Orencia’s Side Effects: What to Know

Orencia is a brand-name prescription drug. It’s a type of drug called an immunomodulator. It contains the active drug abatacept.

This medication comes as a powder that’s mixed into a solution, which is given by IV infusion. It also comes as a solution in prefilled syringes and auto-injectors, which is given by subcutaneous injection.

Orencia is approved by the Food and Drug Administration (FDA) for the following purposes in certain situations to:

• prevent acute (sudden) graft-versus-host disease (aGVHD) after a stem cell transplant in adults and children ages 2 years and older
• treat psoriatic arthritis in adults
• treat rheumatoid arthritis in adults
• treat polyarticular juvenile idiopathic arthritis in children ages 2 years and older

For aGVHD, doctors typically prescribe Orencia for short-term use. For its other uses, doctors can prescribe Orencia long term. Similar to other drugs, Orencia may cause side effects. Read below for information about possible side effects, including common, mild, and serious ones.

For a general overview of Orencia, including details about its uses, see this article.

If you’d like to take Orencia, search here to find a healthcare professional who might prescribe it.

Some of Orencia’s side effects may be more common than others. These side effects may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about any side effects of Orencia.

In Orencia’s clinical studies, these were some side effects that occurred more often:

• infection, such as the common cold or pneumonia
• nausea
• headache
• high blood pressure
• anemia (low level of red blood cells)

Orencia can cause mild side effects, which are listed below. However, this list doesn’t include all possible mild side effects. To learn more about Orencia’s side effects, view the drug’s prescribing information.

Orencia’s mild side effects include:

• anemia (low level of red blood cells)
• pain in the back, arms, or legs
• cough
• dizziness
• fever
• high level of magnesium
• indigestion
• low level of certain white blood cells called lymphocytes
• mild infection, such as urinary tract infection (UTI) or the common cold
• nausea
• headache
• high blood pressure
• rash
• reaction near the drug injection site*
• nosebleed*

The side effects listed above may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about side effects of Orencia.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Orencia and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Orencia: Side effects explained” below.

It’s possible to have serious side effects with Orencia. Serious side effects are listed below, but this list may not include all possibilities. To learn more about Orencia’s side effects, view the drug’s prescribing information.

Call your doctor right away if you have serious side effects with Orencia. However, if you think you’re having a medical emergency or have life threatening side effects, call 911 or your local emergency number.

Serious side effects of Orencia and their possible symptoms include:

• Serious infection, such as pneumonia, those caused by cytomegalovirus (a virus related to chickenpox), and Epstein-Barr virus (EBV). (EBV causes a condition called “mono”). Symptoms can include:
  • body aches
  • cough
  • fever
  • fatigue
  • sore throat
  • chest congestion
  • headache
• Increased risk of cancers, such as lung cancer and lymphoma (a type of blood cancer). Symptoms can include:
  • bruising or bleeding more easily than usual
  • fatigue
  • weight loss
  • chest pain
  • coughing up blood
  • swollen lymph nodes
• Kidney problems, such as acute (sudden) kidney failure. Symptoms can include:
  • trouble urinating or urinating more often than usual
  • painful urination
  • cloudy urine
  • dizziness
  • fatigue
• Side effects after Orencia infusions.*
• Allergic reaction.*

* For more information about this side effect, see “Orencia: Side effects explained” below.

Orencia is approved to treat polyarticular juvenile idiopathic arthritis in children ages 2 years and older. It is also approved to help prevent acute (sudden) graft-versus-host disease (aGVHD) after a stem cell transplant. Orencia is approved to treat this condition in adults and children ages 2 years and older.

Most of Orencia’s side effects in children are expected to be the same as those in adults. For lists of the drug’s possible side effects, see the “Orencia: Mild side effects” and “Orencia: Serious side effects” sections above.

In clinical studies for preventing aGVHD, the side effects in children were the same as those in adults. However, in clinical studies for treating polyarticular juvenile idiopathic arthritis, a few side effects were reported in children that weren’t reported in adults. These include abdominal pain and diarrhea.

If you have questions about your child’s risk of side effects with Orencia, talk with their doctor or pharmacist.

Here are some common questions about the drug’s side effects and answers to them. Talk with your doctor if you have other questions about this drug.

Yes, Orencia infusions will likely cause different side effects than Orencia injections.

