Prescription medicine
Adalimumab Brand names: Amjevita, Humira, Hyrimoz, Hadlima, Yusimry
Adalimumab (Humira) is a prescription medicine with an FDA approval on record since 2002. No generic is listed; pharmacies paid $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the adalimumab FDA label on DailyMed (effective October 21, 2025); the BLA 125057 record on Drugs@FDA; every adalimumab label on DailyMed.
Highlights of the record
FDA label of October 21, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, 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 Adalimumab-adaz if a patient develops a serious infection or sepsis. Reported infections include:
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 Adalimumab-adaz use and during therapy. Initiate treatment for latent TB prior to Adalimumab-adaz use.
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 invasive fungal infections who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. […]
Used for
From the label: indications and usageAdalimumab-adaz 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.
Forms and strengths
- 10 mg/.1ml
- 10 mg/.2ml
- 20 mg/.2ml
- 20 mg/.4ml
- 40 mg/.4ml
- 40 mg/.8ml
- 80 mg/.8ml
Injection (solution); injection; kit; solution.
On the market
- Earliest approval on file
- December 31, 2002 Humira, Abbvie Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 11 of which 0 under generic applications, 11 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1,587.82 per mL Adalimumab-adaz(cf) pen 40 mg/0.4 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest October 10, 2025
- FAERS reports
- 712,308 through July 30, 2026
What is adalimumab used for?
From the label: indications and usageAdalimumab-adaz 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. […]
Conditions named in the indications of adalimumab's FDA labels, with every medicine labeled for each:
From other adalimumab labelsCrohn's disease and ulcerative colitis: Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Psoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
FDA pharmacologic class: Tumor Necrosis Factor Blocker.
Source: FDA drug label (Adalimumab), Sandoz Inc, effective October 21, 2025 (SPL set 3468792f-63ef-4916-8ed1-8214f327d9dd), via openFDA; the full label on DailyMed
What does the patient leaflet for adalimumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Adalimumab-adaz?Adalimumab-adaz is a medicine that affects your immune system. Adalimumab-adaz 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. • Your doctor should test you for TB before starting Adalimumab-adaz. • Your doctor should check you closely for signs and symptoms of TB during treatment with Adalimumab-adaz. You should not start taking Adalimumab-adaz if you have any kind of infection unless your doctor says it is okay. Before starting Adalimumab-adaz, tell your doctor if you: • think you have an infection or have symptoms of an infection such as: o fever, sweats or chills o warm, red, or painful skin or sores on your body o muscle aches o diarrhea or stomach pain o cough o burning when you urinate or urinate more often than normal o shortness of breath o feel very tired o blood in phlegm o weight loss • are being treated for an infection. • get a lot of infections or have infections that keep coming back. • have diabetes. • have TB, or have been in close contact with someone with TB. • were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure. • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Adalimumab-adaz. […]
From the patient leaflet: How should I store Adalimumab-adaz?Store Adalimumab-adaz in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store Adalimumab-adaz in the original carton until use to protect it from light. • Do not freeze Adalimumab-adaz. Do not use Adalimumab-adaz if frozen, even if it has been thawed. • Refrigerated Adalimumab-adaz may be used until the expiration date printed on the carton of the Adalimumab-adaz single-dose prefilled Sensoready Pen or the Adalimumab-adaz single-dose prefilled syringe. Do not use Adalimumab-adaz after the expiration date. […]
Source: FDA drug label (Adalimumab), Sandoz Inc, effective October 21, 2025 (SPL set 3468792f-63ef-4916-8ed1-8214f327d9dd), via openFDA; the full label on DailyMed
Is there a generic for adalimumab (Humira)?
No generic adalimumab is approved (Drugs@FDA, October 8, 2026).
