Actemra

Actemra (tocilizumab) is a prescription medication used to treat conditions caused by inflammation and overactive immune systems. This includes rheumatoid arthritis (RA), giant cell arteritis, systemic juvenile idiopathic arthritis and COVID-19.

Manufactured by Genentech, Actemra is part of a group of drugs called interleukin-6 (IL-6) receptor antagonists. IL-6 is a substance in your body that causes inflammation. Actemra works by blocking it.

People take Actemra weekly as an injection or monthly as an IV infusion. Patients using the injection can give themselves shots at home, while those on the IV infusion receive the drug at a medical center.

Common side effects of Actemra are usually not serious and can include dizziness, headaches and sore throats. Patients should speak with their doctor if these side effects persist or become bothersome.

The most common side effects reported during clinical trials affected 5% or more of the participants.

Actemra poses some dangerous risks, with severe infection being the most common serious side effect. Other potential concerns include allergic reactions and tears in your stomach or intestines.

Serious Infections

Actemra can result in serious or even fatal infections, including TB and other infections caused by viruses, bacteria or fungi. The U.S. Food & Drug Administration (FDA) issued a black box warning about the risk of infections when taking Actemra. This is the agency’s most serious warning.

People with compromised immune systems and those with HIV or diabetes are at increased risk of developing infections while taking Actemra.

The drug’s label advises patients to avoid live vaccines because there has not been enough research to determine if live vaccines could lead to infection while on the medication. Because of the way tocilizumab works, it may interfere with how your immune system processes new vaccinations. The label recommends getting up-to-date on all vaccines before starting treatment.

Make sure you don’t have any active infections before starting treatment with Actemra. Your doctor can test you to make sure you’re healthy enough to take the medication. During treatment, your doctor will monitor you for infections.

Severe Allergic Reactions

During clinical trials, some participants had to stop taking Actemra because they developed urticaria, which is a skin rash with red itchy bumps or hives.

Genentech added fatal anaphylaxis to the drug’s label in 2011 after two people died of severe, life-threatening allergic reactions. According to the label, an allergic reaction to tocilizumab can happen even when patients have not previously reacted to the drug.

Not all allergic reactions to tocilizumab are deadly. However, some patients in clinical trials had to stop taking the drug because of allergic reactions. These reactions included erythema (redness of the skin) and urticaria.

Gastrointestinal Perforation

Some patients who took Actemra in clinical trials reported gastrointestinal (GI) perforation, which is a hole in the wall of the stomach or intestines. Many of these patients suffered inflammation or infection of pouches in the colon, known as diverticulitis.

The drug’s label warns that individuals at an increased risk for GI perforation should be cautious when taking the medication and should report any new abdominal symptoms to their doctor.

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or aspirin may be more likely to suffer a GI perforation. Patients taking corticosteroid or methotrexate drugs may also have a higher risk.

FDA first approved Actemra in 2010 through August 11, 2025, a total of 0.39% of people reported having an intestinal perforation as a side effect from the drug.

Of the patients who reported GI perforation, almost 46% experienced this side effect within one to six months of beginning treatment. Another roughly 27% of affected patients suffered from the condition within six months to two years of starting the drug, while over 19% reported having the issue within two to five years of their first dose.

Women were more than four times more likely to have GI perforation as a side effect compared to men, according to the analysis. More than 64% of people affected by the condition were aged 60 and older. Diverticulitis was also present in more than 17% of those who had GI perforation.

Tell your doctor immediately if you have a fever, persistent stomach pain or changes in bowel habits. These could be signs of a gastrointestinal perforation.

Other serious side effects that might be linked to Actemra use include heart attack, stroke, pancreatitis and more.

Heart Attack and Stroke

Some studies found that people with RA who took Actemra had an increased risk of major cardiovascular events, including heart attack and stroke. Other studies did not have similar results.

Actemra doesn’t have a warning on its label for cardiovascular risks. The FDA has received some reports of heart attacks, but the agency doesn’t think an updated Actemra label is necessary.

Researchers shared clinical trial results at the American College of Rheumatology‘s 2016 Annual Meeting comparing serious side effects in people who took Actemra and Enbrel. Enbrel is a tumor necrosis factor (TNF) inhibitor in the same drug class as Humira. It treats RA and several other forms of arthritis.

