{
 "query": "docusate",
 "ingredient": "docusate",
 "slug": "docusate",
 "rxcui": "82003",
 "brands": [
  "Colace",
  "Doculase",
  "Docusol",
  "DOK",
  "Enemeez",
  "Pedia-Lax Liquid",
  "Phillips Stool Softener",
  "Prolaxa",
  "Promolaxin",
  "Surfak Stool Softener"
 ],
 "names": [
  "docusate",
  "docusate calcium",
  "docusate potassium",
  "docusate sodium"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 322,
   "RECTAL": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Uses \u2022 relieves occasional constipation (irregularity) \u2022 generally produces bowel movement in 12 to 72 hours",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings Do not use \u2022 if you are presently taking mineral oil, unless told to do so by a doctor Ask a doctor before use if you have \u2022 stomach pain \u2022 nausea \u2022 vomiting \u2022 noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. Stop use and ask a doctor if \u2022 you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. \u2022 you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Docusate Sodium",
  "manufacturer": "A-S Medication Solutions",
  "application_number": "M007",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241106",
  "set_id": "122486e9-74dd-4181-97d1-0b07688280f4",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 63394,
  "serious": 45128,
  "death": 7576,
  "hospitalization": 25366,
  "primary_suspect": 63323,
  "top_reactions": [
   [
    "Fatigue",
    5418
   ],
   [
    "Nausea",
    4578
   ],
   [
    "Diarrhoea",
    3904
   ],
   [
    "Constipation",
    3828
   ],
   [
    "Death",
    3779
   ],
   [
    "Dyspnoea",
    3476
   ],
   [
    "Off Label Use",
    3324
   ],
   [
    "Pain",
    3194
   ],
   [
    "Fall",
    3022
   ],
   [
    "Headache",
    2776
   ],
   [
    "Drug Ineffective",
    2768
   ],
   [
    "Vomiting",
    2760
   ],
   [
    "Asthenia",
    2715
   ],
   [
    "Pneumonia",
    2680
   ],
   [
    "Dizziness",
    2378
   ]
  ],
  "by_year": {
   "2019": 6575,
   "2020": 6590,
   "2021": 5259,
   "2022": 4311,
   "2023": 3914,
   "2024": 3442,
   "2025": 3923,
   "2026": 1942
  },
  "by_year_primary": {
   "2019": 6573,
   "2020": 6588,
   "2021": 5254,
   "2022": 4291,
   "2023": 3899,
   "2024": 3435,
   "2025": 3908,
   "2026": 1939
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 64,
  "completed": 42,
  "terminated": 8,
  "with_results": 13,
  "industry": 9,
  "phase3": 12,
  "results_share": 0.30952380952380953,
  "terminated_share": 0.125
 },
 "pubmed": {
  "rct": 11,
  "meta": 2,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "docusate",
   "Colace",
   "Doculase",
   "Docusol",
   "DOK",
   "Enemeez",
   "Pedia-Lax Liquid",
   "Phillips Stool Softener",
   "Prolaxa",
   "Promolaxin",
   "Surfak Stool Softener"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "docusate sodium",
  "matched": "docusate sodium",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (1.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 16,
   "letter": "F",
   "why": [
    "11 randomized trials and 2 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)",
    "Only 31% 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": 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": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, diarrhoea, constipation. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}