{
 "query": "tramadol",
 "ingredient": "tramadol",
 "slug": "tramadol",
 "rxcui": "10689",
 "brands": [
  "ConZip",
  "Qdolo",
  "Ultram"
 ],
 "names": [
  "tramadol",
  "tramadol hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 108
  },
  "boxed_warning": "WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CONZIP WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CONZIP See full prescribing information for complete boxed warning. CONZIP exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess 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 are essential. Instruct patients to swallow CONZIP capsules intact, and not to split, chew, crush, or dissolve content of the capsules to avoid exposure to a potentially fatal dose of tramadol. ( 2.1 , 5.2 ) Accidental ingestion of CONZIP, especially by children, can result in a fatal overdose of tramadol. ( 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 ...",
  "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. CONZIP 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 CONZIP, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) CONZIP is not indicated as an as-needed (prn) analgesic. ( 1 ) Limitation 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 CONZIP, for use in patients for whom alternative treatment options are...",
  "contraindications": "is contraindicated for: All children younger than 12 years of age [see Warnings and Precautions (5.6) ] Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.6) ] CONZIP is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.12) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.12) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.16) ] Hypersensitivity to tramadol (e.g., anaphylaxis) [see Warnings and Precautions (5.17) , Adverse Reactions (6) ] Concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days [see Drug Interactions (7) ] Children younger than 12 years of age. ( 4 ) Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastroint...",
  "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. ( 5.8 ) Serotonin Syndrome Risk: Potentially life-threatening condition could result from use of CONZIP, particularly during concomitant use of serotonergic drugs. ( 5.9 ) Increased Risk of Seizures: Present within recommended dosage range. Risk is increased with higher than recommended doses and concomitant use of SSRIs, SNRIs, anorectics, tricyclic antidepressants and other tricyclic compounds, other opioids, MAOIs, neuroleptics, other drugs that reduce seizure threshold, in patients with epilepsy or at risk for seizures. ( 5.10 , 7 ) Suicide Risk: Do not use CONZIP in suicidal or addiction-prone patients. Use with caution in those taking tranquilizers, antidepressants or abuse alcohol. ( 5.11 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Regularly evaluate, particularly during ini...",
  "warnings": "",
  "adverse_reactions": "The following serious or otherwise important adverse reactions are 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 Benzodiazepines and Other CNS Depressants [see Warnings and Precautions (5.3) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-Threatening Respiratory Depression in Children [see Warnings and Precautions (5.6) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8) ] Serotonin Syndrome [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Suicide [see Warnings and Precautions (5.11) ] Adrenal Insufficiency [see Warnings and Precautions (5.13) ] Severe Hypotension [see Warnings and Precautions (5.14) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.16) ] Hypersensitivity Reactions [see Warnings and Precautions (5.17) ] Withdrawal [see Warnings and Precautions (5.18) ] Most common adverse reactions (incidence \u226510% and twice placebo) are nausea...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance CONZIP contains tramadol, a Schedule IV controlled substance. 9.2 Abuse CONZIP contains tramadol, a substance with 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 CONZIP 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 CONZIP with alcohol and/or other CNS depressants. ...",
  "controlled_substance": "9.1 Controlled Substance CONZIP contains tramadol, a Schedule IV controlled substance.",
  "recent_major_changes": "Boxed Warning 12/2025 Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.5 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.10 , 5.16 , 5.18 ) 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 CONZIP 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 CONZIP 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. Inform patients that medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. If no take back programs or DEA-registered collectors are available, instruct patients to dispose of CONZIP by following these four steps: Mix CONZIP (do not crush) with an unpalatable substance such as dirt, cat litter, or used coffee grounds; Place the mixture in a container such as a sealed plastic bag; Throw the container in the household trash; Remove all personal information on the prescription label of the empty bottle Inform patients that they can v...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: December 2025 Medication Guide CONZIP [KON-zip] (tramadol hydrochloride extended-release capsules), CIV CONZIP 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 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 CONZIP: Get emergency help right away or call 911 right away if you take too much CONZIP (overdose) . When you first start taking CONZIP, 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 op...",
  "clinical_studies": "is bioequivalent under fasting conditions to another extended-release tramadol product [see Clinical Pharmacology (12.3) ] which demonstrated efficacy in two of four clinical trials of patients with chronic pain. To qualify for inclusion into these studies, patients were required to have moderate to moderately severe pain as defined by a pain intensity score of \u226540 mm, off previous medications, on a 0 - 100 mm visual analog scale (VAS). In one 12-week randomized, double-blind, placebo-controlled study, patients with moderate to moderately severe pain due to osteoarthritis of the knee and/or hip were administered doses from 100 mg to 400 mg daily. Treatment with the extended-release tramadol product was initiated at 100 mg once daily for four days then increased by 100 mg per day increments every five days to the randomized fixed dose. Between 51% and 59% of patients in active treatment groups completed the study and 56% of patients in the placebo group completed the study. Discontinuations due to adverse events were more common in the extended-release tramadol product 200 mg, 300 mg and 400 mg treatment groups (20%, 27%, and 30% of discontinuations, respectively) compared to 14% of...",
