{
 "query": "morphine",
 "ingredient": "morphine",
 "slug": "morphine",
 "rxcui": "7052",
 "brands": [
  "MS Contin",
  "Duramorph",
  "Infumorph",
  "Kadian",
  "Mitigo"
 ],
 "names": [
  "morphine",
  "morphine hydrochloride",
  "morphine liposomal",
  "morphine sulfate",
  "morphine sulfate liposomal",
  "morphine tartrate"
 ],
 "classes": [
  {
   "id": "N02AA",
   "name": "Natural opium alkaloids"
  }
 ],
 "alternatives": [
  "dihydrocodeine",
  "hydromorphone",
  "opium",
  "oxycodone",
  "oxymorphone",
  "papaveretum"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 59,
   "INTRAVENOUS": 8,
   "RECTAL": 5,
   "EPIDURAL": 4,
   "INTRATHECAL": 4,
   "INTRAMUSCULAR": 2
  },
  "boxed_warning": "WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MS CONTIN Addiction, Abuse, and Misuse Because the use of MS CONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warning and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of MS CONTIN, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of MS CONTIN are essential. Instruct patients to swallow MS CONTIN tablets whole; crushing, chewing, or dissolving MS CONTIN tablets can cause rapid release and absorption of a potentially fatal dose of morphine [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of MS CONTIN, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.2) ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concom...",
  "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. 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 (5.2) ] , reserve opioid analgesics, including MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. MS CONTIN is not indicated as an as-needed (prn) analgesic. MS CONTIN 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 MS CONTIN, for use in patients for whom alternative treatment options are inef...",
  "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 (5.7) ] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.8) , Drug Interactions (7) ]. Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] Hypersensitivity (e.g., anaphylaxis) to morphine [see Adverse Reactions (6.2) ] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 4 ) Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus ( 4 ) Hypersensitivity to morphine ( 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. ( 5.6 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate, particularly during initiation and titration. ( 5.7 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) Severe Hypotension : Regularly evaluate during dosage initiation and titration. Avoid use 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 MS CONTIN in patients with impaired consciousness or coma. ( 5.11 ) 5.1 Addiction, Abuse, and Misuse MS CONTIN contains morphine, a Schedule II controlled substance. As an opioid, MS CONTIN exposes its users to the...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Interactions with Benzodiazepine 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 (5.6) ] 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 (>10%): constipation, nausea, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals LLC at 1-888-873-5329 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 a drug cannot be directly c...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance MS CONTIN contains morphine, a Schedule II controlled substance. 9.2 Abuse MS CONTIN contains morphine, a substance with a 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 health care 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 to other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of MS CONTIN 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 MS CONTIN with alcohol and/or ...",
  "controlled_substance": "9.1 Controlled Substance MS CONTIN contains morphine, 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 , 2.6 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.12 , 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 MS CONTIN 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 MS CONTIN unsecured can pose a deadly risk to others in the home [see Warnings and Precautions (5.1) , 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 MS CONTIN 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 MS CONTIN, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1) ]....",
  "spl_medguide": "Medication Guide MS CONTIN \u00ae (MS-KON-tin) (morphine sulfate extended-release tablets), CII This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 05/2026 MS CONTIN is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that required 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. 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. Not to be taken on an \"as needed\" basis. Important information about MS CONTIN: Get emergency help or call 911 right away if you take too much MS CONTIN (overdose) . When you first start taking MS CONTIN, when your dose is changed, or if you take too much (overdose), serious or 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 an emergency to reverse an opioi...",
  "clinical_studies": "",
  "brand_name": "MS Contin",
  "manufacturer": "Rhodes Pharmaceuticals LLC",
  "application_number": "NDA019516",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260814",
  "set_id": "c354b3bf-86c0-4bb8-8b1f-be2164942698",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": true
 },
 "faers": {
  "total": 184759,
  "serious": 159670,
  "death": 49939,
  "hospitalization": 47170,
  "primary_suspect": 184202,
  "top_reactions": [
   [
    "Drug Dependence",
    40338
   ],
   [
    "Overdose",
    27722
   ],
   [
    "Pain",
    27066
   ],
   [
    "Death",
    21655
   ],
   [
    "Emotional Distress",
    18331
   ],
   [
    "Toxicity To Various Agents",
    16092
   ],
   [
    "Drug Withdrawal Syndrome",
