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
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]
