{
 "query": "cyproheptadine",
 "ingredient": "cyproheptadine",
 "slug": "cyproheptadine",
 "rxcui": "3013",
 "brands": [],
 "names": [
  "cyproheptadine",
  "cyproheptadine hydrochloride",
  "cyproheptadine pyrid phos"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 35
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
  "contraindications": "CONTRAINDICATIONS Newborn or Premature Infants This drug should not be used in newborn or premature infants. Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Other Conditions Hypersensitivity to cyproheptadine and other drugs of similar chemical structure Monoamine oxidase inhibitor therapy (see Drug Interactions ) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Children Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions and death. Antihistamines may diminish mental alertness; conversely, particularly in the young child, they may occasionally produce excitation. CNS Depressants Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents. Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.",
  "adverse_reactions": "ADVERSE REACTIONS Adverse reactions which have been reported with the use of antihistamines are as follows: Central Nervous System: Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Integumentary: Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Special Senses: Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Cardiovascular: Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. Hematologic: Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Digestive System: Dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice. Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses. Respiratory: Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Miscellaneous: Fatigue, chills, headache, increased appetite/weight gain. To report SUSPECTED ADVERSE REACTIONS, contact Patrin P...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Antihistamines may diminish mental alertness; conversely, particularly in the young child, they may occasionally produce excitation. Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Cyproheptadine Hydrochloride",
  "manufacturer": "Patrin Pharma, Inc.",
  "application_number": "ANDA209108",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220224",
  "set_id": "81d9523f-f945-4410-8b71-8b5fea48a3da",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 5211,
  "serious": 3501,
  "death": 360,
  "hospitalization": 2147,
  "primary_suspect": 5188,
  "top_reactions": [
   [
    "Off Label Use",
    405
   ],
   [
    "Drug Ineffective",
    314
   ],
   [
    "Diarrhoea",
    300
   ],
   [
    "Fatigue",
    295
   ],
   [
    "Vomiting",
    293
   ],
   [
    "Nausea",
    282
   ],
   [
    "Pneumonia",
    225
   ],
   [
    "Headache",
    224
   ],
   [
    "Decreased Appetite",
    213
   ],
   [
    "Pyrexia",
    209
   ],
   [
    "Weight Decreased",
    200
   ],
   [
    "Anxiety",
    192
   ],
   [
    "Serotonin Syndrome",
    187
   ],
   [
    "Infective Pulmonary Exacerbation Of Cystic Fibrosis",
    178
   ],
   [
    "Abdominal Pain",
    175
   ]
  ],
  "by_year": {
   "2019": 726,
   "2020": 628,
   "2021": 390,
   "2022": 436,
   "2023": 341,
   "2024": 410,
   "2025": 450,
   "2026": 217
  },
  "by_year_primary": {
   "2019": 726,
   "2020": 628,
   "2021": 389,
   "2022": 434,
   "2023": 339,
   "2024": 405,
   "2025": 447,
   "2026": 208
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260713",
   "reason": "Presence of Precipitate: medication was crystallizing and particles floating in the bottle",
   "firm": "Rising Pharma Holding, Inc.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 41,
  "nda": 2,
  "anda": 31,
  "first_approval": "19611017",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "AM THERAP",
   "ASCOT",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX",
   "DURAMED PHARMS BARR",
   "HALSEY",
   "HERITAGE PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/17/1961"
 },
 "trials": {
  "total": 105,
  "completed": 73,
  "terminated": 10,
  "with_results": 30,
  "industry": 50,
  "phase3": 25,
  "results_share": 0.410958904109589,
  "terminated_share": 0.09523809523809523
 },
 "pubmed": {
  "rct": 48,
  "meta": 2,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "cyproheptadine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 229286,
  "beneficiaries": 72661,
  "spend": 4521860.82,
  "by_brand": [
   {
    "brand": "CyproHEPtadine HCl",
    "claims": 229286,
    "per_claim": 19.721486789,
    "is_generic": true
   }
  ],
  "per_claim": 19.721486789424564
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1060,
  "fills": 229286,
  "per_million": 4623.04719869508,
  "ratio": 1.6696031382897245,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 91,
   "letter": "A",
   "why": [
    "4,623 FDA reports naming it as the suspect drug per million Medicare fills, 1.7x the median drug on this site (-4)",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 34,
   "letter": "F",
   "why": [
    "48 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 31 generic makers (-1)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (31 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, fatigue. 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?",
  "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.)"
 ]
}