{
 "query": "anastrozole",
 "ingredient": "anastrozole",
 "slug": "anastrozole",
 "rxcui": "84857",
 "brands": [
  "Arimidex"
 ],
 "names": [
  "anastrozole"
 ],
 "classes": [
  {
   "id": "L02BG",
   "name": "Aromatase inhibitors"
  }
 ],
 "alternatives": [
  "aminoglutethimide",
  "exemestane",
  "formestane",
  "letrozole"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 38
  },
  "boxed_warning": "",
  "indications_and_usage": "ARIMIDEX is an aromatase inhibitor indicated for: \u2022 Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) \u2022 First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer ( 1.2 ) \u2022 Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX ( 1.3 ) 1.1 Adjuvant Treatment ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. 1.2 First-Line Treatment ARIMIDEX is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. 1.3 Second-Line Treatment ARIMIDEX is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to A...",
  "contraindications": "Hypersensitivity ARIMIDEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions ( 6.2 )] . Patients with demonstrated hypersensitivity to ARIMIDEX or any excipient ( 4 )",
  "warnings_and_cautions": "\u2022 In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with ARIMIDEX use compared to tamoxifen use. Consider risks and benefits. ( 5.1 , 6.1 ) \u2022 Decreases in bone mineral density may occur. Consider bone mineral density monitoring. ( 5.2 , 6.1 ) \u2022 Increases in total cholesterol may occur. Consider cholesterol monitoring. ( 5.3 , 6.1 ) \u2022 Embryo-Fetal Toxicity: ARIMIDEX may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.4 , 8.1 ) 5.1 Ischemic Cardiovascular Events In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with ARIMIDEX in the ATAC trial (17% of patients on ARIMIDEX and 10% of patients on tamoxifen). Consider risk and benefits of ARIMIDEX therapy in patients with pre-existing ischemic heart disease [see Adverse Reactions ( 6.1 )] . 5.2 Bone Effects Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving ARIMIDEX had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen ...",
  "warnings": "",
  "adverse_reactions": "Serious adverse reactions with ARIMIDEX occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling [see Adverse Reactions ( 6.2 )] . Common adverse reactions (occurring with an incidence of \u226510%) in women taking ARIMIDEX included: hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema. In the ATAC trial, the most common reported adverse reaction (>0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the ARIMIDEX group. Because clinical trials are conducted under widely varying conditions,...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA approved patient labeling (Patient Information). Hypersensitivity Reactions Inform patients of the possibility of serious allergic reactions with swelling of the face, lips, tongue and/or throat (angioedema) which may cause difficulty in swallowing and/or breathing and to seek medical attention immediately [see Contraindications ( 4 )] . Ischemic Cardiovascular Events Patients with pre-existing ischemic heart disease should be informed that an increased incidence of cardiovascular events has been observed with ARIMIDEX use compared to tamoxifen use. Advise patients if new or worsening chest pain or shortness of breath occurs to seek medical attention immediately [see Warnings and Precautions ( 5.1 )] . Bone Effects Inform patients that ARIMIDEX lowers the level of estrogen. This may lead to a loss of the mineral content of bones, which might decrease bone strength. A possible consequence of decreased mineral content of bones is an increase in the risk of fractures [see Warnings and Precautions ( 5.2 )] . Cholesterol Inform patients that an increased level of cholesterol might be seen while receiving ARIMIDEX [see Warnings and Precautions ( 5.3 )] . Carpal Tunnel Patients sh...