Humira side effects: A detailed guide

Specifically, the Food and Drug Administration (FDA) has approved Humira to treat certain autoimmune conditions, including:

• rheumatoid arthritis in adults
• juvenile idiopathic arthritis in some children
• psoriatic arthritis in adults
• ankylosing spondylitis in adults
• Crohn’s disease in adults and some children
• ulcerative colitis in adults and some children
• plaque psoriasis in adults
• hidradenitis suppurativa in adults and some children
• swelling of middle eye layer (uveitis) in adults and some children

This article describes possible side effects of Humira. You can explore this overview article to learn more about Humira, including the drug’s uses, side effects, ways to save on cost, and more.

Humira is a brand-name medication that comes as an injection that’s given under your skin. It’s available in several biosimilar versions, including Amjevita, Cyltezo, Hadlima, and others. This article describes possible side effects of Humira.

Boxed warnings

Humira has boxed warnings about the risk of serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details, see the “Side effects of Humira in detail” section below.

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More common side effects of Humira

Humira injection may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of Humira injection include:

• infections, such as sinusitis or upper respiratory infections
• injection site reactions*
• headache
• rash

* To learn more about this side effect, see the “Side effects of Humira in detail” section below.

Mild side effects of Humira

Humira may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of Humira injection that occurred in studies include:

• infections, such as sinusitis or upper respiratory infections
• injection site reactions*
• headache
• rash
• mild allergic reaction*

* To learn more about this side effect, see the “Side effects of Humira in detail” section below.

Humira injection may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

Serious side effects of Humira

Humira may rarely cause certain serious side effects. If you have any serious side effects from Humira injection, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with Humira.

Serious side effects of Humira injection that occurred in studies include:

• hepatitis B reactivation (a flare-up of hepatitis B infection if the virus is already in your blood)
• nervous system problems (damage to the coating around nerves, such as multiple sclerosis)
• blood reactions, such as cytopenia (when one or more types of blood cells are low)
• liver problems
• heart failure
• lupus-like syndrome
• risk of serious infections*
• risk of cancer*
• severe allergic reaction†

* Humira injection has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Humira in detail” section below.
† To learn more about this side effect, see the “Side effects of Humira in detail” section below.

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Common questions about side effects of Humira

Here are answers to some common questions about side effects of Humira injection. If you have other questions, talk with your doctor or pharmacist.

Does Humira cause long-term side effects?

Yes, in rare cases, Humira injection may cause long-term side effects. These can occur if you take the drug for a long time or may last for a while after you’ve stopped taking the drug.

Some serious side effects*, if they occur, could affect your health long term. Examples of long-term side effects reported with Humira injection include:

• hepatitis B reactivation (a flare-up of hepatitis B infection if the virus is already in your blood)
• nervous system problems (damage to the coating around nerves, such as multiple sclerosis)
• blood reactions, such as cytopenia (when one or more types of blood cells are low)
• liver problems
• congestive heart failure
• lupus-like syndrome
• risk of serious infections, including tuberculosis†
• risk of cancer†

Talk with your doctor to learn more about these side effects and how to prevent or manage them. Ask your doctor for more information about how long these side effects of Humira may last. Your doctor can discuss the risk of these side effects with you or help you manage any side effects you may have while taking Humira.

* For more information about the serious side effects of Humira, see the “Serious side effects of Humira” section above.
† Humira injection has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of Humira in detail” section below.

Is weight gain a possible side effect of Humira?

No, weight gain wasn’t reported in studies involving people using Humira injection.

But heart failure is a possible serious side effect of Humira. Humira could lead to heart failure, or it could worsen heart failure if you already have it. Sudden weight gain or swelling in the feet or ankles can be a symptom of heart failure or worsening heart failure.

If you have weight gain or weight loss that you think may be caused by Humira injection, talk with your doctor.

How long do side effects of Humira usually last?

It depends on several factors, including the specific side effect, why you’re taking Humira, and how your body responds to the drug. Usually, mild side effects caused by Humira injection are temporary and go away on their own in a few days.

Talk with your doctor or pharmacist if you have bothersome side effects or if they don’t go away. Your doctor or pharmacist may be able to recommend ways to limit any side effects you’re having. Or they can help decide if a different treatment could be an option.

In rare cases, Humira injection may cause long-term side effects. To learn more, see the question above, “Does Humira cause long-term side effects,” or talk with your doctor.

Side effects of Humira in detail

Below you’ll find details on some of the side effects of Humira injection.

Risk of serious infections

Humira injection has a boxed warning about the risk of serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

In studies, people taking Humira had a higher risk of developing serious infections, including tuberculosis, severe fungal infections, and sepsis caused by bacteria. These infections are uncommon may lead to hospitalization or death.

Humira injection works by affecting the immune system, which can make it harder for your body to prevent infection. Any infection you get while taking Humira may also be worse than usual.

