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Epipen (Epinephrine Injection) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Epipen (Epinephrine Injection) 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 (256)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Accidental Exposure (131)Drug Ineffective (51)Injury Associated With Device (44)Expired Drug Administered (40)Injection Site Pain (23)Hypoaesthesia (19)Pain in Extremity (16)Contusion (13)Injection Site Pallor (13)Heart Rate Increased (13)Pain (11)Injection Site Discolouration (9)

Below are a few examples of reports where side effects / adverse reactions may be related to Epipen (Epinephrine Injection). For a complete list or a specific selection of reports, please use the links above.

Possible Epipen side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 58.5 kg (128.7 pounds)

Reactions: Device Malfunction

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 36 year old female

Reactions: Contusion, Pain, Hypoaesthesia, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 52 year old female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 52 year old female

Reactions: Product Colour Issue, Drug Ineffective

Drug(s) suspected as cause:
Epipen
    Dosage: 0.3 mg/0.3 ml, prn
    Indication: Swelling

Epipen
    Indication: Arthropod Sting



Possible Epipen side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 55 year old female

Reactions: Heart Rate Increased, Hand Fracture, Injection Site Pallor, Hypoaesthesia, Nail BED Bleeding, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 3 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-21

Patient: 3 year old female

Reactions: Contusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error, Drug Ineffective

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 19 year old female

Reported by a pharmacist from United States on 2012-08-21

Patient: 19 year old female

Reactions: Pharyngeal Oedema, Drug Ineffective

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 47 year old male

Reactions: Injection Site Pain, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 14 year old female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: 14 year old female

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Epipen
    Dosage: 0.3 ml, as needed
    Indication: Hypersensitivity
    Start date: 2011-01-01

Epipen
    Indication: Dyspnoea

Other drugs received by patient: Qvar 40; Ventolin; Accolate; Dulera



Possible Epipen side effects in 69 year old male

Reported by a physician from Netherlands on 2012-08-17

Patient: 69 year old male

Reactions: Device Failure, Underdose, Circulatory Collapse

Drug(s) suspected as cause:
Epipen

Other drugs received by patient: Alutard SQ ^alk^; Perindopril Erbumine; Simvastatin; Ascal Cardio; Rabeprazole Sodium; Metformin



Possible Epipen side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 67 year old female

Reactions: Product Quality Issue, Drug Ineffective

Drug(s) suspected as cause:
Epipen
    Dosage: 0.3 mg/ml
    Indication: Anaphylactic Reaction

Epipen
    Indication: Food Allergy



Possible Epipen side effects in 31 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 31 year old female, weighing 117.9 kg (259.4 pounds)

Reactions: Drug Ineffective, Needle Issue

Drug(s) suspected as cause:
Epipen

Other drugs received by patient: Metformin; Zonisamide; Buspirone; Fluoxetine; Ambien; Calcium; Magnesium; Buspirone; Fluoxetine



Possible Epipen side effects in 5 year old male

Reported by a consumer/non-health professional from Canada on 2012-08-16

Patient: 5 year old male

Reactions: Injection Site Laceration

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 23 year old female

Reported by a pharmacist from United States on 2012-08-16

Patient: 23 year old female

Reactions: Injection Site Discolouration, Pain, Expired Drug Administered, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 38 year old male

Reactions: Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epipen

Other drugs received by patient: Ativan; Zantac; Zofran; Benadryl; Solu-Medrol; Combivent



Possible Epipen side effects in 3 year old female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: 3 year old female

Reactions: Injection Site Haemorrhage, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 3 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-14

Patient: 3 year old female

Reactions: Contusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 41 year old female

Reactions: Pain in Extremity, Hypoaesthesia, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 47 year old male

Reactions: Injection Site Pain, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 55 year old female

Reactions: Heart Rate Increased, Hand Fracture, Injection Site Pallor, Hypoaesthesia, Nail BED Bleeding, Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 5 year old male

Reported by a consumer/non-health professional from Canada on 2012-08-08

Patient: 5 year old male

Reactions: Injection Site Laceration

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient:

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in female

Reported by a pharmacist from United Kingdom on 2012-08-07

Patient: female

Reactions: Device Failure, Injection Site Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient:

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Injection Site Pain

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 80 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 80 year old female

Reactions: Product Quality Issue, Injection Site Pain

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in female

Reported by a pharmacist from United States on 2012-08-03

Patient: female

Reactions: Product Packaging Issue, Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient:

Reactions: Therapeutic Response Unexpected

Drug(s) suspected as cause:
Epipen



Possible Epipen side effects in 20 year old female

Reported by a physician from United Kingdom on 2012-08-03

Patient: 20 year old female

Reactions: Device Failure, Chest Pain

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Epipen

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