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Abatacept Side Effects

Not all side effects for abatacept may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abatacept: powder for solution, solution

In addition to its needed effects, some unwanted effects may be caused by abatacept. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking abatacept, check with your doctor or nurse immediately:

More common
  • Back pain
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • cough producing mucus
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • ear congestion
  • fever
  • flu
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nausea or vomiting
  • noisy breathing
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • unusual tiredness or weakness
Less common
  • Blurred vision
  • burning or stinging of the skin
  • chest pain
  • nervousness
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pounding in the ears
  • skin rash
  • slow or fast heartbeat
  • Abdominal or stomach pain or tenderness
  • confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • flushing
  • hives or welts
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • sweating
  • swelling of the face, throat, or tongue

Some of the side effects that can occur with abatacept may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • heartburn
  • indigestion
  • stomach discomfort or upset
Less common
  • Diarrhea
  • pain in the arms or legs

For Healthcare Professionals

Applies to abatacept: intravenous powder for injection, subcutaneous solution


Respiratory side effects have included upper respiratory tract infection (5.8% to 12.7%), nasopharyngitis (7.8% to 11.5%), sinusitis (6.2%), bronchitis (5.8%), and pneumonia. Patients with COPD treated with abatacept developed adverse effects more frequently than those treated with placebo (97% vs. 88%, respectively). These have included COPD exacerbations, cough, rhonchi, dyspnea, and pneumonia. Bacterial pneumonia and influenzal pneumonia have been reported in 0.4% of patients.[Ref]


Hypersensitivity side effects have included anaphylaxis or anaphylactoid reactions. Other adverse events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea generally occurred within 24 hours of abatacept infusion.[Ref]


Oncologic side effects have included lymphomas and lung cancer. Other malignancies included skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, and uterine cancers.[Ref]


General side effects have included acute infusion-related adverse reactions occurring within one hour of the start of the infusion. The acute infusion-related events have included cardiopulmonary symptoms, such as hypotension, increased blood pressure, and dyspnea. The most frequently reported events were dizziness, headache, and hypertension. Other symptoms reported as mild to moderate included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing. Back pain and pain in extremity have also been reported.[Ref]


Immunologic side effects have included the development of binding antibodies to the entire abatacept molecule or to the CTLA-4 portion of abatacept. No correlation of antibody development to clinical response or adverse effects has been observed. Streptococcal sepsis (0.4%) has been reported.[Ref]


Gastrointestinal side effects including nausea (6.6% to 11.5%), diarrhea (5.8% to 6.91%), diverticulitis (0.4%), peridiverticular abscess (0.4%), and dyspepsia have been reported.[Ref]


Genitourinary side effects have included urinary tract infection.[Ref]


Dermatologic side effects have included rash.[Ref]

Nervous system

Nervous system side effects including headache (11.79%) have been reported.[Ref]


Local side effects including infusion reactions have been reported.[Ref]


Other side effects have included limb abscess (0.4%).[Ref]


1. Gartlehner G, Hansen RA, Jonas BL, Thieda P, Lohr KN "The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis." J Rheumatol 33 (2006): 2398-408

2. Genovese MC, Becker JC, Schiff M, et al. "Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition." N Engl J Med 353 (2005): 1114-23

3. Nogid A, Pham DQ "Role of abatacept in the management of rheumatoid arthritis." Clin Ther 28 (2006): 1764-78

4. "Product Information. Orencia (abatacept)." Bristol-Myers Squibb, Princeton, NJ.

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