Infusion reactions may happen when Orencia is given as an IV infusion. Alternatively, injection site reactions may happen when the drug is given as a subcutaneous injection. Each of these reactions may have different symptoms.

To learn more about injection site reactions and infusion reactions, see the “Orencia: Side effects explained” section below.

Weight gain wasn’t reported as a side effect in clinical studies of Orencia.

However, weight gain is a side effect of some medications prescribed to treat the same conditions as Orencia. Examples include methotrexate (Trexall) and corticosteroids such as prednisone (Rayos).

If you’re concerned about weight gain and Orencia, talk with your doctor. They can suggest ways to help you maintain a body weight that’s healthy for you.

The manufacturer of Orencia has published patient stories on its website. However, these stories may not necessarily mention the side effects people have had with the drug.

The safety and effectiveness of Orencia can be different from person to person. Your experience with the drug may be different from someone else. It’s important to talk with your doctor to determine if Orencia is the right treatment option for you.

It’s not likely. Neurological side effects weren’t reported in clinical studies of Orencia.

Neurological side effects are those that impact the nervous system or brain. They include side effects such as seizures, peripheral neuropathy (a type of nerve damage), and ocular side effects. (“Ocular” refers to eye-related conditions.) However, none of these were reported as side effects in studies of Orencia.

If you’re concerned about neurological side effects and Orencia, talk with your doctor.

Hair loss and depression weren’t reported as side effects in clinical studies of Orencia.

However, hair loss and depression can be related to certain conditions Orencia is prescribed to treat. For example, hair loss can be a symptom of rheumatoid arthritis and juvenile idiopathic arthritis. And people with rheumatoid arthritis have a high risk of depression.

So it’s possible you may experience hair loss and depression while taking Orencia to treat these conditions. However, they’re not necessarily caused by the drug.

If you have hair loss or depression while taking Orencia, talk with your doctor. They can help determine the cause of this symptom and ways to manage it.

In rare cases, Orencia may cause side effects that lead to long-term complications.

Examples of long-term side effects that can happen with Orencia include:

• an increased risk of cancers, such as lung cancer and lymphoma (a type of blood cancer)
• serious infection, such as pneumonia
• kidney problems, such as acute (sudden) kidney failure

If you’re concerned about the risk of long-term side effects with Orencia, talk with your doctor.

Here’s detailed information about some of Orencia’s side effects.

Reactions near injection sites can occur when Orencia is given as a subcutaneous injection. This was a less common side effect in Orencia’s clinical studies for rheumatoid arthritis. However, it wasn’t reported in studies of Orencia’s other approved uses.

Examples of reactions that may happen near Orencia’s injection sites include bruising, itching, and skin discoloration.

Injection site reactions won’t happen when Orencia is given as an IV infusion. Instead, infusion reactions may occur when the drug is given this way. To learn more, see “Side effects after infusions” below.

To reduce your risk of reactions near Orencia’s injection sites, rotate your injection site with each dose. Orencia is typically injected into your thigh or abdomen. A caregiver can also inject Orencia into your upper arm. To learn more about how to inject Orencia, see its prescribing information.

If you have severe or bothersome injection reactions with Orencia, talk with your doctor. They may suggest injection techniques to help prevent reactions, such as avoiding injecting the drug into areas that are scarred or have stretch marks.

Certain side effects can happen when Orencia is given as an IV infusion. These may happen during the infusion or shortly after. Infusion side effects were common in Orencia’s clinical studies for rheumatoid arthritis. However, they weren’t reported in studies of Orencia’s other approved uses.

Examples of infusion reactions that can happen with Orencia include:

• dizziness
• headache
• changes in blood pressure

Other possible infusion reactions that can happen with Orencia are similar to symptoms of an allergic reaction. For details, see “Allergic reaction” below.

Infusion reactions won’t happen when Orencia is given as a subcutaneous injection. Instead, injection site reactions may occur when the drug is given this way. To learn more, see “Reactions near injection sites” above.

Orencia infusions are given in a healthcare facility. A healthcare professional will watch for these side effects while you receive your infusion. If you have an infusion reaction, they’ll be prepared to give you treatments, such as a diphenhydramine injection, right away.

If you have an infusion reaction, your doctor will recommend whether you should continue receiving Orencia infusions.

