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Emla (Prilocaine / Lidocaine Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Emla (Prilocaine / Lidocaine Topical) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (15)
Life Threatening Events (3)
Disability (1)

Reports by Reaction Type

Methaemoglobinaemia (4)Somnolence (4)Overdose (3)Paraesthesia (3)Hypersensitivity (2)Hyperthermia (2)LIP Oedema (2)Face Oedema (2)Cyanosis (2)Application Site Erythema (2)Angioedema (2)Tongue Oedema (2)

Possible Emla side effects in 4 year old male

Reported by a physician from Switzerland on 2012-08-15

Patient: 4 year old male

Reactions: Syncope, Hypotension, Bradycardia, Somnolence

Drug(s) suspected as cause:
Emla



Possible Emla side effects in 1 year old male

Reported by a physician from France on 2012-08-13

Patient: 1 year old male

Reactions: Local Reaction, Application Site Burn, Application Site Exfoliation, Application Site Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emla



Possible Emla side effects in 23 year old female

Reported by a physician from Spain on 2012-08-06

Patient: 23 year old female

Reactions: Dyspnoea, Cyanosis, Dysaesthesia, Erythema, Paraesthesia

Drug(s) suspected as cause:
Emla



Possible Emla side effects in 3 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05

Patient: 3 year old female, weighing 16.0 kg (35.2 pounds)

Reactions: Grand MAL Convulsion, Overdose, Methaemoglobinaemia, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emla



Possible Emla side effects in 75 year old male

Reported by a pharmacist from Germany on 2012-07-05

Patient: 75 year old male

Reactions: Overdose, Arrhythmia

Drug(s) suspected as cause:
Emla



Possible Emla side effects in 8 year old female

Reported by a physician from Germany on 2012-05-09

Patient: 8 year old female, weighing 30.5 kg (67.1 pounds)

Reactions: Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Emla



Possible Emla side effects in male

Reported by a physician from France on 2012-04-19

Patient: male, weighing 21.3 kg (46.9 pounds)

Reactions: Angioedema, Face Oedema, Hyperthermia, Tongue Oedema, Rash, LIP Oedema

Drug(s) suspected as cause:
Minirin
    Start date: 2012-01-17
    End date: 2012-01-17

Emla
    Start date: 2012-01-17
    End date: 2012-01-17

Midazolam
    Start date: 2012-01-17
    End date: 2012-01-17



Possible Emla side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30

Patient: male, weighing 50.0 kg (110.0 pounds)

Reactions: Scratch, Hypersensitivity, Skin Lesion, Application Site Pain, Application Site Erythema, Application Site Pruritus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Qutenza
    Dosage: 2 df, patch, dorsal and thoracici application, fifth right intercostal space, topical)
    Administration route: Topical
    Indication: Neuralgia
    Start date: 2012-01-25
    End date: 2012-01-25

Emla
    Dosage: df
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-25
    End date: 2012-01-25

Other drugs received by patient: Oxycodone HCL; Transcutaneous Electrical Nerve Stimulation; Spiriva; Zolpidem Tartrate; Lyrica; Foradil; Oxycontin



Possible Emla side effects in 5 year old male

Reported by a physician from France on 2012-03-14

Patient: 5 year old male, weighing 21.3 kg (46.9 pounds)

Reactions: Angioedema, Face Oedema, Hyperthermia, Tongue Oedema, Rash, LIP Oedema

Drug(s) suspected as cause:
Minirin
    Start date: 2012-01-17
    End date: 2012-01-17

Emla
    Start date: 2012-01-17
    End date: 2012-01-17

Midazolam
    Start date: 2012-01-17
    End date: 2012-01-17



Possible Emla side effects in 36 year old male

Reported by a physician from Spain on 2012-02-24

Patient: 36 year old male

Reactions: Overdose, Methaemoglobinaemia, Somnolence, Paraesthesia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Emla

Other drugs received by patient: Ciprofloxacin HCL



Possible Emla side effects 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

Drug(s) suspected as cause:
Emla

Other drugs received by patient: Ciprofloxacin HCL



Possible Emla side effects in female

Reported by a pharmacist from United States on 2012-01-19

Patient: female

Reactions: Cardio-Respiratory Arrest, Cyanosis, Methaemoglobinaemia, Unresponsive To Stimuli, Clonus, Toxicity To Various Agents, Convulsion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Emla



Possible Emla side effects 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

Drug(s) suspected as cause:
Emla



Possible Emla side effects in female

Reported by a physician from Russian Federation on 2011-10-27

Patient: female

Reactions: Photophobia, Keratitis

Drug(s) suspected as cause:
Emla



Possible Emla side effects 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

Drug(s) suspected as cause:
Emla

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