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Emla

Last reviewed on RxList: 12/17/2018
Emla Side Effects Center

Last reviewed on RxList 12/17/2018

Emla (lidocaine 2.5% and prilocaine 2.5%) Cream is a topical anesthetic for use on normal intact skin for local analgesia of intact skin and to prevent pain associated with IV cannulation, needle insertion, and superficial surgery on skin and genital mucous membranes. Side effects of Emla include:

  • mild burning/swelling/tingling/changes in skin color where Emla is applied, or
  • skin redness.

Remove Emla cream and get medical help right away if you have rare but very serious side effects of Emla including:

  • slow or shallow breathing,
  • pale or bluish skin around the mouth or lips,
  • dizziness,
  • fainting,
  • fast/slow/irregular heartbeat,
  • mental/mood changes (e.g., confusion, nervousness),
  • seizures, or
  • severe drowsiness.

Emla contains 25 mg each of lidocane and prilocane per gram. For application and dosing information foror adult and pediatric patients; apply only as prescribed by the physician. Emla may interact with heart rhythm medications, acetaminophen, chloroquine, dapsone, nitrates or nitrites, nitrofurantoin, phenobarbital, primaquine, quinine, or sulfa drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Emla; it is not expected to be harmful to a fetus. Emla topical can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Emla (lidocaine 2.5% and prilocaine 2.5%) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Emla Consumer Information

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

Call your doctor at once if you have:

  • severe burning, stinging, or irritation where the medicine was applied;
  • swelling or redness;
  • sudden dizziness or drowsiness after medicine is applied;
  • confusion, blurred vision, ringing in your ears;
  • bruising or purple appearance of the skin; or
  • unusual sensations of temperature.

Common side effects may include:

  • mild burning where the medicine is applied;
  • itching, rash; or
  • changes in skin color 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Emla (Lidocaine and Prilocaine)

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Emla Professional Information

SIDE EFFECTS

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 (see Pharmacokinetics subsection of CLINICAL PHARMACOLOGY). 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 (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). 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.

Read the entire FDA prescribing information for Emla (Lidocaine and Prilocaine)

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© Emla Patient Information is supplied by Cerner Multum, Inc. and Emla Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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