{
 "query": "metoclopramide",
 "ingredient": "metoclopramide",
 "slug": "metoclopramide",
 "rxcui": "6915",
 "brands": [
  "Gimoti",
  "Reglan",
  "Metozolv"
 ],
 "names": [
  "metoclopramide",
  "metoclopramide dihydrochloride",
  "metoclopramide hydrochloride"
 ],
 "classes": [
  {
   "id": "A03FA",
   "name": "Propulsives"
  }
 ],
 "alternatives": [
  "alizapride",
  "bromopride",
  "cinitapride",
  "cisapride",
  "clebopride",
  "domperidone",
  "mosapride"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 45,
   "INTRAMUSCULAR": 16,
   "INTRAVENOUS": 16,
   "NASAL": 1
  },
  "boxed_warning": "WARNING: TARDIVE DYSKINESIA Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1) ] . Discontinue metoclopramide in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped [see Warnings and Precautions (5.1) ] . Avoid treatment with metoclopramide for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1) and Dosage and Administration (2.2 , 2.3) ]. WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treat...",
  "indications_and_usage": "Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide is indicated for the: Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. ( 1 ) Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. ( 1 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. ( 1 , 8.4 ) Limitations of Use : Metoclopramide is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see Use in Specific Populations (8.4) ].",
  "contraindications": "Metoclopramide is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions (5.1 , 5.2) ] . When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor . Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [see Warnings and Precautions (5.5) ] . In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures [see Adverse Reactions (6) ] . In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions (6) ] . History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hyp...",
  "warnings_and_cautions": "Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS) : Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's Disease. If symptoms occur, discontinue metoclopramide and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 ) 5.1 Tardive Dyskinesia Metoclopramide can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetotic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [see Use in Specific Populations (8.5) ] , and in patients with diabetes mellitus. Due to the risk of developing TD, avoid treatment with metoclopramide for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration (2.2 , 2.3) ]. Discontinue metoclopramide ...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions (5.1) ] Other extrapyramidal effects [see Warnings and Precautions (5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Depression [see Warnings and Precautions (5.4) ] Hypertension [see Warnings and Precautions (5.5) ] Fluid retention [see Warnings and Precautions (5.6) ] Hyperprolactinemia [see Warnings and Precautions (5.7) ] Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8) ] The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage an...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Boxed Warning 8/2017 Indications and Usage ( 1 ) 8/2017 Dosage and Administration, Dosage for Gastroesophageal Reflux ( 2.2 ) 8/2017 Dosage and Administration, Dosage for Acute and Recurrent Diabetic Gastroparesis ( 2.3 ) 8/2017 Contraindications ( 4 ) 8/2017 Warnings and Precautions, Tardive Dyskinesia ( 5.1 ) 8/2017 Warnings and Precautions, Other Extrapyramidal Symptoms ( 5.2 ) 8/2017 Warnings and Precautions, Neuroleptic Malignant Syndrome ( 5.3 ) 8/2017 Warnings and Precautions, Hyperprolactinemia ( 5.7 ) 8/2017",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients or their caregivers that metoclopramide can cause serious adverse reactions. Instruct patients to discontinue metoclopramide and contact a healthcare provider immediately if the following serious reactions occur: Tardive dyskinesia and other extrapyramidal reactions [see Warnings and Precautions (5.1 , 5.2) ] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3) ] Depression and/or possible suicidal ideation [see Warnings and Precautions (5.4) ] Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug Interactions (7.1 , 7.2) ] . Explain that the prescriber of any other medication must be made aware that the patient is taking metoclopramide. Inform patients or their caregivers that metoclopramide can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or ...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: September 2017 MEDICATION GUIDE Metoclopramide (met-o-KLO-pra-mide) Oral Solution USP Read this Medication Guide before you start taking Metoclopramide and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN injection, REGLAN orally disintegrating tablets, or metoclopramide oral solution), you should read the Medication Guide that comes with that product. Some of the information may be different. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about Metoclopramide? Metoclopramide can cause serious side effects, including: Tardive dyskinesia (abnormal muscle movements). These movements happen mostly in the face muscles. You cannot control these movements. They may not go away even after stopping Metoclopramide. There is no treatment for tardive dyskinesia, but symptoms may decrease or go away over time after you stop taking Metoclopramide. Your chances for getting tardive dyskinesia i...",
