Belatacept Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 25, 2025.

Applies to belatacept: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Increased risk for developing posttransplant lymphoproliferative disorder (PTLD), predominantly involving the CNS.

Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV-seropositive patients only.

Do not use belatacept in transplant recipients who are EBV seronegative or with unknown EBV serostatus.

Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe belatacept.

Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression.

Use in liver transplant patients is not recommended due to an increased risk of graft loss and death.

Serious side effects of belatacept

Along with its needed effects, belatacept 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 belatacept:

More common side effects

• abdominal or stomach pain
• agitation
• black, tarry stools
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• bone pain
• burning while urinating
• chest pain
• chills
• coma
• confusion
• convulsions
• cough or hoarseness
• decreased frequency or amount of urine
• decreased urine output
• depression
• difficult or labored breathing
• difficult, burning, or painful urination
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• frequent urge to urinate
• headache
• hostility
• inability to move the arms and legs
• increased blood pressure
• increased thirst
• irritability
• itching in other skin areas
• lethargy
• loss of appetite
• loss of bladder control
• lower back or side pain
• mood or mental changes
• muscle pain or cramps
• muscle spasms (tetany) or twitching
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pale skin
• pounding in the ears
• rapid weight gain
• scaling
• shortness of breath
• slow or fast heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• sudden decrease in the amount of urine
• sudden numbness and weakness in the arms and legs
• sweating
• swelling of the face, ankles, or hands
• swollen glands
• tightness in the chest
• trembling
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs
• weight gain
• wheezing

Less common side effects

• back pain
• coughing or spitting up blood
• drowsiness
• joint pain, stiffness, or swelling
• loss of appetite
• night sweats
• persistent non-healing sore
• pink growth reddish patch or irritated area
• shiny bump
• sudden high fever or low-grade fever for months
• swelling of the feet or lower legs
• weight gain
• white, yellow, or waxy scar-like area

Other side effects of belatacept

Some side effects of belatacept 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 side effects

• abdominal or stomach cramps
• blemishes on the skin
• body aches or pain
• collection of blood under the skin
• cough producing mucus
• deep, dark purple bruise
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• dry mouth
• ear congestion
• flushed, dry skin
• fruit-like breath odor
• hair loss or thinning of the hair
• increased hunger
• increased sweating
• increased urination
• itching, pain, redness, or swelling
• loss of consciousness
• loss of voice
• muscle cramps in the hands, arms, feet, legs, or face
• muscle or bone pain
• muscle pain or stiffness
• numbness and tingling around the mouth, fingertips, or feet
• pain in the joints
• pimples
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sleeplessness
• sneezing
• swelling or inflammation of the mouth
• tightness in the chest
• tremor
• trouble sleeping
• unable to sleep
• unexplained weight loss

For healthcare professionals

Applies to belatacept: intravenous powder for injection.

Immunologic adverse events

• Very common (10% or more): Infections (82%), serious infections (36%), herpes infection (14%), cytomegalovirus (12%)
• Common (1% to 10%): Blood immunoglobulin G decreased, blood immunoglobulin M decreased, sepsis, influenza, herpes zoster, herpes simplex, BK virus infection, candidiasis, cellulitis, wound infection, localized infection, fungal infection
• Uncommon (0.1% to 1%): Hypogammaglobinemia, progressive multifocal leukoencephalopathy, cerebral fungal infection, cytomegalovirus (CMV) colitis, polyomavirus-associated nephropathy, genital herpes, staphylococcal infection, endocarditis, tuberculosis (TB), bronchiectasis, strongyloidiasis, blastocystis infection, giardiasis, lymphangitis, Guillain-Barre syndrome, polyoma virus^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (32%), hypotension (18%)
• Common (1% to 10%): Tachycardia, bradycardia, atrial fibrillation, cardiac failure, angina pectoris, left ventricular hypertrophy, shock, infarction, hematoma, lymphocele, angiopathy, arterial fibrosis
• Uncommon (0.1% to 1%): Acute coronary syndrome, atrioventricular block second degree, aortic valve disease, arrhythmia supraventricular, venous thrombosis, arterial thrombosis, thrombophlebitis, arterial stenosis, intermittent claudication, flushing^[Ref]

