Sugammadex Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 2, 2024.

Applies to sugammadex: intravenous solution.

Serious side effects of sugammadex

Along with its needed effects, sugammadex 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 sugammadex:

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
• trouble breathing

Incidence not known

• blue lips and fingernails
• confusion
• cough
• difficult, fast, noisy breathing
• 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

Other side effects of sugammadex

Some side effects of sugammadex 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

• cough
• headache
• nausea
• pain at the injection site
• pain in the arms or legs
• stomach pain
• 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

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

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]

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

• 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]

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

• 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]

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]

Psychiatric

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

Further information

Sugammadex side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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