Abatacept Side Effects
Medically reviewed by Drugs.com. Last updated on Apr 29, 2022.
Commonly reported side effects of abatacept include: headache and nasopharyngitis. Other side effects include: dyspepsia and hypertension. Continue reading for a comprehensive list of adverse effects.
Applies to abatacept: powder for solution, solution.
Serious side effects of Abatacept
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:
- back pain
- bladder pain
- bloody or cloudy urine
- body aches or pain
- chest pain or tightness
- cough producing mucus
- decreased urine output
- difficult, burning, or painful urination
- difficult or labored breathing
- ear congestion
- frequent urge to urinate
- loss of voice
- lower back or side pain
- muscle twitching
- nausea or vomiting
- noisy breathing
- pain or tenderness around the eyes and cheekbones
- rapid weight gain
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
- Blurred vision
- burning or stinging of the skin
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pounding in the ears
- skin rash
- slow or fast heartbeat
- 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
- stomach pain or tenderness
- swelling of the face, throat, or tongue
Incidence not known
- Redness, soreness, or itching of the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- sores, welts, blisters
Other side effects of Abatacept
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:
- 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.
Very common (10% or more): Hypertension (up to 49%)
Common (1% to 10%): Increased blood pressure
Frequency not reported: Hyperemia
Postmarketing reports: Vasculitis (including cutaneous vasculitis, leukocytoclastic vasculitis)[Ref]
Angioedema has occurred as early as after the first dose but also with subsequent doses. Angioedema reactions have occurred within hours of administration and in some cases had delayed onset (i.e., days).[Ref]
Common (1% to 10%): Rash (including dermatitis)
Postmarketing reports: New/worsening psoriasis, angioedema reactions, life-threatening cases of angioedema[Ref]
Very common (10% or more): Nausea
Rare (0.01% to 0.1%): Gastrointestinal infection
Common (1% to 10%): Urinary tract infection
Very common (10% or more): Anemia (up to 69%), CD4 lymphocytes decreased (up to 14%)
Common (1% to 10%): Abnormal liver function test (including increased transaminases), increased ALT, increased AST
Frequency not reported: Abnormal hepatic function, increased transaminases, increased GGT[Ref]
Uncommon (0.1% to 1%): Hypersensitivity reaction
Postmarketing reports: Fatal anaphylaxis after first infusion[Ref]
Frequency not reported: Neutralizing antibodies positive[Ref]
Common (1% to 10%): Local injection site reactions (subcutaneous formulation), injection site reactions (including hematoma, pruritus, erythema)
Frequency not reported: Infusion site extravasation, infusion site pain, infusion site swelling, infusion site erythema[Ref]
Very common (10% or more): Hypermagnesemia (up to 18%)
Common (1% to 10%): Back pain, pain in extremity
Uncommon (0.1% to 1%): Musculoskeletal infections, arthralgia
Frequency not reported: Myalgia, joint wear, soft tissue infection, joint swelling, ligament disorder, musculoskeletal stiffness, systemic lupus erythematosus, rheumatoid nodule, Sjogren's syndrome[Ref]
Very common (10% or more): Headache (up to 18%)
Common (1% to 10%): Dizziness, herpes zoster
Uncommon (0.1% to 1%): Conjunctivitis, dry eye, reduced visual acuity
Frequency not reported: Eye irritation, presbyopia[Ref]
PTLD occurred in patients using this drug for acute graft versus host disease (aGVHD) prophylaxis during unrelated hematopoietic stem cell transplantation (HSCT). Of 116 patients who received this drug, 4 patients (3.4%) had PTLD; all of these events were associated with Epstein-Barr virus (EBV) infection. At baseline, 3 of the 4 patients were EBV serology positive; 1 patient had negative baseline EBV serology with donor EBV serology unknown. Acyclovir prophylaxis was stopped in 3 of the 4 patients at 30 days posttransplant; time to onset of events ranged from 49 to 89 days posttransplant.[Ref]
Common (1% to 10%): Posttransplant lymphoproliferative disorder (PTLD), malignancies
Uncommon (0.1% to 1%): Basal cell carcinoma, skin papilloma, lung cancer
Rare (0.01% to 0.1%): Lymphoma, malignant lung neoplasm, squamous cell carcinoma
Frequency not reported: Skin cancer, breast cancer, bile duct cancer, bladder cancer, cervical cancer, endometrial cancer, melanoma, myelodysplastic syndrome, ovarian cancer, prostate cancer, renal cancer, thyroid cancer, uterine cancer, acute lymphocytic leukemia, lung neoplasm
Postmarketing reports: Nonmelanoma skin cancers (basal cell carcinoma, squamous cell carcinoma)[Ref]
In clinical trials, infections at least possibly related to therapy were reported in 22.7% of patients treated with this drug compared to 20.5% of patients treated with placebo. Serious infections at least possibly related to therapy were reported in 1.5% of patients treated with this drug and 1.1% of placebo-treated patients; the type of serious infections was similar between both treatment groups.