  "brand_name": "ConZip",
  "manufacturer": "Vertical Pharmaceuticals, LLC",
  "application_number": "NDA022370",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251229",
  "set_id": "a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": true
 },
 "faers": {
  "total": 184696,
  "serious": 144221,
  "death": 24335,
  "hospitalization": 57672,
  "primary_suspect": 183917,
  "top_reactions": [
   [
    "Drug Dependence",
    21432
   ],
   [
    "Pain",
    14820
   ],
   [
    "Overdose",
    13441
   ],
   [
    "Nausea",
    11513
   ],
   [
    "Fatigue",
    10614
   ],
   [
    "Drug Ineffective",
    9839
   ],
   [
    "Vomiting",
    9145
   ],
   [
    "Headache",
    8759
   ],
   [
    "Diarrhoea",
    8622
   ],
   [
    "Dependence",
    8565
   ],
   [
    "Death",
    7628
   ],
   [
    "Dyspnoea",
    7591
   ],
   [
    "Off Label Use",
    7255
   ],
   [
    "Dizziness",
    7035
   ],
   [
    "Arthralgia",
    6784
   ]
  ],
  "by_year": {
   "2019": 18884,
   "2020": 21804,
   "2021": 23393,
   "2022": 14912,
   "2023": 14632,
   "2024": 7543,
   "2025": 10501,
   "2026": 4714
  },
  "by_year_primary": {
   "2019": 18874,
   "2020": 21791,
   "2021": 23322,
   "2022": 14703,
   "2023": 14519,
   "2024": 7418,
   "2025": 10347,
   "2026": 4639
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240426",
   "reason": "Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol",
   "firm": "Rubicon Research Private Limited",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 41,
  "nda": 6,
  "anda": 35,
  "first_approval": "19950303",
  "rems": true,
  "rems_last": "20260618",
  "labeling_supplements": 42,
  "labeling_recent": 10,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "AMNEAL PHARMS",
   "APOTEX",
   "ASTA",
   "AUROBINDO PHARMA LTD",
   "CIPHER PHARMS INC",
   "CSPC OUYI PHARM CO"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/03/1995"
 },
 "trials": {
  "total": 700,
  "completed": 461,
  "terminated": 38,
  "with_results": 67,
  "industry": 128,
  "phase3": 89,
  "results_share": 0.14533622559652928,
  "terminated_share": 0.054285714285714284
 },
 "pubmed": {
  "rct": 783,
  "meta": 62,
  "recent_rct": 67,
  "cochrane": [
   {
    "pmid": "31132298",
    "title": "Tramadol for osteoarthritis",
    "year": "2019"
   },
   {
    "pmid": "28616956",
    "title": "Tramadol for neuropathic pain in adults",
    "year": "2017"
   },
   {
    "pmid": "28510996",
    "title": "Tramadol with or without paracetamol (acetaminophen) for cancer pain",
    "year": "2017"
   },
   {
    "pmid": "27654994",
    "title": "Single fixed-dose oral dexketoprofen plus tramadol for acute postoperative pain in adults",
    "year": "2016"
   },
   {
    "pmid": "25785365",
    "title": "Tramadol for postoperative pain treatment in children",
    "year": "2015"
   },
   {
    "pmid": "16856101",
    "title": "Tramadol for osteoarthritis",
    "year": "2006"
   },
   {
    "pmid": "16856016",
    "title": "Tramadol for neuropathic pain",
    "year": "2006"
   },
   {
    "pmid": "15106216",
    "title": "Tramadol for neuropathic pain",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 642.12,
  "records": 43,
  "by_name": [
   [
    "Qdolo",
    642.12
   ]
  ],
  "names_checked": [
   "tramadol",
   "ConZip",
   "Qdolo",
   "Ultram"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 13163232,
  "beneficiaries": 4039716,
  "spend": 103334767.74,
  "by_brand": [
   {
    "brand": "Tramadol HCl",
    "claims": 12939330,
    "per_claim": 6.8116946612,
    "is_generic": true
   },
   {
    "brand": "Tramadol HCl ER",
    "claims": 223842,
    "per_claim": 67.702658348,
    "is_generic": false
   },
   {
    "brand": "Conzip",
    "claims": 60,
    "per_claim": 688.4035,
    "is_generic": false
   }
  ],
  "per_claim": 7.850258032373811
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20170420",
   "title": "FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm",
   "kind": "drug",
   "matched": "tramadol"
  },
  {
   "date": "20150921",
   "title": "FDA evaluating the risks of using the pain medicine tramadol in children aged 17 and younger",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm462991.htm",
   "kind": "drug",
   "matched": "tramadol"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "tramadol",
  "matched": "tramadol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 22404,
  "fills": 13163232,
  "per_million": 1702.0136088158288,
  "ratio": 0.6146784016163265,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 34,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2017 (-16)",
    "1,702 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x 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 share in reports is near or below the FAERS average (1.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 72,
   "letter": "C",
   "why": [
    "783 randomized trials and 62 systematic reviews/meta-analyses indexed in PubMed",
    "8 independent Cochrane review(s) exist",
    "Only 15% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 76,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 35 generic makers (-1)",
    "REMS program in force (-10)",
    "10 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 $642 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (35 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 63,
 "grade": "C",
 "questions": [
  "In 2017 the FDA issued a safety communication about this drug (FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; re). Does that risk apply to me?",
  "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, nausea. How would we recognize and handle those?",
  "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.)"
 ]
}