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.
