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Benzocaine, the active ingredient in Orajel and many other topical oral pain relievers, has been linked to methemoglobinemia, a life-threatening disorder that causes oxygen levels in the blood to drop.

What is Benzocaine?

Benzocaine is a topical local anesthetic used to relieve pain and/or itching caused by teething, poison ivy, minor burns, and more. It is sold over-the-counter (OTC) in the form of ointments, sprays, gels, creams, and lozenges.

Benzocain blocks nerve signals that cause pain when applied to the skin or gums.

Benzocaine Side Effects

Side effects associated with the use of benzocaine may include:

• Skin reactions, such as blistering, burning, crusting, dryness, and flaking, as well as itching, scaling, redness, soreness, stinging, or swelling.
• Dark urine
• Breathing difficulty
• Problems walking
• Dizziness or lightheadedness
• Fainting
• Fever
• Headache
• Loss of feeling in hands and feet
• Irritability
• Nose irritation
• Pale skin
• Rapid heart rate
• Eye redness & irritation
• Sore throat
• Unusual bleeding or bruising
• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

FDA Warning for Benzocaine Oral Products

Benzocaine is the active ingredient in many OTC drugs used to relieve mouth, gum, and teething pain, including:

• Anbesol and Baby Anbesol
• Benzodent
• Cepacol Lozenges
• Cetacaine
• Exactacain
• HurriCaine
• Instant Pain Relief Maximum Strength
• Orabase
• Orabrite Oral Pain Reliever
• Orajel and Baby Orajel
• Topex
• Various store brand teething products

Benzocaine and Methemoglobinemia

In May 2018, the FDA urged the manufacturers of Orajel and and other OTC benzocaine-based teething remedies to stop marketing their products for use in children under 2 because of a potential association with methemoglobinemia. The agency also requested that the makers of other benzocaine-containing oral medications modify their product labels to warn of this potential risk.

Parents and caregivers have been advised not to administer benzocaine-based teething remedies to children under the age of 2.

“We have been closely monitoring the risk of methemoglobinemia with the use of OTC and prescription local anesthetics and previously communicated about this risk in 2014, 2011, and 2006,” the FDA stated in a Drug Safety Communication dated May 23, 2018. “We estimate that more than 400 cases of benzocaine-associated methemoglobinemia have been reported to FDA* or published in the medical literature since 1971. There are likely additional cases about which we are unaware.”

What is Methemoglobinemia?

Methemoglobinemia is a dangerous condition that causes blood oxygen levels to drop significantly. The disorder can lead to death if not treated in a timely manner.

Methemoglobinemia can either be congenital – present at birth – or it may be acquired following exposure to certain drugs, chemicals, or foods. Babies are especially susceptible to acquired methemoglobinemia.

Initial symptoms of acquired methemoglobinemia may include:

• Cyanosis (a bluish color in the skin, especially the lips and fingers)
• Chocolate-brown colored blood

As the condition progresses, patients may experience:

• Headache
• Shortness of breath
• Nausea
• Rapid heart rate
• Fatigue and lethargy
• Confusion or stupor
• Loss of consciousness

Methylene blue is used to treat severe cases of methemoglobinemia. Doctors may also prescribe ascorbic acid to reduce the level of methemoglobin in the blood.

People with severe methemoglobinemia may require a blood transfusion or exchange transfusion. Oxygen therapy might also be needed.