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Entereg (Alvimopan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Entereg (Alvimopan) 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 (8)
Death (6)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Myocardial Infarction (4)Respiratory Failure (3)Metabolic Acidosis (2)Ventricular Fibrillation (2)Agitation (1)Electrocardiogram QT Prolonged (1)Pyrexia (1)Acute Myocardial Infarction (1)Intestinal Ischaemia (1)Colon Cancer (1)Hypothermia (1)Diastolic Dysfunction (1)

Possible Entereg side effects in 69 year old male

Reported by a physician from United States on 2012-08-09

Patient: 69 year old male, weighing 91.8 kg (202.0 pounds)

Reactions: Intestinal Ischaemia, Diarrhoea, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Alprazolam
    Dosage: po
    Administration route: Oral
    Indication: Anxiety

Entereg
    Dosage: 12 mg, bid, po
    Administration route: Oral
    Indication: Colectomy
    Start date: 2012-07-11
    End date: 2012-07-17

Ferrous Sulfate TAB
    Dosage: 350 mg, qd, po
    Administration route: Oral
    Indication: Anaemia

Lisinopril
    Dosage: 10 mg, qd, po
    Administration route: Oral
    Indication: Hypertension

Multi-Vitamin
    Indication: Medical Diet



Possible Entereg side effects in female

Reported by a physician from United States on 2012-02-07

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Entereg



Possible Entereg side effects in 73 year old female

Reported by a physician from United States on 2012-02-07

Patient: 73 year old female

Reactions: Agitation, Pulmonary Hypertension, Bundle Branch Block Left, Lactic Acidosis, Pyrexia, Lobar Pneumonia, Cardio-Respiratory Arrest, Dilatation Atrial, Small Intestinal Perforation, Respiratory Failure, Sepsis, Myocardial Infarction, Sinus Tachycardia, Pulseless Electrical Activity

Adverse event resulted in: death

Drug(s) suspected as cause:
Entereg

Other drugs received by patient: Lasix



Possible Entereg side effects in 79 year old male

Reported by a pharmacist from United States on 2011-11-29

Patient: 79 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Colon Cancer, Metabolic Acidosis, Respiratory Failure, Hypothermia, Ventricular Fibrillation, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Entereg

Other drugs received by patient: Metformin HCL; Glipizide; Simvastatin; Maxzide



Possible Entereg side effects in 81 year old male

Reported by a pharmacist from United States on 2011-11-16

Patient: 81 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: Acute Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Entereg



Possible Entereg side effects in 79 year old male

Reported by a pharmacist from United States on 2011-11-09

Patient: 79 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Electrocardiogram QT Prolonged, Metabolic Acidosis, Respiratory Failure, Diastolic Dysfunction, Left Ventricular Hypertrophy, Ventricular Fibrillation

Adverse event resulted in: death

Drug(s) suspected as cause:
Entereg

Other drugs received by patient: Plavix; Metformin HCL; Glipizide; Simvastatin; Maxzide



Possible Entereg side effects in 84 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-26

Patient: 84 year old male, weighing 78.0 kg (171.6 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Entereg

Other drugs received by patient: Simvastatin; Atenolol; Aspirin; Aricept; Oxybutynin; Hydralazine HCL



Possible Entereg side effects in female

Reported by a physician from United States on 2011-10-18

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Entereg

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