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Sugammadex Side Effects

For the Consumer

Applies to sugammadex: intravenous solution

As well as its needed effects, sugammadex may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sugammadex, check with your doctor or nurse immediately:

More common:
  • Blurred vision
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • sweating
  • unusual tiredness or weakness
Less common:
  • Chest pain or discomfort
  • chills
  • fever
  • shortness of breath
Incidence not known:
  • Blue lips and fingernails
  • confusion
  • cough
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty with breathing
  • difficulty with swallowing
  • feeling of warmth
  • hives or welts, itching, or rash
  • hoarseness
  • increased sweating
  • irritation
  • joint pain, stiffness, or swelling
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the face, neck, arms, and occasionally, upper chest
  • severe, sudden headache
  • swelling in the legs and ankles
  • unusual bleeding or bruising

Minor Side Effects

Some sugammadex side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Abdominal or stomach pain
  • cough
  • headache
  • nausea
  • pain at the injection site
  • pain in the arms or legs
  • vomiting
Less common:
  • Bloated
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dry mouth
  • feeling sad or empty
  • full feeling
  • irritability
  • joint or muscle pain
  • lack of appetite
  • loss of interest or pleasure
  • passing gas
  • restlessness
  • sore throat
  • tiredness
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to sugammadex: intravenous solution

General

The most commonly reported adverse reactions have included vomiting, pain, nausea, hypotension and headache.[Ref]

Cardiovascular

Common (1% to 10%): Abnormal ECG, hypertension, hypotension, tachycardia, bradycardia, abnormal or prolonged QT interval
Postmarketing reports: Bradycardia with cardiac arrest, atrial fibrillation, atrioventricular block, cardiac/cardiorespiratory arrest, ST segment changes, supraventricular tachycardia/extrasystoles, tachycardia, ventricular fibrillation, and ventricular tachycardia[Ref]

Cases of marked bradycardia, some resulting in cardiac arrest, have occurred within minutes of administering this drug. Cardiac electrophysiology studies have shown that at 2 times the maximum recommended dose, the QT interval was not prolonged to any clinically relevant extent.[Ref]

Hypersensitivity

In a dedicated hypersensitivity study in healthy volunteers, anaphylaxis occurred in 1 of 299 patients (0.3%). This patient experienced anaphylaxis with the first dose (16 mg/kg) and symptoms included conjunctival edema, urticaria, erythema, swelling of the uvula, and reduction in peak expiratory flow. Hypersensitivity reactions including nausea, pruritus, and urticaria occurred in a dose-related manner with more reactions occurring in the 16 mg/kg dose group compared to the 4 mg/kg group.

Anaphylaxis has been reported at all doses. The most commonly described reactions included in reports of anaphylaxis have included dermatologic reactions (e.g., urticaria, rash, erythema, flushing, and skin eruption), and clinically important hypotension often requiring vasopressors for circulatory support. There have also been reports of prolonged hospitalization with the use of additional respiratory support in some patients.[Ref]

Uncommon (0.1% to 1%): Anaphylaxis, hypersensitivity reactions
Postmarketing reports: Anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, Type I hypersensitivity[Ref]

Gastrointestinal

Common (1% to 10%): Nausea (up to 26%), vomiting (up to 15%)
Uncommon (0.1% to 1%): Abdominal pain, flatulence, dry mouth[Ref]

Respiratory

Bronchospasm was observed in patients with a history of pulmonary complications.[Ref]

Common (1% to 10%): Airway complication of anesthesia, oropharyngeal pain, cough
Frequency not reported: Bronchospasm
Postmarketing reports: Laryngospasm, dyspnea, wheezing, pulmonary edema, respiratory arrest[Ref]

Dermatologic

Common (1% to 10%): Pruritus, erythema[Ref]

Hematologic

Common (1% to 10%): Decreased red blood cell count, hematoma, anemia[Ref]

Local

Common (1% to 10%): Injection site pain[Ref]

Metabolic

Common (1% to 10%): Hypocalcemia[Ref]

Musculoskeletal

Common (1% to 10%): Extremity pain, musculoskeletal pain, myalgia, creatine phosphokinase increased[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, hypoesthesia, dysgeusia[Ref]

Other

In clinical studies using this drug at doses labeled for the depth of neuromuscular blockade (n=2022), less than 1% of patients were observed to have recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence.

Airway complications of anesthesia have included bucking against the endotracheal tube, coughing, mild bucking, arousal reaction during surgery, coughing during the anesthetic procedure or during surgery, or anesthetic procedure related spontaneous breath of patient. Anesthetic complications include reports of the restoration of neuromuscular function (e.g., movement of limb or body, grimacing, or suckling on the endotracheal tube). Procedural complications include coughing, tachycardia, bradycardia, movement, and increased heart rate.[Ref]

Very common (10% or more): Pain (up to 52%)
Common (1% to 10%): Procedural complication, anesthetic complication, wound hemorrhage, pyrexia, chills, ear and labyrinth disorders
Uncommon (0.1% to 1%): Recurrence of neuromuscular blockade[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, restlessness, depression, sleep disorder[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Bridion (sugammadex)." Merck & Company Inc, Whitehouse Station, NJ.

It is possible that some side effects of sugammadex may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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