Rocuronium Side Effects

Brand Names: Zemuron

Please note - some side effects for Rocuronium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Rocuronium - for the Consumer

Rocuronium

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Rocuronium. Seek medical attention right away if any of these SEVERE side effects occur when using Rocuronium:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Rocuronium Side Effects - for the Professional

Rocuronium

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension.

The following adverse reactions are described, or described in greater detail, in other sections:

• Anaphylaxis [see WARNINGS AND PRECAUTIONS (5.2)]
• Residual paralysis [see WARNINGS AND PRECAUTIONS (5.4)]
• Myopathy [see WARNINGS AND PRECAUTIONS (5.5)]
• Increased pulmonary vascular resistance [see WARNINGS AND PRECAUTIONS (5.11)]

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 U.S. (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the U.S. clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered Rocuronium bromide (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):

Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia

Digestive: nausea, vomiting

Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup

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 U.S. studies (0.1% and 0.1%). Changes in heart rate and blood pressure were defined differently from in the U.S. 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, Rocuronium bromide 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 Rocuronium bromide 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%).

Post-Marketing Experience

In clinical practice, there have been reports, of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with Rocuronium bromide, including some that have been life-threatening and fatal [see WARNINGS AND PRECAUTIONS (5.2)].

Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included transient hypotension (2%), hypertension (2%), arrhythmia (less than 1%), abnormal electrocardiogram (less than 1%), tachycardia (less than 1%) and increased pulmonary vascular resistance (less than 1%).
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Dermatologic

Dermatologic side effects have included rash (less than 1%), injection site edema (less than 1%), and pruritus (less than 1%).

Gastrointestinal

Gastrointestinal side effects have included nausea (less than 1%), and vomiting (less than 1%).

Hypersensitivity

Hypersensitivity reactions have included postmarketing reports of severe allergic reactions (anaphylactic and
anaphylactoid reactions and shock).

Respiratory

Respiratory side effects have included asthma (less than 1%), and hiccup (less than 1%).

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