Balfaxar Side Effects

Generic name: prothrombin complex

Medically reviewed by Drugs.com. Last updated on Jan 11, 2024.

Note: This document contains side effect information about prothrombin complex. Some dosage forms listed on this page may not apply to the brand name Balfaxar.

Applies to prothrombin complex: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Patients receiving treatment with vitamin K antagonists (VKAs) may be at increased risk of thromboembolic events (TE) due to underlying disease states. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported. The potential benefits of reversing VKAs should be weighed against the potential risk of TE. Monitor patients receiving prothrombin complex concentrate (human) for signs and symptoms of TE. Resumption of anticoagulation should be carefully considered as soon as the risk of TE outweighs the risk of acute bleeding. Prothrombin complex concentrate (human) may not be suitable in patients with TE within the last 3 months prior to use.

Serious side effects of Balfaxar

Along with its needed effects, prothrombin complex (the active ingredient contained in Balfaxar) 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 or nurse immediately if any of the following side effects occur while taking prothrombin complex:

Less common

Blurred vision
chest pain
confusion
convulsions
decrease in the amount of urine
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
dry mouth
fast, pounding, or irregular heartbeat or pulse
headache, sudden, severe
increased thirst
irregular heartbeat
loss of appetite
muscle pain or cramps
nausea or vomiting
nervousness
noisy, rattling breathing
numbness or tingling in the hands, feet, or lips
pounding in the ears
slow or fast heartbeat
sweating
swelling of the fingers, hands, feet, or lower legs
tightness in the chest
troubled breathing
troubled breathing at rest
unusual tiredness or weakness
weakness
weight gain

Incidence not known

Anxiety
blood in the stools or urine
blue lips and fingernails
bruising
chest discomfort
coughing or vomiting blood
coughing that sometimes produces a pink frothy sputum
difficult or labored breathing
difficult, fast, noisy breathing, sometimes with wheezing
difficulty with speaking
double vision
fainting
feeling of warmth
headache
hives or welts
inability to move the arms, legs, or facial muscles
increased sweating
itching
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
noisy breathing
pain or discomfort in the arms, jaw, back, or neck
pain, redness, or swelling in the arm or leg
pale skin
persistent bleeding or oozing from puncture sites, mouth, or nose
rash
redness of the face, neck, arms, and occasionally, upper chest
redness of the skin
slow speech
sudden shortness of breath or troubled breathing
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

Other side effects of Balfaxar

Some side effects of prothrombin complex 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:

More common

Difficulty with moving
muscle pain or stiffness
pain in the joints

Less common

Diarrhea
difficulty having a bowel movement (stool)
tearing of skin
trouble sleeping

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to prothrombin complex: intravenous powder for injection.

General

The most common adverse reactions were headache, nausea/vomiting, arthralgia, and hypotension.

The most serious adverse reactions were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension (4.9%), tachycardia (2.9%), increased blood pressure/hypertension (2.9%)

Uncommon (0.1% to 1%): Venous thrombosis, calf (1.0%), deep vein thrombosis (1.0%), fistula clot (1.0%)

Postmarketing reports: Arterial thromboembolic events (including acute myocardial infarction and arterial thrombosis), venous thromboembolic events (including pulmonary embolism and venous thrombosis), and disseminated intravascular coagulation^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/vomiting (3.9%), constipation (1.9%)^[Ref]

Hypersensitivity

Postmarketing reports: Flushing, urticaria, tachycardia, anxiety, angioedema, wheezing, nausea, vomiting, hypotension, tachypnea, dyspnea, pulmonary edema, and bronchospasm^[Ref]