| Document Date: 2014-11-18 14:16:12
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City Reference / / Company Janssen Pharmaceuticals Inc. / / Event Product Issues / Product Recall / FDA Phase / / IndustryTerm Monitor for signs of serotonin syndrome / non-prescription products / machinery / opioid drug product / Chronic Pulmonary Disease Monitor / mg/mL oral solution / food / healthcare team / resuscitative equipment / dangerous machinery / / MedicalCondition tremors / significant chronic obstructive pulmonary disease / CNS depression / headache / Seizures / Neonatal Withdrawal Syndrome / Debilitated Patients Respiratory depression / alcohol abuse / coma / hallucinations / nausea / severe hypotension / fatal respiratory depression / chronic therapy / convulsive disorders / mental illness / biliary tract disease / Hypersensitivity / diarrhea / central nervous system depression / chronic pulmonary disease / circulatory shock / respiratory and central nervous system depression / seizure disorders / brain tumors / head injury / asthma / hypotension / incoordination / e.g. anaphylaxis / insomnia / precipitate withdrawal symptoms / convulsions / hyperreflexia / Life Threatening Respiratory Depression Respiratory depression / Carcinogenesis / chronic obstructive pulmonary disease / seizure disorder / addiction disorders / worsened seizure / Withdrawal Withdrawal symptoms / apnea / Seizures NUCYNTA / severe bronchial asthma / paralytic ileus / vomiting / pain / Serotonin Syndrome / Illicit Drugs Hypotension / angioedema / Drug Abuse / rigors / Significant respiratory depression / respiratory depression / dizziness / spasm / opioid-induced respiratory depression / Withdrawal symptoms / Life Threatening Respiratory Depression / acute pancreatitis / depression / cor pulmonale / tachycardia / labile blood pressure / / MedicalTreatment Orthopedic Surgery / / Organization FDA / / Person Injury / / / Position physician / / Product Serotonin Syndrome Risk 5.12 Use / mirtazapine / morphine sulfate / symptoms / Neonatal / nalbuphine / NUCYNTA® oral / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NUCYNTA® safely and effectively. See full prescribing information for NUCYNTA®.