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Relistor (Methylnaltrexone Subcutaneous) - Side Effect Reports to FDA

 
 



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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