Lidoderm Side Effects

Please note - some side effects for Lidoderm 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 Lidoderm - for the Consumer

Lidoderm Patch

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 Lidoderm Patch:

Mild redness, swelling, burning, blisters, bruising, irritation, change in skin color, or numbness at the application site.

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

Lidoderm Side Effects - for the Professional

Lidoderm

Application Site Reactions

During or immediately after treatment with Lidoderm (lidocaine patch 5%), the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours.

Allergic Reactions

Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Other Adverse Events

Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including:

Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.

Systemic (Dose-Related) Reactions

Systemic adverse reactions following appropriate use of Lidoderm are unlikely, due to the small dose absorbed. Systemic adverse effects of lidocaine are similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light-headedness, 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). Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness. Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.

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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