"The US Food and Drug Administration (FDA) today approved a drug for children and adults with hemophilia B called albutrepenonacog alfa (Idelvion, CSL Behring), which combines albumin with factor IX to reduce injection frequency."...
Zemuron Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zemuron (rocuronium bromide) is a nondepolarizing neuromuscular blocking agent given before general anesthesia in preparation for surgery. Zemuron helps keep the body still during surgery and also relaxes the throat so a breathing tube can be more easily inserted before surgery. Zemuron is available in generic form. Common side effects of Zemuron include nausea, vomiting, swelling or discomfort at the injection site, sleepiness or light-headedness, mild itching or skin rash, or high or low blood pressure (hypertension or hypotension).
Zemuron is only administered by clinicians experienced with the use, actions, characteristics and complications of neuromuscular blocking agents. Doses of Zemuron injection are individualized based on the condition being treated and the patient's weight, among other factors. Zemuron may interact with lithium, procainamide, seizure medication, antacids or mineral supplements containing magnesium, steroids, or antibiotics. Tell your doctor all medications and supplements you use. During pregnancy, Zemuron should only be used if prescribed. It is unknown if this medication passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.
Our Zemuron (rocuronium bromide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zemuron in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers right away if you have any of these serious side effects:
- fast or uneven heart rate;
- noisy breathing, feeling short of breath;
- ongoing muscle weakness; or
- inability to move your muscles.
Less serious side effects may include:
- nausea, vomiting;
- swelling or discomfort where the medicine was injected;
- feeling sleepy or light-headed; or
- mild itching or skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Zemuron (Rocuronium Bromide Injection)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zemuron FDA Prescribing Information: Side Effects
The following adverse reactions are described, or described in greater detail, in other sections:
- Anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Residual paralysis [see WARNINGS AND PRECAUTIONS]
- Myopathy [see WARNINGS AND PRECAUTIONS]
- Increased pulmonary vascular resistance [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical studies in the US (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the US clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered ZEMURON (all events judged by investigators during the clinical trials to have a possible causal relationship):
Adverse reactions in greater than 1% of patients: None
Adverse reactions in less than 1% of patients (probably related or relationship unknown):
Digestive: nausea, vomiting
Skin and Appendages: rash, injection site edema, pruritus
In the European studies, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the US studies (0.1% and 0.1%). Changes in heart rate and blood pressure were defined differently from in the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related.
In a clinical study in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs. In some patients, ZEMURON was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients receiving ZEMURON 0.6 or 0.9 mg/kg.
In pediatric patient studies worldwide (n=704), tachycardia occurred at an incidence of 5.3% (n=37), and it was judged by the investigator as related in 10 cases (1.4%).
The following adverse reactions have been identified during post-approval use of ZEMURON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders
In clinical practice, there have been reports of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with ZEMURON, including some that have been life-threatening and fatal [see WARNINGS AND PRECAUTIONS].
General Disorders And Administration Site Conditions
Read the entire FDA prescribing information for Zemuron (Rocuronium Bromide Injection)
Additional Zemuron Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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