{
 "query": "adalimumab",
 "ingredient": "adalimumab",
 "slug": "adalimumab",
 "rxcui": "327361",
 "brands": [
  "Humira",
  "Abrilada",
  "Amjevita",
  "Cyltezo",
  "Hadlima",
  "Hulio",
  "Hyrimoz",
  "Idacio",
  "Simlandi",
  "Yuflyma",
  "Yusimry"
 ],
 "names": [
  "adalimumab"
 ],
 "classes": [
  {
   "id": "L04AB",
   "name": "Tumor necrosis factor alpha (TNF-alpha) inhibitors"
  }
 ],
 "alternatives": [
  "certolizumab pegol",
  "etanercept",
  "golimumab",
  "infliximab"
 ],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 11
  },
  "boxed_warning": "WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including HYRIMOZ, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HYRIMOZ if a patient develops a serious infection or sepsis. Reported infections include: \u2022 Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HYRIMOZ use and during therapy. Initiate treatment for latent TB prior to HYRIMOZ use. \u2022 Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for...",
  "indications_and_usage": "HYRIMOZ is a tumor necrosis factor (TNF)-blocker indicated for: \u2022 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1) \u2022 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2) \u2022 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3) \u2022 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4) \u2022 Treatment of moderately to severely active Crohn\u2019s disease in adults and pediatric patients 6 years of age and older. (1.5) \u2022 Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use : Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. \u2022 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when oth...",
  "contraindications": "None ( 4 )",
  "warnings_and_cautions": "\u2022 Serious infections: Do not start HYRIMOZ during an active infection. If an infection develops, monitor carefully, and stop HYRIMOZ if infection becomes serious. (5.1) \u2022 Invasive fungal infections: For patients who develop a systemic illness on HYRIMOZ, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. (5.1) \u2022 Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. (5.2) \u2022 Anaphylaxis or serious hypersensitivity reactions may occur. (5.3) \u2022 Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HYRIMOZ and begin anti-viral therapy. (5.4) \u2022 Demyelinating disease: Exacerbation or new onset, may occur. (5.5) \u2022 Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HYRIMOZ. (5.6) \u2022 Heart failure: Worsening or new onset, may occur. (5.8) \u2022 Autoimmunity: Stop HYRIMOZ if lupus-like syndrome or autoimmune hepatitis develop. (5.9) 5.1 Serious Infections Patients treated with adalimumab products, including HYRIMOZ, are at increased risk for developing serious i...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Serious Infections [see Warnings and Precautions (5.1) ] \u2022 Malignancies [see Warnings and Precautions (5.2) ] \u2022 Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] \u2022 Hepatitis B Virus Reactivation [see Warnings and Precautions (5.4) ] \u2022 Neurologic Reactions [see Warnings and Precautions (5.5) ] \u2022 Hematological Reactions [see Warnings and Precautions (5.6) ] \u2022 Heart Failure [see Warnings and Precautions (5.8) ] \u2022 Autoimmunity [see Warnings and Precautions (5.9) ] Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Cordavis at 1-800-556-8091 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction with adalimumab was injection s...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage, Hidradenitis Suppurativa ( 1.8 ) 10/2025 Indications and Usage, Uveitis ( 1.9 ) 10/2025 Dosage and Administration, Uveitis ( 2.3 ) 10/2025 Dosage and Administration, Hidradenitis Suppurativa ( 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025",
  "information_for_patients": "Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections Inform patients that HYRIMOZ may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 )] . Malignancies Counsel patients about the risk of malignancies while receiving HYRIMOZ [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions. Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias. Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions ( 5.5 , 5.6 , 5.8 , 5.9 )] . Instructions on Injection Technique Inform patients that the first injectio...",
  "spl_medguide": "MEDICATION GUIDE HYRIMOZ \u00ae (hye-RI-moze) (adalimumab-adaz) injection, for subcutaneous use Read the Medication Guide that comes with HYRIMOZ before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about HYRIMOZ? HYRIMOZ is a medicine that affects your immune system. HYRIMOZ can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections. \u2022 Your doctor should test you for TB before starting HYRIMOZ. \u2022 Your doctor should check you closely for signs and symptoms of TB during treatment with HYRIMOZ. You should not start taking HYRIMOZ if you have any kind of infection unless your doctor says it is okay. Before starting HYRIMOZ, tell your doctor if you: \u2022 think you have an infection or have symptoms of an infection such as: o fever, sw...",
