Simponi and Simponi Aria (golimumab) are brand-name prescription medications. They’re approved by the Food and Drug Administration (FDA) to treat the following conditions in adults:

Simponi is also prescribed to treat moderate to severe ulcerative colitis in adults. And Simponi Aria is also prescribed to treat PsA and polyarticular juvenile idiopathic arthritis in children ages 2 years and older.

Whichever condition they’re prescribed to treat, Simponi and Simponi Aria are typically long-term treatments.

Here are some fast facts about Simponi and Simponi Aria:

Like other drugs, Simponi and Simponi Aria can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Simponi and Simponi Aria, including details about their uses, see this article.

Both Simponi and Simponi Aria can cause side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

These are just a few of the more common side effects reported by people who received Simponi or Simponi Aria in clinical trials:

* For more information about this side effect, see “Side effect specifics” below.
† In some instances, large increases in blood levels of liver enzymes can be a sign of liver damage. But, there were no reports of liver damage in Simponi’s or Simponi Aria’s clinical trials.

Mild side effects can occur with Simponi or Simponi Aria use. This list doesn’t include all the possible mild side effects of these drugs. For more information, you can refer to the prescribing information for Simponi and Simponi Aria.

Mild side effects that have been reported with Simponi and Simponi Aria include:

These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.

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 using Simponi or Simponi Aria and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Side effect specifics” below.
† In some instances, large increases in blood levels of liver enzymes can be a sign of liver damage. But, there were no reports of liver damage in Simponi’s or Simponi Aria’s clinical trials.

Simponi and Simponi Aria may cause serious side effects. The list below may not include all the possible serious side effects of the drug. For more information, you can refer to the prescribing information for Simponi and Simponi Aria.

If you develop serious side effects while using Simponi or Simponi Aria, 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.

Serious side effects that have been reported and their symptoms include:

  • Blood disorders, including decreased levels of white blood cells or neutrophils (a type of white blood cell). Symptoms can include:
    • wounds that don’t heal or are slow to heal
    • weight loss
  • Heart failure, which can cause sudden weight gain and other symptoms, such as:
    • fatigue
    • irregular heartbeat
    • shortness of breath
    • swelling in your ankles, feet, or lower legs
  • Lupus-like syndrome (a type of immune system reaction). Symptoms can include:
    • sensitivity to sunlight
    • shortness of breath
  • Nerve problems, including conditions such as multiple sclerosis. Symptoms can include:
    • numbness or tingling anywhere in your body
    • vision changes, including loss of vision
    • weakness in your arms or legs
  • Serious infection.*†
  • Cancer.*†
  • Allergic reaction. †

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

Simponi and Simponi Aria may cause several side effects. Here are answers to some frequently asked questions about the drug’s side effects.

What are the side effects of golimumab, the active drug in Simponi and Simponi Aria?

The side effects caused by golimumab are the same as those reported in clinical trials of Simponi and Simponi Aria. Refer to the various sections above to learn more about side effects that golimumab may cause. You can also view the full prescribing information for Simponi and Simponi Aria to learn about all the side effects reported during clinical trials.

Note: Simponi and Simponi Aria aren’t available in generic or biosimilar forms. A generic drug has the same name as the active drug in a brand-name medication because it’s an exact copy of that active drug.

If you have questions about Simponi’s and Simponi Aria’s side effects, talk with your doctor or pharmacist.

How do side effects of the Simponi injection compare with those of the Simponi Aria infusion?

Simponi injections may cause a few mild side effects that haven’t been reported with Simponi Aria infusion.

Specifically, mild reactions at the injection site have been reported with Simponi injections. These reactions can include:

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

It’s also possible to have infusion reactions, such as a skin rash, with Simponi Aria infusions.

No serious injection or infusion reactions were reported with either Simponi or Simponi Aria in clinical trials.

To learn more 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.

Does Simponi or Simponi Aria cause weight gain?

No, neither Simponi nor Simponi Aria are known to cause weight gain. No one who used either medication reported weight gain as a side effect in clinical trials.

However, both medications can, rarely, cause heart failure as a side effect. They can also worsen existing heart failure in people who already have this condition. Sudden weight gain (gaining 3 to 5 pounds over a day or two) can be a symptom of new or worsening heart failure.

Other medications that may be used to treat the same conditions as Simponi and Simponi Aria may cause weight gain. These medications include methotrexate (Trexall) and prednisone (Rayos). Simponi or Simponi Aria may be prescribed in combination with methotrexate for some of the conditions they’re used to treat.

And it’s not uncommon for people with some of these conditions, such as rheumatoid arthritis, to have weight gain due to the condition or symptoms of the condition.

