{
 "query": "hydromorphone",
 "ingredient": "hydromorphone",
 "slug": "hydromorphone",
 "rxcui": "3423",
 "brands": [
  "Dilaudid"
 ],
 "names": [
  "hydromorphone",
  "hydromorphone hydrochloride"
 ],
 "classes": [
  {
   "id": "N02AA",
   "name": "Natural opium alkaloids"
  }
 ],
 "alternatives": [
  "dihydrocodeine",
  "morphine",
  "opium",
  "oxycodone",
  "oxymorphone",
  "papaveretum"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 19,
   "INTRAMUSCULAR": 10,
   "INTRAVENOUS": 10,
   "SUBCUTANEOUS": 10,
   "RECTAL": 2
  },
  "boxed_warning": "WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of hydromorphone hydrochloride extended-release tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient\u2019s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride extended-release tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of hydromorphone hydrochloride extended-release tablets are essential. Instruct patients to swallow hydromorphone hydrochloride extended-release tablets whole to avoid exposure to a potentially fatal dose of hydromorphone [see Warnings and Precautions ( 5.2 )] . Accidental Ingestion Accidental ingestion of even one dose of hydromorphone hydrochloride extended-release tablets...",
  "indications_and_usage": "Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients 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. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use \u2022 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 hydromorphone hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. \u2022 Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Hydromor...",
  "contraindications": "Hydromorphone hydrochloride extended-release tablets are contraindicated in: \u2022 Opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant. \u2022 Patients with significant respiratory depression [see Warnings and Precautions ( 5.2 )] . \u2022 Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.7 )] . \u2022 Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.11 )] . \u2022 Patients who have had surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or have \u201cblind loops\u201d of the gastrointestinal tract or gastrointestinal obstruction [see Warnings and Precautions ( 5.11 )] . \u2022 Patients with hypersensitivity (e.g., anaphylaxis) to hydromorphone [see Warnings and Precautions ( 5.14 )]. \u2022 Opioid non-tolerant patients ( 4 ) \u2022 Significant respiratory depression ( 4 ) \u2022 Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment ( 4 ) \u2022 Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) \u2022 Narrowed or obstr...",
  "warnings_and_cautions": "\u2022 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. ( 5.6 ) \u2022 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or Elderly Cachectic Debilitated Patients : Regularly evaluate, particularly during initiation and titration. ( 5.7 ) \u2022 Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.8 ) \u2022 Severe Hypotension : Regularly evaluate during dose initiation and titration. Avoid use of hydromorphone hydrochloride extended-release tablets in patients with circulatory shock. ( 5.9 ) \u2022 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 hydromorphone hydrochloride extended-release tablets in patients with impaired consciousness or coma. ( 5.10 ) 5.1 Addiction, Abuse, and Misuse Hydromorphone h...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed elsewhere in the labeling: \u2022 Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] \u2022 Life-Threatening Respiratory Depression [see Warnings and Precautions ( 5.2 )] \u2022 Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.4 )] \u2022 Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions ( 5.3 )] \u2022 Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions ( 5.6 )] \u2022 Adrenal Insufficiency [see Warnings and Precautions ( 5.8 )] \u2022 Severe Hypotension [see Warnings and Precautions ( 5.9 )] \u2022 Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.11 )] \u2022 Seizures [see Warnings and Precautions ( 5.12 )] \u2022 Withdrawal [see Warnings and Precautions ( 5.13 )] Most common adverse reactions (incidence >10%) are: constipation, nausea, vomiting, somnolence, headache, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis \u00ae at 1-866-634-9120 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 t...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Hydromorphone hydrochloride extended-release tablets contains hydromorphone, a Schedule II controlled substance. 9.2 Abuse Hydromorphone hydrochloride extended-release tablets contains hydromorphone, 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 hydromorphone hydrochloride extended-release tablets increases risk of overdose, which may lead to central nervous system and r...",
