Side Effects of Simponi and Simponi Aria: What You Need to Know

If you have certain autoimmune conditions, your doctor might suggest Simponi or Simponi Aria as a treatment option for you.

Simponi and Simponi Aria are prescription medications used to treat the following conditions in adults:

• rheumatoid arthritis
• psoriatic arthritis (PsA)
• ankylosing spondylitis

Simponi is also used to treat ulcerative colitis in adults. And Simponi Aria is used for PsA and polyarticular juvenile idiopathic arthritis in some children.

The active ingredient in Simponi and Simponi Aria is golimumab. (An active ingredient is what makes a drug work.) Golimumab is a type of biologic medication.

Simponi comes as a liquid solution that’s given as an injection under the skin. It’s available as a single-dose, prefilled syringe and autoinjector pen.

Simponi Aria also comes as a liquid solution, but it’s given as an intravenous (IV) infusion. (An IV infusion is an injection into your vein given over time.) You’ll receive Simponi Aria infusions at a hospital, a clinic, or an infusion center.

Simponi and Simponi Aria are meant to be long-term treatments. For more information about these drugs, including details about their uses, see this in-depth article.

Like other drugs, Simponi and Simponi Aria can cause mild or serious side effects. Keep reading to learn more.

These are just a few of the more common side effects reported by people who took Simponi or Simponi Aria in studies. These side effects can vary depending on which condition the drug is prescribed to treat.

More common side effects reported by people treated with Simponi in studies include:

• upper respiratory infection, such as the common cold
• stuffy or runny nose and sore throat
• injection side effects*

More common side effects reported in studies of Simponi Aria include:

• upper respiratory infection, such as the common cold
• increased level of liver enzymes
• viral infection, such as flu or oral herpes
• low levels of neutrophils, a type of white blood cell
• high blood pressure

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

Mild side effects can occur with Simponi and Simponi Aria. Examples of mild side effects that have been reported with these drugs include:

• constipation
• dizziness
• numbness, tingling, or weakness in your arms, hands, feet, or legs
• increased level of liver enzymes
• stuffy or runny nose and sore throat
• upper respiratory infection, such as the common cold
• viral infection, such as flu or oral herpes
• infusion or injection side effects*
• skin-related side effects, such as skin rash or itching*

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

In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And do not stop your Simponi or Simponi Aria treatment unless your doctor recommends it.

Simponi and Simponi Aria may cause mild side effects other than the ones listed above. See the prescribing information for Simponi and Simponi Aria for details.

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

In some cases, serious side effects can occur with Simponi or Simponi Aria. Serious side effects that have been reported with these drugs include:

• blood disorders, including low levels of neutrophils (a type of white blood cell) and low levels of platelets (cells that help with blood clotting)
• heart failure
• high blood pressure
• lupus-like syndrome (a type of immune system reaction)
• nervous system problems, including conditions such as multiple sclerosis
• risk of serious infection*
• risk of cancer*
• allergic reaction†

If you develop serious side effects during your treatment with Simponi or Simponi Aria, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* Simponi and Simponi Aria have a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section below.
† To learn more about this side effect, see the “Side effects explained” section below.

Get answers to some frequently asked questions about Simponi’s and Simponi Aria’s side effects.

Do Simponi Aria infusion side effects differ from Simponi injection side effects?

Simponi and Simponi Aria are very similar medications. They cause some of the same side effects, but some side effects vary because of how the drugs are given.

Simponi is given as an injection under the skin, and Simponi Aria is given as an intravenous (IV) infusion. (An IV infusion is an injection into your vein given over time.)

Injection site reactions have been reported with Simponi. These reactions can include:

• bruising
• burning
• hardened skin bump
• hives
• itchiness
• numbness or tingling
• pain
• skin discoloration

Simponi can cause infusion reactions, such as a skin rash.

For more information about how Simponi and Simponi Aria compare, talk with your doctor or pharmacist. You can also view the full prescribing information for Simponi and Simponi Aria.

