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Humira is a brand name product for the generic medication adalimumab. Humira belongs to the drug class called biologic agents, which are medications or products such as vaccines and gene therapy produced from a living system, such as a microorganism, animal cell, or plant cell. Humira is used alone or with other medications to treat autoimmune conditions in adults and children, including rheumatoid arthritis (RA), juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, non-infectious uveitis, and hidradenitis suppurativa. 

Humira is classified as a tumor necrosis factor (TNF) blocker. Humira works by blocking TNF-alpha (tumor necrosis factor-alpha), an inflammation-causing protein. This medication comes in the form of an injectable solution, which is available as a single-dose prefilled syringe, single-dose pen, and single-dose vial of injectable solution. All Humira products are given through a subcutaneous (under the skin) injection. Please continue reading to learn about the potential side effects of Humira.

What are the side effects of Humira?

Common side effects of Humira are listed below. Talk with your doctor if these side effects are severe or persist after a few days.

• Injection site reactions with redness, bruising, pain, itching, or swelling

• Headache

• Common cold symptoms with sore throat, sneezing, stuffy nose

• Rash

Other side effects of Humira that are not as common include: 

• Muscle cramps 

• Bone fracture, bone disorder

• Tendon disorder

• Pelvic pain 

Though rare, Humira can cause more serious adverse effects. Call your doctor immediately or seek emergency medical help if you develop the following symptoms, which could be signs of serious side effects:

• Anaphylactic allergic reaction: hives, rash, shortness of breath, swelling of the throat, tongue, or face; 

• Liver problems: right-sided upper abdominal pain, nausea, vomiting, loss of appetite, jaundice, unusual tiredness, dark urine, clay-colored stools;

• Aplastic anemia: pale skin, persistent fever, unusual bruising, or unusual bleeding that doesn’t stop;

• Increased risk of infection leading to sepsis: chills, confusion, fever, swollen glands, muscle aches, night sweats, flu-like symptoms, symptoms of upper respiratory infections, tiredness, drowsiness, racing heart rate, feeling extremely ill

• New or worsening psoriasis: red, silvery flaking of the skin

• Drug-induced lupus (lupus-like syndrome): chest pain, joint pain, shortness of breath, skin rash due to sun sensitivity on the arms or cheeks 

• Heart failure symptoms: shortness of breath, unusual/sudden weight gain, swelling of the ankles or feet  

• Nervous system problems (Guillain-Barré and multiple sclerosis): new vision problems, tingling or numbness, dizziness, weakness in the legs or arms

• Weakness in the legs

• Numbness or tingling

• Visual loss, visual disturbances

Is weight gain a side effect of Humira?

Weight changes are not common side effects of Humira. However, this medication can worsen heart failure, which can lead to sudden weight gain from fluid buildup. Humira can also increase your risk of serious infections and other serious illnesses, which can eventually lead to weight loss. 

Does Humira have long-term side effects?

Humira can have the following long-term side effects and adverse reactions.

Serious infections

Humira affects the immune system and the body’s ability to fight infections. People treated with Humira are at an increased risk of infections in various parts of the body, including serious infections leading to hospitalization. This includes opportunistic bacterial, viral, fungal, and parasitic infections that can sometimes be fatal infections. 

The concomitant use of certain other medications, such as abatacept and anakinra, has been linked to an increased risk of life-threatening infections in people with rheumatoid arthritis (RA). Therefore, this combination therapy is not recommended due to drug interactions.

Other risk factors for serious infections while on Humira include age above 65 years, chronic comorbid conditions, and the use of immunosuppressant drugs such as corticosteroids or methotrexate. 

Before starting Humira treatment, tell your healthcare professionals if you have:

• A history of chronic, recurrent, or opportunistic infections 

• Medical conditions that increase your risk of infections 

• Exposure to tuberculosis 

• Traveled to an area where tuberculosis or invasive fungal infections (histoplasmosis, blastomycosis, coccidioidomycosis) are endemic. 

Your healthcare provider will perform an initial latent TB test. They will not start treatment with Humira if you have an active infection. Tell your doctor immediately if you develop any signs or symptoms of a serious infection, such as an upper respiratory infection or urinary tract infection, while on this medication. 

Malignancies

Clinical trials have shown tumor necrosis factor blockers, including Humira, are linked to an increased risk of malignancies such as lymphoma, leukemia, non-melanoma skin cancer, melanoma, breast cancer, prostate cancer, colon cancer, lung cancer, and other cancers. 

