{
 "query": "norethindrone",
 "ingredient": "norethindrone",
 "slug": "norethindrone",
 "rxcui": "7514",
 "brands": [
  "Gallifrey"
 ],
 "names": [
  "norethindrone",
  "norethindrone acetate",
  "norethindrone enanthate"
 ],
 "classes": [
  {
   "id": "G03AC",
   "name": "Progestogens"
  },
  {
   "id": "G03DC",
   "name": "Estren derivatives"
  }
 ],
 "alternatives": [
  "allylestrenol",
  "desogestrel",
  "drospirenone",
  "ethisterone",
  "ethynodiol",
  "etonogestrel",
  "levonorgestrel",
  "lynestrenol",
  "medroxyprogesterone",
  "megestrol",
  "norgestrienone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 54,
   "TRANSDERMAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year Method (1) Typical Use Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason. (2) Perfect Use Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregn...",
  "contraindications": "CONTRAINDICATIONS Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. Camila does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin-only pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1. Ectopic Pregnancy The incidence of ectopic pregnancies for progestin-only oral contraceptive users ...",
  "adverse_reactions": "ADVERSE REACTIONS Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely. To report SUSPECTED ADVERSE EVENTS, contact Dr. Reddy\u2019s Laboratories Inc, at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "INFORMATION FOR THE PATIENT See PATIENT LABELING for detailed information. Counseling Issues The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives: The necessity of taking pills at the same time every day, including throughout all bleeding episodes. The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late. The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities. The need to inform the clinician of prolonged episodes of bleeding, amenorrhea or severe abdominal pain. The importance of using a barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STDs/HIV.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "CAMILA",
  "manufacturer": "Dr. Reddy's Labratories Inc.",
  "application_number": "ANDA076177",
  "pharm_class_epc": [
   "Progestin [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240401",
  "set_id": "59985565-af09-21ba-0336-3f6db7711bd1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 6861,
  "serious": 3506,
  "death": 115,
  "hospitalization": 1338,
  "primary_suspect": 6841,
  "top_reactions": [
   [
    "Headache",
    553
   ],
   [
    "Nausea",
    553
   ],
   [
    "Fatigue",
    463
   ],
   [
    "Off Label Use",
    439
   ],
   [
    "Drug Ineffective",
    416
   ],
   [
    "Hot Flush",
    382
   ],
   [
    "Pain",
    360
   ],
   [
    "Abdominal Pain",
    312
   ],
   [
    "Dizziness",
    304
   ],
   [
    "Vaginal Haemorrhage",
    283
   ],
   [
    "Diarrhoea",
    275
   ],
   [
    "Arthralgia",
    267
   ],
   [
    "Dyspnoea",
    267
   ],
   [
    "Vomiting",
    267
   ],
   [
    "Migraine",
    256
   ]
  ],
  "by_year": {
   "2019": 495,
   "2020": 567,
   "2021": 495,
   "2022": 519,
   "2023": 524,
   "2024": 486,
   "2025": 490,
   "2026": 226
  },
  "by_year_primary": {
   "2019": 495,
   "2020": 567,
   "2021": 494,
   "2022": 517,
   "2023": 513,
   "2024": 484,
   "2025": 488,
   "2026": 225
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 25,
  "nda": 5,
  "anda": 20,
  "first_approval": "19730102",
  "rems": false,
  "rems_last": "19790621",
  "labeling_supplements": 41,
  "labeling_recent": 2,
  "sponsors": [
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BARR",
   "DR REDDYS LABS SA",
   "DURAMED RES",
   "GLENMARK PHARMS LTD",
   "INGENUS PHARMS LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/02/1973"
 },
 "trials": {
  "total": 153,
  "completed": 106,
  "terminated": 19,
  "with_results": 43,
  "industry": 93,
  "phase3": 42,
  "results_share": 0.4056603773584906,
  "terminated_share": 0.12418300653594772
 },
 "pubmed": {
  "rct": 65,
  "meta": 1,
  "recent_rct": 3,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "norethindrone",
   "Gallifrey"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 142678,
  "beneficiaries": 42210,
  "spend": 3994510.14,
  "by_brand": [
   {
    "brand": "Norethindrone Acetate",
    "claims": 60334,
    "per_claim": 38.863061789,
    "is_generic": true
   },
   {
    "brand": "Norethindrone",
    "claims": 54776,
    "per_claim": 18.800028845,
    "is_generic": true
   },
   {
    "brand": "Jencycla",
    "claims": 6733,
    "per_claim": 20.608398931,
    "is_generic": false
   },
   {
    "brand": "Heather",
    "claims": 5775,
    "per_claim": 23.722012121,
    "is_generic": false
   },
   {
    "brand": "Errin",
    "claims": 4727,
    "per_claim": 23.860810239,
    "is_generic": false
   },
   {
    "brand": "Incassia",
    "claims": 3887,
    "per_claim": 22.877067147,
    "is_generic": false
   },
   {
    "brand": "Deblitane",
    "claims": 2106,
    "per_claim": 19.998793922,
    "is_generic": false
   },
   {
    "brand": "Nora-Be",
    "claims": 1593,
    "per_claim": 23.781556811,
    "is_generic": false
   },
   {
    "brand": "Sharobel",
    "claims": 1190,
    "per_claim": 18.311319328,
    "is_generic": false
   },
   {
    "brand": "Gallifrey",
    "claims": 880,
    "per_claim": 32.333227273,
    "is_generic": false
   },
   {
    "brand": "Camila",
    "claims": 638,
    "per_claim": 18.298746082,
    "is_generic": false
   },
   {
    "brand": "Lyleq",
    "claims": 39,
    "per_claim": 14.662051282,
    "is_generic": false
   }
  ],
  "per_claim": 27.996678815234304
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1197,
  "fills": 142678,
  "per_million": 8389.520458655154,
  "ratio": 3.029856517681717,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "8,390 FDA reports naming it as the suspect drug per million Medicare fills, 3.0x the median drug on this site (-10)",
    "Death share in reports is near or below the FAERS average (0.2x)",
    "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": [
    "65 randomized trials and 1 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": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)"
   ],
   "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 (20 applications)",
    "11 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are headache, nausea, 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?",
  "Why this one over allylestrenol, desogestrel, drospirenone? 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.)"
 ]
}