{
 "query": "azelastine",
 "ingredient": "azelastine",
 "slug": "azelastine",
 "rxcui": "18603",
 "brands": [
  "Astepro"
 ],
 "names": [
  "azelastine",
  "azelastine hydrochloride"
 ],
 "classes": [
  {
   "id": "R01AC",
   "name": "Antiallergic agents, excl. corticosteroids"
  }
 ],
 "alternatives": [
  "antazoline",
  "cromolyn",
  "levocabastine",
  "nedocromil",
  "olopatadine",
  "thonzylamine"
 ],
 "label": {
  "route_mode": "NASAL",
  "route_counts": {
   "NASAL": 27,
   "INTRAOCULAR": 5,
   "OPHTHALMIC": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Azelastine hydrochloride Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride Nasal Spray is an H 1 -receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. ()",
  "contraindications": "None. None. ()",
  "warnings_and_cautions": "\u2022 Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking Azelastine hydrochloride Nasal Spray. () \u2022 Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with Azelastine hydrochloride Nasal Spray because further decreased alertness and impairment of CNS performance may occur. () 5.1 Somnolence in Activities Requiring Mental Alertness In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine hydrochloride Nasal Spray [ see ]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of Azelastine hydrochloride Nasal Spray. Concurrent use of Azelastine hydrochloride Nasal Spray with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see ].",
  "warnings": "",
  "adverse_reactions": "Use of Azelastine hydrochloride Nasal Spray has been associated with somnolence [ see ]. The most common adverse reactions (\u22652% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase. () To report SUSPECTED ADVERSE REACTIONS, Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Seasonal Allergic Rhinitis Azelastine hydrochloride Nasal Spray Two Sprays Per Nostril Twice Daily Adverse experience information for Azelastine hydrochloride Nasal Spray is derived from six placebo-and active-controlled, 2-day to 8-week clinical trials which included 391 patients, 12 years of age and older, with seasonal allergic rhinitis who received Azelastine hydrochloride Nasal Spray at a dose of 2 sprays per nostril twice daily. In ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved patient labeling (Patient Information and Instructions for Use). Activities Requiring Mental Alertness Somnolence has been reported in some patients taking Azelastine hydrochloride Nasal Spray. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Azelastine hydrochloride Nasal Spray [ see ]. Concurrent Use of Alcohol and other Central Nervous System Depressants Instruct patients to avoid concurrent use of Azelastine hydrochloride Nasal Spray with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur [ see ]. Common Adverse Reactions Inform patients that the treatment with Azelastine hydrochloride Nasal Spray may lead to adverse reactions, which include bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase [ see ]. Priming Instruct patients to prime the pump before initial use and when Azelastin...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Seasonal Allergic Rhinitis Two Sprays Per Nostril Twice Daily The efficacy and safety of Azelastine hydrochloride Nasal Spray were evaluated in three placebo-controlled clinical trials of Azelastine hydrochloride Nasal Spray including 322 patients with seasonal allergic rhinitis who received two sprays per nostril twice a day for up to 4 weeks. These trials included 55 pediatric patients ages 12 to 16 years. Assessment of efficacy was based on the 12-hour reflective Total Symptom Complex (TSC) and Major Symptom Complex (MSC). The MSC was calculated as the average of individual symptoms of nose blows, sneezes, runny nose/sniffles, itchy nose, and watery eyes as assessed by patients on a 0 to 5 categorical scale. Azelastine hydrochloride Nasal Spray two sprays per nostril twice daily demonstrated a greater decrease in the MSC than placebo (Table 3). Table 1: Mean Change from Baseline in Reflective MSC* in Adults and Adolescents \u226512 Years with Seasonal Allergic Rhinitis Treated with Azelastine hydrochloride Nasal Spray Two Sprays Per Nostril Twice Daily Versus Placebo * Major Symptom Comlex (MSC): Average of individual symptoms of nose blows, sneezes, runny nose/sniffles, itchy n...",
  "brand_name": "AZELASTINE HYDROCHLORIDE",
  "manufacturer": "Preferred Pharmaceuticals Inc.",
  "application_number": "ANDA212289",
  "pharm_class_epc": [],
  "route": [
   "NASAL"
  ],
  "effective_time": "20260311",
  "set_id": "37c40f8d-269c-4df8-8ac7-cbe78f4ca5c4",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 21902,
  "serious": 8134,
  "death": 605,
  "hospitalization": 3451,
  "primary_suspect": 21884,
  "top_reactions": [
   [
    "Treatment Failure",
    1884
   ],
   [
    "Drug Ineffective",
    1781
   ],
   [
    "Fatigue",
    1430
   ],
   [
    "Headache",
    1248
   ],
   [
    "Nausea",
    1139
   ],
   [
    "Dyspnoea",
    1090
   ],
   [
    "Product Dose Omission Issue",
    1014
   ],
   [
    "Pain",
    934
   ],
   [
    "Diarrhoea",
    927
   ],
   [
    "Cough",
    919
   ],
   [
    "Dizziness",
    850
   ],
   [
    "Sinusitis",
    815
   ],
   [
    "Off Label Use",
    680
   ],
   [
    "Arthralgia",
    642
   ],
   [
    "Asthma",
    625
   ]
  ],
  "by_year": {
   "2019": 1478,
   "2020": 3654,
   "2021": 1473,
   "2022": 1838,
   "2023": 1962,
   "2024": 1900,
   "2025": 2585,
   "2026": 1299
  },
  "by_year_primary": {
   "2019": 1478,
   "2020": 3653,
   "2021": 1472,
   "2022": 1834,
   "2023": 1961,
   "2024": 1897,
   "2025": 2579,
   "2026": 1297
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250528",
   "reason": "Lack of Assurance of Sterility",
   "firm": "Apotex Corp.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20180205",
   "reason": "Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20110615",
   "reason": "CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.",
   "firm": "Apotex Corp.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 31,
  "nda": 4,
  "anda": 27,
  "first_approval": "19961101",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 16,
  "labeling_recent": 4,
  "sponsors": [
   "ALEMBIC",
   "ALKEM LABS LTD",
   "AMNEAL",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BAYER HLTHCARE"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/01/1996"
 },
 "trials": {
  "total": 66,
  "completed": 48,
  "terminated": 4,
  "with_results": 22,
  "industry": 50,
  "phase3": 24,
  "results_share": 0.4583333333333333,
  "terminated_share": 0.06060606060606061
 },
 "pubmed": {
  "rct": 116,
  "meta": 2,
  "recent_rct": 8,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "azelastine",
   "Astepro"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3263509,
  "beneficiaries": 1382184,
  "spend": 86143660.95,
  "by_brand": [
   {
    "brand": "Azelastine HCl",
    "claims": 3263509,
    "per_claim": 26.396023713,
    "is_generic": true
   }
  ],
  "per_claim": 26.396023712513127
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5773,
  "fills": 3263509,
  "per_million": 1768.954827457194,
  "ratio": 0.6388540727529113,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,769 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 41,
   "letter": "F",
   "why": [
    "116 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 46% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 27 generic makers (-2)",
    "4 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 (27 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are treatment failure, fatigue, headache. How would we recognize and handle those?",
  "Why this one over antazoline, cromolyn, levocabastine? 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.)"
 ]
}