Topicaine Side Effects

Generic name: lidocaine topical

Note: This document contains side effect information about lidocaine topical. Some of the dosage forms listed on this page may not apply to the brand name Topicaine.

Some side effects of Topicaine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to lidocaine topical: topical cream, topical film, topical gel, topical gel with applicator, topical kit, topical liquid, topical lotion, topical ointment, topical solution, topical spray

Get emergency medical help if you have any of these signs of an allergic reaction while taking lidocaine topical (the active ingredient contained in Topicaine) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using lidocaine topical and call your doctor at once if you have any of these serious side effects:

• uneven heartbeats;

• drowsiness, confusion;

• tremors, seizure (convulsions); or

• blurred vision.

Less serious side effects include:

• mild irritation, redness, or swelling where the medication is applied; or

• numbness in places where the medicine is accidentally applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to lidocaine topical: intradermal device, mucous membrane solution, mucous membrane spray, topical cream, topical film, topical gel, topical gel with applicator, topical kit, topical liquid, topical lotion, topical ointment, topical solution, topical spray, topical stick

Local

Local side effects associated with lidocaine topical (the active ingredient contained in Topicaine) 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 (the active ingredient contained in Topicaine) 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 (the active ingredient contained in Topicaine) patch have included metallic taste, taste alteration, nausea, and vomiting. Causality has not been established.

Ocular

Ocular side effects associated with lidocaine topical (the active ingredient contained in Topicaine) 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 (the active ingredient contained in Topicaine) jelly residue in the inner lumen of the tube.

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