Summary

More frequently reported side effects include: diarrhea, dizziness, headache, and rhinitis. Continue reading for a comprehensive list of adverse effects.

Applies to bisoprolol / hydrochlorothiazide: oral tablet.

Serious side effects

Along with its needed effects, bisoprolol/hydrochlorothiazide 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 / hydrochlorothiazide:

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain or discomfort
• lightheadedness, dizziness, or fainting
• rapid weight gain
• slow or irregular heartbeat
• tingling of the hands or feet
• trouble breathing
• unusual tiredness or weakness
• unusual weight gain or loss

Incidence not known

• Persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• white, yellow or waxy scar-like area

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

Symptoms of overdose

• Anxiety
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in consciousness
• chills
• cold, clammy skin
• cold sweats
• confusion as to time, place, or person
• cool, pale skin
• cough
• decrease in amount of urine
• depression
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fast or pounding heartbeat or pulse
• fast, weak pulse
• frequent urination
• holding false beliefs that cannot be changed by fact
• increased hunger
• increased thirst
• increased volume of pale, dilute urine
• irregular breathing
• irritability
• loss of appetite
• loss of consciousness
• mood changes
• muscle pain or cramps
• nausea or vomiting
• nervousness
• nightmares
• no breathing
• noisy breathing
• not able to pass urine
• numbness or tingling in the hands, feet, or lips
• pain or aching in the lower legs
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness
• slurred speech
• sweating
• swelling of the face, hands, fingers, feet, ankles, or lower legs
• tightness in the chest
• trembling
• unconsciousness
• unusual drowsiness, dullness, or feeling of sluggishness
• unusual excitement, nervousness, or restlessness
• very drowsy or sleepy
• weakness and heaviness of legs
• weight gain

Other side effects

Some side effects of bisoprolol / hydrochlorothiazide 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

• Acid or sour stomach
• belching
• decreased interest in sexual intercourse
• diarrhea
• difficulty with moving
• heartburn
• inability to have or keep an erection
• indigestion
• joint pain
• loss in sexual ability, desire, drive, or performance
• muscle aching or stiffness
• sleepiness
• stomach discomfort, upset, or pain
• swollen joints

Rare

• Runny or stuffy nose
• sneezing

For Healthcare Professionals

Applies to bisoprolol / hydrochlorothiazide: oral tablet.

General

Frequency not reported side effects were seen with hydrochlorothiazide doses of generally 25 mg and higher.^[Ref]

The more commonly reported side effects observed with this drug are fatigue, dizziness, and diarrhea.^[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia, chest pain, peripheral edema

Frequency not reported: Arrhythmia, peripheral ischemia

Bisoprolol:

Frequency not reported: Bradycardia, palpitations, rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, exertional dyspnea, edema

Hydrochlorothiazide:

Frequency not reported: Orthostatic hypotension, necrotizing angiitis, vasculitis^[Ref]

Orthostatic hypotension may be potentiated by alcohol, barbiturates, or narcotics.^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, dyspepsia

Bisoprolol:

Frequency not reported: Gastric pain, epigastric pain, abdominal pain, peptic ulcer, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, dry mouth, mesenteric arterial thrombosis, ischemic colitis

Hydrochlorothiazide:

Frequency not reported: Gastric irritation, constipation, pancreatitis, sialadenitis, dry mouth^[Ref]

Nervous system

Common (1% to 10%): Dizziness, somnolence

Frequency not reported: Headache

Bisoprolol:

Frequency not reported: Unsteadiness, dizziness, vertigo, headache, syncope, paresthesia, hypoesthesia, hyperesthesia, somnolence, decreased concentration, decreased memory, tremor, taste abnormality, slightly clouded sensorium

Hydrochlorothiazide:

Frequency not reported: Vertigo, paresthesia^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps, myalgia

Bisoprolol:

Frequency not reported: Arthralgia, muscle pain, joint pain, back pain, neck pain, muscle cramps, twitching

Hydrochlorothiazide:

Frequency not reported: Cramping, muscle spasm^[Ref]

Respiratory

Common (1% to 10%): Cough, upper respiratory tract infection

Uncommon (0.1% to 1%): Rhinitis

Bisoprolol:

Frequency not reported: Asthma, bronchospasm, bronchitis, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory infection, sore throat, laryngospasm, respiratory distress

Hydrochlorothiazide:

Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema^[Ref]

Other

Common (1% to 10%): Fatigue

Bisoprolol:

Frequency not reported: Tinnitus, decreased hearing, earache, fatigue, asthenia, malaise, fever, aching

Hydrochlorothiazide:

Frequency not reported: Weakness, fever^[Ref]

Genitourinary

Common (1% to 10%): Impotence

Bisoprolol:

Frequency not reported: Impotence, polyuria, Peyronie's disease

Hydrochlorothiazide:

Frequency not reported: Sexual dysfunction^[Ref]

Metabolic

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

Uncommon (0.1% to 1%): Hypokalemia

Frequency not reported: Increased uric acid, increased serum triglycerides, decreased HDL

Bisoprolol:

Frequency not reported: Gout, weight gain, increased serum triglycerides, increased uric acid, increased serum potassium, increased glucose, increased phosphorus

Hydrochlorothiazide:

Common (1% to 10%): Hypokalemia

Frequency not reported: Anorexia, gout, hyperglycemia, hyperuricemia, hyperlipidemia, hypercalcemia, increased uric acid, other electrolyte imbalances^[Ref]

Psychiatric

Frequency not reported: Insomnia, loss of libido

Bisoprolol:

Frequency not reported: Sleep disturbance, vivid dreams, insomnia, depression, anxiety, restlessness, decreased libido, hallucination, disorientation to time and space, emotional lability

Hydrochlorothiazide:

Frequency not reported: Restlessness^[Ref]

Immunologic

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

Bisoprolol:

Very common: Antinuclear antibody (ANA) conversions to a positive titer (up to 15%)^[Ref]

Renal

Bisoprolol:

Frequency not reported: Cystitis, renal colic, increased creatinine, increased BUN

Hydrochlorothiazide:

Frequency not reported: Renal failure, renal dysfunction, interstitial nephritis, glycosuria^[Ref]

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

Dermatologic

Bisoprolol:

Frequency not reported: Rash, acne, eczema, psoriasis, skin irritation, pruritus, flushing, sweating, alopecia, dermatitis, cutaneous vasculitis, exfoliative dermatitis

Hydrochlorothiazide:

Frequency not reported: Photosensitivity, rash, cutaneous vasculitis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis^[Ref]

Ocular

Bisoprolol:

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

Hydrochlorothiazide:

Frequency not reported: Transient blurred vision, xanthopsia^[Ref]

Hematologic

Bisoprolol:

Frequency not reported: Purpura, decreased WBCs, decreased platelets, eosinophilia, agranulocytosis, thrombocytopenia

Hydrochlorothiazide:

Frequency not reported: Purpura, leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia^[Ref]

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

Hypersensitivity

Bisoprolol:

Frequency not reported: Angioedema

Hydrochlorothiazide:

Frequency not reported: Urticaria, anaphylactic reactions^[Ref]

Hepatic

Bisoprolol:

Common (1% to 10%): Increased serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT)

Hydrochlorothiazide:

Frequency not reported: Intrahepatic cholestatic jaundice, cholecystitis^[Ref]

SGOT and SGPT 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.^[Ref]