{
 "query": "oxycodone",
 "ingredient": "oxycodone",
 "slug": "oxycodone",
 "rxcui": "7804",
 "brands": [
  "Oxycontin",
  "Roxicodone",
  "Roxybond",
  "Oxaydo",
  "Xtampza"
 ],
 "names": [
  "oxycodone",
  "oxycodone hydrochloride",
  "oxycodone terephthalate"
 ],
 "classes": [
  {
   "id": "N02AA",
   "name": "Natural opium alkaloids"
  }
 ],
 "alternatives": [
  "dihydrocodeine",
  "hydromorphone",
  "morphine",
  "opium",
  "oxymorphone",
  "papaveretum"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 163
  },
  "boxed_warning": "WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF XTAMPZA ER See full prescribing information for complete boxed warning . XTAMPZA ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of XTAMPZA ER are essential. ( 5.2 ) Accidental ingestion of XTAMPZA ER, especially by children, can result in fatal overdose of oxycodone. ( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) Advise pregnant using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may ...",
  "indications_and_usage": "is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. XTAMPZA ER is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death,which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including XTAMPZA ER, for use in patients for whom alternative treatment optionsare ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) XTAMPZA ER is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ], reserve opioid analgesics, including XTAMPZA ER, for use in patients for whom alternative treatme...",
  "contraindications": "is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity (e.g., anaphylaxis) to oxycodone. Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to oxycodone ( 4 )",
  "warnings_and_cautions": "Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.7 ) Risk of life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Regularly evaluate. ( 5.8 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) Severe hypotension : Regularly evaluate. Avoid use of XTAMPZA ER in patients with circulatory shock. ( 5.10 ) Risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness : Monitor for sedation and respiratory depression. Avoid use of XTAMPZA ER in patients with impaired consciousness or coma. ( 5.11 ) 5.1 Addiction, Abuse, and Misuse XTAMPZA ER contains oxycodone, a Schedule II controlled substance. As an opioid, XTAMPZA ER exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Depe...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Severe Hypotension [see Warnings and Precautions (5.10) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] Seizures [see Warnings and Precautions (5.13) ] Withdrawal [see Warnings and Precautions (5.14) ] Most common adverse reactions (>5%) were nausea, headache, constipation, somnolence, pruritus, vomiting, and dizziness. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Collegium Pharmaceutical, Inc. at 1-855-331-5615 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance XTAMPZA ER contains oxycodone, a Schedule II controlled substance. 9.2 Abuse XTAMPZA ER contains oxycodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of XTAMPZA ER increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. The risk is increased with concurrent abuse of XTAMPZA ER with alcohol and/or ...",
  "controlled_substance": "9.1 Controlled Substance XTAMPZA ER contains oxycodone, a Schedule II controlled substance.",
  "recent_major_changes": "Boxed Warning 12/2025 Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.1 , 2.3 , 2.5 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.14 ) 12/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store XTAMPZA ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving XTAMPZA ER unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1 , 5.2) , Drug Abuse and Dependence (9.2) ]. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused XTAMPZA ER should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines. Addiction, Abuse, and Misuse Inform patients that the use of XTAMPZA ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precaution...",
  "spl_medguide": "Medication Guide XTAMPZA \u00ae ER (ex tamp' zah ee ar) (oxycodone) extended-release capsules, CII This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: December 2025 XTAMPZA ER is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid medicine, when other pain medicines do not treat your pain well enough or you cannot tolerate them. A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death. Not to be taken on an \"as needed\" basis Important information about XTAMPZA ER: Get emergency help or call 911 right away if you take too much XTAMPZA ER (overdose). When you first start taking XTAMPZA ER, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in a...",
  "clinical_studies": "An enriched-enrollment, randomized-withdrawal, double-blind, placebo-controlled, parallel group, study was conducted in 740 patients with persistent, moderate-to-severe chronic lower back pain, with inadequate pain control from their prior therapy. During screening, patients stopped their prior opioid analgesics and/or non-opioid analgesics prior to starting XTAMPZA ER treatment. Patients were titrated to a stable and tolerated dose between 18 mg (equivalent to 20 mg oxycodone HCl) twice daily and 72 mg (equivalent to 80 mg oxycodone HCl) twice daily of XTAMPZA ER in an open-label fashion during the first six weeks of the trial. Optional use of rescue medication (acetaminophen 500 mg tablets) up to 2 tablets every 4-6 hours was permitted during the dose titration phase, up to 2000 mg per day. XTAMPZA ER was titrated once every three to seven days until a stable and tolerable dose was identified (maximum dose of 72 mg [equivalent to 80 mg oxycodone HCl] twice daily). Following the titration phase, 389 subjects (53%) met the study randomization criteria of adequate analgesia (pain reduction of at least 2 points from screening baseline to a score of 4 or less on a 0-10 numerical ratin...",
  "brand_name": "XTAMPZA ER",
  "manufacturer": "Collegium Pharmaceutical, Inc.",
  "application_number": "NDA208090",
  "pharm_class_epc": [
   "Opioid Agonist [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251230",
  "set_id": "b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": true
 },
 "faers": {
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 },
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  {
   "class": "Class II",
   "date": "20260114",
   "reason": "Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20231020",
   "reason": "Sub-potent Drug: Lower potency than labeled.",
   "firm": "Zyla Life Sciences US Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220222",
   "reason": "Impurity failure at 0-time of the repackaged lot.",
   "firm": "American Health Packaging",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20211229",
   "reason": "Out-of-specification impurity test result observed at 18-month long term stability time point.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210819",
