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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.

In Summary

Common side effects of Orencia include: headache and nasopharyngitis. Other side effects include: dyspepsia and hypertension. See below for a comprehensive list of adverse effects.

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
  • chills
  • cough
  • cough producing mucus
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • dizziness
  • ear congestion
  • fever
  • 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
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest
  • troubled breathing
  • 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

Rare

  • 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
  • stomach pain or tenderness
  • sweating
  • swelling of the face, throat, or tongue

Incidence Not Known

  • Redness, soreness, or itching of the skin
  • sores, welts, blisters

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

  • 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

For Healthcare Professionals

Applies to abatacept: intravenous powder for injection, subcutaneous solution

Respiratory

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]

Hypersensitivity

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

Oncologic

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

Immunologic

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]

Gastrointestinal

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]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Pelvic inflammatory disease, amenorrhea, menorrhagia[Ref]

Dermatologic

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]

Local

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

Cardiovascular

Common (1% to 10%): Hypertension, flushing

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

Hepatic

Common (1% to 10%): Liver function test abnormal (including transaminases increased)

Frequency not reported: abnormal liver function tests and increased transaminases[Ref]

Hematologic

Common (1% to 10%): Leukopenia

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

Metabolic

Frequency not reported: Weight gain[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity

Uncommon (0.1% to 1%): Musculoskeletal infections, arthralgia[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

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

Psychiatric

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

Renal

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

References

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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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