Abatacept Side Effects

Brand Names: Orencia

Please note - some side effects for Abatacept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Abatacept - for the Consumer

Abatacept

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Abatacept:

Diarrhea; dizziness; headache; mild pain, swelling, bruising, or redness at the injection site; mild sore throat; nausea; stomach pain or upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills, fever, or persistent sore throat; fainting; flu-like symptoms; increased cough; increased, decreased, or painful urination; light-headedness; night sweats; severe or persistent headache or dizziness; shortness of breath; unexplained weight loss; unusual lumps or growths; unusual tiredness; warm, red, or painful skin; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Respiratory

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.

Hypersensitivity

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.

Oncologic

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.

General

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.

Immunologic

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.

Gastrointestinal

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.

Genitourinary

Genitourinary side effects have included urinary tract infection.

Dermatologic

Dermatologic side effects have included rash.

Nervous system

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

Local

Local side effects including infusion reactions have been reported.

Other

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

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