Amjevita side effects: What you should know

Amjevita (adalimumab-atto) is a brand-name subcutaneous injection that’s prescribed for certain inflammatory conditions in adults and some children. As with other drugs, Amjevita can cause side effects, such as infections and headache.
Amjevita has boxed warnings about the risks of serious infections and certain cancers. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section below.
boxed warnings
Side effect specifics
More common side effects of Amjevita
Amjevita can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
In clinical trials, most people took Amjevita at a dosage of 40 milligrams (mg) every other week. Here are just a few of the more common side effects reported by people who took Amjevita in clinical trials:
clinical trials
clinical trials
injection site reactions*
upper respiratory infections, such as colds, flu, and sinusitis
upper respiratory infections
colds
flu
sinusitis
rash
headache
* For more information about this side effect, see “Side effect specifics.”
Mild side effects of Amjevita
Mild side effects can occur with Amjevita use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Amjevita’s prescribing information.
prescribing information
Mild side effects that have been reported with Amjevita include:
nausea
abdominal pain
back pain
headache
upper respiratory infections, such as colds, flu, and sinusitis
urinary tract infections
urinary tract infections
rash
injection site reactions*
These side effects may be temporary, lasting a few days to weeks. However, 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 and reviews side effects of the medication. If you develop a side effect while using Amjevita and want to tell the FDA about it, visit MedWatch.
MedWatch
* For more information about this side effect, see “Side effect specifics.”
Serious side effects of Amjevita
Amjevita may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Amjevita’s prescribing information.
prescribing information
If you develop serious side effects while receiving Amjevita, 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:
liver problems, which may include symptoms such as: nausea and vomitingpain on the right-hand side of your abdomenloss of appetitejaundice (yellowing of your skin or whites of your eyes)
nausea and vomiting
pain on the right-hand side of your abdomen
loss of appetite
jaundice (yellowing of your skin or whites of your eyes)
jaundice
blood cell problems, which may include symptoms such as: bruising or bleeding easilyfeverfatigue (low energy)skin, gums, or nailbeds that look paler than usual
bruising or bleeding easily
fever
fatigue (low energy)
skin, gums, or nailbeds that look paler than usual
new or worsening heart failure, which may include symptoms such as: shortness of breathswelling of your lower legs or feetsudden weight gain
heart failure
shortness of breath
swelling of your lower legs or feet
sudden weight gain
new or worsening nerve problems, such as multiple sclerosis, which may include symptoms such as: vision problemsnumbness or tinglingweakness in your arms or legsdizziness
multiple sclerosis
vision problems
numbness or tingling
weakness in your arms or legs
dizziness
lupus-like syndrome (an immune system problem), which may include symptoms such as: chest pain or discomfortshortness of breathjoint painrash on your cheeks or arms that gets worse in the sun
lupus-like syndrome
chest pain or discomfort
shortness of breath
joint pain
rash on your cheeks or arms that gets worse in the sun
new or worsening psoriasis, which may include symptoms such as: red, dark brown, or purple scaly patches of skinraised bumps filled with pus
psoriasis
red, dark brown, or purple scaly patches of skin
raised bumps filled with pus
risk of serious infections*
risk of certain cancers*
* For more information about this side effect, see “Side effect specifics.”
For some people, Amjevita injection can cause an allergic reaction.
allergic reaction
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep using the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Amjevita injection, your doctor may recommend using a different medication instead.
FAQ about the side effects of Amjevita
Amjevita may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Amjevita has not been reported to cause weight loss. However, some of Amjevita’s side effects, such as infections and cancer, can cause weight loss as a symptom.
reported
If you have unintended weight loss while receiving Amjevita, talk with your doctor. They can help determine the possible cause.
It’s not likely. Hair loss wasn’t a side effect seen during clinical trials of Amjevita. There have been reports of this side effect in people using Amjevita, but it’s unclear how often this has happened or if Amjevita was the cause.
clinical trials
If you have hair loss while using Amjevita, talk with your doctor. They can help determine the possible cause.
Side effect specifics
Learn more about some of the side effects that Amjevita may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Amjevita.
prescribing information
Amjevita has a boxed warning about the risk of serious infections. A boxed warning is the most serious warning from the FDA.
boxed warning
Amjevita weakens your immune system and makes it harder for your body to fight infections. Because of this, Amjevita can raise your risk of serious infections. These infections may need treatment in the hospital and, on rare occasions, can be fatal. Examples include pneumonia, tuberculosis (TB), infections that spread throughout the body, and sepsis.
pneumonia
tuberculosis (TB)
sepsis
In clinical trials, serious infections weren’t common in people using Amjevita.
clinical trials
Symptoms of serious infections depend on the type of infection but can include:
fever
cough that doesn’t get better
muscle aches
sore, hot, swollen, red, or discolored areas of skin
pain when urinating
unintended weight loss
You may have a higher risk of serious infections if you use Amjevita with other medications that weaken your immune system. Examples include methotrexate (Trexall, Otrexup) and corticosteroids such as prednisone (Rayos). You may also have a higher risk if you have a condition that raises your risk of infections, such as diabetes.
