Pronunciation: Hu-MAR-ah
Generic name: adalimumab
Dosage form: injection for subcutaneous use
Drug classes: Antirheumatics, TNF alfa inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 11, 2024.

What is Humira?

Humira is used to treat many inflammatory conditions in adults, such as rheumatoid arthritis (RA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis, and a skin condition called hidradenitis suppurativa.

Humira is also used in adults and children to treat Crohn's disease, juvenile idiopathic arthritis, ulcerative colitis, and uveitis.

Humira's mechanism of action involves specifically targeting and blocking tumor necrosis factor (TNF)-alpha, a key inflammatory protein in the immune system. This interrupts immune system signals that cause excessive inflammation. Humira belongs to the drug class tumor necrosis factor (TNF) blockers and is also called a biologic.  

Humira gained FDA approval on December 31, 2002. There are several Humira generics (more correctly called biosimilars).

What are the Humira biosimilars?

There are 10 biosimilars of Humira. Some are fully interchangeable, others have mixed interchangeability, and others are not interchangeable.

• Abrilada is a fully interchangeable biosimilar of Humira (all strengths). An interchangeable biosimilar can automatically substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.
• For Amjevita, the following strengths are interchangeable: prefilled syringe, 20mg/0.4mL, 40mg/0.8mL, 10mg/0.2mL; autoinjector 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe 20mg/0.2mL, 40mg/0.4mL, 80mg/0.8mL; autoinjector 40mg/0.4mL, 80mg/0.8mL.
• For Cyltezo, the following strengths are interchangeable: prefilled syringe, 40mg/0.8mL, 20mg/0.4mL, 10mg/0.2mL; autoinjector 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe/autoinjector 40mg/0.4mL.
• For Hadlima, the following strengths are interchangeable: prefilled syringe/single-dose vial 40mg/0.8mL.  The following strengths are not interchangeable: prefilled syringe/autoinjector 40mg/0.4mL, autoinjector 40mg/0.8mL.
• For Hyrimoz, the following strengths are interchangeable: prefilled syringe, 40mg/0.8mL, 80mg/0.8mL, 20mg/0.4mL, 20mg/0.2mL, 10mg/0.2mL, 10mg/0.1mL. The following strengths are not interchangeable: prefilled syringe 40mg/0.4mL; autoinjector 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL. 
• For Simlandi, the following strengths are interchangeable: prefilled syringe/autoinjector, 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe 20mg/0.2mL, 80mg/0.8mL.
• Hulio, Idacio, Yuflyma, and Yusimry, are also biosimilars of Humira, but they are not interchangeable. This means they can only be dispensed in place of Humira if the healthcare provider specifically prescribes the biosimilar product by name. 

Humira uses

Humira is used to treat:

• moderate to severe RA in adults. Humira can be used alone, with methotrexate, or with certain other medicines
• moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Humira can be used alone or with methotrexate
• psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines
• ankylosing spondylitis (AS) in adults
• moderate to severe hidradenitis suppurativa (HS) in people 12 years and older
• moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older
• moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if Humira is effective in people who stopped responding to or could not tolerate TNF-blocker medicines
• moderate to severe chronic (lasting a long time) plaque psoriasis in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)
• non-infectious intermediate, posterior, and panuveitis in adults and children 2 years of age and older.

Humira side effects

The most common side effects of Humira include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually go away within a few days. Call your doctor right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse
• upper respiratory infections (including sinus infections)
• headaches
• rash.

Serious side effects and warnings

Humira is a medicine that affects your immune system and has a Boxed Warning for serious infections and cancer.

Serious infections. Humira can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Humira. 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 Humira.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Humira.
• You should not start taking Humira if you have any kind of infection unless your doctor says it is okay.

After starting Humira, call your doctor right away if you have an infection or any signs of an infection. Humira can make you more likely to get infections or worsen any infection you may have.

Cancer. For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including Humira, the chances of getting cancer may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.

• People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including Humira your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal.
• Some people receiving TNF blockers including Humira developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP).

Tuberculosis (TB). Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Humira and during treatment with Humira. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Humira. People who had a negative TB skin test before receiving Humira have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Humira:

• cough that does not go away
• low-grade fever
• weight loss
• loss of body fat and muscle (wasting).

Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Humira. Your doctor should do blood tests before you start treatment, while you are using Humira, and for several months after you stop treatment with Humira. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:

• muscle aches
• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• clay-colored bowel movements
• fever
• chills
• stomach discomfort
• skin rash.

Allergic reactions. Allergic reactions can happen in people who use Humira. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:

• hives
• trouble breathing
• swelling of your face, eyes, lips, or mouth.

Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.

Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking Humira, including:

• shortness of breath
• sudden weight gain
• swelling of your ankles or feet.

Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that get worse in the sun. Symptoms may improve when you stop Humira.

Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:

• feel very tired
• skin or eyes look yellow
• poor appetite or vomiting
• pain on the right side of your stomach (abdomen).

Psoriasis. Some people using Humira had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Humira. Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Humira may be stopped.

Call your doctor right away if you:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

These are not all the possible side effects of Humira. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.  