Symptoms of an infection may include:

• muscle aches
• chills, fever, or sweating
• feeling very tired
• weight loss
• shortness of breath
• cough
• blood in phlegm

Certain factors can increase the risk of serious infections with Humira injection. These include being age 65 years and older, having diabetes, and taking certain other medications that can weaken the immune system.

Ways to manage

Due to the risk of serious infections, your doctor will likely not prescribe Humira injection if you have an infection or if you often have infections. Your doctor will also test you for tuberculosis before you start Humira. And they’ll monitor you for symptoms of tuberculosis while you’re taking Humira.

If you experience symptoms of an infection while taking Humira, tell your doctor right away. They may prescribe an antibiotic or other treatment to manage the infection. If you have a serious infection, your doctor will likely have you stop taking Humira.

Risk of cancer

Humira injection has a boxed warning about the risk of cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

In studies, certain types of cancer, such as lymphoma, were rare in children and adolescents taking Humira injection. Some types of cancer also occurred more often in adults taking Humira compared to those who weren’t taking the drug. Some of these cancers aren’t life threatening if treated, but others can be fatal.

Humira can weaken the immune system, which may increase the risk of developing certain types of cancer.

Symptoms of cancer may include:

• swollen lymph nodes
• bumps or sores on the skin that don’t heal
• chills, fever, or sweating
• loss of appetite or weight loss
• fatigue

Certain factors can increase the risk of cancer with Humira injection. These include being age 65 years and older or taking some other drugs that can weaken the immune system, such as azathioprine or 6-mercaptopurine. People who have certain inflammatory conditions, such as rheumatoid arthritis, may also be at higher risk of developing lymphoma, even without taking drugs like Humira.

Ways to manage

If you have symptoms of cancer or if you have concerns about this possible side effect, tell your doctor. It’s also important to let your doctor know if you have cancer or you’ve had it in the past. Your doctor may not prescribe Humira injection if you’ve had cancer or develop cancer. Your doctor will also discuss the risks and benefits of treatment before you start Humira.

Injection site reactions

In studies, injection site reactions were the most common side effect in people taking Humira. This side effect is usually mild and goes away in a few days.

Humira comes as an injection that’s given under your skin. With injection site reactions, you may have these symptoms at or near the area where you inject Humira:

• redness or discoloration
• itching
• swelling
• pain
• bruising

Ways to manage

Your doctor, nurse, or pharmacist will show you how to inject Humira before you start the drug.

If you experience injection site reactions, tell your doctor, nurse, or pharmacist. They can help determine if the reaction is due to the injection or another cause. They can also recommend ways to help prevent injection site reactions, such as rotating where you inject Humira each time. Don’t inject Humira in any areas that are bruised, hard, red or discolored, or tender.

Contact your doctor if you have pain, swelling, or redness or discoloration in the area where you inject Humira that doesn’t get better or gets worse after a few days.

In rare cases, symptoms such as itching, rash, or swelling may be signs of an allergic reaction. See the section below for details about how to manage a possible allergic reaction.

Allergic reaction

For some people, Humira injection can cause an allergic reaction. This side effect was reported in the drug’s studies.

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, usually affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Humira, your doctor may recommend taking a different medication instead.

Warnings for Humira

Below are some factors you may want to discuss with your doctor before taking Humira injection.

Boxed warnings

This drug has boxed warnings about the risk of serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details, see the “Side effects of Humira in detail” section above.

Other warnings

It may not be safe for you to take Humira injection if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether Humira is a safe treatment option for you.

Before taking Humira injection, tell your doctor about your health and medications you take. Things to consider include:

• tuberculosis, hepatitis B, or other infections
• cancer
• nervous system problems
• diabetes
• liver problems
• low blood cell counts
• heart failure
• whether you take certain medications that can weaken the immune system
• your vaccine history or if you are due for vaccines
• if you are scheduled for major surgery
• pregnancy or breastfeeding
• past allergic reaction to Humira

Humira and pregnancy

It’s not known whether Humira injection should be taken during pregnancy.

If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. You and your doctor can discuss risks and benefits of using Humira while pregnant. Also, tell your doctor if you took Humira while you were pregnant before the newborn gets any vaccines.

Humira and breastfeeding

It’s not known whether Humira injection should be taken while breastfeeding.

If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Humira and alcohol

Humira is not known to interact with alcohol. But drinking heavily may weaken your immune system. This could possibly increase your risk of infections and cancer.

Humira can also weaken the immune system. And it has boxed warnings about the risk of serious infections and cancer. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects of Humira in detail” section above.

Alcohol may also worsen symptoms of some of the conditions that Humira is used to treat.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with Humira.

What to ask your doctor

This article describes common and serious side effects of Humira. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

Here’s a list of some possible questions you may want to ask your doctor:

• Does Humira cause long-term side effects?
• Can Humira cause weight gain?
• Am I at higher risk for certain side effects because of my condition?
• What monitoring is needed to see if I’m having side effects with Humira?
• What side effects of Humira are serious and need to be reported right away?

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.