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Emla (Prilocaine / Lidocaine Topical) - Side Effects and Adverse Reactions



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 (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.


Below is a sample of reports where side effects / adverse reactions may be related to Emla. The information is not vetted and should not be considered as verified clinical evidence.

Possible Emla side effects / adverse reactions in 22 month old female

Reported by a physician from France on 2011-10-27

Patient: 22 month old female

Reactions: Skin Burning Sensation, Intentional Drug Misuse

Adverse event resulted in: hospitalization

Suspect drug(s):

Possible Emla side effects / adverse reactions in 43 year old female

Reported by a physician from Russian Federation on 2011-10-28

Patient: 43 year old female

Reactions: Hypersensitivity, Counterfeit Drug Administered, Cyclitis, Uveitis, Keratitis

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):

Possible Emla side effects / adverse reactions in 36 year old male

Reported by a physician from Spain on 2012-02-20

Patient: 36 year old male

Reactions: Methaemoglobinaemia, Somnolence, Paraesthesia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):

Other drugs received by patient: Ciprofloxacin HCL

See index of all Emla side effect reports >>

Drug label data at the top of this Page last updated: 2009-10-05

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