Xylocaine Jelly Side Effects

Please note - some side effects for Xylocaine Jelly may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Xylocaine Jelly - for the Consumer

Xylocaine Jelly Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xylocaine Jelly Gel:

Redness or swelling at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); choking; confusion; dizziness or lightheadedness; fast breathing; fast, slow, or irregular heartbeat; fever; mood or mental changes; ringing in the ears or hearing changes; seizures; shortness of breath; swelling of the throat; vision changes.

Xylocaine Jelly Side Effects - for the Professional

Xylocaine Jelly

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported:

There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube.

Central Nervous System:

CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.

Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.

Cardiovascular System:

Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic:

Allergic reactions are characterized by cutaneous lesions, urticaria, edema, or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity either to the local anesthetic agent or to other components in the formulation. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Side Effects by Body System

Local

Local side effects associated with lidocaine topical patch have included erythema, edema, bruising, papules, vesicles, discoloration, depigmentation, burning sensation, pruritus, dermatitis, petechiae, blisters, exfoliation, skin irritation, and locus of abnormal sensation.

Local side effects associated with other forms of lidocaine topical have included erythema, edema, and locus of abnormal sensation.

Local side effects reported with the use of lidocaine topical patch were generally experienced during or immediately following treatment. The reactions were generally reported as transient and mild, and appeared to resolve spontaneously within a few minutes to a few hours.

Hypersensitivity

Hypersensitivity reactions associated with systemic lidocaine have rarely included urticaria, angioedema, bronchospasm, laryngospasm, dermatitis, pruritus, dyspnea, and shock.

Other

Other side effects associated with lidocaine topical patch have included asthenia, tinnitus, tremor, and flushing. Causality has not been established.

Nervous system

Systemic lidocaine can exhibit CNS excitation and/or depression. Excitatory CNS effects may occur briefly or not at all. Drowsiness may be an early clinical symptom of high lidocaine serum levels.

Nervous system side effects associated with lidocaine topical patch have included paresthesia, hyperesthesia, hypoesthesia, headache, dizziness, lightheadedness, nervousness, somnolence, disorientation, and confusion. Causality has not been established.

Nervous system side effects associated with systemic lidocaine have included lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold, or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression, and respiratory arrest.

Gastrointestinal

Gastrointestinal side effects associated with lidocaine topical patch have included metallic taste, taste alteration, nausea, and vomiting. Causality has not been established.

Ocular

Ocular side effects associated with lidocaine topical patch have included visual disturbances and blurred vision. Causality has not been established.

Cardiovascular

Cardiovascular side effects associated with systemic lidocaine have included bradycardia, hypotension, and cardiovascular collapse leading to possible cardiac arrest.

Respiratory

Respiratory side effects have included occlusion of the endotracheal tube. This effect is typically the result of the presence of dried lidocaine topical jelly residue in the inner lumen of the tube.

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