Avsola (infliximab-axxq) is a prescription drug that’s used to treat certain autoimmune conditions. Avsola can cause side effects that range from mild to serious. Examples include infections and infusion reactions.

Autoimmune conditions occur when your immune system mistakenly attacks healthy tissues in your body. Specifically, Avsola is used in certain situations in adults to help treat:

Avsola is also used in certain situations in children ages 6 years and older to help treat:

  • ulcerative colitis
  • Crohn’s disease

The active ingredient in Avsola is infliximab-axxq. (An active ingredient is what makes a drug work.) Avsola is a biologic (a drug made using living cells).

Avsola comes as a powder that’s mixed for intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of time. A healthcare professional gives you the infusion at a hospital or clinic.

Keep reading to learn about the common, mild, and serious side effects that Avsola can cause. For a general overview of the drug, including details about its uses, see this article.

Some people may experience mild to serious side effects during Avsola treatment. Some examples of Avsola’s commonly reported side effects are:

  • mild infections, such as cough; cold; and infections of the throat, sinuses, and urinary tract
  • infusion reactions, such as flushing, headache, shortness of breath, or rash
  • headache
  • abdominal (belly) pain

Mild side effects have been reported with Avsola. These include:

  • mild infections, such as cough; cold; and infections of the throat, sinuses, and urinary tract
  • mild infusion reactions, such as flushing, shortness of breath, fever, itching, or rash
  • headache
  • abdominal (belly) pain
  • indigestion
  • rash
  • itching
  • fatigue (low energy)
  • mild allergic reaction*

In most cases, these side effects should be temporary. And some may be managed easily. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop getting Avsola infusions unless your doctor recommends it.

Avsola may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

* To learn more about this side effect, see the “Side effects explained” section below.

Serious side effects have been reported with Avsola. These include:

If you develop serious side effects at any time during Avsola treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* To learn more about this side effect, see the “Side effects explained” section below.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Avsola, visit MedWatch.

Avsola is used to help treat Crohn’s disease and ulcerative colitis in children ages 6 years and older.

In the drug’s studies for Crohn’s disease, the following side effects were more common in children than in adults.

In the drug’s studies for ulcerative colitis, infections were more common in children than in adults.

For more information about potential side effects of Avsola in children, talk with your doctor or pharmacist.

Get answers to some frequently asked questions about Avsola’s side effects.

How do side effects of Avsola compare with those of Remicade?

Avsola can cause side effects similar to those of Remicade.

Both Avsola and Remicade are biologics (drugs made using living cells). Avsola contains the active drug infliximab-axxq. It’s a biosimilar of Remicade, which contains the active drug infliximab.

Biosimilars are considered to be just as safe and effective as their parent drug.

If you’d like to learn more about how these drugs and their side effects compare, you can ask your doctor.

Does Avsola cause hair loss or weight gain?

No, Avsola is not known to cause hair loss or weight gain.

But Avsola can sometimes cause onset of heart failure. It also can worsen heart failure for people who already have it. Symptoms of worsening heart failure include weight gain, shortness of breath, and swollen ankles or feet.

If you have sudden weight gain or other symptoms of heart failure during Avsola treatment, call your doctor immediately. They’ll likely want to see you right away to check your heart health.

Learn more about some of the side effects Avsola may cause.

Risk of serious infections

Avsola has a boxed warning for the risk of serious infections. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). They alert doctors and patients about drug effects that may be dangerous.

Avsola weakens your immune system, which defends your body from foreign substances. The drug can increase your risk of serious infections such as tuberculosis (TB). Other infections can be caused by fungus and spread throughout your body. Or they can be caused by bacteria or viruses.

These infections may need treatment in the hospital. In extreme cases or if untreated, they could lead to death.

Serious infections weren’t commonly reported in studies of Avsola. These infections may cause symptoms such as:

  • fever or chills
  • tiredness
  • cough
  • sore throat
  • sore, hot, red, or discolored areas of skin

Some factors can increase the risk of serious infections during Avsola treatment. These include older age and health conditions such as diabetes. Another factor is the use of other drugs that weaken your immune system. These drugs include:

What might help

Your doctor will likely test you for TB and hepatitis B virus (HBV) before prescribing Avsola. If you’ve had these infections before, Avsola could make them active again in your body. If you test positive for TB or HBV, your doctor likely will prescribe medication to treat the infection before you start Avsola.

Before starting treatment with Avsola, tell your doctor if you have any active infections or ones that keep coming back. Your doctor may prescribe medication to treat an infection before you start Avsola. Your doctor also may recommend that you get up to date with certain vaccinations before starting Avsola.

