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Orencia Side Effects

Generic Name: abatacept

Note: This page contains side effects data for the generic drug abatacept. It is possible that some of the dosage forms included below may not apply to the brand name Orencia.

It is possible that some side effects of Orencia may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to abatacept: powder for solution, solution

As well as its needed effects, abatacept (the active ingredient contained in Orencia) may cause unwanted side effects that 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 abatacept side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

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


Very common (10% or more): Upper respiratory tract infection (including tracheitis, nasopharyngitis)
Common (1% to 10%): Lower respiratory tract infection (including bronchitis), rhinitis, pneumonia, cough, sinusitis
Uncommon (0.1% to 1%): Bronchospasm, wheezing, dyspnea
Rare (less than 0.1%): Throat tightness, bacterial pneumonia, influenza pneumonia
Frequency not reported: Tracheitis[Ref]


Uncommon (0.1% to 1%): Hypersensitivity[Ref]


Frequency not reported: Cancer of lung, skin, breast, bile duct, bladder, cervical, endometrial, lymphoma, melanoma, myelodysplastic syndrome, ovarian, prostate, renal, thyroid, uterus[Ref]


Common (1% to 10%): Herpes infections (including herpes simplex, oral herpes, and herpes zoster), influenza
Uncommon (0.1% to 1%): Streptococcal sepsis
Rare (less than 0.1%): Tuberculosis, bacteremia[Ref]


Common (1% to 10%): Abdominal pain, diarrhea, nausea, dyspepsia, mouth ulceration, aphthous stomatitis, vomiting
Uncommon (0.1% to 1%): Tooth infection, gastritis, weight increased
Rare (less than 0.1%): Gastrointestinal infection, diverticulitis, peridiverticular abscess[Ref]


Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Pelvic inflammatory disease, amenorrhea, menorrhagia[Ref]


Common (1% to 10%): Rash (including dermatitis), alopecia, pruritus
Uncommon (0.1% to 1%): Onychomycosis, skin abscess
Frequency not reported: Dry skin, cellulitis, increased tendency to bruise, infected skin ulcers[Ref]

Nervous system

Very common (10% or more): Headache (12%)
Common (1% to 10%): Dizziness, paresthesia
Uncommon (0.1% to 1%): Migraine
Frequency not reported: Vertigo[Ref]


Common (1% to 10%): Local injection site reactions[Ref]


Common (1% to 10%): Hypertension, flushing
Uncommon (0.1% to 1%): Palpitations, tachycardia, bradycardia, hypotension, hot flush, vasculitis, hypotension[Ref]


Common (1% to 10%): Liver function test abnormal (including transaminases increased)
Frequency not reported: abnormal liver function tests and increased transaminases[Ref]


Common (1% to 10%): Leukopenia
Uncommon (0.1% to 1%): Thrombocytopenia[Ref]


Frequency not reported: Weight gain[Ref]


Common (1% to 10%): Pain in extremity
Uncommon (0.1% to 1%): Musculoskeletal infections, arthralgia[Ref]


Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Dry eye, visual acuity reduced[Ref]


Uncommon (0.1% to 1%): Depression, anxiety, sleep disorder (including insomnia)[Ref]


Uncommon (0.1% to 1%): Pyelonephritis[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.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. Cerner Multum, Inc. "Australian Product Information." O 0

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