  "controlled_substance": "9.1 Controlled Substance Hydromorphone hydrochloride extended-release tablets contains hydromorphone, a Schedule II controlled substance.",
  "recent_major_changes": "Boxed Warning 12/2025 Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.2 , 2.3 , 2.5 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.11 , 5.13 ) 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 hydromorphone hydrochloride extended-release tablets 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 hydromorphone hydrochloride extended-release tablets unsecured can pose a deadly risk to others in the home [see Warnings and Precautions ( 5.1 , 5.5 ), 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 hydromorphone hydrochloride extended-release tablets 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 hydromorphone hydrochlor...",
  "spl_medguide": "Medication Guide Dispense with Medication Guide available at www.padagis.com/medguide/HDMRTabs Medication Guide Hydromorphone Hydrochloride (hy-dr uh -mor-fon hy-dr uh -klawr-ahyd) Extended-Release Tablets, CII Hydromorphone hydrochloride extended-release tablets are: \u2022 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 pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them. \u2022 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 you are at risk for opioid addiction, abuse, and misuse that can lead to death. \u2022 Not to be taken on an \u201cas needed\u201d basis. Important information about hydromorphone hydrochloride extended-release tablets: \u2022 Get emergency help or call 911 right away if you take too much hydromorphone hydrochloride extended-release tablets (overdose). When you first start taking hydromorphone hydrochloride extended-release tablets, when your dose is changed, or if you take too much (overdose), serio...",
  "clinical_studies": "Hydromorphone hydrochloride extended-release tablets was investigated in a double-blind, placebo-controlled, randomized withdrawal study in opioid tolerant patients with moderate-to-severe low back pain. Patients were considered opioid tolerant if they were currently on opioid therapy that was \u2265 60 mg/day of oral morphine equivalent for at least 2 months prior to screening. Patients entered an open-label conversion and titration phase with hydromorphone hydrochloride extended-release tablets, were converted to a starting dose that was approximately 75% of their total daily morphine equivalent dose, and were dosed once daily until adequate pain control was achieved while exhibiting tolerable side effects. Supplemental immediate-release hydromorphone tablets were allowed throughout the study. Patients who achieved a stable dose entered a 12-week, double-blind, placebo-controlled, randomized treatment phase. Mean daily dose at randomization was 37.8 mg/day (range of 12 mg/day to 64 mg/day). Fifty-eight (58) percent of patients were successfully titrated to a stable dose of hydromorphone hydrochloride extended-release tablets during the open-label conversion and titration phase. During...",
  "brand_name": "hydromorphone hydrochloride",
  "manufacturer": "Padagis US LLC",
  "application_number": "ANDA204278",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251222",
  "set_id": "780a2616-0392-4715-bc50-71799bea1957",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": true
 },
 "faers": {
  "total": 120079,
  "serious": 110840,
  "death": 34048,
  "hospitalization": 27899,
  "primary_suspect": 119904,
  "top_reactions": [
   [
    "Drug Dependence",
    39853
   ],
   [
    "Overdose",
    25665
   ],
   [
    "Pain",
    24930
   ],
   [
    "Emotional Distress",
    18553
   ],
   [
    "Death",
    17501
   ],
   [
    "Drug Withdrawal Syndrome",
    14998
   ],
   [
    "Toxicity To Various Agents",
    11081
   ],
   [
    "Drug Ineffective",
    6990
   ],
   [
    "Nausea",
    6883
   ],
   [
    "Off Label Use",
    6355
   ],
   [
    "Fatigue",
    5730
   ],
   [
    "Vomiting",
    5212
   ],
   [
    "Headache",
    4242
   ],
   [
    "Anxiety",
    4058
   ],
   [
    "Drug Abuse",
    4050
   ]
  ],
  "by_year": {
   "2019": 5919,
   "2020": 14266,
   "2021": 22354,
   "2022": 18875,
   "2023": 4687,
   "2024": 4630,
   "2025": 4070,
   "2026": 1731
  },
  "by_year_primary": {
   "2019": 5916,
   "2020": 14266,
   "2021": 22341,
