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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