{
 "query": "scopolamine",
 "ingredient": "scopolamine",
 "slug": "scopolamine",
 "rxcui": "9601",
 "brands": [
  "Transderm Scop"
 ],
 "names": [
  "scopolamine",
  "scopolamine hydrobromide"
 ],
 "classes": [
  {
   "id": "S01FA",
   "name": "Anticholinergics"
  }
 ],
 "alternatives": [
  "atropine",
  "cyclopentolate",
  "homatropine",
  "methscopolamine",
  "tropicamide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "TRANSDERMAL": 21,
   "ORAL": 8,
   "SUBLINGUAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Scopolamine Transdermal System is indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. Scopolamine transdermal system is an anticholinergic indicated in adults for the prevention of: nausea and vomiting associated with motion sickness. ( 1 ) post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery. ( 1 )",
  "contraindications": "Scopolamine transdermal system is contraindicated in patients with: angle closure glaucoma [see Warnings and Precautions (5.1) ] . hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Reactions have included rash generalized and erythema [see Adverse Reactions (6.2) , Description (11) ] . Angle closure glaucoma. ( 4 , 6.2 ) Hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient or component of the formulation or delivery system. ( 4 , 7 )",
  "warnings_and_cautions": "Acute Angle Closure Glaucoma: Monitor for increased intraocular pressure in patients with open-angle glaucoma and adjust glaucoma therapy as needed. Discontinue if signs or symptoms of acute angle closure glaucoma develop. ( 5.1 ) Neuropsychiatric Adverse Reactions : May cause psychiatric and cognitive effects, seizures and impair mental and/or physical abilities. Monitor patients for new or worsening psychiatric symptoms during treatment and during concomitant treatment with other drugs that are associated with similar psychiatric effects. ( 5.2 , 7.1 ) Eclamptic Seizures in Pregnant Women : Avoid use in patients with severe preeclampsia. ( 5.3 ) Gastrointestinal and Urinary Disorders : Consider more frequent monitoring during treatment in patients suspected of having intestinal obstruction; patients with pyloric obstruction, patients with impeded urine flow, or receiving other anticholinergic drugs. Discontinue if patient develops difficulty in urination. ( 5.4 , 7.2 ) Hyperthermia : Serious adverse reactions have been reported postmarketing in adult and pediatric patients, including fatal cases. If symptoms occur, remove the transdermal system, and contact a healthcare provider....",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in labeling: Acute Angle Closure Glaucoma [see Warnings and Precautions (5.1) ] Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.2) ] Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (5.3) ] Gastrointestinal and Urinary Disorders [see Warnings and Precautions (5.4) ] Hyperthermia [see Warnings and Precautions (5.5) ] Drug Withdrawal/Post-Removal Symptoms [see Warnings and Precautions (5.6) ] Blurred Vision [see Warnings and Precautions (5.7) ] MRI Skin Burns [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Motion Sickness (>15%): dry mouth, drowsiness, blurred vision and dilation of the pupils. ( 6.1 ) PONV (\u2265 3%): dry mouth, dizziness, somnolence, agitation, visual impairment, confusion, mydriasis, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals LLC at 1-888-873-5329 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 r...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Scopolamine transdermal system contains scopolamine, which is not a controlled substance. 9.3 Dependence Termination of scopolamine transdermal system, usually after several days of use, may result in withdrawal symptoms such as disturbances of equilibrium, dizziness, nausea, vomiting, abdominal cramps, sweating, headache, mental confusion, muscle weakness, bradycardia, and hypotension. These withdrawal symptoms indicate that scopolamine, like other anticholinergic drugs, may produce physical dependence. The onset of these symptoms, generally 24 hours or more after the transdermal system has been removed, can be severe and may require medical intervention [see Warnings and Precautions (5.6) ].",
  "controlled_substance": "9.1 Controlled Substance Scopolamine transdermal system contains scopolamine, which is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions, Hyperthermia ( 5.5 ) 4/2025",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration Instructions Counsel patients on how to apply and remove the transdermal system [see Dosage and Administration (2.1) ] : Only wear one transdermal system at any time. Do not cut the transdermal system. Apply the transdermal system to the skin in the postauricular (hairless area behind one ear) area. After the transdermal system is applied on the dry skin behind the ear, wash hands thoroughly with soap and water and dry hands. If the transdermal system becomes displaced, discard the transdermal system, and apply a new transdermal system on the hairless area behind the other ear. Once the transdermal system has been affixed, avoid touching or applying pressure to the transdermal system, since pressure exerted on it may cause scopolamine to ooze out at the edge. Upon removal, fold the used transdermal system in half with the sticky side together, and discard in household trash in a manner that prevents accidental contact or ingestion by children, pets, or others. Wash the hands and application site with soap and water after transdermal system removal. Patients wi...