If you’re concerned about your weight, talk with your doctor or pharmacist. They can help suggest ways to maintain a moderate weight. They can also review your treatment plan to see if any medications may be causing weight gain.

Is hair loss a side effect of Simponi or Simponi Aria?

No, hair loss isn’t a known side effect of either Simponi or Simponi Aria. In clinical trials, hair loss was not reported.

Other medications that may be used to treat the same conditions as Simponi and Simponi Aria may cause hair loss. These medications include methotrexate (Trexall) and leflunomide (Arava). Hair loss has also, rarely, been reported with adalimumab (Humira) and etanercept (Enbrel).

Simponi or Simponi Aria may be prescribed in combination with methotrexate for some of the conditions they’re used to treat. However, hair loss hasn’t been reported with either Simponi or Simponi Aria.

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

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

Skin rash

It’s possible that you’ll have a skin rash from using Simponi or Simponi Aria.

A skin rash wasn’t reported as a side effect by people using Simponi in clinical trials. It was rarely reported by people using Simponi Aria.

However, a skin rash can be a symptom of an injection site reaction from using Simponi, or an infusion reaction caused by Simponi Aria infusions. In these cases, the rash should go away soon after the injection or infusion.

A skin rash can also be a symptom of lupus-like syndrome (a type of immune system reaction), a rare, serious side effect of both Simponi and Simponi Aria. It can also be a symptom of an allergic reaction to either medication.

What you can do

Contact your doctor if you have a skin rash from Simponi or Simponi Aria that bothers you or doesn’t go away. They’ll likely want to examine your rash in person. This can help them determine the best way to treat it.

Injection site or infusion site reactions

Using Simponi or Simponi Aria can result in injection or infusion site reactions, such as itchiness, pain, and bruising. While this was one of the more common side effects reported in Simponi’s clinical trials, it didn’t affect most people using the medication.

These reactions can include any of the following at the place where you inject Simponi:

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

What you can do

Injection or infusion site reactions caused by Simponi or Simponi Aria should go away within a few days. No one who received either drug in clinical trials had to stop using the medication due to injection or infusion site reactions.

However, if you have reactions to Simponi injections that bother you or don’t go away, talk with your doctor. They may recommend a medication other than Simponi. They may also suggest trying Simponi Aria, which is given by IV infusion instead of a subcutaneous injection. But Simponi Aria may cause infusion site reactions.

Following these tips may lower your risk of injection site reactions with Simponi:

  • remove Simponi from the refrigerator and let it 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 inject Simponi into skin that is bruised, hard, damaged, scarred, or tender

Serious infection

Treatment with Simponi or Simponi Aria raises your risk of serious infections. Simponi has a boxed warning about this side effect. This is a serious warning from the Food and Drug Administration (FDA).

Simponi and Simponi Aria both work by affecting your immune system. Both medications can weaken your immune system’s ability to fight off infections. This raises your risk of infections, including serious infections, such as tuberculosis (TB) and other serious bacterial, fungal, and viral infections. In extreme cases, these infections have led to hospitalization and, in rare cases, death.

Symptoms of an infection vary, based on the type, but some general symptoms can include:

Certain people may have a higher risk of infections, including serious infections, if they use Simponi or Simponi Aria. This includes people:

  • with a chronic (long-term) infection
  • who are immunocompromised
  • with other medical conditions that increase the risk of infection, such as diabetes
  • with a history of repeated infection
  • who live in certain areas with higher risks of fungal infection (such as the Southwestern United States or the Ohio River valley)
  • who take certain other medications that affect the immune system

What you can do

Before you begin using Simponi or Simponi Aria, your doctor should test you for TB. They’ll also likely test you for hepatitis B.

If you’ve been exposed to either TB or hepatitis B in the past, using Simponi or Simponi Aria could cause either infection to become active again. (This means that the infection causes symptoms again). Your doctor will want to treat the TB or hepatitis B before prescribing Simponi or Simponi Aria.

You should also tell your doctor if you have any other current infection before using Simponi or Simponi Aria. Your doctor will want to treat the infection before starting treatment with Simponi or Simponi Aria.

Talk with your doctor right away if you develop symptoms of an infection while using Simponi or Simponi Aria. They can prescribe treatment. If your infection is serious, they may recommend that you stop using Simponi or Simponi Aria.

Cancer

Using Simponi or Simponi Aria raises the risk of certain cancers, including leukemia, lymphoma, and skin cancer. Both drugs have a boxed warning about this side effect. These are serious warnings from the FDA.