  "clinical_studies": "14.1 Clinical Studies in Rheumatoid Arthritis The efficacy and safety of adalimumab were assessed in five randomized, double-blind studies in subjects \u226518 years of age with active rheumatoid arthritis (RA) diagnosed according to American College of Rheumatology (ACR) criteria. Subjects had at least 6 swollen and 9 tender joints. Adalimumab was administered subcutaneously in combination with methotrexate (MTX) (12.5 to 25 mg, Studies RA-I, RA-III and RA-V) or as monotherapy (Studies RA-II and RA-V) or with other disease-modifying anti-rheumatic drugs (DMARDs) (Study RA-IV). Study RA-I evaluated 271 subjects who had failed therapy with at least one but no more than four DMARDs and had inadequate response to MTX. Doses of 20, 40 or 80 mg of adalimumab or placebo were given every other week for 24 weeks. Study RA-II evaluated 544 subjects who had failed therapy with at least one DMARD. Doses of placebo, 20 mg or 40 mg of adalimumab were given as monotherapy every other week or weekly for 26 weeks. Study RA-III evaluated 619 subjects who had an inadequate response to MTX. Subjects received placebo, 40 mg of adalimumab every other week with placebo injections on alternate weeks, or 20 mg...",
  "brand_name": "HYRIMOZ",
  "manufacturer": "Cordavis Limited",
  "application_number": "BLA761071",
  "pharm_class_epc": [
   "Tumor Necrosis Factor Blocker [EPC]"
  ],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20251017",
  "set_id": "3e303a4a-980b-4f2a-9d03-786928758637",
  "has_boxed_warning": true,
  "boxed_labels": "11 of 11",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 535936,
  "serious": 301814,
  "death": 24397,
  "hospitalization": 117025,
  "primary_suspect": 535842,
  "top_reactions": [
   [
    "Drug Ineffective",
    78981
   ],
   [
    "Pain",
    41614
   ],
   [
    "Arthralgia",
    39412
   ],
   [
    "Fatigue",
    32520
   ],
   [
    "Rheumatoid Arthritis",
    32381
   ],
   [
    "Injection Site Pain",
    29544
   ],
   [
    "Headache",
    22234
   ],
   [
    "Nausea",
    21643
   ],
   [
    "Joint Swelling",
    20692
   ],
   [
    "Rash",
    20691
   ],
   [
    "Diarrhoea",
    20424
   ],
   [
    "Pain In Extremity",
    20152
   ],
   [
    "Off Label Use",
    19889
   ],
   [
    "Psoriasis",
    18730
   ],
   [
    "Malaise",
    18121
   ]
  ],
  "by_year": {
   "2019": 46612,
   "2020": 50048,
   "2021": 40070,
   "2022": 78675,
   "2023": 39819,
   "2024": 23760,
   "2025": 21245,
   "2026": 7475
  },
  "by_year_primary": {
   "2019": 46608,
   "2020": 50043,
   "2021": 40064,
   "2022": 78651,
   "2023": 39796,
   "2024": 23747,
   "2025": 21236,
   "2026": 7468
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 11,
  "nda": 0,
  "anda": 0,
  "first_approval": "20021231",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ABBVIE INC",
   "ALVOTECH USA INC",
   "AMGEN INC",
   "BOEHRINGER INGELHEIM",
   "CELLTRION",
   "EMERGE BIOSCIENCE PTE LTD",
   "FRESENIUS KABI USA",
   "MYLAN PHARMS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/31/2002"
 },
 "trials": {
  "total": 800,
  "completed": 506,
  "terminated": 75,
  "with_results": 292,
  "industry": 505,
  "phase3": 200,
  "results_share": 0.5770750988142292,
  "terminated_share": 0.09375
 },
 "pubmed": {
  "rct": 438,
  "meta": 96,
  "recent_rct": 114,
  "cochrane": [
   {
    "pmid": "32413933",
    "title": "Adalimumab for maintenance of remission in Crohn's disease",
    "year": "2020"
   },
   {
    "pmid": "31742665",
    "title": "Adalimumab for induction of remission in Crohn's disease",
    "year": "2019"
   },
   {
    "pmid": "16034967",
    "title": "Adalimumab for treating rheumatoid arthritis",
    "year": "2005"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 879633.5599999999,
  "records": 31561,
  "by_name": [
   [
    "Humira",
    374106.85
   ],
   [
    "Idacio",
    149435.13
   ],
   [
    "Hadlima",
    112403.95
   ],
   [
    "Cyltezo",
    107815.83
   ],
   [
    "Hyrimoz",
    95929.71
   ],
   [
    "Amjevita",
    15084.1
   ],
   [
    "Hulio",
    12762.26
   ],
   [
    "Abrilada",
    6484.2
   ],
   [
    "Simlandi",
    5271.01
   ],
   [
    "Yuflyma",
    340.52
   ]
  ],
  "names_checked": [
   "adalimumab",
   "Humira",
   "Abrilada",
   "Amjevita",
   "Cyltezo",
   "Hadlima",
   "Hulio",
   "Hyrimoz",
   "Idacio",
   "Simlandi",
   "Yuflyma",
   "Yusimry"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 652028,
  "beneficiaries": 90349,
  "spend": 5715863099.68,
  "by_brand": [
   {
    "brand": "Humira(Cf) Pen",
    "claims": 490303,
    "per_claim": 8828.6199844,
    "is_generic": false
   },
   {
    "brand": "Humira Pen",
    "claims": 85167,
    "per_claim": 8188.6788006,
    "is_generic": false
   },
   {
    "brand": "Humira(Cf)",
    "claims": 46620,
    "per_claim": 8599.3245549,
    "is_generic": false
   },
   {
    "brand": "Humira",
    "claims": 25521,
    "per_claim": 8185.6179127,
    "is_generic": false
   },
   {
    "brand": "Humira(Cf) Pen Crohn'S-Uc-Hs",
    "claims": 2890,
    "per_claim": 20489.932301,
    "is_generic": false
   },
   {
    "brand": "Humira(Cf) Pen Psor-Uv-Adol Hs",
    "claims": 1527,
    "per_claim": 13580.522737,
    "is_generic": false
   }
  ],
  "per_claim": 8766.284729612838
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "adalimumab",
  "matched": "adalimumab",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 52451,
  "fills": 652028,
  "per_million": 80442.86441686553,
  "ratio": 29.051760259190893,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "80,443 FDA reports naming it as the suspect drug per million Medicare fills, 29.1x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 80,
   "letter": "B",
   "why": [
    "438 randomized trials and 96 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $879,634 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "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, fatigue. How would we recognize and handle those?",
  "Why this one over certolizumab pegol, etanercept, golimumab? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}