Children, adolescents, and young adults who receive Humira before 18 years of age are at risk of aggressive and potentially fatal cancers, including Hodgkin's and non-Hodgkin's lymphoma and a rare type of aggressive lymphoma called hepatosplenic T-cell lymphoma. 

Your health care professional will evaluate your cancer risk before starting Humira and during treatment. If you have a history of cancer or chronic exposure to immunosuppressive therapies (for example, azathioprine, 6-mercaptopurine), this medication may not be suitable for you. 

Allergic reactions

Rarely, Humira administration can cause anaphylaxis (throat closing) and angioedema (swelling). Stop Humira immediately, call your healthcare provider, and seek emergency medical attention if you develop signs and symptoms of a serious allergic reaction, such as skin rash, swelling, or difficulty breathing. 

Hepatitis B reactivation

TNF blockers, including Humira, can lead to the reactivation of hepatitis B virus (HBV) in people who are chronic carriers. The reactivated HBV infection can be fatal in some cases, especially in people who are also receiving other medications that suppress the immune system. Your healthcare professional will evaluate your risk of HBV infection before initiating Humira therapy. If you are an HBV carrier, they may prescribe antiviral therapy along with Humira to prevent virus reactivation. 

Neurologic reactions

Rarely, Humira and other TNF-blocking agents have been linked to new onset or worsening of clinical symptoms and/or radiological findings of central nervous system demyelinating diseases (multiple sclerosis and optic neuritis) and peripheral demyelinating diseases (Guillain-Barré syndrome). Tell your doctor if you have a history of these conditions. If you develop neurologic symptoms, you may need to discontinue Humira. 

Hematologic abnormalities

There are rare reports of pancytopenia (low levels of white blood cells, red blood cells, and platelets) in people taking TNF blockers such as Humira. Seek immediate medical attention if you develop signs and symptoms of low white blood cells (fever, infections), low red blood cells (pale skin, dizziness), or low platelets (unusual bleeding or bruising) while on Humira. Your healthcare provider may discontinue Humira if you develop significant hematologic reactions.

Heart failure

There are reports of new onset or worsening congestive heart failure in patients treated with TNF blockers, including Humira. If you have heart failure, your health care professional will weigh the risks versus benefits of Humira and monitor you carefully during treatment.

Autoimmune reactions

Rarely, treatment with Humira can lead to the formation of autoantibodies, which can cause a lupus-like syndrome. If this happens, your healthcare professional may recommend stopping Humira.

Vaccinations

Clinical trials have shown that there is no difference in the response to the influenza vaccine and pneumococcal polysaccharide vaccine between people treated with Humira and those who are not on this biologic agent. People on Humira can receive all vaccinations except live vaccines. Pediatric patients are usually brought up to date on immunizations before starting Humira. 

What should I avoid while taking Humira?

• Avoid eating raw or undercooked food to lower your risk of gastrointestinal infections.

• Avoid drinking alcohol or limit your alcohol intake. Alcohol can lead to worsening of some of the autoimmune diseases that Humira is used to treat.

• Do not change the dose of Humira without your doctor’s approval. Your provider may start you on an initial dose and gradually increase you to a maintenance dose.

• Do not use the prefilled syringe, dosing pen, or automatic injection device more than once.

• Do not inject the medicine within 2 inches (about 5 centimeters) of your navel or at an injection site you have used before (choose an injection site about 1 inch away). Do not inject the medicine in an area where the skin is red, bruised, tender, hard, or scarred. 

• Avoid storing Humira in extreme heat or cold. Do not freeze this medicine. If a Humira product has been refrigerated, allow it to come to room temperature for 15 to 30 minutes before use.

• Try not to miss a dose of Humira. In case of a missed dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Do not use someone else’s Humira or let anyone else use your medicine.

• Do not miss your healthcare appointments while on Humira. 

• While you can get all vaccines except for the live vaccines, do not get any vaccinations while on Humira without checking with your doctor or pharmacist first to make sure that the vaccination is appropriate for you to receive. 

References:

1. https://medlineplus.gov/druginfo/meds/a603010.html

2. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d

3. https://www.mayoclinic.org/drugs-supplements/adalimumab-subcutaneous-route/side-effects/drg-20066817?p=1