{
 "query": "loperamide",
 "ingredient": "loperamide",
 "slug": "loperamide",
 "rxcui": "6468",
 "brands": [
  "Diamode",
  "Imodium"
 ],
 "names": [
  "loperamide",
  "loperamide hydrochloride"
 ],
 "classes": [
  {
   "id": "A07DA",
   "name": "Antipropulsives"
  }
 ],
 "alternatives": [
  "difenoxin",
  "diphenoxylate",
  "eluxadoline",
  "opium"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 224
  },
  "boxed_warning": "WARNING: TORSADES DE POINTES AND SUDDEN DEATH Cases of Torsades de Pointes, cardiac arrest, and death have been reported with the use of a higher than recommended dosages of loperamide hydrochloride (see WARNINGS and OVERDOSAGE ). Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age (see CONTRANIDICATIONS ). Avoid loperamide hydrochloride dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see DOSAGE AND ADMINISTRATION ).",
  "indications_and_usage": "INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.",
  "contraindications": "CONTRAINDICATIONS Loperamide hydrochloride capsules are contraindicated in: pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS ). patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. patients with abdominal pain in the absence of diarrhea. patients with acute dysentery, which is characterized by blood in stools and high fever. patients with acute ulcerative colitis. patients with bacterial enterocolitis caused by invasive organisms including Salmonella , Shigella, and Campylobacter . patients with pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Cardiac Adverse Reactions, Including Torsades de Pointes and Sudden Death Cases of prolongation of the QT/QTc interval, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, some resulting in death, have been reported in adults with use of higher than recommended doses per day of loperamide hydrochloride. Cases include patients who were abusing or misusing loperamide hydrochloride (see OVERDOSAGE and DRUG ABUSE AND DEPENDENCE ). Cases of syncope and ventricular tachycardia have been reported in adult patients receiving the recommended dosage of loperamide hydrochloride. Some of these patients were taking other drugs or had other risk factors that may have increased their risk of cardiac adverse reactions. Additionally, postmarketing cases of cardiac arrest, syncope, and respiratory depression have been reported in pediatric patients less than 2 years of age. Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions. Avoid loperamide hydrochloride dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the r...",
  "adverse_reactions": "ADVERSE REACTIONS Clinical Trial Experience The adverse effects reported during clinical investigations of loperamide hydrochloride are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with loperamide hydrochloride were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea. The adverse events reported are summarized irrespective of the causality assessment of the investigators. 1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below. Acute Diarrhea Loperamide Hydrochloride Placebo No. of treated patients 231 236 Gastrointestinal AE% Constipation 2.6% 0.8% The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic. 2) Adverse events from 20 placebo-controlled studies in patients with c...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Loperamide is not a controlled substance. Abuse Loperamide is a mu-opioid agonist. A human abuse potential study of loperamide hydrochloride at single doses up to 60 mg (3.75 times the recommended maximum adult dosage of 16 mg per day) was compared, in a double-blind cross-over design using nine subjects who had been active opiate users, to a threshold dose of codeine sulfate at 120 mg (96 mg base) or placebo. This resulted in one subject (11%) feeling a drug on placebo and identifying it as \"dope\" (heroin) and liking it slightly. Codeine was felt by 56% of subjects and identified as \"dope\" by 44%. Loperamide was felt by 44% of subjects and identified as \"dope\" by 11% and possibly dope mixed with some other kind of drug by another 22%. Loperamide abuse and misuse have been reported, especially at doses of 60 mg or greater. Loperamide can have greater CNS opioid effects at higher doses or with co-administration of drugs that increase systemic exposure and/or increase CNS penetration of loperamide (through inhibition of the CYP450 enzyme system or inhibition of P-glycoprotein). Loperamide is primarily being misused for relief from opioid...",