Among people with severe, active RA and elevated, preexisting cardiovascular risk factors who took Actemra, scientists found a 5% increased risk of major cardiovascular events compared to Enbrel.

The study also found a 53% increased risk of non-fatal stroke and a 50% increase in hospitalizations for heart failure in those who took Actemra compared to Enbrel.

A separate study published the following year in Arthritis & Rheumatology didn’t find an increased cardiovascular risk in RA patients who switched from other biologic drugs to Actemra.

Lung Complications

There have been rare reports of interstitial lung disease (ILD) in people who took Actemra. ILD causes inflammation and scarring in your lungs, and there’s no warning on the drug’s label about this risk.

People with RA may develop ILD. The main symptom is shortness of breath, and some people may have a dry cough. Certain drugs may increase the risk for ILD or make it worse. This complication typically starts in the first 20 weeks of using the drug, and older adults have an increased risk.

If you experience shortness of breath while taking Actemra, talk to your doctor. Drug-induced ILD might be misdiagnosed as another condition.

Cancer Risk

Research in clinical trials found that people taking tocilizumab may be at an increased risk of certain cancers. Actemra’s label warns patients to tell their doctor if they have “ever had any type of cancer” before starting treatment.

Tocilizumab is an immunosuppressive drug. These types of drugs “make the immune system less able to detect and destroy cancer cells or fight off infections that cause cancer,” according to the National Cancer Institute.

However, a 2016 study published in Rheumatic & Musculoskeletal Diseases Open found no increased malignancy rates among patients taking tocilizumab. Researchers evaluated 4,009 patients being treated with the drug. They reported “malignancy types and rates were consistent with those expected” in rheumatoid arthritis patients.

Actemra’s label also warns that, while rare, multiple sclerosis has been diagnosed in people who take the drug. The medication’s potential effect on some nervous system disorders is unknown.

Pancreatitis

Pancreatitis affected 0.35% of the Actemra users who reported side effects to the FDA from 2010 through July 9, 2025.

Data showed that almost 60% of all pancreatitis cases developed in the first six months of starting Actemra. It also found that women reported 82.45% of pancreatitis side effects.

Studies haven’t found that Actemra can increase the risk of death on its own, but it may increase the risk of serious or fatal infections.

A 2017 report by STAT, a subsidiary of Boston Globe Media, found the FDA received 1,128 reports of deaths linked to Actemra. That said, the FDA was unable to determine whether those deaths were related to the drug.

Deaths associated with the medication occurred from stroke, heart attack, heart failure, pancreatitis, infection, bowel perforation, severe allergic reactions and other serious side effects.

The investigation suggested Actemra may not be more dangerous than other arthritis drugs on the market, but that it is being misrepresented as a safer alternative to drugs like Humira, Enbrel and Remicade. While these other medications have warnings on their labels for various fatal side effects, but Actemra’s drug label does not alert consumers or doctors to these risks.

Actemra’s manufacturer, Genentech, and the FDA have not recalled the drug. However, it does have a black box warning for the risk of serious infections. People on Actemra have been hospitalized for infections, with some cases resulting in death.

Most people who suffered serious infections while taking Actemra were also taking other drugs that suppress the immune system, like methotrexate or corticosteroids.

Your health care provider should monitor you for infections during treatment with Actemra. Before taking this drug, talk about the risks and benefits with your doctor.

People who are most at risk for Actemra complications and side effects include older people, those with preexisting medical conditions and people with weak immune systems.

Patients who are elderly or regularly take NSAIDs or other drugs that suppress the immune system are also at high risk. Make sure to discuss your medical history with your doctor before taking Actemra.

If you have increased risk factors, inform your doctor immediately about any adverse effects you experience while taking Actemra.

If you are taking Actemra and experience side effects, immediately inform your doctor. Mild side effects typically subside on their own and don’t require medical intervention, but serious side effects may require hospitalization or urgent treatment.

You and your doctor can report any side effects you experience to the FDA’s MedWatch program.

Actemra injuries have led to Actemra lawsuits, with plaintiffs claiming that Genentech failed to properly warn people about the risk of heart attacks, lung disease, stroke and more.

These lawsuits were based on reports suggesting that Actemra had a similar or higher risk of these health problems than other similar drugs on the market.

Drugwatch’s legal partners aren’t currently accepting Actemra lawsuits, but other firms may still be accepting cases.