  "clinical_studies": "",
  "brand_name": "Metoclopramide",
  "manufacturer": "PAI Holdings, LLC dba PAI Pharma",
  "application_number": "ANDA072744",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241113",
  "set_id": "3cc8ca5b-8b71-4c77-a181-9ce154597b9a",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 57638,
  "serious": 51161,
  "death": 8917,
  "hospitalization": 31394,
  "primary_suspect": 57373,
  "top_reactions": [
   [
    "Nausea",
    6061
   ],
   [
    "Vomiting",
    4451
   ],
   [
    "Diarrhoea",
    4062
   ],
   [
    "Off Label Use",
    3515
   ],
   [
    "Fatigue",
    3329
   ],
   [
    "Pyrexia",
    3100
   ],
   [
    "Dyspnoea",
    2711
   ],
   [
    "Acute Kidney Injury",
    2473
   ],
   [
    "Febrile Neutropenia",
    2325
   ],
   [
    "Headache",
    2222
   ],
   [
    "Pneumonia",
    2178
   ],
   [
    "Decreased Appetite",
    2140
   ],
   [
    "Constipation",
    2011
   ],
   [
    "Abdominal Pain",
    1986
   ],
   [
    "Drug Ineffective",
    1977
   ]
  ],
  "by_year": {
   "2019": 5831,
   "2020": 5553,
   "2021": 5427,
   "2022": 5000,
   "2023": 4491,
   "2024": 4193,
   "2025": 3758,
   "2026": 1839
  },
  "by_year_primary": {
   "2019": 5822,
   "2020": 5545,
   "2021": 5404,
   "2022": 4947,
   "2023": 4454,
   "2024": 4139,
   "2025": 3713,
   "2026": 1814
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20261006",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "American Health Packaging",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260929",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250523",
   "reason": "Presence of foreign tablets/capsules.",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210729",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210426",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210215",
   "reason": "Chemical contamination; Unknown brown residue adhering to the inside of one vial.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210210",
   "reason": "Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130924",
   "reason": "Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 67,
  "nda": 6,
  "anda": 42,
  "first_approval": "19790207",
  "rems": false,
  "rems_last": "20110822",
  "labeling_supplements": 73,
  "labeling_recent": 4,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "AIPING PHARM INC",
   "ANI PHARMS",
   "AVET LIFESCIENCES",
   "BAXTER HLTHCARE CORP",
   "BEDFORD",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/07/1979"
 },
 "trials": {
  "total": 222,
  "completed": 135,
  "terminated": 33,
  "with_results": 52,
  "industry": 31,
  "phase3": 38,
  "results_share": 0.3851851851851852,
  "terminated_share": 0.14864864864864866
 },
 "pubmed": {
  "rct": 698,
  "meta": 34,
  "recent_rct": 30,
  "cochrane": [
   {
    "pmid": "25564770",
    "title": "Metoclopramide for post-pyloric placement of naso-enteral feeding tubes",
    "year": "2015"
   },
   {
    "pmid": "20464724",
    "title": "WITHDRAWN: Metoclopramide, thickened feedings, and positioning for gastro-oesophageal reflux in children under two years",
    "year": "2010"
   },
   {
    "pmid": "15495056",
    "title": "Metoclopramide, thickened feedings, and positioning for gastro-oesophageal reflux in children under two years",
    "year": "2004"
   },
   {
    "pmid": "12519594",
    "title": "Metoclopramide for migration of naso-enteral tube",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 269748.17,
  "records": 3368,
  "by_name": [
   [
    "Gimoti",
    269748.17
   ]
  ],
  "names_checked": [
   "metoclopramide",
   "Gimoti",
   "Reglan",
   "Metozolv"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1095227,
  "beneficiaries": 409280,
  "spend": 12895275.19,
  "by_brand": [
   {
    "brand": "Metoclopramide HCl",
    "claims": 1092954,
    "per_claim": 7.5726040346,
    "is_generic": true
   },
   {
    "brand": "Gimoti",
    "claims": 2151,
    "per_claim": 2115.7921757,
    "is_generic": false
   },
   {
    "brand": "Reglan",
    "claims": 122,
    "per_claim": 554.9045082,
    "is_generic": false
   }
  ],
  "per_claim": 11.774066189018349
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "metoclopramide",
  "matched": "metoclopramide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 9666,
  "fills": 1095227,
  "per_million": 8825.567667707242,
  "ratio": 3.1873339903065565,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 53,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "8,826 FDA reports naming it as the suspect drug per million Medicare fills, 3.2x the median drug on this site (-10)",
    "Death appears in 1.7x the share of reports seen across all of FAERS (-2)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 75,
   "letter": "B",
   "why": [
    "698 randomized trials and 34 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 85,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 7 Class II, 0 Class III across 42 generic makers (-6)",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $269,748 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (42 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, vomiting, diarrhoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over alizapride, bromopride, cinitapride? 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.)"
 ]
}