Is weight gain a side effect of Simponi and Simponi Aria?

No, neither Simponi nor Simponi Aria cause weight gain. This side effect wasn’t reported by people receiving either drug in studies.

In rare cases, both Simponi and Simponi Aria can cause heart failure or worsen heart failure if you already have this condition. And sudden weight gain (such as gaining 3 to 5 pounds over a day or two) can be a symptom of new or worsening heart failure.

It’s also important to note that methotrexate (Trexall, Otrexup), a medication sometimes prescribed with Simponi or Simponi Aria, can cause weight gain.

Weight gain can also be related to symptoms of the conditions these drugs are prescribed to treat, such as rheumatoid arthritis.

If you’re concerned about weight changes during your treatment with Simponi or Simponi Aria, talk with your doctor or pharmacist.

Can Simponi and Simponi Aria cause hair loss?

No. Hair loss isn’t a side effect of Simponi or Simponi Aria. Hair loss wasn’t a side effect reported for either drug in studies.

However, methotrexate, which may be prescribed with Simponi or Simponi Aria, can cause hair loss.

If you’re experiencing hair loss that bothers you, talk with your doctor or pharmacist. They can review your treatment plan to see if any of your medications may be causing this side effect.

Will I get headaches from treatment with either Simponi or Simponi Aria?

It isn’t likely. Headache wasn’t a side effect reported by people being treated with Simponi or Simponi Aria in studies.

If you’re experiencing bothersome headaches, talk with your doctor or pharmacist. They can suggest ways to relieve your headache.

Learn more about some of the side effects Simponi and Simponi Aria may cause.

Infusion or injection side effects

Infusion or injection side effects can occur with Simponi or Simponi Aria. But these side effects weren’t common in studies of either drug.

Simponi is given as an injection under the skin. Side effects at the injection site may include:

• bruising
• burning
• hardened skin bump
• hives
• itchiness
• numbness or tingling
• pain
• skin discoloration

Simponi Aria is given as an intravenous (IV) infusion. (An IV infusion is an injection into your vein given over time.) Infusion side effects from Simponi Aria can include:

• fever
• skin rash

What might help

Side effects caused by Simponi injections should go away within a few days after you take a dose.

These tips may lower your risk for side effects with Simponi injections:

• Let Simponi sit at room temperature for at least 30 minutes before giving your injection.
• Rotate the site where you inject Simponi with each dose.
• Don’t give Simponi injections into skin that is bruised, hard, damaged, scarred, or tender.

For Simponi Aria, your doctor or another healthcare professional will monitor you during the infusion. They can pause the infusion if you have infusion-related side effects that bother you.

The infusion or injection side effects seen in studies of Simponi or Simponi Aria were mild. But if you have side effects after an injection or infusion that bother you or seem severe, call your doctor. They may switch you to a different medication or suggest treatment for your side effects.

Skin-related side effects, such as rash or itching

Skin-related side effects, such as rash or itching, may occur with Simponi or Simponi Aria.

In studies, itching was reported as an injection side effect in some people during Simponi treatment, but it wasn’t common. Rash was reported as an infusion side effect in people receiving Simponi Aria infusions in studies, but this wasn’t common, either.

What might help

If you have side effects (such as itching) after a Simponi injection that bother you or don’t go away, talk with your doctor. They may have you try a different treatment for your condition.

For Simponi Aria, your doctor or another healthcare professional will monitor you during the infusion. They can pause the infusion if you have infusion-related side effects that bother you.

Risk of serious infection

Simponi and Simponi Aria have a boxed warning about the risk of serious infection. 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.

Simponi and Simponi Aria work by weakening your immune system. This raises your risk of infection, including serious infections such as tuberculosis (TB). These infections have led to hospitalization and, in very rare cases, have caused death.

