![]() Severe adverse effects such as respiratory depression can be treated with the opioid antagonist naloxone. Postmarketing reports: Serotonin syndrome Respiratoryįrequency not reported: Apnea, respiratory arrest, bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, sinusitis Very common (10% or more): Headache (14%, pediatrics)Ĭommon (1% to 10%): Dizziness (pediatrics)įrequency not reported: Confusion, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, migraine In pediatric patients, the most frequently observed adverse reactions included vomiting, nausea, headache, pyrexia, and constipation. ![]() The most commonly reported adverse reactions in adults included constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating. For Healthcare ProfessionalsĪpplies to oxycodone: compounding powder, oral capsule, oral capsule extended release, oral concentrate, oral solution, oral tablet, oral tablet extended release. See the FDA REMS page ( ).Ĭonstipation, nausea, sedation/somnolence, dizziness, lightheadedness, vomiting, pruritus, headache, insomnia, dry mouth, sweating, asthenia. The REMS may apply to one or more preparations of oxycodone and consists of the following: medication guide and elements to assure safe use. Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.įDA approved a REMS for oxycodone to ensure that the benefits outweigh the risk. Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS). This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal. Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.Ī new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA). The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. FDA drug safety communication (): 500 As part of its ongoing efforts to address the nation’s opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines.
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