Bisoprolol Fumarate/hydro

More frequently reported side effects include: fatigue. See below for a comprehensive list of adverse effects.

Applies to bisoprolol: oral tablet

Along with its needed effects, bisoprolol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bisoprolol:

Less common

• Body aches or pain
• chest pain
• chills
• cough
• difficult or labored breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• pain or tenderness around eyes and cheekbones
• shortness of breath or troubled breathing
• sneezing
• sore throat
• stuffy or runny nose
• tightness in chest
• unusual tiredness or weakness
• wheezing

Rare

• Chest discomfort
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur while taking bisoprolol:

Symptoms of overdose

• Anxiety
• blurred vision
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased urine output
• depression
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• extreme fatigue
• fast heartbeat
• increased hunger
• irregular breathing
• nausea
• nervousness
• nightmares
• noisy breathing
• seizures
• shakiness
• slurred speech
• sweating
• swelling of face, fingers, feet, or lower legs
• weight gain

Some side effects of bisoprolol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abnormal or decreased touch sensation
• diarrhea
• difficulty in moving
• lack or loss of strength
• muscle pain or stiffness
• pain in joints
• sleeplessness
• trouble sleeping
• unable to sleep
• vomiting

Applies to bisoprolol: oral tablet

The more commonly reported side effects observed with this drug are bradycardia, dizziness, and hypotension.

Bradycardia occurred as a dose-related event.

Cardiac failure occurred in 18.4% of patients (n=1328) compared with 22.8% of placebo-treated patients (n=1321).

Very common (10% or more): Bradycardia (up to 15.2%)

Common (1% to 10%): Chest pain, heart failure aggravation, hypotension, cold extremities, peripheral edema, ischemia, conduction disorder, left cardiac failure, palpitation, vein disorder

Uncommon (0.1% to 1%): Atrioventricular (AV) disturbances, orthostatic hypotension

Frequency not reported: Other rhythm disturbances, claudication

Very common (10% or more): Dizziness (up to 13.3%)

Common (1% to 10%): Headache, extremity numbness, cerebrovascular disorder, syncope, hypoesthesia

Frequency not reported: Vertigo, paresthesia, hypoesthesia, hyperesthesia, somnolence, decreased concentration/memory, tremor, taste abnormalities

Postmarketing reports: Unsteadiness

Very common (10% or more): Dyspnea (up to 13.8%)

Common (1% to 10%): Pneumonia, bronchitis, coughing, exertional dyspnea, upper respiratory tract infection, respiratory distress, stridor, respiratory tract edema, respiratory tract hemorrhage, sinusitis

Uncommon (0.1% to 1%): Bronchospasm

Rare (0.01% to 0.1%): Allergic rhinitis

Sinusitis occurred as a dose-related event.

Very common: Antinuclear antibody (ANA) conversions (up to 15%)

Common (1% to 10%): Viral infection

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Sweating

Rare (0.01% to 0.1%): Itching, flushing, rash

Very rare (less than 0.01%): Alopecia, psoriasis-like rash, psoriasis exacerbation

Frequency not reported: Acne, eczema, skin irritation, cutaneous vasculitis

Postmarketing reports: Dermatitis, exfoliative dermatitis

Diarrhea occurred as a dose-related event.

Common (1% to 10%): Nausea, vomiting, diarrhea, constipation, dyspepsia, epigastric pain (not food related), abdominal pain, gastritis, dry mouth

Frequency not reported: Gastric pain, peptic ulcer

Common (1% to 10%): Purine metabolism disorder, carbohydrate metabolism disturbed, weight changes, cholesterol changes, potassium levels altered, blood lipid changes

Rare (0.01% to 0.1%): Increased triglycerides

Frequency not reported: Gout

Postmarketing reports: Increased uric acid and glucose

Uric acid, serum potassium, glucose, and phosphorus increases associated with use of this drug were not of clinical importance and rarely resulted in discontinuation.

Common (1% to 10%): Limb pain, myalgia, arthropathy, arthralgia

Uncommon (0.1% to 1%): Muscular weakness, cramps

Frequency not reported: Back pain, neck pain, twitching

Common (1% to 10%): Asthenia, fatigue, body pain, fever, malaise

Rare (0.01% to 0.1%): Hearing disorders

Frequency not reported: Earache, tinnitus

Fatigue and asthenia occurred as dose-related events.

Common (1% to 10%): Insomnia, anxiety

Uncommon (0.1% to 1%): Sleep disorders, depression

Rare (0.01% to 0.1%): Nightmares, hallucinations

Frequency not reported: Restlessness

Common (1% to 10%): Urinary tract infection

Rare (0.01% to 0.1%): Potency disorders

Frequency not reported: Decreased libido, Peyronie's disease, polyuria

Common (1% to 10%): Hepatomegaly

Rare (0.01% to 0.1%): Increased liver enzymes (ALT, AST), hepatitis

Transaminase elevations of 1 to 2 times the upper limit of normal were reported in 6.2% of patients, with a multiple occurrence rate of 1.9%. Generally, this increase was the result of underlying disorders or resolved with continued use of this drug.

Rare (0.01% to 0.1%): Hypersensitivity

Postmarketing reports: Angioedema

Of the 15% of patients who developed positive ANA status, one-third of patients converted back to a negative titer with continued use.

Rare (0.01% to 0.1%): Reduced tear flow

Very rare (less than 0.01%): Conjunctivitis

Frequency not reported: Visual disturbances, ocular pain, ocular pressure

Creatinine and BUN were associated with slightly increased levels, but these effects were generally not of clinical importance and rarely resulted in discontinuation.

Frequency not reported: Cystitis, renal colic

Postmarketing reports: Increased creatinine and BUN

During treatment with this drug, decreased levels of WBCs and platelets were not of clinical importance and rarely resulted in discontinuation.

Postmarketing reports: Purpura, decreases in WBC and platelets