   "2022": 18844,
   "2023": 4631,
   "2024": 4617,
   "2025": 4026,
   "2026": 1722
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20180207",
   "reason": "Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20180207",
   "reason": "Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170822",
   "reason": "Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170726",
   "reason": "Presence of Particulate Matter: Silicone oil",
   "firm": "HOSPIRA INC, LAKE FOREST",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170726",
   "reason": "Presence of Particulate Matter: Silicone oil",
   "firm": "HOSPIRA INC, LAKE FOREST",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170726",
   "reason": "Presence of Particulate Matter: Silicone oil",
   "firm": "HOSPIRA INC, LAKE FOREST",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141001",
   "reason": "Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20120815",
   "reason": "Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20120512",
   "reason": "Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 9,
 "drugsfda": {
  "applications": 30,
  "nda": 7,
  "anda": 23,
  "first_approval": "19840111",
  "rems": true,
  "rems_last": "20260618",
  "labeling_supplements": 46,
  "labeling_recent": 11,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "ASCENT PHARMS INC",
   "AUROLIFE PHARMA LLC",
   "BARR",
   "FRESENIUS KABI USA",
   "GENUS",
   "HIKMA",
   "HOSPIRA"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/11/1984"
 },
 "trials": {
  "total": 345,
  "completed": 212,
  "terminated": 62,
  "with_results": 114,
  "industry": 68,
  "phase3": 63,
  "results_share": 0.5377358490566038,
  "terminated_share": 0.17971014492753623
 },
 "pubmed": {
  "rct": 186,
  "meta": 18,
  "recent_rct": 40,
  "cochrane": [
   {
    "pmid": "34350974",
    "title": "Hydromorphone for cancer pain",
    "year": "2021"
   },
   {
    "pmid": "27727452",
    "title": "Hydromorphone for cancer pain",
    "year": "2016"
   },
   {
    "pmid": "27216018",
    "title": "Hydromorphone for neuropathic pain in adults",
    "year": "2016"
   },
   {
    "pmid": "24162935",
    "title": "WITHDRAWN: Hydromorphone for acute and chronic pain",
    "year": "2013"
   },
   {
    "pmid": "11869661",
    "title": "Hydromorphone for acute and chronic pain",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 32966.04,
  "records": 12,
  "by_name": [
   [
    "Dilaudid",
    32966.04
   ]
  ],
  "names_checked": [
   "hydromorphone",
   "Dilaudid"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 790921,
  "beneficiaries": 213185,
  "spend": 18344225.62,
  "by_brand": [
   {
    "brand": "Hydromorphone HCl",
    "claims": 775285,
    "per_claim": 17.246320024,
    "is_generic": true
   },
   {
    "brand": "Hydromorphone ER",
    "claims": 14879,
    "per_claim": 310.71596277,
    "is_generic": false
   },
   {
    "brand": "Dilaudid",
    "claims": 757,
    "per_claim": 462.70751651,
    "is_generic": false
   }
  ],
  "per_claim": 23.193499249609
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "hydromorphone",
  "matched": "hydromorphone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10365,
  "fills": 790921,
  "per_million": 13104.975086007325,
  "ratio": 4.732832391800467,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 5,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "13,105 FDA reports naming it as the suspect drug per million Medicare fills, 4.7x the median drug on this site (-13)",
    "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 3.1x the share of reports seen across all of FAERS (-12)",
    "4 Class I recall(s): reasonable probability of serious harm (-20)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "186 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "5 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 47,
   "letter": "F",
   "why": [
    "Recalls since 2016: 2 Class I, 4 Class II, 0 Class III across 23 generic makers (-30)",
    "REMS program in force (-10)",
    "11 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": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $32,966 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (23 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 51,
 "grade": "D",
 "questions": [
  "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, overdose, pain, emotional distress. How would we recognize and handle those?",
  "Why this one over dihydrocodeine, morphine, opium? What would make you pick one of those instead?",
  "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.)"
 ]
}