This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue AMJEVITA if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting AMJEVITA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products, including AMJEVITA, are at increased risk fo...
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is a tumor necrosis factor (TNF) blocker indicated for: 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 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) 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. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemi...
None. None ( 4 )
Serious infections: Do not start AMJEVITA during an active infection. If an infection develops, monitor carefully, and stop AMJEVITA if infection becomes serious. ( 5.1 ) Invasive fungal infections: For patients who develop a systemic illness on AMJEVITA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. ( 5.1 ) Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. ( 5.2 ) Anaphylaxis or serious hypersensitivity reactions may occur. ( 5.3 ) Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop AMJEVITA and begin anti-viral therapy. ( 5.4 ) Demyelinating disease: Exacerbation or new onset, may occur. ( 5.5 ) Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping AMJEVITA. ( 5.6 ) Heart failure: Worsening or new onset, may occur. ( 5.8 ) Autoimmunity: Stop AMJEVITA if lupus-like syndrome or autoimmune hepatitis develop. ( 5.9 ) 5.1 Serious Infections Patients treated with adalimumab products, including AMJEVITA, are at increased risk for developing se...
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatitis B Virus Reactivation [see Warnings and Precautions (5.4) ] Neurologic Reactions [see Warnings and Precautions (5.5) ] Hematological Reactions [see Warnings and Precautions (5.6) ] Heart Failure [see Warnings and Precautions (5.8) ] 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 Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) 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 ad...
Indications and Usage ( 1.8 , 1.9 ) 10/2025 Dosage and Administration ( 2.1 , 2.3 , 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025
Source: FDA SPL label for AMJEVITA (Amgen, Inc), effective 20260625. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 46,612 | 50,048 | 40,070 | 78,675 | 39,819 | 23,760 | 21,245 | 7,475 |
80,443 reports blaming this drug for every million Medicare prescriptions filled, which is 29.1× the typical drug on this site. (52,451 reports in 2024–2026, against 652,028 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $374,107 in payments to US physicians and hospitals tied to this drug across 9,468 transactions (Humira $374,107).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Humira(Cf) Pen | 490,303 | $8,829 |
| Humira Pen | 85,167 | $8,189 |
| Humira(Cf) | 46,620 | $8,599 |
| Humira | 25,521 | $8,186 |
| Humira(Cf) Pen Crohn'S-Uc-Hs | 2,890 | $20,490 |
| Humira(Cf) Pen Psor-Uv-Adol Hs | 1,527 | $13,581 |
1 drug in the same class grades a letter or more higher than adalimumab on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.