LidoSite Side Effects

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

LidoSite Patch Iontophoretic 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 LidoSite Patch Iontophoretic Patch:

Minor redness, burning, irritation, or numbness at the application site; lightheadedness; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; fainting; fast, slow, or irregular heartbeat; loss of consciousness; mental or mood changes; nervousness; paleness; redness or warmth of skin; ringing in the ears or hearing changes; seizures; sensation of heat or cold; shortness of breath; swelling or blistering of skin; tremors or twitching; vision changes or double vision; vomiting.

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.

LidoSite Side Effects - for the Professional

LidoSite

Systemic (Dose Related) Reactions: Systemic adverse reactions following the iontophoresis of lidocaine and epinephrine using the LidoSite™ System according to the directions for use are unlikely due to the absorbed dose.

Systemic adverse effects of lidocaine are similar in nature to those observed with other amide-type local anesthetics including either excitatory and/or depressant (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) CNS manifestations. Excitatory CNS reactions may be brief or may not occur at all, in which case the first manifestation may be drowsiness leading to unconsciousness. Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, conduction abnormalities, dysrhythmias and/or cardiovascular collapse which may lead to cardiac arrest.

Systemic adverse effects of epinephrine may include palpitations, tachycardia, hypertension, sweating, nausea and vomiting, respiratory difficulty, pallor, dizziness, weakness, tremor, headache, apprehension, nervousness and anxiety. Cardiac arrhythmias may follow the administration of epinephrine.

Allergic: Allergic reactions, including anaphylactoid and anaphylactic, may occur as a result of sensitivity either to the local anesthetic agents or to the preservatives such as sodium metabisulfite. They may be characterized by cutaneous lesions, urticaria, angioedema, bronchospasm, tachycardia, hypotension or shock. 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.

Most Common Adverse Events

In placebo-controlled studies with LidoSite™ System, 4.5% of patients on placebo (N=333) and 4.5% of patients on LidoSite™ System (N=330) reported an adverse event. Because the placebo groups were not "no treatment" groups, but instead generally utilized an unaltered LidoSite™ Patch or an epinephrine only-containing patch with application of current, comparing the incidence of adverse events between the placebo and LidoSite™ System groups may not fully elucidate the incidence of adverse events that are attributable to iontophoresis, epinephrine or local irritation from patch application. In these studies, adverse events that occurred at a higher incidence in LidoSite™ System treated subjects compared to placebo treated subjects included subcutaneous hematoma (0.9% vs. 0.3%) and vasoconstriction (0.9% vs. 0.3%). In one study, the incidence of application site papules was reported to be as high as 12% and in another study the incidence of burns was reported to be as high as 8%. There were no serious adverse events attributed to LidoSite™ System treatment. In the overall safety database (812 patients administered LidoSite™ System) 0.8% of patients discontinued due to an adverse event. The most common reasons for discontinuation were: application site pain, N=4 (0.5%), application site burning, N=3 (0.4%), and pruritus, N=1 (0.1%).

The most frequently observed adverse events from all studies are presented below:

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