{
 "query": "lactulose",
 "ingredient": "lactulose",
 "slug": "lactulose",
 "rxcui": "6218",
 "brands": [
  "Enulose",
  "Constulose",
  "Kristalose",
  "Generlac"
 ],
 "names": [
  "lactulose"
 ],
 "classes": [
  {
   "id": "A06AD",
   "name": "Osmotically acting laxatives"
  }
 ],
 "alternatives": [
  "lactitol",
  "magnesium carbonate",
  "magnesium citrate",
  "magnesium oxide",
  "magnesium peroxide",
  "magnesium sulfate",
  "mannitol",
  "pentaerythritol",
  "polyethylene glycols",
  "sodium phosphate",
  "sodium sulfate",
  "sodium tartrate",
  "sorbitol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 25,
   "RECTAL": 9
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
  "contraindications": "CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution. Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.",
  "adverse_reactions": "ADVERSE REACTIONS Precise frequency data are not available. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Lactulose",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "ANDA218858",
  "pharm_class_epc": [
   "Osmotic Laxative [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250804",
  "set_id": "391cfd01-c1fa-41f9-abd7-d0abe9a27634",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 34118,
  "serious": 29956,
  "death": 5637,
  "hospitalization": 18798,
  "primary_suspect": 33942,
  "top_reactions": [
   [
    "Constipation",
    2283
   ],
   [
    "Nausea",
    2272
   ],
   [
    "Fall",
    2128
   ],
   [
    "Fatigue",
    1894
   ],
   [
    "Death",
    1826
   ],
   [
    "Vomiting",
    1819
   ],
   [
    "Diarrhoea",
    1798
   ],
   [
    "Off Label Use",
    1745
   ],
   [
    "Dyspnoea",
    1700
   ],
   [
    "Pneumonia",
    1550
   ],
   [
    "Pain",
    1537
   ],
   [
    "Acute Kidney Injury",
    1438
   ],
   [
    "Hypotension",
    1379
   ],
   [
    "Confusional State",
    1303
   ],
   [
    "Pyrexia",
    1209
   ]
  ],
  "by_year": {
   "2019": 3404,
   "2020": 3417,
   "2021": 3391,
   "2022": 2660,
   "2023": 2434,
   "2024": 2294,
   "2025": 2170,
   "2026": 1059
  },
  "by_year_primary": {
   "2019": 3402,
   "2020": 3415,
   "2021": 3379,
   "2022": 2623,
   "2023": 2405,
   "2024": 2258,
   "2025": 2135,
   "2026": 1038
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 38,
  "nda": 3,
  "anda": 29,
  "first_approval": "19760325",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 11,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "ALRA",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "BAJAJ",
   "CHARTWELL RX",
   "FRESENIUS KABI"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/25/1976"
 },
 "trials": {
  "total": 227,
  "completed": 124,
  "terminated": 18,
  "with_results": 27,
  "industry": 46,
  "phase3": 29,
  "results_share": 0.21774193548387097,
  "terminated_share": 0.07929515418502203
 },
 "pubmed": {
  "rct": 169,
  "meta": 21,
  "recent_rct": 18,
  "cochrane": [
   {
    "pmid": "27153247",
    "title": "Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis",
    "year": "2016"
   },
   {
    "pmid": "27089005",
    "title": "Non-absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis",
    "year": "2016"
   },
   {
    "pmid": "20614462",
    "title": "Lactulose versus Polyethylene Glycol for Chronic Constipation",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 156905.99,
  "records": 1189,
  "by_name": [
   [
    "Kristalose",
    156905.99
   ]
  ],
  "names_checked": [
   "lactulose",
   "Enulose",
   "Constulose",
   "Kristalose",
   "Generlac"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2019249,
  "beneficiaries": 723069,
  "spend": 75077819.25,
  "by_brand": [
   {
    "brand": "Lactulose",
    "claims": 1544889,
    "per_claim": 39.146255084,
    "is_generic": true
   },
   {
    "brand": "Enulose",
    "claims": 236911,
    "per_claim": 23.673276842,
    "is_generic": false
   },
   {
    "brand": "Constulose",
    "claims": 228452,
    "per_claim": 21.871730692,
    "is_generic": false
   },
   {
    "brand": "Kristalose",
    "claims": 6944,
    "per_claim": 570.08241647,
    "is_generic": false
   },
   {
    "brand": "Generlac",
    "claims": 2053,
    "per_claim": 18.240511447,
    "is_generic": false
   }
  ],
  "per_claim": 37.18106050813941
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "lactulose",
  "matched": "lactulose",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5431,
  "fills": 2019249,
  "per_million": 2689.6138118676795,
  "ratio": 0.9713480023195952,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 96,
   "letter": "A",
   "why": [
    "2,690 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-4)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 54,
   "letter": "D",
   "why": [
    "169 randomized trials and 21 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 22% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $156,906 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 (29 applications)",
    "13 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are constipation, nausea, fall, fatigue. How would we recognize and handle those?",
  "Why this one over lactitol, magnesium carbonate, magnesium citrate? 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.)"
 ]
}