    15160
   ],
   [
    "Drug Hypersensitivity",
    11865
   ],
   [
    "Nausea",
    9787
   ],
   [
    "Drug Ineffective",
    9293
   ],
   [
    "Fatigue",
    7382
   ],
   [
    "Vomiting",
    7261
   ],
   [
    "Off Label Use",
    7224
   ],
   [
    "Drug Abuse",
    6573
   ],
   [
    "Diarrhoea",
    6024
   ]
  ],
  "by_year": {
   "2019": 12940,
   "2020": 20184,
   "2021": 30409,
   "2022": 18822,
   "2023": 13407,
   "2024": 8158,
   "2025": 6985,
   "2026": 3067
  },
  "by_year_primary": {
   "2019": 12930,
   "2020": 20171,
   "2021": 30368,
   "2022": 18739,
   "2023": 13315,
   "2024": 8043,
   "2025": 6893,
   "2026": 2975
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20260804",
   "reason": "Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20251126",
   "reason": "Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.",
   "firm": "Winder Laboratories, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250206",
   "reason": "Failed Dissolution Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240312",
   "reason": "The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20231020",
   "reason": "Subpotent Drug",
   "firm": "Edenbridge Pharmaceuticals, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210917",
   "reason": "Defective container: Cracked vials leading to lack of sterility assurance",
   "firm": "Fresenius Kabi USA LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190410",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190410",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190410",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190410",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190410",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20180823",
   "reason": "Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testin",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  }
 ],
 "recall_total": 14,
 "drugsfda": {
  "applications": 76,
  "nda": 17,
  "anda": 59,
  "first_approval": "19840918",
  "rems": true,
  "rems_last": "20260618",
  "labeling_supplements": 112,
  "labeling_recent": 28,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ALKEM LABS LTD",
   "ALLERGAN",
   "ANDA REPOSITORY",
   "ANI PHARMS",
   "CHARTWELL MOLECULAR",
   "DAVA PHARMS INC",
   "DR REDDYS LABS SA"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/18/1984"
 },
 "trials": {
  "total": 2773,
  "completed": 1712,
  "terminated": 331,
  "with_results": 544,
  "industry": 541,
  "phase3": 413,
  "results_share": 0.3177570093457944,
  "terminated_share": 0.11936530833032817
 },
 "pubmed": {
  "rct": 2530,
  "meta": 142,
  "recent_rct": 200,
  "cochrane": [
   {
    "pmid": "28530786",
    "title": "Morphine for chronic neuropathic pain in adults",
    "year": "2017"
   },
   {
    "pmid": "27140500",
    "title": "Single dose intra-articular morphine for pain control after knee arthroscopy",
    "year": "2016"
   },
   {
    "pmid": "27105021",
    "title": "Oral morphine for cancer pain",
    "year": "2016"
   },
   {
    "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": "23881654",
    "title": "Oral morphine for cancer pain",
    "year": "2013"
   },
   {
    "pmid": "23740540",
    "title": "Slow-release oral morphine as maintenance therapy for opioid dependence",
    "year": "2013"
   },
   {
    "pmid": "17943804",
    "title": "Oral morphine for cancer pain",
    "year": "2007"
   },
   {
    "pmid": "14583997",
    "title": "Oral morphine for cancer pain",
    "year": "2003"
   },
   {
    "pmid": "12137662",
    "title": "Nebulised morphine for severe interstitial lung disease",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 62.72,
  "records": 3,
  "by_name": [
   [
    "Mitigo",
    62.72
   ]
  ],
  "names_checked": [
   "morphine",
   "MS Contin",
   "Duramorph",
   "Infumorph",
   "Kadian",
   "Mitigo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2640552,
  "beneficiaries": 488428,
  "spend": 75991802.66,
  "by_brand": [
   {
    "brand": "Morphine Sulfate ER",
    "claims": 1918463,
    "per_claim": 30.347331353,
    "is_generic": false
   },
   {
    "brand": "Morphine Sulfate",
    "claims": 721076,
    "per_claim": 23.652760888,
    "is_generic": true
   },
   {
    "brand": "Ms Contin",
    "claims": 1013,
    "per_claim": 706.94185587,
    "is_generic": false
   }
  ],
  "per_claim": 28.778756358518976
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "morphine",
  "matched": "morphine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 17911,
  "fills": 2640552,
  "per_million": 6783.051422581339,
  "ratio": 2.449683824452198,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 20,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "6,783 FDA reports naming it as the suspect drug per million Medicare fills, 2.4x the median drug on this site (-8)",
    "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 3.0x the share of reports seen across all of FAERS (-12)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 79,
   "letter": "B",
   "why": [
    "2530 randomized trials and 142 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "9 independent Cochrane review(s) exist",
    "Only 32% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 47,
   "letter": "F",
   "why": [
    "Recalls since 2016: 1 Class I, 4 Class II, 8 Class III across 59 generic makers (-30)",
    "REMS program in force (-10)",
    "28 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 $63 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 (59 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 59,
 "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, death. How would we recognize and handle those?",
  "Why this one over dihydrocodeine, hydromorphone, 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.)"
 ]
}