During Avsola treatment, you should not receive live vaccines because they could cause serious infections. (Live vaccines contain a weakened version of the bacteria or virus they protect against.) Examples of live vaccines include:

During Avsola treatment, talk with your doctor if you develop symptoms of infection. They’ll likely prescribe medication to treat the infection. If it becomes serious, they’ll likely pause your Avsola treatment until the infection is treated.

If you have questions or concerns about the risk of infections with Avsola, talk with your doctor.

Risk of lymphoma and other cancers

Avsola has a boxed warning for the risk of lymphoma and other cancers. Boxed warnings are the most serious warnings from the FDA. They alert doctors and patients about drug effects that may be dangerous.

Avsola can increase your risk of developing lymphoma and other cancers, such as skin cancer and cervical cancer. In studies of Avsola, cancers weren’t common.

A rare type of cancer called hepatosplenic T-cell lymphoma has been reported with drugs similar to Avsola. This type of lymphoma mainly occurred in teenage and young adult males* with ulcerative colitis or Crohn’s disease. These teenage and young adult males were also taking azathioprine (Imuran, others) or mercaptopurine (Purinethol).

Cancers can cause different symptoms depending on the type of cancer. Skin cancer can cause symptoms such as:

  • new moles or skin growths
  • moles or skin growths that grow or change
  • unusual skin patches that change in appearance, itch, bleed, or don’t heal

Lymphoma can cause symptoms such as:

  • cold or flu-like symptoms that don’t go away
  • fever
  • night sweats
  • swollen lymph nodes, for instance in your neck, groin, or armpits
  • unusual tiredness
  • weight loss

Certain factors can increase the risk of cancer during Avsola treatment. These include:

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

What might help

If you’ve had cancer before, talk with your doctor about whether Avsola is right for you.

During treatment with Avsola, your doctor will regularly screen you for cancer. See your doctor right away if you develop any skin changes, unusual lumps or swellings, or other symptoms you don’t recognize or can’t explain.

Talk with your doctor about lifestyle factors that can help reduce your risk of cancer. These include protecting your skin from the sun and not smoking.

If you have questions or concerns about the risk of cancer with Avsola, talk with your doctor.

Allergic reaction

Like most drugs, Avsola can cause an allergic reaction in some people. This side effect was reported rarely in studies.

Symptoms can be mild to serious and can include:

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

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an antihistamine you swallow, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Avsola, they’ll decide whether you should continue receiving it.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Avsola, they may have you switch to a different treatment.

Keeping track of side effects

During your Avsola treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combine treatments.

Your side effect notes can include things such as:

  • what dose of the drug you received when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Avsola affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before starting Avsola.

Boxed warnings

Avsola has boxed warnings about the risks of serious infections and lymphoma and other cancers. Boxed warnings are the most serious warnings from the FDA.

Risk of serious infections: Avsola can increase your risk of serious infections that may need treatment in the hospital. In extreme cases or if untreated, they could lead to death.

Risk of lymphoma and other cancers: Avsola can increase your risk of developing lymphoma and other cancers, such as skin cancer.

To learn more about these boxed warnings, see the “Side effects explained” section above.

Other warnings

Avsola can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Avsola is a good treatment option for you.

Talk with your doctor about your health history before you start Avsola. Be sure to tell them if any of the following factors apply to you:

Alcohol and Avsola

No interactions between alcohol and Avsola are known. But drinking large amounts of alcohol could increase your risk of certain Avsola side effects. These include headache, infection, and liver problems.

If you have questions about consuming alcohol during Avsola treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Avsola

Before starting Avsola treatment, it’s important to talk with your doctor if you’re pregnant, breastfeeding, or planning to become pregnant or breastfeed.

Pregnancy

It’s not known whether Avsola is safe to receive during pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor before starting treatment with Avsola.

If you receive this drug while pregnant, your baby’s immune system may have difficulty fighting infection after birth. Your baby should not receive live vaccines until they’re at least 6 months old. (Live vaccines contain a weakened version of the bacteria or virus they protect against. Examples of live vaccines include those for measles, mumps, and rubella (MMR); rotavirus; and chickenpox.)

Breastfeeding

It isn’t known whether Avsola is safe to receive while breastfeeding. If you’re breastfeeding or planning to do so, talk with your doctor before starting this medication.

Like most drugs, Avsola can cause a number of side effects that range from mild to serious. But most are temporary and go away after a few days to weeks. If you have questions about side effects that Avsola can cause, talk with your doctor.

Examples of questions to help get you started include:

  • Does having long-term treatment with Avsola raise my risk of side effects?
  • How will you monitor me for Avsola side effects?
  • If I have certain side effects, will I need to stop Avsola treatment?
  • How do Avsola’s side effects compare with side effects of other treatment options for my condition?

To learn more about Avsola, see this “Avsola (infliximab-axxq)” article.

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Disclaimer: Healthline 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.