Symptoms of an infection can vary but may include:

• chills
• cough, which may include blood
• diarrhea
• fatigue (low energy)
• fever
• muscle aches
• shortness of breath

People with certain health factors may have a higher risk for infection (including serious infection) with Simponi or Simponi Aria. This includes people who:

• have certain conditions that weaken their immune system (also known as being immunocompromised)
• take certain other medications that affect the immune system
• have other medical conditions, such as diabetes, that raise their risk of infection
• have a chronic (long-term) infection
• have a history of repeated infections
• live in certain areas with higher risks for fungal infections (such as the Southwestern United States or the Ohio River Valley)

What might help

Before starting treatment with Simponi or Simponi Aria, be sure to tell your doctor if you have an infection.

Your doctor will likely test you for TB and the hepatitis B virus (HBV) before prescribing Simponi or Simponi Aria. These drugs could cause TB or HBV to reactivate (cause symptoms to return) if you’ve had these conditions in the past. If you do have TB or HBV, your doctor will treat the infection before prescribing Simponi or Simponi Aria for you.

If you develop symptoms of an infection during your treatment with Simponi or Simponi Aria, call your doctor right away. They can prescribe treatment for your infection. If your infection is serious, they may have you stop Simponi or Simponi Aria and switch to a different treatment.

Risk of cancer

Simponi and Simponi Aria have a boxed warning about the risk of cancer. Boxed warnings are the most serious warnings from the FDA.

Simponi and Simponi Aria belong to a group of drugs called tumor necrosis factor (TNF) blockers. This kind of drug raises the risk of certain cancers in children and young adults. These can include leukemia, lymphoma, and skin cancer.

In studies of Simponi and Simponi Aria, reports of people developing new cancers were extremely rare. But in some cases, these cancers can be fatal.

It’s important to note that inflammatory conditions such as rheumatoid arthritis may raise the risk of lymphoma. So people with this kind of condition may have a higher risk of cancer, even without using a TNF blocker such as Simponi or Simponi Aria.

Symptoms of cancer vary but may include:

• changes to your skin’s appearance, including new growths (lumps)
• fatigue (low energy)
• fever or night sweats
• frequent infections
• unintended weight loss

What might help

Your doctor will monitor you for any symptoms of cancer during your treatment with Simponi or Simponi Aria. They may also suggest having a skin exam from time to time to check for any symptoms of skin cancer.

If you notice symptoms of cancer, call your doctor right away. They may want to examine you in person.

If you’ve had cancer in the past, you may have a higher risk of new or worsening cancer with Simponi or Simponi Aria. Your doctor can determine the safest treatment for you.

Allergic reaction

Like most drugs, Simponi or Simponi Aria can cause an allergic reaction in some people.

Symptoms can be mild or serious and can include:

• skin rash
• itching
• 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 an over-the-counter oral antihistamine, such as Benadryl (diphenhydramine), or a topical product, such as hydrocortisone cream, to manage your symptoms.

If your doctor confirms you had a mild allergic reaction to Simponi or Simponi Aria, they’ll decide if you should continue the treatment.

If you have symptoms of a severe allergic reaction, such as swelling or trouble 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 had a serious allergic reaction to Simponi or Simponi Aria, they may have you switch to a different treatment.

Keeping track of side effects

During your Simponi or Simponi Aria treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

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

Keeping notes and sharing them with your doctor will help your doctor learn more about how Simponi or Simponi Aria affects you. And your doctor can use this information to adjust your treatment plan if needed.

There are certain precautions to consider before taking Simponi or Simponi Aria. This includes two boxed warnings.

Boxed warnings

Simponi and Simponi Aria have boxed warnings about the risk of serious infection and the risk of cancer. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

• Risk of serious infection. Treatment with Simponi or Simponi Aria weakens your immune system. This can raise your risk for a serious infection.
• Risk of cancer. Simponi and Simponi Aria belong to a group of drugs called tumor necrosis factor (TNF) blockers. These drugs raise the risk of certain cancers in children and young adults. These cancers can include leukemia, lymphoma, and skin cancer.

