{
 "query": "colestipol",
 "ingredient": "colestipol",
 "slug": "colestipol",
 "rxcui": "2685",
 "brands": [
  "Colestid"
 ],
 "names": [
  "colestipol",
  "colestipol hydrochloride"
 ],
 "classes": [
  {
   "id": "C10AC",
   "name": "Bile acid sequestrants"
  }
 ],
 "alternatives": [
  "cholestyramine resin",
  "colesevelam"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 13
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD. According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C i...",
  "contraindications": "CONTRAINDICATIONS Colestipol hydrochloride tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.",
  "warnings_and_cautions": "",
  "warnings": "",
  "adverse_reactions": "ADVERSE REACTIONS Gastrointestinal The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-C lowering effect, a gradual increase of dosage starting with 2 grams, once or twice daily is recommended. Constipation is the major single complaint and at times is severe. Most instances of constipation are mild, transient, and controlled with standard treatment. Increased fluid intake and inclusion of additional dietary fiber should be the first step; a stool softener may be added if needed. Some patients require decreased dosage or discontinuation of therapy. Hemorrhoids may be aggravated. Other, less frequent gastrointestinal complaints consist of abdominal discomfort (abdominal pain and cramping), intestinal gas (bloating and flatulence), indigestion and heartburn, diarrhea and loose stools, and nausea and vomiting. Bleeding hemorrhoids and blood in the stool have been infrequently reported. Peptic ulceration, cholecystitis, and cholelithiasis have been rarely reported in patients receiving colestipol hydrochloride granules, and are not necessarily drug related. Difficulty swallowing and transient esophageal obs...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Colestipol hydrochloride tablets may be larger than pills you have taken before. If you have had swallowing problems or choking with food, liquids or other tablets or capsules in the past, you should discuss this with your doctor before taking colestipol hydrochloride tablets. It is important that you take colestipol hydrochloride tablets correctly: Always take one tablet at a time and swallow promptly. Swallow each tablet whole. Do not cut, crush, or chew the tablets. Colestipol hydrochloride tablets must be taken with water or another liquid that you prefer. Swallowing the tablets will be easier if you drink plenty of liquid as you swallow each tablet. Difficulty swallowing and temporary obstruction of the esophagus (the tube between your mouth and stomach) have been rarely reported in patients taking colestipol hydrochloride tablets. If a tablet does get stuck after you swallow it, you may notice pressure or discomfort. If this happens to you, you should contact your doctor. Do not take colestipol hydrochloride tablets again without your doctor's advice. If you are taking other medications, you should take them at least one hour before or four hours afte...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Colestipol Hydrochloride",
  "manufacturer": "American Health Packaging",
  "application_number": "ANDA077510",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251001",
  "set_id": "153e9154-1804-4d73-94b7-a31a1d37c420",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 4728,
  "serious": 2659,
  "death": 203,
  "hospitalization": 1129,
  "primary_suspect": 4725,
  "top_reactions": [
   [
    "Diarrhoea",
    717
   ],
   [
    "Fatigue",
    430
   ],
   [
    "Off Label Use",
    424
   ],
   [
    "Nausea",
    322
   ],
   [
    "Drug Ineffective",
    292
   ],
   [
    "Headache",
    222
   ],
   [
    "Pain",
    210
   ],
   [
    "Weight Decreased",
    196
   ],
   [
    "Vomiting",
    175
   ],
   [
    "Pneumonia",
    173
   ],
   [
    "Arthralgia",
    172
   ],
   [
    "Malaise",
    172
   ],
   [
    "Dyspnoea",
    171
   ],
   [
    "Asthenia",
    168
   ],
   [
    "Product Dose Omission Issue",
    162
   ]
  ],
  "by_year": {
   "2019": 488,
   "2020": 451,
   "2021": 463,
   "2022": 390,
   "2023": 375,
   "2024": 376,
   "2025": 431,
   "2026": 223
  },
  "by_year_primary": {
   "2019": 488,
   "2020": 451,
   "2021": 462,
   "2022": 389,
   "2023": 374,
   "2024": 376,
   "2025": 431,
   "2026": 223
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 9,
  "nda": 2,
  "anda": 7,
  "first_approval": "19770404",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 16,
  "labeling_recent": 0,
  "sponsors": [
   "ANI PHARMS",
   "EDENBRIDGE PHARMS",
   "IMPAX LABS",
   "MACLEODS PHARMS",
   "PFIZER",
   "RICONPHARMA LLC",
   "ZYDUS PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/04/1977"
 },
 "trials": {
  "total": 8,
  "completed": 6,
  "terminated": 1,
  "with_results": 4,
  "industry": 2,
  "phase3": 3,
  "results_share": 0.6666666666666666,
  "terminated_share": 0.125
 },
 "pubmed": {
  "rct": 36,
  "meta": 0,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "colestipol",
   "Colestid"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 529167,
  "beneficiaries": 161826,
  "spend": 44664304.07,
  "by_brand": [
   {
    "brand": "Colestipol HCl",
    "claims": 528967,
    "per_claim": 84.359789363,
    "is_generic": true
   },
   {
    "brand": "Colestid",
    "claims": 200,
    "per_claim": 203.79685,
    "is_generic": false
   }
  ],
  "per_claim": 84.40493090083093
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1030,
  "fills": 529167,
  "per_million": 1946.455466799706,
  "ratio": 0.7029580309773354,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,946 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 33,
   "letter": "F",
   "why": [
    "36 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (7 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, fatigue, nausea. 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 cholestyramine resin, colesevelam? 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.)"
 ]
}