{
 "query": "omalizumab",
 "ingredient": "omalizumab",
 "slug": "omalizumab",
 "rxcui": "302379",
 "brands": [
  "Xolair"
 ],
 "names": [
  "omalizumab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] . WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has ...",
  "indications_and_usage": "is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance ( 1.3 ) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment ( 1.4 ) Limitations of Use : Not indicated for acute bronchospasm or status asthmaticus. ( 1.1 , 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis ( 1.3 ) Not indicated for other forms of urticaria. ( 1.4 ) 1.1 Asthma XOLAIR is indicated for adults and p...",
  "contraindications": "is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR [see Warnings and Precautions (5.1) ] . Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR ( 4 , 5.1 )",
  "warnings_and_cautions": "Anaphylaxis: Initiate XOLAIR therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration. ( 5.1 ) Malignancy: Malignancies have been observed in clinical studies. ( 5.2 ) Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus. ( 5.3 ) Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of XOLAIR therapy. ( 5.4 ) Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. ( 5.5 ) Fever, Arthralgia, and Rash: Stop XOLAIR if patients develop signs and symptoms similar to serum sickness. ( 5.6 ) Potential Medication Error Related to Emergency Treatment of Anaphylaxis: XOLAIR should not be used for emergency treatment of allergic reactions, including anaphylaxis. ( 5.9 ) 5.1 Anaphylaxis Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports [see Boxed Warning and Adverse Reactions (6.2) ] . ...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma : The most common adverse reactions (\u2265 1% of patients) in clinical studies with adult and adolescent patients \u226512 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions (\u22653% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps : The most common adverse reactions (\u2265 3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness. ( 6.1 ) IgE-Mediated Food Allergy : The most common adverse reactions (\u22653% of patients) were injection site reactions and pyrexia. ( 6.1 ) Chronic Spontaneous Urticaria : The most common adverse reaction...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.5 , 2.7 ) 8/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Anaphylaxis Inform patients of the risk of life-threatening anaphylaxis with XOLAIR including the following points [see Boxed Warning and Warnings and Precautions (5.1) ] : There have been reports of anaphylaxis occurring up to 4 days after administration of XOLAIR Initiate XOLAIR only in a healthcare setting by healthcare providers Observe patients closely following administration Inform patients of the signs and symptoms of anaphylaxis Instruct patients to seek immediate medical care should such signs or symptoms occur Potential Medication Error Related to Emergency Treatment of Anaphylaxis Advise patients, parents, or caregivers that XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis [see Warnings and Precautions (5.9) ] . Continuation of Other Medications Instruct patients receiving XOLAIR not to decrease the dose of, or stop taking any other asthma, CRSwNP, CSU or IgE-mediated food allergy medications or allergen immunotherapy unless otherwise instructed by their physician. Inform patients that they may not see immediate im...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 8/2026 MEDICATION GUIDE XOLAIR \u00ae (ZOHL-air) (omalizumab) injection, for subcutaneous use XOLAIR \u00ae (ZOHL-air) (omalizumab) for injection, for subcutaneous use What is the most important information I should know about XOLAIR? XOLAIR may cause serious side effects, including: Severe allergic reaction . A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of \"impending doom\" flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOL...",
  "clinical_studies": "14.1 Asthma Adult and Adolescent Patients 12 Years of Age and Older The safety and efficacy of XOLAIR were evaluated in three randomized, double-blind, placebo-controlled, multicenter trials. The trials enrolled patients 12 to 76 years old, with moderate to severe persistent (NHLBI criteria) asthma for at least one year, and a positive skin test reaction to a perennial aeroallergen. In all trials, XOLAIR dosing was based on body weight and baseline serum total IgE concentration. All patients were required to have a baseline IgE between 30 and 700 IU/mL and body weight not more than 150 kg. Patients were treated according to a dosing table to administer at least 0.016 mg/kg/IU (IgE/mL) of XOLAIR or a matching volume of placebo over each 4-week period. The maximum XOLAIR dose per 4 weeks was 750 mg. In all three trials an exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose. Most exacerbations were managed in the outpatient setting and the majority were treated with systemic steroids. Hospitalization rates were not significantly different between XOLAIR and placebo-treated patients; however, the...",
  "brand_name": "XOLAIR",
  "manufacturer": "Genentech, Inc.",
  "application_number": "BLA103976",
  "pharm_class_epc": [
   "Anti-IgE [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260813",
  "set_id": "7f6a2191-adfb-48b9-9bfa-0d9920479f0d",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 75660,
  "serious": 37030,
  "death": 1877,
  "hospitalization": 12938,
  "primary_suspect": 75642,
  "top_reactions": [
   [
    "Urticaria",
    11030
   ],
   [
    "No Adverse Event",
    10861
   ],
   [
    "Off Label Use",
    10668
   ],
   [
    "Asthma",
    10615
   ],
   [
    "Dyspnoea",
    9390
   ],
   [
    "Drug Ineffective",
    8007
   ],
   [
    "Cough",
    6625
   ],
   [
    "Pruritus",
    6049
   ],
   [
    "Fatigue",
    5710
   ],
   [
    "Malaise",
    5384
   ],
   [
    "Wheezing",
    5117
   ],
   [
    "Headache",
    4999
   ],
   [
    "Pneumonia",
    4995
   ],
   [
    "Pain",
    4273
   ],
   [
    "Anaphylactic Reaction",
    3767
   ]
  ],
  "by_year": {
   "2019": 5463,
   "2020": 5479,
   "2021": 5302,
   "2022": 5311,
   "2023": 5718,
   "2024": 13058,
   "2025": 9843,
   "2026": 4830
  },
  "by_year_primary": {
   "2019": 5463,
   "2020": 5479,
   "2021": 5299,
   "2022": 5306,
   "2023": 5718,
   "2024": 13054,
   "2025": 9838,
   "2026": 4830
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250730",
   "reason": "CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.",
   "firm": "Cardinal Health Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250730",
   "reason": "CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.",
   "firm": "Cardinal Health Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20210609",
   "reason": "Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.",
   "firm": "Genentech Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 1,
  "nda": 0,
  "anda": 0,
  "first_approval": "20030620",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "GENENTECH"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/20/2003"
 },
 "trials": {
  "total": 259,
  "completed": 171,
  "terminated": 21,
  "with_results": 86,
  "industry": 154,
  "phase3": 53,
  "results_share": 0.5029239766081871,
  "terminated_share": 0.08108108108108109
 },
 "pubmed": {
  "rct": 168,
  "meta": 85,
  "recent_rct": 34,
  "cochrane": [
   {
    "pmid": "24414989",
    "title": "Omalizumab for asthma in adults and children",
    "year": "2014"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2238193.01,
  "records": 22269,
  "by_name": [
   [
    "Xolair",
    2238193.01
   ]
  ],
  "names_checked": [
   "omalizumab",
   "Xolair"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 95356,
  "beneficiaries": 11011,
  "spend": 313118328.76,
  "by_brand": [
   {
    "brand": "Xolair",
    "claims": 95356,
    "per_claim": 3283.6772595,
    "is_generic": false
   }
  ],
  "per_claim": 3283.6772595326984
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20140926",
   "title": "FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm414911.htm",
   "kind": "drug",
   "matched": "omalizumab"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 57,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2014 (-8)",
    "Death share in reports is near or below the FAERS average (0.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 77,
   "letter": "B",
   "why": [
    "168 randomized trials and 85 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III (-9)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $2,238,193 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "In 2014 the FDA issued a safety communication about this drug (FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of h). Does that risk apply to me?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are urticaria, no adverse event, asthma. 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?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}