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

Applies to lidocaine topical: topical application cream, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray, topical application swab.

Serious side effects of RadiaGuard

Along with its needed effects, lidocaine topical (the active ingredient contained in RadiaGuard) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

Rare

• Blistering, crusting, irritation, itching, or reddening of the skin
• cough
• cracked, dry, or scaly skin
• fast heartbeat
• fever
• hives or welts, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• noisy breathing
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble breathing or swallowing

Incidence not known

• Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
• bluish-colored lips, fingernails, or palms
• blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• dark urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness or dizziness
• false or unusual sense of well-being
• fear or nervousness
• headache
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• no blood pressure or pulse
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid heart rate
• seizures
• shakiness in the legs, arms, hands, or feet
• slow or irregular heartbeat
• sore throat
• stopping of the heart
• trembling or shaking of the hands or feet
• twitching
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects of RadiaGuard

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bad, unusual, or unpleasant (after) taste
• change in taste
• cold or numbness
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• double vision
• hearing loss
• heat sensation
• lack or loss of strength
• metallic taste
• sleepiness or unusual drowsiness

For Healthcare Professionals

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

General

The most common adverse events were administration site reactions: burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles.^[Ref]

Dermatologic

Very common (10% or more): Erythema (up to 67.3%), petechiae (up to 46.4%)

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Skin lesion, skin injury

Frequency not reported: Flushing, cutaneous lesions, urticaria, dermatitis^[Ref]

Local

Very common (10% or more): Administration site reactions

Common (1% to 10%): Irritation, redness, itching, application site erythema, application site burning, application site pain, application site pruritus, edema

Uncommon (0.1% to 1%): Venipuncture site hemorrhage, burning sensation

Frequency not reported: Locus of abnormal sensation, paleness (pallor or blanching), alteration in temperature sensation, blisters, bruising, depigmentation, dermatitis, discoloration, exfoliation, papules, petechiae, vesicles, application site dermatitis, application site vesicles, skin irritation^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness

Frequency not reported: Lightheadedness, nervousness, apprehension, euphoria, confusion, drowsiness, tinnitus, nystagmus, headache, nausea, vomiting, sensations of heat, cold or numbness, twitching, tremors, paraesthesia, convulsions, unconsciousness, respiratory depression and arrest, pain and/or dysesthesia in the buttocks or legs, unconsciousness

Postmarketing reports: Headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, somnolence, taste alteration^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting^[Ref]

Immunologic

Common (1% to 10%): Nasopharyngitis^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reaction, hypersensitivity

Frequency not reported: Anaphylactoid reactions, anaphylactic shock, angioedema, bronchospasm, shock, dyspnea, laryngospasm^[Ref]

Cardiovascular

Frequency not reported: Bradycardia, hypotension, arrhythmia, cardiovascular collapse, cardiac arrest, AV block, myocardial depression^[Ref]

Hematologic

Frequency not reported: Methemoglobinemia^[Ref]

Ocular

Frequency not reported: Corneal irritation, blurred or double vision

Postmarketing reports: Visual disturbances^[Ref]

Respiratory

Rare (less than 0.1%): Endotracheal tube occlusion

Frequency not reported: Sore throat, hoarseness, loss of voice^[Ref]

Psychiatric

Frequency not reported: Confusion, psychosis, disorientation, dizziness^[Ref]

Other

Postmarketing reports: Open wound, asthenia, pain exacerbated^[Ref]