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Prevention of Motion Sickness In 195 adult subjects of different racial origins who participated in clinical efficacy studies at sea or in a controlled motion environment, there was a 75% reduction in the incidence of motion-induced nausea and vomiting. Scopolamine transdermal system was applied from 4 to 16 hours prior to the onset of motion in these studies. 14.2 Prevention of Post-Operative Nausea and Vomiting A clinical efficacy study evaluated 168 adult female patients undergoing gynecological surgery with anesthesia and opiate analgesia. Patients received scopolamine transdermal system or placebo applied approximately 11 hours before anesthesia/opiate analgesia. No retching/vomiting during the 24-hour post-operative period was reported in 79% of those treated with scopolamine transdermal system compared to 72% of those receiving placebo. When the need for additional antiemetic medication was assessed during the same period, there was no need for medication in 89% of patients treated with scopolamine transdermal system as compared to 72% of placebo-treated patients.",
  "brand_name": "Scopolamine",
  "manufacturer": "Rhodes Pharmaceuticals LLC",
  "application_number": "ANDA215329",
  "pharm_class_epc": [
   "Anticholinergic [EPC]"
  ],
  "route": [
   "TRANSDERMAL"
  ],
  "effective_time": "20260506",
  "set_id": "ba5a1237-4d23-441a-808e-96b97045fbe2",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7442,
  "serious": 5318,
  "death": 1107,
  "hospitalization": 2652,
  "primary_suspect": 7401,
  "top_reactions": [
   [
    "Off Label Use",
    828
   ],
   [
    "Nausea",
    707
   ],
   [
    "Vomiting",
    533
   ],
   [
    "Headache",
    467
   ],
   [
    "Dizziness",
    457
   ],
   [
    "Drug Ineffective",
    430
   ],
   [
    "Death",
    373
   ],
   [
    "Malaise",
    324
   ],
   [
    "Diarrhoea",
    306
   ],
   [
    "Fatigue",
    295
   ],
   [
    "Product Adhesion Issue",
    277
   ],
   [
    "Product Use In Unapproved Indication",
    268
   ],
   [
    "Confusional State",
    265
   ],
   [
    "Vision Blurred",
    255
   ],
   [
    "Pneumonia",
    251
   ]
  ],
  "by_year": {
   "2019": 739,
   "2020": 636,
   "2021": 512,
   "2022": 578,
   "2023": 607,
   "2024": 550,
   "2025": 562,
   "2026": 307
  },
  "by_year_primary": {
   "2019": 739,
   "2020": 636,
   "2021": 512,
   "2022": 574,
   "2023": 602,
   "2024": 535,
   "2025": 558,
   "2026": 294
  }
 },
 "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"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 8,
  "nda": 1,
  "anda": 7,
  "first_approval": "19791231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 10,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS LABS UT INC",
   "AMNEAL",
   "BAXTER HLTHCARE CORP",
   "MYLAN TECHNOLOGIES",
   "PADAGIS US",
   "RHODES PHARMS",
   "RICONPHARMA LLC",
   "ZYDUS PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/1979"
 },
 "trials": {
  "total": 450,
  "completed": 360,
  "terminated": 34,
  "with_results": 188,
  "industry": 290,
  "phase3": 121,
  "results_share": 0.5222222222222223,
  "terminated_share": 0.07555555555555556
 },
 "pubmed": {
  "rct": 190,
  "meta": 11,
  "recent_rct": 6,
  "cochrane": [
   {
    "pmid": "21678338",
    "title": "Scopolamine (hyoscine) for preventing and treating motion sickness",
    "year": "2011"
   },
   {
    "pmid": "17636710",
    "title": "Scopolamine (hyoscine) for preventing and treating motion sickness",
    "year": "2007"
   },
   {
    "pmid": "15266468",
    "title": "Scopolamine for preventing and treating motion sickness",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "scopolamine",
   "Transderm Scop"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 400551,
  "beneficiaries": 230710,
  "spend": 31498678.259999998,
  "by_brand": [
   {
    "brand": "Scopolamine",
    "claims": 398915,
    "per_claim": 78.2322487,
    "is_generic": true
   },
   {
    "brand": "Transderm-Scop",
    "claims": 1636,
    "per_claim": 177.66550733,
    "is_generic": false
   }
  ],
  "per_claim": 78.63837129354314
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20250618",
   "title": "FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Sc\u014dp (scopolamine transdermal system)",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-adds-warning-about-serious-risk-heat-related-complications-antinausea-patch-transderm-scop",
   "kind": "drug",
   "matched": "scopolamine"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1387,
  "fills": 400551,
  "per_million": 3462.7300893019865,
  "ratio": 1.250557213817919,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 83,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2025 (-8)",
    "3,463 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death appears in 1.6x the share of reports seen across all of FAERS (-2)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 66,
   "letter": "C",
   "why": [
    "190 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "3 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 88,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)",
    "2 label changes approved since 2021 (-4)",
    "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 (7 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "In 2025 the FDA issued a safety communication about this drug (FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Sc\u014dp (scopol). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, vomiting, headache. 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 atropine, cyclopentolate, homatropine? 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.)"
 ]
}