Reports of new cancers in clinical trials for Simponi and Simponi Aria were extremely rare. However, the cancer may, in some cases, be fatal. In clinical trials, there have been reports of cancer in children and young adults who began using tumor necrosis factor blockers. This was reported in people ages 18 years or younger.

It’s important to note that people with inflammatory diseases, such as those Simponi and Simponi Aria are prescribed to treat, may have a higher risk of lymphoma due to their condition.

Symptoms of cancer vary depending on the type. But some general symptoms include:

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

What you can do

Simponi Aria is only approved for use in people ages 18 years or younger. It’s approved for polyarticular juvenile idiopathic arthritis in children ages 2 years and older.

While using Simponi or Simponi Aria, your doctor will monitor you for any signs of cancer. They may also recommend routine skin exams to check for any symptoms of skin cancer. But if you notice symptoms of cancer, contact your doctor right away. They’ll want to examine your symptoms more closely.

Be sure to tell your doctor if you have or have had cancer in the past before you start using Simponi or Simponi Aria. You may have a higher risk of new or worsening cancer if you use either of these drugs. Your doctor can help determine the safest treatment for your condition.

Allergic reaction

As with most drugs, Simponi and Simponi Aria can cause an allergic reaction in some people.

Symptoms can be mild or serious and can include:

  • skin rash
  • itching
  • flushing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

What you can do

For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep using Simponi or Simponi Aria. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Click here for more links and local resources.

Before you use Simponi or Simponi Aria, there are several precautions to consider. These include two boxed warnings.

Boxed warnings

Simponi and Simponi Aria have boxed warnings about serious infections and cancer. These are serious warnings from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.

Other precautions

Be sure to talk with your doctor about your health history before you use Simponi or Simponi Aria. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:

Heart failure. Treatment with Simponi or Simponi Aria can cause heart failure. Both medications may also worsen heart failure in people who already have this condition. Talk with your doctor about whether Simponi or Simponi Aria are safe.

Hepatitis B or tuberculosis (TB). If you’ve been exposed to hepatitis B or TB previously, using Simponi or Simponi Aria may cause the infection to become active again. (This means that the infection causes symptoms again).

If your doctor decides to prescribe Simponi or Simponi Aria to you, they’ll want to monitor you. They may have you stop using Simponi or Simponi Aria if the infection becomes active again.

Weakened immune system. Treatment with Simponi or Simponi Aria raises your risk of infections, including serious infections. People who are already immunocompromised have weakened immune systems, placing them at higher risk of an infection. Simponi or Simponi Aria may not be safe for you if you’re immunocompromised. Your doctor can help determine whether these medications are safe for you.

Nervous system problems. In rare cases, both Simponi and Simponi Aria can cause nervous system problems, such as multiple sclerosis. If you already have a nervous system problem, using either medication could worsen your condition. Talk with your doctor to discuss whether these medications are safe for you.

Rubber or latex allergy. Before you use Simponi, tell your doctor if you have a rubber or latex allergy. The syringes and autoinjector for giving Simponi by injection contain a type of rubber on the needle cover. This could cause an allergic reaction in people with a rubber or latex allergy. In this case, using Simponi Aria may be a better option for you. Talk with your doctor about the best treatment option 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 either drug. Ask what other medications may be better options for you.

Alcohol use with Simponi or Simponi Aria

There’s no known interaction between drinking alcohol and treatment with Simponi or Simponi Aria.

However, alcohol may interact with other medications you may take for your condition. And alcohol can worsen symptoms of inflammatory conditions, such as rheumatoid arthritis, which Simponi and Simponi Aria are used to treat.

Talk with your doctor about the amount of alcohol that’s safe for you to drink while using Simponi or Simponi Aria.

Pregnancy and breastfeeding while using Simponi or Simponi Aria

It’s not known if it’s safe to use Simponi or Simponi Aria while you’re pregnant. It’s known that the drug crosses the placenta. Children born to people who used either drug during pregnancy may have a higher risk of infections. But it’s not known whether there are other risks linked to using either medication during pregnancy.

It also isn’t known if it’s safe to breastfeed while using either Simponi or Simponi Aria. It’s not known whether the medications pass into breast milk during breastfeeding.

If you’re pregnant, planning to become pregnant, or breastfeeding, talk with your doctor about the safest treatment for your condition. They can recommend safe feeding options for your child.

Like most medications, Simponi and Simponi Aria can cause side effects. Most side effects of either medication are mild and aren’t common. However, if you have bothersome side effects that don’t go away, talk with your doctor or pharmacist.

If you’d like to learn more about Simponi and Simponi Aria, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of these drugs.

Besides talking with your doctor, you can do some research on your own. These articles might help:

Disclaimer: Medical News Today 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.