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 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 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 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 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
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
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