{
 "query": "upadacitinib",
 "ingredient": "upadacitinib",
 "slug": "upadacitinib",
 "rxcui": "2196092",
 "brands": [
  "Rinvoq"
 ],
 "names": [
  "upadacitinib"
 ],
 "classes": [
  {
   "id": "L04AF",
   "name": "Janus-associated kinase (JAK) inhibitors"
  }
 ],
 "alternatives": [
  "baricitinib",
  "deucravacitinib",
  "deuruxolitinib",
  "ritlecitinib",
  "tofacitinib"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /RINVOQ LQ until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ /RINVOQ LQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ /RINVOQ LQ use. Invasive fungal infections, including cryptococcosis and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. The risks and benefits of treatment with RINVOQ /RINVOQ LQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be...",
  "indications_and_usage": "is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.1 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.2 ) Limitation s of Use RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.2 ) RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. ( 1.3 ) Limitations of Use RINVOQ is not recommended...",
  "contraindications": "is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients [see Warnings and Precautions ( 5.6 )] . Known hypersensitivity to upadacitinib or any of the excipients in RINVOQ/RINVOQ LQ. ( 4 , 5.6 )",
  "warnings_and_cautions": "Serious Infections : Avoid use in patients with active, serious infection, including localized infections. ( 5.1 ) Hypersensitivity : Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. Discontinue if a serious hypersensitivity reaction occurs. ( 5.6 ) Gastrointestinal (GI) Perforations : Monitor patients at risk for GI perforations and promptly evaluate patients with symptoms. ( 5.7 ) Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose; advise patients with diabetes to notify their healthcare provider if they develop signs or symptoms of hypoglycemia. ( 5.8 ) Laboratory Abnormalities : Monitoring recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. ( 5.9 ) Embryo-Fetal Toxicity : May cause fetal harm based on animal studies. Advise female patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.10 , 8.1 , 8.3 ) Vaccinations : Avoid use with live vaccines. ( 5.11 ) Medication Residue in Stool : Observed in stool or ostomy output in patients with shortened GI transit times. Monitor patients clinically and consider alternative...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Diabetes [see Warnings and Precautions ( 5.8 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.9 )] Rheumatoid arthritis , psoriatic arthritis , ankylosi ng spondylitis , and n on-radiographic a xial s pondyloarthritis : Adverse reactions (\u2265 1%) were: upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache. ( 6.1 ) Giant cell arteritis : Adverse reactions (\u2265 5%) are upper respiratory tract infections, headache, fatigue, peripheral edema, cough, anemia, rash, herpes zoster, and nausea. ( 6.1 ) Atopic d ermatitis : Adverse reactions (\u2265 1%) a...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.4 , 1.5 ) 10/2025 Warnings and Precautions ( 5.8 ) 6/2026",
  "information_for_patients": "Advise the patient and caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Serious Infections Inform patients that they may be more likely to develop infections when taking RINVOQ/RINVOQ LQ. Instruct patients to contact their healthcare provider immediately during treatment if they develop any signs or symptoms of an infection [see Warnings and Precautions ( 5.1 ) ] . Advise patients that the risk of herpes zoster is increased in patients taking RINVOQ/RINVOQ LQ and in some cases can be serious [see Warnings and Precautions ( 5.1 )] . Malignancies Inform patients that RINVOQ/RINVOQ LQ may increase their risk of certain cancers and that periodic skin examinations should be performed while using RINVOQ/RINVOQ LQ. Advise patients that exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen [see Warnings and Precautions ( 5.3 )] . Major Adverse Cardiovascular Events Inform patients that RINVOQ/RINVOQ LQ may increase their risk of major adverse cardiovascular events (MACE) including myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially curre...",
  "spl_medguide": "MEDICATION GUIDE RINVOQ \u00ae (RIN-VOKE) (upadacitinib) extended-release tablets, for oral use RINVOQ \u00ae LQ (RIN-VOKE EL-CUE) (upadacitinib) oral solution What is the most important information I should know about RINVOQ/RINVOQ LQ? RINVOQ/RINVOQ LQ can cause serious side effects, including: 1. Serious Infections. RINVOQ/RINVOQ LQ is a medicine that affects your immune system. RINVOQ/RINVOQ LQ can lower the ability of your immune system to fight infections. Some people have had serious infections while taking RINVOQ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment with RINVOQ/RINVOQ LQ. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with RINVOQ/RINVOQ LQ. You should not start taking RINVOQ/RINVOQ LQ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). Before starting RINVOQ/RINVOQ LQ, tell your healthcare provider if you : \u25cb are being treated for an in...",
