 2.0% of patients treated with BYVALSON 5 mg/ 80 mg versus 3.2% of patients given placebo and approximately 1% of patients given nebivolol 5 mg or valsartan 80 mg as monotherapy.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of either nebivolol or valsartan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nebivolol

The following adverse reactions have been reported in post-marketing experience:

Cardiac: atrioventricular block (both second and third degree), myocardial infarction

Central Nervous System: somnolence, syncope, vertigo

Circulatory: Raynaud's phenomenon, peripheral ischemia/claudication, thrombocytopenia

Dermatologic: pruritus, psoriasis, various rashes and skin disorders

Digestive: vomiting

Hepatic: Abnormal hepatic function (including increased AST, ALT and bilirubin)

Hypersensitivity: hypersensitivity (including urticaria, allergic vasculitis and rare reports of angioedema)

Renal: acute renal failure Respiratory: acute pulmonary edema, bronchospasm

Sexual Dysfunction: erectile dysfunction

Valsartan

The following additional adverse reactions have been reported in post-marketing experience:

Hypersensitivity: Angioedema.

Digestive: Elevated liver enzymes, hepatitis

Renal: Impaired renal function, renal failure

Clinical Laboratory Tests: Hyperkalemia

Dermatologic: Alopecia, bullous dermatitis

Blood and Lymphatic: thrombocytopenia

Vascular: Vasculitis

Read the entire FDA prescribing information for Byvalson (Nebivolol and Valsartan Tablets)

© Byvalson Patient Information is supplied by Cerner Multum, Inc. and Byvalson Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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