Orencia Side Effects
Generic name: abatacept
Note: This document contains side effect information about abatacept. Some of the dosage forms listed on this page may not apply to the brand name Orencia.
Some side effects of Orencia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to abatacept: powder for solution, solution
Along with its needed effects, abatacept (the active ingredient contained in Orencia) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking abatacept:More common
- Back pain
- bladder pain
- bloody or cloudy urine
- body aches or pain
- cough producing mucus
- difficult or labored breathing
- difficult, burning, or painful urination
- ear congestion
- frequent urge to urinate
- 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
- sore throat
- stuffy or runny nose
- tightness of the chest or wheezing
- unusual tiredness or weakness
- Blurred vision
- burning or stinging of the skin
- chest pain
- 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
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hives or welts
- itching, pain, redness, swelling, tenderness, or warmth on the skin
- swelling of the face, throat, or tongue
Some side effects of abatacept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- 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
- stomach discomfort or upset
- 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 (the active ingredient contained in Orencia) 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 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 (the active ingredient contained in Orencia) infusion.
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 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 side effects have included the development of binding antibodies to the entire abatacept (the active ingredient contained in Orencia) 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 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 side effects have included urinary tract infection.
Dermatologic side effects have included rash.
Nervous system side effects including headache (11.79%) have been reported.
Local side effects including infusion reactions have been reported.
Other side effects have included limb abscess (0.4%).
More Orencia resources
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