{
 "query": "dicyclomine",
 "ingredient": "dicyclomine",
 "slug": "dicyclomine",
 "rxcui": "3361",
 "brands": [
  "Bentyl"
 ],
 "names": [
  "dicyclomine",
  "dicyclomine hydrochloride"
 ],
 "classes": [
  {
   "id": "A03AA",
   "name": "Synthetic anticholinergics, esters with tertiary amino group"
  }
 ],
 "alternatives": [
  "camylofine",
  "difemerine",
  "dihexyverine",
  "mebeverine",
  "oxyphencyclimine",
  "piperidolate",
  "trimebutine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 109,
   "INTRAMUSCULAR": 7
  },
  "boxed_warning": "",
  "indications_and_usage": "Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( 1 )",
  "contraindications": "Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations ( 8.4 )] , nursing mothers [see Use in Specific Populations ( 8.3 )], and in patients with: unstable cardiovascular status in acute hemorrhage myasthenia gravis [see Warnings and Precautions ( 5.4 )] glaucoma [see Adverse Reactions ( 6.3 ) and Drug Interactions ( 7.1 )] obstructive uropathy [see Warnings and Precautions ( 5.8 )] obstructive disease of the gastrointestinal tract [see Warnings and Precautions ( 5.5 )] severe ulcerative colitis [see Warnings and Precautions ( 5.7 )] reflux esophagitis Infants less than 6 months of age ( 4 ) Glaucoma ( 4 ) Nursing mothers ( 4 ) Obstructive uropathy ( 4 ) Unstable cardiovascular status in the acute hemorrhage ( 4 ) Obstructive disease of gastrointestinal tract ( 4 ) Myasthenia gravis ( 4 ) Severe ulcerative colitis ( 4 ) Reflux esophagitis ( 4 )",
  "warnings_and_cautions": "Cardiovascular conditions : worsening of conditions ( 5.2 ) Peripheral and central nervous system : heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted ( 5.3 ) Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride tablets ( 5.3 ) Myasthenia Gravis : overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride tablets should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase ( 5.4 ) Incomplete intestinal obstruction : diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride tablets would be inappropriate and possibly fatal ( 5.5 ) Salmonella dysenteric patients : due to risk of toxic megacolon ( 5.6 ) Ulcerative colitis : Dicyclomine hydrochloride tablets should be used with caution in these patients; large doses may suppress intestinal m...",
  "warnings": "",
  "adverse_reactions": "The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology ( 12 )] . They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued. The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see Warnings and Precautions ( 5.2 , 5.3 )] . The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions, Peripheral and Central Nervous System ( 5.3 ) 07/2012",
  "information_for_patients": "17.2 Use in Infants Inform parents and caregivers not to administer dicyclomine hydrochloride tablets in infants less than 6 months of age [see Use in Specific Populations ( 8.4 )]. 17.3 Use in Nursing Mothers Advise lactating women that dicyclomine hydrochloride tablets should not be used while breastfeeding their infants [see Use in Specific Populations ( 8.3 , 8.4 )] . 17.4 Peripheral and Central Nervous System In the presence of a high environmental temperature, heat prostration can occur with dicyclomine hydrochloride tablets use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride tablets may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking dicyclomine hydrochloride tablets [see Warnings and Precautions ( 5.3 )]. Distributed By: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Manufactured by: Rubicon Research Ltd., Thane 421506, India. Rev.: 02, 03/25",
  "spl_medguide": "",
  "clinical_studies": "In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).",
  "brand_name": "Dicyclomine hydrochloride",
  "manufacturer": "Northwind Health Company, LLC",
  "application_number": "ANDA216736",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260101",
  "set_id": "1d9acff5-6e8c-58dd-e063-6394a90a38f2",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 19240,
  "serious": 11485,
  "death": 1141,
  "hospitalization": 5672,
  "primary_suspect": 19209,
  "top_reactions": [
   [
    "Diarrhoea",
    1766
   ],
   [
    "Nausea",
    1726
   ],
   [
    "Fatigue",
    1614
   ],
   [
    "Headache",
    1264
   ],
   [
    "Pain",
    1219
   ],
   [
    "Drug Ineffective",
    1171
   ],
   [
    "Off Label Use",
    1139
   ],
   [
    "Vomiting",
    955
   ],
   [
    "Chronic Kidney Disease",
    943
   ],
   [
    "Dizziness",
    931
   ],
   [
    "Abdominal Pain",
    893
   ],
   [
    "Dyspnoea",
    848
   ],
   [
    "Abdominal Pain Upper",
    754
   ],
   [
    "Acute Kidney Injury",
    742
   ],
   [
    "Fall",
    737
   ]
  ],
  "by_year": {
   "2019": 1976,
   "2020": 1850,
   "2021": 1535,
   "2022": 1334,
   "2023": 1304,
   "2024": 1185,
   "2025": 1532,
   "2026": 775
  },
  "by_year_primary": {
   "2019": 1976,
   "2020": 1850,
   "2021": 1528,
   "2022": 1330,
   "2023": 1298,
   "2024": 1181,
   "2025": 1524,
   "2026": 775
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260723",
   "reason": "shortfill; reports of empty capsules.",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 46,
  "nda": 3,
  "anda": 38,
  "first_approval": "19500511",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 32,
  "labeling_recent": 0,
  "sponsors": [
   "ABBVIE",
   "ALLERGAN",
   "ALPHARMA US PHARMS",
   "AM REGENT",
   "ANNORA PHARMA",
   "APTALIS PHARMA US",
   "AUROBINDO PHARMA USA",
   "BIONPHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/11/1950"
 },
 "trials": {
  "total": 10,
  "completed": 7,
  "terminated": 2,
  "with_results": 1,
  "industry": 6,
  "phase3": 3,
  "results_share": 0.14285714285714285,
  "terminated_share": 0.2
 },
 "pubmed": {
  "rct": 9,
  "meta": 0,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "dicyclomine",
   "Bentyl"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2350765,
  "beneficiaries": 906883,
  "spend": 42947679.730000004,
  "by_brand": [
   {
    "brand": "Dicyclomine HCl",
    "claims": 2350747,
    "per_claim": 18.260557427,
    "is_generic": true
   },
   {
    "brand": "Bentyl",
    "claims": 18,
    "per_claim": 1207.1744444,
    "is_generic": false
   }
  ],
  "per_claim": 18.269661038002525
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3480,
  "fills": 2350765,
  "per_million": 1480.3691564235473,
  "ratio": 0.5346320042091975,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,480 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 23,
   "letter": "F",
   "why": [
    "9 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 38 generic makers (-3)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (38 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea, fatigue, headache. How would we recognize and handle those?",
  "Why this one over camylofine, difemerine, dihexyverine? 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.)"
 ]
}