Humira Safety, Side Effects, and FDA Warnings
Humira (adalimumab) is a prescription injection used to treat various autoimmune conditions. It’s often effective but also associated with several side effects and FDA warnings. These include a boxed warning for serious infections that may lead to hospitalization or death.
- Last update: June 24, 2025
What Is Humira and How Does It Work?
Humira is the brand name for adalimumab, a prescription biologic medication used to treat various autoimmune and inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and others. It’s part of a drug class called tumor necrosis factor (TNF) blockers or inhibitors and was approved in 2002.
AbbVie had a monopoly on adalimumab until 2023. That year, biosimilars began to hit the market.
- Adult rheumatoid arthritis (RA). This condition causes pain and swelling in the tissues lining your joints.
- Juvenile idiopathic arthritis (JIA) in children ages two and up. JIA is a condition in which a child’s immune system attacks the tissues lining the joints, leading to growth and developmental issues, swelling and pain.
- Crohn‘s disease in adults and children. Symptoms of Crohn’s disease include unexpected weight loss, diarrhea, rectal bleeding and abdominal pain. It’s caused by the immune system attacking the lining of the digestive tract.
- Ulcerative colitis (UC) in people ages five and up. UC starts as inflammation in the rectum that can spread to the colon. Symptoms include abdominal pain, weight loss and diarrhea.
- Adult ankylosing spondylitis. Ankylosing spondylitis causes lower back pain because the body attacks the joints in the spine.
- Adult psoriatic arthritis. This type of inflammatory arthritis causes morning stiffness, swelling, joint pain and scaly skin.
- Hidradenitis suppurativa in people ages 12 and up. This causes pimple-like bumps and scarring by attacking hair follicles near sweat glands.
- Uveitis in people ages two and up. This affects the eyes, causing redness, pain and inflammation.
- Plaque psoriasis in adults. This chronic condition manifests as red, scaly patches of skin.
Autoimmune diseases can cause your body to produce excess TNF, and Humira injections stop TNF-alpha from binding to its receptors and attacking healthy cells. This helps prevent inflammatory responses.
While Humira helps many people with autoimmune conditions, it is also accused of causing serious side effects such as an increased risk of cancer, nerve damage and life-threatening infections. Some people who took Humira and developed these conditions sued Abbott — the parent company of the drug’s manufacturer, AbbVie — claiming the manufacturer didn’t properly warn the public of the risks.
Common and Serious Side Effects of Humira
The most common side effects of Humira are sinus infections, rash, headaches, nausea and injection site reactions. Reactions at the injection site may include redness, rash, pain, swelling, bruising or itching. While these side effects typically resolve on their own, you should consult your doctor if they become concerning or don’t go away.
Serious Side Effects
Humira can cause serious side effects, and some are life-threatening. These less-common reactions are medical emergencies. If you experience any of these side effects, call your doctor or get medical help right away.
- Serious infections, including tuberculosis (TB).
- Hepatitis B infection occurs in individuals who carry the virus.
- Allergic reactions, such as trouble breathing, hives, and swelling of the mouth, lips, face or eyes.
- Nervous system problems, such as vision problems, limb weakness or numbness and tingling.
- A decreased number of blood cells that help fight infection or stop bleeding. You may bruise or bleed more easily, have a constant fever or look very pale.
- New or worsening heart failure. Signs include sudden weight gain, shortness of breath and swelling in the ankles or feet.
- Immune reactions with symptoms such as chest pain or discomfort, trouble breathing, rashes on the face and arms and joint pain. These reactions can resemble lupus.
- Liver problems that may lead to liver failure or death. Symptoms include yellowing of the skin or eyes, fatigue, vomiting, poor appetite and pain in the right side of the abdomen.
- New or worsening psoriasis that presents as red scaly patches or raised pus-filled bumps.
FDA Warnings and Label Changes
The most serious warning on the Humira label is the boxed warning for infections and malignancies (cancers). Over the years, FDA has updated the label to include more serious warnings for these conditions.
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2002 - 2009:
When the drug was released, the black box warning focused on infections, specifically tuberculosis. Infections listed in the current warning include tuberculosis, fungal infections and bacterial sepsis (a blood infection).
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2009 - 2011:
The FDA added the lymphoma warning in 2009. In 2011, it updated the warning to include legionella and listeria infections.
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2016:
The FDA issued a safety communication for the increased risk of developing a rare cancer called hepatosplenic T-cell lymphoma (HSTCL).
Cancers mentioned in the current warning include cases of lymphoma, some fatal, in children and adolescents. People have also reported cases of HSTCL, which have been aggressive and fatal. Most patients with that rare cancer were adolescent or young adult males with Crohn’s or ulcerative colitis, and they were also treated with azathioprine or 6-MP alongside their TNF blocker at some point.
Is Humira Still Considered Safe?
Like all medications, including others approved by the FDA, Humira has side effects. Patients should consult their doctors and weigh the risks and benefits of taking Humira.
Humira Safety Lawsuits
Some who experienced significant side effects have filed Humira lawsuits, saying they weren’t warned of potential side effects.
For example, in 2011, a Montana woman with Crohn’s disease sued Abbott Laboratories after suffering nerve damage in her feet, which her doctors believed was caused by Humira.
After a North Dakota woman took Humira for seven months between 2009 and 2010, she developed disseminated histoplasmosis and spent 21 days in the hospital. She and her husband sued the drug’s manufacturer in 2012, claiming Abbott Laboratories had waited two years to notify doctors of this risk. Her husband was awarded over $2.2 million in 2013 (after her death, which was not related to this illness).
Has Humira Been Recalled?
Despite the serious warnings on the prescription label, Humira has not had safety-related recalls in the U.S.
Patients and medical providers can report side effects to the FDA’s MedWatch Program.
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