Nosebleeds can occur with Orencia. This was a common side effect in Orencia’s clinical studies for the prevention of graft-versus-host disease after a stem cell transplant. However, nosebleeds weren’t reported in studies of Orencia’s other approved uses.

If you have a nosebleed with Orencia, you can try to stop the bleeding. To do this, lean forward and pinch your nose between your thumb and index finger for at least 15 minutes.

If your nosebleed is severe or you’re unable to stop the bleeding, call your doctor right away. They may need to pack your nose with gauze or sponges to help stop your nosebleed. 

If you’re concerned about nosebleeds with Orencia, talk with your doctor.

Be sure to talk with your doctor about your health history before you take Orencia. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health.

The conditions and factors to consider include those described below.

Hepatitis B. Before receiving Orencia, tell your doctor if you have or have had hepatitis B, which is caused by the hepatitis B virus (HBV). The drug may cause HBV to become active again (cause symptoms). If you have HBV, your doctor can recommend whether Orencia is right for you.

Infections, including tuberculosis (TB). Orencia may cause serious infections. Before taking the drug, tell your doctor if you have an infection or have infections that keep coming back. These factors could increase your risk of getting an infection with Orencia. And be sure to tell them if you have TB or if you’ve had it in the past. Your doctor will test you for TB before starting Orencia. If you have TB or other infections, your doctor will treat the infections before starting Orencia. Or they may prescribe a drug other than Orencia for you instead.

Chronic obstructive pulmonary disease (COPD). Before taking Orencia, tell your doctor if you have COPD. People with this condition may have a higher risk of certain side effects of the drug. Examples include cough and shortness of breath. Your doctor can advise if Orencia is a safe treatment option for you.

Cytomegalovirus (CMV) or Epstein-Barr virus (EBV). Before receiving Orencia, tell your doctor if you have CMV (a virus related to chickenpox) or EBV, which causes a condition called “mono.” The drug may cause CMV or EBV to become active again (cause symptoms) in people receiving Orencia to prevent acute (sudden) graft-versus-host disease (aGVHD). If you have CMV or EBV, your doctor can recommend whether Orencia is right for you.

Diabetes. If you receive Orencia as an IV infusion, be sure to tell your doctor if you have diabetes. The infusion solution contains a type of sugar that can make your blood sugar readings appear higher than they really are. Your doctor can recommend ways to check your blood sugar while you’re receiving Orencia.

Allergic reaction. If you’ve had an allergic reaction to Orencia or any of its ingredients, your doctor will likely not prescribe Orencia. Ask your doctor what other medications may be better options for you.

There are no known interactions between alcohol and Orencia. If you drink alcohol, talk with your doctor about an amount that’s safe to consume while receiving Orencia.

Below is important information about pregnancy and breastfeeding during Orencia treatment.

Pregnancy and Orencia. It’s not known if Orencia is safe to receive while pregnant. There haven’t been enough clinical studies of the drug in human pregnancies. If you’re pregnant or planning a pregnancy, talk with your doctor before receiving Orencia. They can recommend the safest treatment options while pregnant.

If you received Orencia while you’re pregnant, your doctor might recommend that you enroll in a pregnancy registry. Pregnancy registries gather important information about the safety of a drug when used during pregnancy. To learn more, call 877-311-8972, or talk with your doctor.

If you received Orencia during pregnancy, talk with your child’s doctor before your child receives any vaccines after birth.

Breastfeeding and Orencia. It’s not known if Orencia passes into breast milk. If you’re breastfeeding or planning to do so, talk with your doctor before receiving Orencia. They can talk with you about the risks and benefits of receiving the drug while breastfeeding.

Talk with your doctor or pharmacist to find out more information about Orencia. If you have questions about the drug’s side effects, your pharmacist or healthcare professional can help answer them for you.

In addition to discussing Orencia with your doctor, you may find the following articles helpful in learning more.

• Overview of Orencia. To read an overview of Orencia, see this article.
• Drug comparison. Learn how Orencia compares with Humira and Enbrel. 
• Details about your condition. To learn more about the conditions Orencia is prescribed for, see these articles.
  • psoriatic arthritis
  • rheumatoid arthritis
  • juvenile idiopathic arthritis
  • bone marrow transplant

Disclaimer: Healthgrades 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.