This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Relistor (Methylnaltrexone Subcutaneous) 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 (11)
Death (3)
Life Threatening Events (1)
Reports by Reaction Type
Vomiting (3),
Nausea (3),
Mental Status Changes (2),
Metabolic Acidosis (2),
Hypotension (2),
NO Therapeutic Response (2),
Agitation (1),
Confusional State (1),
Haematocrit Decreased (1),
Abdominal Distension (1),
Renal Failure Acute (1),
General Physical Health Deterioration (1)
Possible Relistor side effects in 51 year old female
Reported by a pharmacist from United States on 2012-07-30
Patient: 51 year old female
Reactions: Bladder Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Relistor
Possible Relistor side effects in 58 year old female
Reported by a physician from United States on 2012-06-04
Patient: 58 year old female, weighing 76.7 kg (168.7 pounds)
Reactions: Confusional State, Agitation, Hypotension, Mental Status Changes, Blood Thyroid Stimulating Hormone Decreased, Somnolence, Sedation, Depressed Level of Consciousness, Adrenal Insufficiency, Sluggishness, Renal Failure Acute, Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Avinza; Valproate Sodium; Paroxetine; Lisinopril; Pravastatin; Arthrotec; Morphine Sulfate; Cyclobenzaprine; Propranolol; Zopidem
Possible Relistor side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31
Patient: 53 year old male
Reactions: Migraine, Visual Impairment, Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Allopurinol; Percocet; Urocit-K; Kadian; Hydrochlorothiazide
Possible Relistor side effects in 46 year old female
Reported by a physician from Canada on 2012-05-08
Patient: 46 year old female
Reactions: Vomiting, Nausea, NO Therapeutic Response
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Polyethylene Glycol; Colace; Hydromorph Contin (Sustained Release Capsule); Senokot; Dilaudid; Nozinan; Alendronate Sodium; Epipen
Possible Relistor side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-02
Patient: male, weighing 95.2 kg (209.5 pounds)
Reactions: Diarrhoea
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Sertraline Hydrochloride; Methadone; Lipitor; Singulair; Coumadin; Metformin; Avodart; Furosemide; Methadone; Advair Diskus 100 / 50; Neurontin; Metoprolol; Vicodin; Sertraline Hydrochloride; Digoxin
Possible Relistor side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-01
Patient: 73 year old male, weighing 87.0 kg (191.4 pounds)
Reactions: Mental Status Changes, Coma, Chest X-RAY Abnormal, Multi-Organ Failure, Haematocrit Decreased, Abdominal Distension, Gastrointestinal Sounds Abnormal, Metabolic Acidosis, General Physical Health Deterioration, Atrial Fibrillation, Renal Impairment, Escherichia Test Positive, Bacteraemia, Respiratory Failure, Ventricular Tachycardia, Platelet Count Decreased, Cardiac Arrest, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Synthroid; Miralax; Flomax; Metolazone; Dilaudid; Lasix; Potassium Chloride; MS Contin; Avodart
Possible Relistor side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-19
Patient: 73 year old male
Reactions: Metabolic Acidosis, Pain in Extremity, Hypotension, Swelling, Escherichia Infection, Constipation, Hypovolaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Lasix; Dilaudid; Miralax; MS Contin; Metolazone; Avodart; Potassium; Flomax; Synthroid
Possible Relistor side effects in 46 year old female
Reported by a physician from Canada on 2011-12-14
Patient: 46 year old female
Reactions: Vomiting, Nausea, NO Therapeutic Response
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Relistor
Dosage: (12 mg), subcutaneous)
Naltrexone Hydrochloride
Dosage: (as required),subcutaneous
Indication: Constipation
Start date: 2009-03-15
End date: 2009-10-24
Other drugs received by patient: Hydromorph Contin (Sustained-Release Capsule); Senokot; Dilaudid; Epipen; Alendronate Sodium; Nozinan; Polyethylene Glycol; Colace
Possible Relistor side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-09
Patient: male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Relistor
Possible Relistor side effects in 46 year old female
Reported by a physician from Canada on 2011-11-03
Patient: 46 year old female
Reactions: Vomiting, Nausea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Relistor
Other drugs received by patient: Hydromorphone (Sustained-Release Capsule); Fentanyl
Possible Relistor side effects in 71 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-05
Patient: 71 year old male
Reactions: Anxiety, Malaise, Tachypnoea, Pallor, Hyperhidrosis, Respiratory Distress
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Relistor
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