In clinical trials in rheumatoid arthritis patients, infections were reported in 54% of patients treated with this drug IV compared to 48% treated with placebo. The infections reported most often (up to 13%) were upper respiratory tract infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, and bronchitis; other infections reported in less than 5% of patients were rhinitis, herpes simplex, and pneumonia.
In clinical trials in patients with adult rheumatoid arthritis, patients coadministered this drug IV and tumor necrosis factor (TNF) antagonist therapy had more infections and serious infections (63% and 4.4%, respectively) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively).
Serious infections (including sepsis, pneumonia) have been reported in patients receiving this drug; serious infections were reported in 3% of rheumatoid arthritis patients treated with the IV formulation. Some of these infections were fatal. Many of the serious infections occurred in patients on concomitant immunosuppressive therapy which, along with underlying disease, may have further predisposed them to infection. A higher rate of serious infections has been observed in adult rheumatoid arthritis patients treated with concomitant TNF antagonists and this drug compared to those treated with this drug alone.
CMV invasive disease occurred in patients using this drug for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received this drug, 7% had CMV invasive diseases up to day 225 posttransplant; all patients with CMV invasive disease were CMV serology positive at baseline. The median time to event onset was 91 days posttransplant; CMV invasive diseases primarily involved the gastrointestinal tract.
Acute infusion-related events (side effects occurring within 1 hour of the start of the infusion) were more common in patients treated with this drug than those treated with placebo; the most frequently reported events (up to 2%) were dizziness, headache, and hypertension.
Acute infusion-related events that were uncommon included cardiopulmonary symptoms (e.g., hypotension, decreased blood pressure, tachycardia, bronchospasm, dyspnea); other symptoms included myalgia, nausea, erythema, flushing, urticaria, cough, hypersensitivity, pruritus, throat tightness, chest discomfort, chills, infusion site extravasation, infusion site pain, infusion site swelling, infusion-related reaction, rash, and wheezing. Most of these reactions were mild (68%) to moderate (28%) in severity.
Very common (10% or more): Infections (up to 63%), CMV reactivation/CMV infection (up to 32%), pyrexia (up to 28%)
Common (1% to 10%): Serious infections (including sepsis, pneumonia), CMV invasive disease, herpes infections (including herpes simplex, oral herpes, herpes zoster), fatigue, asthenia, systemic injection reactions (e.g., pruritus, throat tightness, dyspnea), acute infusion-related events, increased weight
Uncommon (0.1% to 1%): Localized infection, sepsis, ear infection, influenza-like illness
Frequency not reported: Chest discomfort, chills, infusion-related reaction, varicella infection, disease flare, EBV reactivation, malaise, chest pain, axillary pain, feeling hot, sudden death, bacterial infection, increased blood alkaline phosphatase, breast mass, breast pain, otitis externa
Postmarketing reports: Systemic infusion reactions after IV formulation, systemic injection reactions (e.g., pruritus, throat tightness, dyspnea) after subcutaneous formulation
Frequency not reported: Insomnia, nervousness[Ref]
Very common (10% or more): Acute kidney injury (up to 15%)[Ref]
Very common (10% or more): Respiratory disorders (including chronic obstructive pulmonary disease [COPD] exacerbation, cough, rhonchi, dyspnea; up to 43%), pneumonia (up to 19%), epistaxis (up to 16%), nasopharyngitis (up to 12%), upper respiratory tract infection (including tracheitis, nasopharyngitis, sinusitis)
Common (1% to 10%): Lower respiratory tract infection (including bronchitis), cough, sinusitis, bronchitis, influenza, pharyngitis
Uncommon (0.1% to 1%): Rhinitis, COPD exacerbated, bronchospasm, wheezing, dyspnea, throat tightness
Frequency not reported: Rhonchi, respiratory tract infection, tonsillitis, viral upper respiratory tract infection, bronchopneumonia, laryngitis, pseudomonal lung infection, nasal congestion, pharyngolaryngeal pain, rhinorrhea, sinus congestion, exertional dyspnea, nasal discomfort, nasal dryness[Ref]
Frequently asked questions
More about abatacept
- Check interactions
- Reviews (62)
- Dosage information
- During pregnancy
- Drug class: antirheumatics
- En español
- Drug Information
- Abatacept Intravenous (Advanced Reading)
- Abatacept Infusion
- Abatacept Prefilled Syringes
Related treatment guides
1. "Product Information. Orencia (abatacept)." Bristol-Myers Squibb (2005):
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. 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
5. Nogid A, Pham DQ "Role of abatacept in the management of rheumatoid arthritis." Clin Ther 28 (2006): 1764-78
6. 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
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.