Trexall
corticosteroids
prednisone
diabetes
Before you start using Amjevita, tell your doctor if you have any active infections or infections that keep coming back. Also, talk with your doctor about infections you’ve had in the past. In particular, tell your doctor if you have ever had TB or hepatitis B. Your doctor may test you for these infections before prescribing Amjevita. Your doctor may prescribe medication to treat any infections you have before starting Amjevita treatment.
hepatitis B
If you develop symptoms of an infection during Amjevita treatment, talk with your doctor right away. If you have an infection, your doctor may prescribe medication to treat it. If you develop a serious infection, your doctor will likely have you stop using Amjevita.
If you have questions or concerns about the risk of infections with Amjevita, talk with your doctor or pharmacist.
Amjevita has a boxed warning about the risk of certain cancers. A boxed warning is the most serious warning from the FDA.
boxed warning
Because Amjevita weakens your immune system, it can raise your risk of developing certain cancers. Examples include skin cancer, lymphoma, and leukemia.
skin cancer
lymphoma
leukemia
In clinical trials, cancers were rare in people using Amjevita.
clinical trials
Rare cancers, including lymphoma, have been reported in children and teenagers taking drugs similar to Amjevita. These drugs are called tumor necrosis factor (TNF) blockers. In some cases, these cancers were fatal.
tumor necrosis factor (TNF)
Also, a rare, aggressive type of lymphoma has been reported in teenage and young adult males* receiving TNF blockers for inflammatory bowel disease. Most cases occurred in those receiving a TNF blocker with azathioprine (Azasan, Imuran) or mercaptopurine (Purinethol, Purixan). Many of these cancers were fatal.
inflammatory bowel disease
Symptoms of cancer depend on the type of cancer but can include:
skin sore that doesn’t heal
new skin bump or lump
fatigue with no obvious cause
unexplained weight loss
fever
night sweats
Certain factors may raise your risk of developing cancer while using Amjevita. For example, you may have a higher risk if you’ve ever smoked or have had cancer in the past. You may also have a higher risk if you’ve had past treatment with phototherapy or with other medications that weaken your immune system.
* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.
Sex and gender
Before starting Amjevita treatment, talk with your doctor about any risk factors you may have for cancer. This can help your doctor determine whether Amjevita is safe for you.
Your doctor will monitor you closely for signs of cancer during your Amjevita treatment. See your doctor right away if you develop any changes in your skin or any other possible symptoms of cancer.
If you have questions or concerns about the risk of cancer with Amjevita, talk with your doctor or pharmacist.
You may have injection site reactions while using Amjevita. These are mild side effects that occur in the area where you inject the medication. In clinical trials, injection site reactions were the most common side effect of Amjevita.
clinical trials
Symptoms of injection site reactions can include:
pain
swelling
redness or discoloration
itching
rash
bruising or bleeding
You should not inject Amjevita yourself unless you have received training on the correct way to inject the medication.
To help avoid injection site reactions, you should inject Amjevita in a slightly different place each time you take a dose. Always choose a healthy area of skin. Do not inject into skin that’s hard, swollen, tender, red, discolored, or bruised. Also, avoid places with scars or stretch marks.
If you have an injection site reaction after injecting Amjevita, this will usually go away in a few days. To ease discomfort, it may help to apply a cool pack to the area.
If you have an injection site reaction that doesn’t get better in a few days, talk with your doctor.
Precautions for Amjevita
Below is important information you should consider before using Amjevita.
Amjevita has boxed warnings about the risk of serious infections and certain cancers. A boxed warning is the most serious warning from the FDA. For details, see the “Side effect specifics” section above.
boxed warnings
Side effect specifics
Before using Amjevita, discuss your health history with your doctor. Amjevita may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
infections, including infections that keep coming back
blood conditions, such as cytopenia
history or risk of TB
liver problems, including a history of hepatitis B
diabetes
heart failure
nerve conditions, such as multiple sclerosis
history of cancer
previous allergic reaction to this or a similar drug
allergic reaction
pregnancy
breastfeeding
alcohol consumption
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.