  "clinical_studies": "Figure 1. Percent of Patients Achieving ACR20 in Trial RA-IV Figure 2. Percent of Patients Achieving ACR20 in Study PsA-II Figure 3: Proportion of Patients with Moderate to Severe AD with \u22654-point Improvement in the Worst Pruritus NRS in Monotherapy Trials Figure 4: Proportion of Patients with Moderate to Severe AD with \u22654-point Improvement in the Worst Pruritus NRS in Concomitant TCS Trial Figure 5. Percent of Patients Achieving ASAS40 in Trial AS-II* Figure 6. Percent of Patients Achieving ASAS40* 14.1 Rheumatoid Arthritis The efficacy and safety of RINVOQ 15 mg once daily were assessed in five Phase 3 randomized, double-blind, multicenter trials in patients with moderately to severely active rheumatoid arthritis and fulfilling the ACR/EULAR 2010 classification criteria. Patients 18 years of age and older were eligible to participate. The presence of at least 6 tender and 6 swollen joints and evidence of systemic inflammation based on elevation of hsCRP was required at baseline. Although other doses have been studied, the recommended dosage of RINVOQ is 15 mg once daily. Trial RA-I (NCT02706873) was a 24-week monotherapy trial in 947 patients with moderately to severely active rh...",
  "brand_name": "Rinvoq",
  "manufacturer": "AbbVie Inc.",
  "application_number": "NDA211675",
  "pharm_class_epc": [
   "Janus Kinase Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260630",
  "set_id": "2966aec7-2ef0-923c-d8ff-fe1a957bf095",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 81054,
  "serious": 55034,
  "death": 3017,
  "hospitalization": 20111,
  "primary_suspect": 81018,
  "top_reactions": [
   [
    "Pain",
    5355
   ],
   [
    "Arthralgia",
    4798
   ],
   [
    "Drug Ineffective",
    4661
   ],
   [
    "Rheumatoid Arthritis",
    3290
   ],
   [
    "Covid-19",
    3209
   ],
   [
    "Pain In Extremity",
    2807
   ],
   [
    "Fatigue",
    2692
   ],
   [
    "Surgery",
    2550
   ],
   [
    "Fall",
    2493
   ],
   [
    "Headache",
    1972
   ],
   [
    "Pneumonia",
    1944
   ],
   [
    "Death",
    1913
   ],
   [
    "Therapy Interrupted",
    1839
   ],
   [
    "Diarrhoea",
    1805
   ],
   [
    "Back Pain",
    1756
   ]
  ],
  "by_year": {
   "2019": 223,
   "2020": 2841,
   "2021": 5932,
   "2022": 16500,
   "2023": 15074,
   "2024": 15233,
   "2025": 17234,
   "2026": 7999
  },
  "by_year_primary": {
   "2019": 223,
   "2020": 2841,
   "2021": 5928,
   "2022": 16499,
   "2023": 15069,
   "2024": 15222,
   "2025": 17223,
   "2026": 7995
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 4,
  "nda": 2,
  "anda": 1,
  "first_approval": "20190816",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 10,
  "labeling_recent": 9,
  "sponsors": [
   "ABBVIE",
   "AUROBINDO PHARMA LTD",
   "SANDOZ INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/16/2019"
 },
 "trials": {
  "total": 180,
  "completed": 73,
  "terminated": 7,
  "with_results": 38,
  "industry": 111,
  "phase3": 52,
  "results_share": 0.5205479452054794,
  "terminated_share": 0.03888888888888889
 },
 "pubmed": {
  "rct": 109,
  "meta": 32,
  "recent_rct": 88,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 18140917.5,
  "records": 245014,
  "by_name": [
   [
    "Rinvoq",
    18140917.5
   ]
  ],
  "names_checked": [
   "upadacitinib",
   "Rinvoq"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 193904,
  "beneficiaries": 29077,
  "spend": 1385938732.73,
  "by_brand": [
   {
    "brand": "Rinvoq",
    "claims": 193864,
    "per_claim": 7146.5555825,
    "is_generic": false
   },
   {
    "brand": "Rinvoq Lq",
    "claims": 40,
    "per_claim": 11972.03325,
    "is_generic": false
   }
  ],
  "per_claim": 7147.551018699975
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 40440,
  "fills": 193904,
  "per_million": 208556.81161812032,
  "ratio": 75.31982526321576,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "208,557 FDA reports naming it as the suspect drug per million Medicare fills, 75.3x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "109 randomized trials and 32 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "9 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 55,
   "letter": "D",
   "why": [
    "Pharma paid doctors $18,140,918 tied to this drug last year (-45)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (1 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "questions": [
  "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 pain, arthralgia, rheumatoid arthritis. How would we recognize and handle those?",
  "Why this one over baricitinib, deucravacitinib, deuruxolitinib? What would make you pick one of those instead?",
  "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.)"
 ]
}