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Adjuvant Treatment of Breast Cancer in Postmenopausal Women A multicenter, double-blind trial (ATAC) randomized 9,366 postmenopausal women with operable breast cancer to adjuvant treatment with ARIMIDEX 1 mg daily, tamoxifen 20 mg daily, or a combination of the two treatments for five years or until recurrence of the disease. The primary endpoint of the trial was disease-free survival (i.e., time to occurrence of a distant or local recurrence, or contralateral breast cancer or death from any cause). Secondary endpoints of the trial included distant disease-free survival, the incidence of contralateral breast cancer and overall survival. At a median follow-up of 33 months, the combination of ARIMIDEX and tamoxifen did not demonstrate any efficacy benefit when compared with tamoxifen in all patients as well as in the hormone receptor positive subpopulation. This treatment arm was discontinued from the trial. Based on clinical and pharmacokinetic results from the ATAC trial, tamoxifen should not be administered with anastrozole [see Drug Interactions ( 7.1 )] . Demographic and other baseline characteristics were similar among the three treatment groups (see Table 7). Table 7 - De...",
  "brand_name": "ARIMIDEX",
  "manufacturer": "ANI Pharmaceuticals, Inc.",
  "application_number": "NDA020541",
  "pharm_class_epc": [
   "Aromatase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260302",
  "set_id": "acbfaaa9-503c-4691-9828-76a7146ed6de",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 38",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 26548,
  "serious": 18925,
  "death": 1825,
  "hospitalization": 5909,
  "primary_suspect": 26475,
  "top_reactions": [
   [
    "Fatigue",
    2916
   ],
   [
    "Nausea",
    2321
   ],
   [
    "Alopecia",
    2275
   ],
   [
    "Diarrhoea",
    2128
   ],
   [
    "Arthralgia",
    2038
   ],
   [
    "Headache",
    1400
   ],
   [
    "Pain",
    1365
   ],
   [
    "Malignant Neoplasm Progression",
    1315
   ],
   [
    "Dyspnoea",
    1297
   ],
   [
    "Asthenia",
    1262
   ],
   [
    "Off Label Use",
    1201
   ],
   [
    "Dizziness",
    1200
   ],
   [
    "Vomiting",
    1164
   ],
   [
    "Drug Ineffective",
    1089
   ],
   [
    "Malaise",
    1053
   ]
  ],
  "by_year": {
   "2019": 2729,
   "2020": 2414,
   "2021": 2197,
   "2022": 2294,
   "2023": 2589,
   "2024": 2270,
   "2025": 2258,
   "2026": 1239
  },
  "by_year_primary": {
   "2019": 2726,
   "2020": 2413,
   "2021": 2192,
   "2022": 2290,
   "2023": 2571,
   "2024": 2241,
   "2025": 2254,
   "2026": 1234
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20190509",
   "reason": "GMP Deviations: Potential cross contamination due to cleaning procedure failure.",
   "firm": "American Health Packaging",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190509",
   "reason": "GMP Deviations: Potential cross contamination due to cleaning procedure failure.",
   "firm": "American Health Packaging",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 21,
  "nda": 2,
  "anda": 18,
  "first_approval": "19951227",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 13,
  "labeling_recent": 1,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ANI PHARMS",
   "APOTEX INC",
   "ASTRAZENECA",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX",
   "CIPLA",
   "EUGIA PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/27/1995"
 },
 "trials": {
  "total": 494,
  "completed": 232,
  "terminated": 64,
  "with_results": 133,
  "industry": 232,
  "phase3": 121,
  "results_share": 0.5732758620689655,
  "terminated_share": 0.12955465587044535
 },
 "pubmed": {
  "rct": 186,
  "meta": 9,
  "recent_rct": 15,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "anastrozole",
   "Arimidex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1704262,
  "beneficiaries": 434573,
  "spend": 35611318.25,
  "by_brand": [
   {
    "brand": "Anastrozole",
    "claims": 1702914,
    "per_claim": 18.83412372,
    "is_generic": true
   },
   {
    "brand": "Arimidex",
    "claims": 1348,
    "per_claim": 2624.9445772,
    "is_generic": false
   }
  ],
  "per_claim": 20.895448147057202
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "anastrozole",
  "matched": "anastrozole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5729,
  "fills": 1704262,
  "per_million": 3361.57234040306,
  "ratio": 1.2140243194378564,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 98,
   "letter": "A",
   "why": [
    "3,362 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "186 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 0 Class III across 18 generic makers (-6)"
   ],
   "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 (18 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, alopecia, diarrhoea. How would we recognize and handle those?",
  "Why this one over aminoglutethimide, exemestane, formestane? 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.)"
 ]
}