Retre-Gel Side Effects

Generic name: benzocaine topical

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

Some side effects of Retre-Gel 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 benzocaine topical: mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical (the active ingredient contained in Retre-Gel) in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• headache, tired feeling, confusion;

• fast heart rate;

• feeling light-headed or short of breath; and

• pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have any of these signs of an allergic reaction while taking benzocaine topical: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

• headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

• severe burning, stinging, or sensitivity where the medicine is applied;

• swelling, warmth, or redness; or

• oozing, blistering, or any signs of infection.

Less serious side effects of benzocaine topical may include:

• mild stinging, burning, or itching where the medicine is applied;

• skin tenderness or redness; or

• dry white flakes where the medicine was 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 benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

Dermatologic side effects have included contact dermatitis and urticaria.

Local

Local side effects have included burning and stinging.

Other

Other side effects have included edema.

Cardiovascular

Cardiovascular side effects have included angioedema.

Hematologic

Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.

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