What side effects are possible with this medication?
A side effect is an unwanted response to a medication when it is taken in normal doses. It can be mild or severe, temporary or permanent, but does not occur in everyone.
The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.
- abdominal pain
- back pain
- blood in the urine
- changes in cholesterol levels
- flu-like symptoms
- high blood pressure
- pain, itching, redness, or swelling at the site of the injection
- skin rash
- upper respiratory infections (such as colds or sinus infections)
- urinary tract infections
to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, difficulty breathing, or swelling of the face, eyes, lips, or mouth. If these occur, contact your doctor or get medical help right away. The needle cover on the prefilled syringe contains dry natural rubber. Before you start injections, tell your doctor if you have an allergy to rubber or latex.
Blood disorders: This medication can cause the levels of certain blood cells to drop, though rarely. This may lead to problems with blood clotting, the immune system, or the transport of oxygen through the body. Contact your doctor immediately if you develop a fever, easy bruising, paleness, or bleeding while taking this medication.
Cancer: Compared to the general population, people taking adalimumab have a slightly greater risk of developing a cancer. However, the risk is still small. In general, people with severe rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing cancer, even if they don't take adalimumab. If you experience any of the following or other unusual symptoms, contact your doctor immediately:
- decreased appetite
- night sweats
- one or more enlarged lymph node
- unusual fatigue
- weight loss
Signs and symptoms of cancer can vary depending on the extent of the disease and the parts of the body involved (e.g., chest, abdomen, or bowel).
Heart failure: In rare cases, some people develop congestive heart failure (CHF), or their CHF gets worse on the medication. If you have CHF, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you notice symptoms of CHF such as swelling of ankles or feet, sudden weight gain, or shortness of breath, contact your doctor immediately.
Hepatitis B:If you are a carrier of Hepatitis B virus, the virus can become active while you use adalimumab. Tell your doctor if you have any of the following symptoms of a possible Hepatitis B infection:.
- muscle aches
- feel very tired
- dark urine
- skin or eyes look yellow
- little or no appetite
- clay-colored bowel movements
- stomach discomfort
- skin rash
Infections: This medication, like other TNF blockers, can increase the risk of developing serious infections such as tuberculosis (TB) and those caused by bacteria (e.g., sepsis) and fungi. This medication should not be started if you have an active infection. You should be closely monitored for signs and symptoms of infection during and after using this medication. If you develop a serious infection or sepsis, the medication should be discontinued. If you notice signs of an infection such as fever, chills, pain, swelling, or pus, contact your doctor as soon as possible. People greater than 65 years of age, people with medical conditions, and people taking immunosuppressants (such as corticosteroids or methotrexate) may be at greater risk for infection.Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections, including fungal infections. This medication should not be used in combination with anakinra and abatacept, as this can increase the risk of severe infections.
Liver problems: Adalimumab has in rare cases been associated with severe liver damage. Tell your doctor if you develop sudden tiredness, yellowing of the skin or eyes, poor apetite, or vomiting, or pain in the right side of your stomach (abdomen).
Lupus-like symptoms: In rare cases, some people develop lupus-like symptoms that get better after their treatment is stopped. Contact your doctor immediately if you experience chest pains that don't go away, shortness of breath, joint pain, and rash on your cheeks or arms that gets worse in the sun.
Nervous system diseases: Rare cases of disorders that affect the nervous system have been reported in people taking this medication or other TNF blockers. If you are experiencing numbness and tingling, vision problems, weakness in your legs, and dizziness, contact your doctor immediately.
Tuberculosis: Rarely, reactivation of tuberculosis (TB) infections has occurred in people taking adalimumab and similar medications. Before you start treatment with adalimumab, your doctor may recommend a TB test. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with adalimumab. Contact your doctor if you notice symptoms of TB, such as a cough that does not go away, unintended weight loss, loss of body fat and muscle (wasting) or fever.
Vaccines: Live vaccines are not recommended for people taking this medication. Talk to your doctor if you need any vaccinations while taking this medication.
Pregnancy: This medication is not recommended for use during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding:This medication passes into breast milk. If you are a breast-feeding mother and are taking adalimumab, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of this medication has not been established for children less than 4 years of age.
Seniors: Seniors may have a higher risk of side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between adalimumab and any of the following:
- live vaccines
- other TNF blocking medications (e.g., infliximab)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.