   "reason": "Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle",
   "firm": "Rhodes Pharmaceuticals, L.P.",
   "status": "Terminated"
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  {
   "class": "Class III",
   "date": "20201223",
   "reason": "Presence of Foreign Substance: Particulate matter was found in multiple lots of product.",
   "firm": "Genus Lifesciences Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180122",
   "reason": "Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol",
   "firm": "Ascent Pharmaceuticals, Inc.",
   "status": "Terminated"
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  {
   "class": "Class III",
   "date": "20160519",
   "reason": "Failed Impurities/Degradation Specification; 9 month stability",
   "firm": "West-Ward Columbus Inc",
   "status": "Terminated"
  }
 ],
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   "ACTAVIS ELIZABETH",
   "ADAPTIS",
   "ALKEM LABS LTD",
   "ALVOGEN",
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "ASCENT PHARMS INC"
  ],
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 },
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  "cochrane": [
   {
    "pmid": "35679121",
    "title": "Oxycodone for cancer-related pain",
    "year": "2022"
   },
   {
    "pmid": "28829910",
    "title": "Oxycodone for cancer-related pain",
    "year": "2017"
   },
   {
    "pmid": "27582266",
    "title": "Oxycodone for pain in fibromyalgia in adults",
    "year": "2016"
   },
   {
    "pmid": "27465317",
    "title": "Oxycodone for neuropathic pain in adults",
    "year": "2016"
   },
   {
    "pmid": "25723351",
    "title": "Oxycodone for cancer-related pain",
    "year": "2015"
   },
   {
    "pmid": "24956205",
    "title": "Oxycodone for neuropathic pain and fibromyalgia in adults",
    "year": "2014"
   },
   {
    "pmid": "24874470",
    "title": "Impact of morphine, fentanyl, oxycodone or codeine on patient consciousness, appetite and thirst when used to treat cancer pain",
    "year": "2014"
   },
   {
    "pmid": "23801549",
    "title": "Single dose oral ibuprofen plus oxycodone for acute postoperative pain in adults",
    "year": "2013"
   },
   {
    "pmid": "19588335",
    "title": "Single dose oral oxycodone and oxycodone plus paracetamol (acetaminophen) for acute postoperative pain in adults",
    "year": "2009"
   },
   {
    "pmid": "11034756",
    "title": "Single dose oxycodone and oxycodone plus paracetamol (acetominophen) for acute postoperative pain",
    "year": "2000"
   }
  ]
 },
 "payments": {
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   "Roxicodone",
   "Roxybond",
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   "Xtampza"
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 },
 "partd": {
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   {
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   {
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   {
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 "mdl": [
  {
   "number": "2804",
   "title": "National Prescription Opiate Litigation",
   "judge": "Polster, Dan A.",
   "court": "OHN",
   "docket": "1:17-md-2804",
   "actions": "",
   "matched": "opiate"
  },
  {
   "number": "2996",
   "title": "McKinsey & Company, Inc., National Prescription Opiate Consultant Litigation",
   "judge": "Breyer, Charles R.",
   "court": "CAN",
   "docket": "3:21-md-2996",
   "actions": "",
   "matched": "opiate"
  }
 ],
 "dsc": [
  {
   "date": "20250731",
   "title": "FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-opioid-pain-medicine-manufacturers-update-prescribing-information-regarding-long-term",
   "kind": "class",
   "matched": "opioid"
  },
  {
   "date": "20230413",
   "title": "FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-use",
   "kind": "class",
   "matched": "opioid"
  },
  {
   "date": "20220630",
   "title": "FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-recommends-health-care-professionals-discuss-naloxone-all-patients-when-prescribing-opioid-pain",
   "kind": "class",
   "matched": "opioid"
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  {
   "date": "20190409",
   "title": "FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm",
   "kind": "class",
   "matched": "opioid"
  },
  {
   "date": "20180111",
   "title": "FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm590435.htm",
   "kind": "class",
   "matched": "opioid"
  },
  {
   "date": "20170920",
   "title": "FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm575307.htm",
   "kind": "class",
   "matched": "opioid"
  },
  {
   "date": "20160831",
   "title": "FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm518473.htm",
   "kind": "class",
   "matched": "opioid"
  },
  {
   "date": "20160322",
   "title": "FDA warns about several safety issues with opioid pain medicines; requires label changes",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm489676.htm",
   "kind": "class",
   "matched": "opioid"
  }
 ],
 "settlements": [
  {
   "year": 2007,
   "company": "Purdue Pharma",
   "amount_usd": 601000000.0,
   "amount_text": "$601 million",
   "violations": "Off-label promotion",
   "products": "Oxycontin",
   "laws": "False Claims Act",
   "urls": [
    "https://www.justice.gov/usao/eousa/foia_reading_room/usab5701.pdf"
   ],
   "matched": "oxycontin"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "oxycodone",
  "matched": "oxycodone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 26325,
  "fills": 10012757,
  "per_million": 2629.1459984497774,
  "ratio": 0.9495101869763852,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 30,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 8 Drug Safety Communication(s) about this drug's class since 2010 (-8)",
    "2,629 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death appears in 2.6x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 71,
   "letter": "C",
   "why": [
    "442 randomized trials and 35 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "10 independent Cochrane review(s) exist",
    "Only 47% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 71,
   "letter": "C",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 5 Class III across 45 generic makers (-6)",
    "REMS program in force (-10)",
    "31 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 15,
   "letter": "F",
   "why": [
    "Maker paid $601 million in 2007 to settle federal allegations naming this drug (Off-label promotion) (-15)",
    "Pharma paid doctors $3,041,014 tied to this drug last year (-30)",
    "Named in 2 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (45 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 51,
 "grade": "D",
 "questions": [
  "The maker paid $601 million in 2007 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are drug dependence, pain, overdose, emotional distress. How would we recognize and handle those?",
  "Why this one over dihydrocodeine, hydromorphone, morphine? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}