  "controlled_substance": "Controlled Substance Loperamide is not a controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Advise patients: to take loperamide hydrochloride at the prescribed dosage. Use of a higher than prescribed dosage is not recommended (see WARNINGS ). Report to a healthcare facility if you or someone you are caring for taking loperamide hydrochloride experiences fainting episode, a rapid or irregular heartbeat or become unresponsive. with acute diarrhea, that if clinical improvement is not observed in 48 hours, discontinue loperamide hydrochloride and contact their healthcare provider. to contact their healthcare provider if they see blood in their stools, or if they develop a fever or abdominal distention. to use caution when driving a car or operating machinery, as tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with loperamide hydrochloride. (see ADVERSE REACTIONS ). to tell their healthcare provider about all the medications they are taking, including prescription and over-the-counter medications, vitamins and herbal supplements, especially if they take Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g., chlorpromazine, haloperidol, thiorida...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "LOPERAMIDE HYDROCHLORIDE",
  "manufacturer": "NuCare Pharmaceuticals,Inc.",
  "application_number": "ANDA218122",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240819",
  "set_id": "1adb7a28-9dc6-3f8b-e063-6394a90a9335",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 71273,
  "serious": 49013,
  "death": 7473,
  "hospitalization": 28457,
  "primary_suspect": 71109,
  "top_reactions": [
   [
    "Diarrhoea",
    13082
   ],
   [
    "Nausea",
    6474
   ],
   [
    "Fatigue",
    6149
   ],
   [
    "Drug Ineffective",
    5397
   ],
   [
    "Off Label Use",
    5054
   ],
   [
    "Vomiting",
    4252
   ],
   [
    "Constipation",
    3425
   ],
   [
    "Dyspnoea",
    3297
   ],
   [
    "Weight Decreased",
    3240
   ],
   [
    "Headache",
    3154
   ],
   [
    "Decreased Appetite",
    2951
   ],
   [
    "Asthenia",
    2728
   ],
   [
    "Dizziness",
    2655
   ],
   [
    "Abdominal Pain",
    2636
   ],
   [
    "Pneumonia",
    2636
   ]
  ],
  "by_year": {
   "2019": 6388,
   "2020": 6540,
   "2021": 6306,
   "2022": 5960,
   "2023": 6362,
   "2024": 6325,
   "2025": 6382,
   "2026": 3201
  },
  "by_year_primary": {
   "2019": 6385,
   "2020": 6536,
   "2021": 6297,
   "2022": 5923,
   "2023": 6313,
   "2024": 6300,
   "2025": 6362,
   "2026": 3190
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20181226",
   "reason": "Labeling Not Elsewhere Classified:  The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 39,
  "nda": 7,
  "anda": 30,
  "first_approval": "19761228",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 41,
  "labeling_recent": 0,
  "sponsors": [
   "ABLE",
   "ALLIED",
   "ALPHARMA US PHARMS",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BIONPHARMA",
   "CHARTWELL RX",
   "CONTRACT PHARMACAL"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/28/1976"
 },
 "trials": {
  "total": 116,
  "completed": 55,
  "terminated": 27,
  "with_results": 31,
  "industry": 49,
  "phase3": 21,
  "results_share": 0.5636363636363636,
  "terminated_share": 0.23275862068965517
 },
 "pubmed": {
  "rct": 105,
  "meta": 6,
  "recent_rct": 3,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "loperamide",
   "Diamode",
   "Imodium"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 897042,
  "beneficiaries": 429638,
  "spend": 16889293.85,
  "by_brand": [
   {
    "brand": "Loperamide",
    "claims": 897042,
    "per_claim": 18.827762635,
    "is_generic": false
   }
  ],
  "per_claim": 18.827762635417294
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20180130",
   "title": "FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use.",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm594232.htm",
   "kind": "drug",
   "matched": "imodium"
  },
  {
   "date": "20160607",
   "title": "FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm504617.htm",
   "kind": "drug",
   "matched": "imodium"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "loperamide",
  "matched": "loperamide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15852,
  "fills": 897042,
  "per_million": 17671.41337863779,
  "ratio": 6.381991350492088,
  "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 2018 (-16)",
    "17,671 FDA reports naming it as the suspect drug per million Medicare fills, 6.4x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "105 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "23% of registered trials were terminated, withdrawn, or suspended (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 98,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 30 generic makers (-2)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (30 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 63,
 "grade": "C",
 "questions": [
  "In 2018 the FDA issued a safety communication about this drug (FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use). Does that risk apply to me?",
  "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 diarrhoea, nausea, fatigue. 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 difenoxin, diphenoxylate, eluxadoline? 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.)"
 ]
}