Emla Side Effects

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

EMLA Cream

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 EMLA Cream:

Abnormal skin sensations; burning; change in hot or cold sensation; pale skin; redness or swelling at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

EMLA Disc

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 EMLA Disc:

Abnormal skin sensations; burning; change in feelings of hot or cold sensation; pale skin; redness or swelling at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Emla Side Effects - for the Professional

EMLA

Localized Reactions: During or immediately after treatment with EMLA Cream on intact skin, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Rare cases of discrete purpuric or petechial reactions at the application site have been reported. Rare cases of hyperpigmentation following the use of EMLA Cream have been reported. The relationship to EMLA Cream or the underlying procedure has not been established. In clinical studies on intact skin involving over 1,300 EMLA Cream-treated subjects, one or more such local reactions were noted in 56% of patients, and were generally mild and transient, resolving spontaneously within 1 or 2 hours. There were no serious reactions that were ascribed to EMLA Cream.

Two recent reports describe blistering on the foreskin in neonates about to undergo circumcision. Both neonates received 1.0 g of EMLA Cream.

In patients treated with EMLA Cream on intact skin, local effects observed in the trials included: paleness (pallor or blanching) 37%, redness (erythema) 30%, alterations in temperature sensations 7%, edema 6%, itching 2% and rash, less than 1%.

In clinical studies on genital mucous membranes involving 378 EMLA Cream-treated patients, one or more application site reactions, usually mild and transient, were noted in 41% of patients. The most common application site reactions were redness (21%), burning sensation (17%) and edema (10%).

Allergic Reactions: Allergic and anaphylactoid reactions associated with lidocaine or prilocaine can occur. They are characterized by urticaria, angioedema, bronchospasm, and shock. If they occur they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.

Systemic (Dose Related) Reactions: Systemic adverse reactions following appropriate use of EMLA Cream are unlikely due to the small dose absorbed. Systemic adverse effects of lidocaine and/or prilocaine 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 have included erythema, edema, and abnormal sensation. Local effects observed in the trials of the cream on intact skin have included paleness (37%), erythema (30%), alterations in temperature sensations (7%), edema (6%), itching (2%), and rash (<1%). The most commonly reported local side effects in clinical studies on genital mucous membranes were redness (21%), burning sensation (17%), and edema (10%).

Cardiovascular

Cardiovascular side effects have included bradycardia, hypotension, and cardiovascular collapse leading to arrest.

Nervous system

Nervous system side effects have included CNS excitation and/or depression. Excitatory CNS reactions may be brief or not occur at all.

Hypersensitivity

Hypersensitivity side effects have included angioedema, bronchospasm, and shock.

Dermatologic

Dermatologic side effects have included urticaria. The detection of sensitivity by skin testing is of doubtful value.

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