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Abatacept Side Effects

In Summary

Commonly reported side effects of abatacept 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 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
  • Diarrhea
  • pain in the arms or legs

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

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

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

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

Some side effects of abatacept may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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