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Index of reports
> Cases with Respiratory Depression (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Opana (Oxymorphone) where reactions include respiratory depression. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Opana side effects in 42 year old male
Reported by a individual with unspecified qualification from United States on 2012-04-18
Patient: 42 year old male, weighing 97.3 kg (214.1 pounds)
Reactions: Unresponsive To Stimuli, Respiratory Depression, Toxicity To Various Agents, Drug Abuse, Cardiomegaly, Hepatic Steatosis, Multiple Drug Overdose Accidental, Visceral Congestion, Aortic Arteriosclerosis, Respiratory Arrest, Depressed Level of Consciousness, Arteriosclerosis Coronary Artery
Adverse event resulted in: death
Drug(s) suspected as cause:
Carbamazepine
Indication: Product Used FOR Unknown Indication
Opana
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Oxycodone HCL
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Diazepam
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Morphine SUL TAB
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Alprazolam
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Oxycodone / Acetaminophen (Paracetamol, Oxycodone Hydrochloride) (Tablet; Metoprolol Succinate; Lithium Carbonate; Naproxen
Possible Opana side effects in male
Reported by a consumer/non-health professional on 2012-01-11
Patient: male
Reactions: Agitation, Dyspnoea, Wrong Technique in Drug Usage Process, Tinnitus, Drug Ineffective FOR Unapproved Indication, Respiratory Depression, Drug Abuse, Delusion, Brain Injury, Psychotic Disorder, Syncope, Insomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Opana ER
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Opana
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Other drugs received by patient: Xanax
Possible Opana side effects in male
Reported by a pharmacist from United States on 2012-01-04
Patient: male
Reactions: Agitation, Product Quality Issue, Weight Decreased, Respiratory Depression, Delusion, Brain Stem Syndrome, Brain Injury, Hypoacusis, Psychotic Disorder, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
End date: 2011-08-01
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-16
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
MS Contin
Dosage: 60 mg, unk
Start date: 2010-10-01
End date: 2011-08-01
Possible Opana side effects in male
Reported by a pharmacist from United States on 2011-12-29
Patient: male
Reactions: Product Quality Issue, Agitation, Weight Decreased, Respiratory Depression, Delusion, Hypoacusis, Brain Stem Syndrome, Brain Injury, Psychotic Disorder, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
End date: 2011-08-01
Lorcet-HD
Indication: Product Used FOR Unknown Indication
MS Contin
Dosage: 60 mg, unk
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
End date: 2011-08-01
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-16
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-28
Patient: male
Reactions: Product Quality Issue, Agitation, Weight Decreased, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-01
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-22
Patient: male
Reactions: Weight Decreased, Agitation, Product Quality Issue, Respiratory Depression, Brain Injury, Hypoacusis, Brain Stem Syndrome, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-16
Patient: male
Reactions: Agitation, Tinnitus, Dyspnoea, Wrong Technique in Drug Usage Process, Drug Ineffective FOR Unapproved Indication, Respiratory Depression, Drug Abuse, Brain Injury, Syncope, Insomnia
Drug(s) suspected as cause:
Opana
Dosage: 10 mg
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Opana ER
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Other drugs received by patient: Xanax
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-01
Patient: male
Reactions: Agitation, Wrong Technique in Drug Usage Process, Dyspnoea, Tinnitus, Drug Ineffective FOR Unapproved Indication, Respiratory Depression, Drug Abuse, Syncope, Insomnia
Drug(s) suspected as cause:
Opana
Dosage: 10 mg
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Opana ER
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2007-01-01
Other drugs received by patient: Xanax
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: male
Reactions: Weight Decreased, Agitation, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Insomnia, Product Taste Abnormal, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Lorcet-HD
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-01
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-23
Patient: male
Reactions: Agitation, Weight Decreased, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Insomnia, Product Taste Abnormal, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-11
Patient: male
Reactions: Agitation, Weight Decreased, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Insomnia, Product Taste Abnormal, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Lorcet-HD
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-01
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-07
Patient: male
Reactions: Weight Decreased, Agitation, Respiratory Depression, Brain Injury, Hypoacusis, Brain Stem Syndrome, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Lorcet-HD
Indication: Product Used FOR Unknown Indication
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