- 2002 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for adalimumab (Humira)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Adalimumab-aacf(cf) pen 40 mg/0.8 mL (2 pack) (generic)
- Hadlima 40 mg/0.8 mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Adalimumab-aacf(cf) pen 40 mg/0.8 mL (2 pack) | Generic | $872.72 per pen | n/a | no change |
| Adalimumab-adaz(cf) pen 40 mg/0.4 mL | Generic | $1,587.82 per mL | n/a | -0.3% |
| Hadlima 40 mg/0.8 mL syringe | Brand | $617.14 per mL | $493.71 per single-dose syringe | n/a |
| Hadlima pushtouch 40 mg/0.8 mL | Brand | $623.49 per mL | n/a | -1% |
| Hadlima(cf) 40 mg/0.4 mL syringe | Brand | $1,258.38 per mL | $503.35 per single-dose syringe | +0.2% |
| Hadlima(cf) pushtouch 40 mg/0.4 mL | Brand | $1,259.15 per mL | n/a | +0.2% |
| Humira 40 mg/0.8 mL syringe | Brand | $3,369.09 per syringe | n/a | +0.1% |
| Humira pen 40 mg/0.8 mL | Brand | $3,366.90 per pen | n/a | no change |
| Humira(cf) 20 mg/0.2 mL syringe | Brand | $3,366.12 per syringe | n/a | -0.1% |
| Humira(cf) 40 mg/0.4 mL syringe | Brand | $3,367.18 per syringe | n/a | +0.1% |
| Humira(cf) pen 40 mg/0.4 mL | Brand | $3,367.41 per pen | n/a | +0.1% |
| Humira(cf) pen 80 mg/0.8 mL | Brand | $6,736.72 per pen | n/a | no change |
| Humira(cf) pen crohn's-uc-hs starter 80 mg/0.8 mL | Brand | $6,745.43 per pen | n/a | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has adalimumab been recalled?
The FDA's Enforcement Report lists 1 recall naming adalimumab since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 10, 2025 | Class II | Samsung Bioepis Co., Ltd. | Lack of Assurance of Sterility. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the adalimumab label say about other medicines?
The adalimumab label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name adalimumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abatacept | drug interactions | In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF-blockers with anakinra or abatacept, with no added benefit; therefore, use of Adalimumab-adaz with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions … |
| Adalimumab-aacf | boxed warning | SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-aacf are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. |
| Adalimumab-adaz | boxed warning | SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. |
| Anakinra | drug interactions | In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF-blockers with anakinra or abatacept, with no added benefit; therefore, use of Adalimumab-adaz with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions … |
| Azathioprine | boxed warning | Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of Adalimumab-adaz in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as … |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Rituximab | drug interactions | A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF-blocker. |
| Theophylline | drug interactions | Upon initiation or discontinuation of Adalimumab-adaz in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as … |
| Warfarin | drug interactions | Upon initiation or discontinuation of Adalimumab-adaz in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as … |
Other labels that name adalimumab
Source: FDA drug label (Adalimumab), Sandoz Inc, effective October 21, 2025 (SPL set 3468792f-63ef-4916-8ed1-8214f327d9dd), via openFDA; the full label on DailyMed
What do FAERS reports show for adalimumab?
The FDA Adverse Event Reporting System holds 712,308 reports that list adalimumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 30,985 are coded as a death and 151,145 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as adalimumab?
9 other medicines are given the same way (subcutaneous) and in the same FDA class as adalimumab or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Etanercept | Rheumatoid arthritis, Psoriasis | none listed | $2,084.14 per mL 25 mg/0.5 mL syringe | No current entry |
| Certolizumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $6,094.02 per syringe 2x200 mg/mL syringe kit | No current entry |
| Golimumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | none listed | $12,890.32 per mL 50 mg/0.5 mL pen injec | No current entry |
| Methotrexate | Rheumatoid arthritis, Psoriasis | none listed | $289.37 per mL 25 mg/0.5 mL autoinj | In shortage |
| Tocilizumab | Rheumatoid arthritis | none listed | $821.00 per mL 162 mg/0.9 mL autoinjct | No current entry |
| Adalimumab-ryvk | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $499.12 per unit 40 mg/0.4 mL autoinjector | A presentation being discontinued |
| Sarilumab | Rheumatoid arthritis | none listed | $2,075.30 per mL 200 mg/1.14 mL pen injection | No current entry |
| Abatacept | Rheumatoid arthritis | none listed | $1,469.23 per mL 125 mg/mL syringe | No current entry |
Every medicine labeled for the same conditions as adalimumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does adalimumab compare with medicines for the same use?
6 side-by-side pages set adalimumab beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to adalimumab
- 9 medicines for the same use
- Other TNF blockers
- the pharmacologic class, with prices and generics
- Adalimumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other