Related/similar drugs

Before taking this medicine

Do not use Humira if you are allergic to adalimumab, Humira, Abrilada, Cyltezo, Simlandi, Amjevita, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry, or any of the inactive ingredients in the Humira injection.

Before starting Humira, tell your doctor if you:

• think you have an infection or have symptoms of an infection such as:
  • fever, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feel very tired
  • 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 Humira. Ask your doctor if you do not know if you have lived in an area where these infections are common
• have or have had hepatitis B
• use the medicine Orencia (abatacept), Kineret (anakinra), Rituxan (rituximab), Imuran (azathioprine), or Purinethol (6–6-mercaptopurine, 6-MP)
• are scheduled to have major surgery.

Children using this medicine should be current on all childhood immunizations before starting treatment.

Tany numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;

• an allergy to latex rubber;

• if you are scheduled to have major surgery; or

• if you have recently received or are scheduled to receive any vaccine.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common to certain areas of the world.

Humira may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant. Make sure any doctor caring for your newborn baby knows if you used adalimumab while you were pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

How should I use Humira?

Use Humira exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

• Humira is injected under the skin. A healthcare provider will teach you how to properly use this medicine by yourself. See the Instructions for Use in the Humira Package Insert for the right way to inject and prepare Humira.
• Do not start using this medicine if you have any signs of an infection. Call your doctor for instructions.
• Read and carefully follow any instruction sheet provided with your medicine. Do not use Humira if you do not understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

The dose schedule for Humira is highly variable and depends on the condition you are treating. Follow your doctor's dosing instructions very carefully.

• For most conditions, Humira is injected every week or every other week.

Prepare your injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Humira affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you regularly.

Store Humira in its original carton in a refrigerator. Do not freeze. If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.

• Throw away any Humira that has become frozen.
• Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Humira dosing

Usual Adult Dose of Humira for Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis:

• Humira 40 mg subcutaneously every other week.

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week or 80 mg every other week.

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease-modifying agents may be given concomitantly.

Usual Adult Dose of Humira for Crohn's Disease:

• Initial dose, Humira 160 mg SC on Day 1. The initial dose may be given in 1 day or split over 2 consecutive days.
• Day 15: Humira 80 mg SC
• Day 29 (maintenance dose): Humira 40 mg SC every other week.

Usual Adult Dose of Humira for Ulcerative Colitis:

• Initial dose, Humira 160 mg SC on Day 1. The initial dose may be given in 1 day or split over 2 consecutive days.
• Day 15: Humira 80 mg SC
• Day 29 (maintenance dose): Humira 40 mg SC every other week.

Discontinue in patients without evidence of a clinical remission by 8 weeks.

Usual Adult Dose of Humira for Plaque Psoriasis or Uveitis:

• Initial dose: Humira 80 mg SC.
• Maintenance dose: Humira 40 mg SC every other week, starting one week after the initial dose.

Usual Adult Dose of Humira for Hidradenitis Suppurativa:

• Initial dose: Humira 160 mg SC (given in 1 day or split of 2 consecutive days)
• Day 15: Humira 80 mg SC
• Day 29 and subsequent doses: Humira 40 mg every week or 80 mg every other week.

What happens if I miss a dose?

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up for the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Humira?

Do not inject Humira into skin that is bruised, red, tender, or hard.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using adalimumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

Does Humira contain latex?

Yes, some strengths of Humira include natural rubber or latex in the needle cover.

Humira products that contain latex in the needle cover: Humira Pen 40 mg/0.8 mL, Humira 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL prefilled syringe.

Humira products that DO NOT contain latex in the needle cover: Humira Pen 80 mg/0.8 mL and 40 mg/0.4 mL, Humira 80 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL, and 10 mg/0.1 mL prefilled syringe. The vial stopper on the Humira institutional use vial is not made with natural rubber or latex.

What other drugs will affect Humira?

Some drugs should not be used together with adalimumab. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Humira, especially:

• abatacept, etanercept;

• anakinra;

• azathioprine, 6-mercaptopurine; or

• certolizumab, golimumab, infliximab, rituximab.

This list is not complete. Other drugs may interact with adalimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Humira ingredients

Active ingredient: adalimumab

Inactive ingredients in the Humira Pen 40 mg/0.8 mL, Humira 40 mg/0.8 mL prefilled syringe, Humira 20 mg/0.4 mL prefilled syringe, Humira 10 mg/0.2 mL prefilled syringe, and Humira 40 mg/0.8 mL institutional use vial: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium chloride, sodium citrate and Water for Injection. Sodium hydroxide is added as necessary to adjust pH.

Inactive ingredients in the Humira Pen 80 mg/0.8 mL, Humira 80 mg/0.8 mL prefilled syringe, Humira Pen 40 mg/0.4 mL, Humira 40 mg/0.4 mL prefilled syringe, Humira 20 mg/0.2 mL prefilled syringe and Humira 10 mg/0.1 mL prefilled syringe: mannitol, polysorbate 80, and Water for Injection. 

Who makes Humira?

AbbVie Inc. makes Humira.

Humira Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Humira.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Humira biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

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