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Review Naltrexone Safety Reports submitted to FDA

Total Naltrexone reports: 10.
Naltrexone FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 4.
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FDA Reported Naltrexone Side Effects: accidental overdose, agitation, suicidal ideation, intentional self-injury, hypomania, homicidal ideation, frustration, feeling of despair, depression, condition aggravated, vomiting.
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Naltrexone Side Effects Report #5591368-1
Consumer or non-health professional from UNITED STATES reported NALTREXONE problem on Jan 11, 2008. Female patient, weighting 170.0 lb, was diagnosed with alcohol abuse and was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, diarrhoea, hepatocellular injury, malaise, vomiting. NALTREXONE dosage: 50MG WHENEVER NEEDED PO. Patient was hospitalized. Patient recovered.

Naltrexone Side Effects Report #5564257-6
NALTREXONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 04, 2007. Male patient, 40 years of age, was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: dependence, mental disorder, mouth injury. NALTREXONE dosage: unknown. Patient recovered.

Naltrexone Side Effects Report #5568872-5
Consumer or non-health professional from UNITED KINGDOM reported NALTREXONE problem on Oct 04, 2007. Male patient, 40 years of age, was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: mouth injury, self mutilation. NALTREXONE dosage: unknown. Patient recovered.

Naltrexone Side Effects Report #5493238-6
NALTREXONE problem was reported by a Physician from UNITED STATES on Oct 22, 2007. Male patient, weighting 200.0 lb, was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: lip swelling, swelling face, swollen tongue, throat tightness, urticaria. NALTREXONE dosage: unknown. Patient recovered.

Naltrexone Side Effects Report #5504471-9
Consumer or non-health professional from UNITED KINGDOM reported NALTREXONE problem on Oct 24, 2007. Female patient, 37 years of age, was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. NALTREXONE dosage: 25 MILLIGRAM ORAL. During the same period patient was treated with AMITRIPTYLINE, PROPRANOLOL HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Naltrexone Side Effects Report #5458154-4
NALTREXONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 05, 2007. Male patient, 20 years of age, was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, dehydration, liver function test abnormal, renal failure acute, vomiting. NALTREXONE dosage: 50 MILLIGRAM ORAL. Patient was hospitalized. Patient recovered.

Naltrexone Side Effects Report #5474729-0
Pharmacist from UNITED STATES reported NALTREXONE problem on Sept 27, 2007. Female patient, 15 years of age, weighting 199.0 lb, was diagnosed with alcoholism, self mutilation, depression and was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: agitation, condition aggravated, depression, feeling of despair, frustration, homicidal ideation, hypomania, intentional self-injury, suicidal ideation. NALTREXONE dosage: 50MG DAILY IN THE AM PO. During the same period patient was treated with CITALOPRAM. Patient recovered.

Naltrexone Side Effects Report #5767011-5
NALTREXONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 03, 2008. Female patient, 63 years of age, was diagnosed with multiple sclerosis and was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: withdrawal syndrome. NALTREXONE dosage: 4.5 MILLIGRAM 1 DAY. Patient recovered.

Naltrexone Side Effects Report #5675058-2
Physician from UNITED STATES reported NALTREXONE problem on Nov 09, 2007. Male patient, 49 years of age, was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: hypoxic encephalopathy, respiratory arrest. NALTREXONE dosage: 25 MG QD. During the same period patient was treated with SUBUTEX, BENZODIAZEPINE DERIVATIVES. Patient was hospitalized. Patient died on 11/11/2007.

Naltrexone Side Effects Report #5314585-4
NALTREXONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Apr 12, 2007. Male patient, 41 years of age, was diagnosed with alcoholism and was treated with NALTREXONE. After drug was administered, patient experienced the following problems/side effects: gamma-glutamyltransferase increased, hypercholesterolaemia, hypertriglyceridaemia. NALTREXONE dosage: 50 MILLIGRAM ORAL. During the same period patient was treated with HALOPERIDOL, LITHIUM CARBONATE, PAROXETINE. Patient recovered.


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abdominal pain upper, diarrhoea, hepatocellular injury, malaise, vomiting, dependence, mental disorder, mouth injury, , was diagnosed with alcohol abuse and was diagnosed with alcoholism, self mutilation, depression and