To learn more, see the “Side effects explained” section above.

Other warnings

Simponi or Simponi Aria may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Simponi or Simponi Aria. The list below includes factors to consider.

Heart failure. In rare cases, Simponi or Simponi Aria can cause heart failure. If you already have heart failure, these drugs may worsen your condition. Your doctor can help determine whether Simponi or Simponi Aria is safe for you.

Hepatitis B virus (HBV) or tuberculosis (TB). Simponi or Simponi Aria may cause TB or HBV infection to reactivate (cause symptoms to return) if you’ve previously had these conditions. Your doctor will monitor you closely for any signs that the condition has become active again. If this occurs, they may have you stop Simponi or Simponi Aria and switch to a different treatment.

Conditions that weaken your immune system. Having certain conditions that weaken your immune system (also known as being immunocompromised) raises your risk of infection. Treatment with Simponi or Simponi Aria also increases your risk of infection, including serious infections. These drugs may not be safe for you if you’re immunocompromised, so talk with your doctor before starting treatment with Simponi or Simponi Aria.

Nervous system problems. In rare cases, Simponi and Simponi Aria can cause nervous system problems, such as multiple sclerosis. If you already have a nervous system problem, taking either of these drugs could make your condition worse. Your doctor can help determine if Simponi or Simponi Aria is safe for you.

Allergic reaction. If you’ve had an allergic reaction to Simponi or Simponi Aria or any of their ingredients, your doctor will likely not prescribe Simponi or Simponi Aria. Ask your doctor what other medications are better options for you.

Alcohol and Simponi and Simponi Aria

It should be safe to drink alcohol during treatment with Simponi or Simponi Aria.

But alcohol can worsen symptoms of inflammatory conditions, such as rheumatoid arthritis, which Simponi and Simponi Aria treat.

If you drink alcohol, talk with your doctor about how much may be safe to consume during your Simponi or Simponi Aria treatment.

Pregnancy and breastfeeding during Simponi or Simponi Aria treatment

It’s not known if Simponi or Simponi Aria treatment is safe during pregnancy or while breastfeeding. If you’re pregnant or breastfeeding, or planning to become pregnant or breastfeed, talk with your doctor before treatment with either of these drugs.

Simponi and Simponi Aria cross the placenta and can affect a fetus. If you have a baby and had treatment with Simponi or Simponi Aria during pregnancy, talk with your child’s doctor before they receive any vaccines during their first 6 months. Your child may not be able to get any live vaccines for up to 6 months after you received your last dose while pregnant.

Live vaccines contain a weakened version of the virus or bacteria they’re meant to protect against. This usually triggers the immune system to respond to the live virus or bacteria. But Simponi and Simponi Aria weaken your immune system. A baby exposed to either of these drugs in the womb has a higher risk of getting the condition the vaccine is meant to prevent. Talk with your child’s doctor before they receive any vaccines from birth to the age of 6 months.

Like most medications, Simponi and Simponi Aria can cause side effects in some people.

Before taking Simponi or Simponi Aria, talk with your doctor. Ask questions to help you become familiar with this medication and its side effects. Some example questions to help get you started include:

• How do side effects with Simponi and Simponi Aria compare with other treatments for my condition?
• If I have side effects while taking Simponi, is there a lower dose I can try instead?
• Do other medications I take raise my risk for side effects from Simponi or Simponi Aria?
• Will I take Simponi or Simponi Aria with other medications for my condition?

If you have ulcerative colitis, consider signing up for Healthline’s inflammatory bowel disease (IBD) newsletter for news on current treatments, tips for managing flare-ups, and more. There’s also a Healthline newsletter for rheumatoid arthritis.

If you’re looking to connect with people who live with the same condition, you might want to join a Bezzy community. Currently, there are communities for rheumatoid arthritis, inflammatory bowel disease, and psoriatic arthritis.

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.