Dermatologic

• Common (1% to 10%): Onychomycosis, acne, pruritus, alopecia, skin lesion, rash, night sweats, hyperhidrosis
• Uncommon (0.1% to 1%): Psoriasis, hair growth abnormal, onychoclasis, penile ulceration, swelling face, trichorrhexis, alopecia^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (39%), constipation (33%), nausea (24%), vomiting (22%), abdominal pain (19%)
• Common (1% to 10%): Gastroenteritis, oral candidiasis, dyspepsia, aphthous stomatitis, abdominal hernia, stomatitis
• Uncommon (0.1% to 1%): Cholelithiasis, ulcer, GI disorder, pancreatitis, large intestinal ulcer, melena, gastroduodenal ulcer, rectal hemorrhage, small intestinal obstruction, cheilitis, gingival hyperplasia, salivary gland pain, feces discolored^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (37%), hematuria (16%), proteinuria (16%), dysuria (11%)
• Common (1% to 10%): Hydrocele, glycosuria
• Uncommon (0.1% to 1%): Epididymitis, priapism, cervical dysplasia, breast mass, testicular pain, vulval ulceration, atrophic vulvovaginitis, infertility, scrotal edema, urinary incontinence, urinary retention, nocturia, epididymitis, hemorrhagic cystitis, genital herpes^[Ref]

Hematologic

• Very common (10% or more): Anemia (45%), leukopenia (20%)
• Common (1% to 10%): Thrombocytopenia, neutropenia, leukocytosis, polycythemia, lymphopenia, hematoma
• Uncommon (0.1% to 1%): Monocytopenia, pure red cell aplasia, agranulocytosis, hemolysis, hypercoagulation^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (21%), hyperkalemia (20%), hypophosphatemia (19%), dyslipidemia (19%), hyperglycemia (16%), hypercholesterolemia (11%)
• Common (1% to 10%): Weight increase, diabetes mellitus, dehydration, weight decrease, acidosis, fluid retention, hypoproteinemia, hypomagnesemia, hyperuricemia
• Uncommon (0.1% to 1%): Diabetic ketoacidosis, diabetic foot, alkalosis, decreased appetite, vitamin D deficiency^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (17%), back pain (13%)
• Common (1% to 10%): Chest pain, musculoskeletal pain
• Uncommon (0.1% to 1%): Osteomyelitis
• Frequency not reported: Extremity pain, myalgia, muscular weakness, bone pain, joint swelling, intervertebral disc disorder, joint lock, muscle spasms, bone metabolism disorder, osteitis, osteolysis, synovitis, osteoarthritis^[Ref]

Nervous system

• Very common (10% or more): Headache
• Common (1% to 10%): Tremor, paraesthesia, cerebrovascular accident, dizziness, syncope, lethargy, peripheral neuropathy
• Uncommon (0.1% to 1%): Encephalitis, Guillain-Barre syndrome, brain edema, intracranial pressure increased, encephalopathy, convulsion, hemiparesis, demyelination, facial palsy, dysgeusia, cognitive disorder, memory impairment, migraine, burning sensation, diabetic neuropathy, restless leg syndrome^[Ref]

Oncologic

• Common (1% to 10%): Squamous cell carcinoma of skin, basal cell carcinoma, skin papilloma
• Uncommon (0.1% to 1%): EBV associated lymphoproliferative disorder, lung cancer, rectal cancer, breast cancer, sarcoma, Kaposi's sarcoma, prostate cancer, cervix carcinoma, laryngeal cancer, lymphoma, multiple myeloma, transitional cell carcinoma^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (15%), anxiety (10%)
• Common (1% to 10%): Depression
• Uncommon (0.1% to 1%): Abnormal dreams, mood swings, attention deficit/hyperactivity disorder, libido increased, irritability^[Ref]

Renal

• Very common (10% or more): Blood creatinine increased (5%), proteinuria, dysuria, hematuria
• Common (1% to 10%): Pyelonephritis, renal tubular necrosis, renal vein thrombosis, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia
• Uncommon (0.1% to 1%): Renal artery thrombosis, nephritis, nephrosclerosis, renal tubular atrophy, cystitis hemorrhagic, kidney fibrosis^[Ref]

Respiratory

• Very common (10% or more): Cough (24%), upper respiratory tract infection (15%), nasopharyngitis (13%), dyspnea (12%), bronchitis (10%)
• Common (1% to 10%): Pneumonia, sinusitis, rhinitis, pulmonary edema, wheezing, hypocapnia, orthopnea, epistaxis, oropharyngeal pain
• Uncommon (0.1% to 1%): Acute respiratory distress syndrome, pulmonary hypertension, pneumonitis, hemoptysis, bronchopneumopathy, painful respiration, pleural effusion, sleep apnea syndrome, dysphonia, oropharyngeal blistering, bronchiectasis, lymphangitis^[Ref]

Hepatic

• Common (1% to 10%): Cytolytic hepatitis, liver function test abnormal
• Uncommon (0.1% to 1%): Hepatic cyst, hepatic steatosis, cholelithiasis^[Ref]

Local

• Uncommon (0.1% to 1%): Infusion related reaction^[Ref]

Ocular

• Common (1% to 10%): Cataract, ocular hyperemia, blurred vision
• Uncommon (0.1% to 1%): Retinitis, conjunctivitis, eye inflammation, keratitis, photophobia, eyelid edema^[Ref]

Other

• Very common (10% or more): Pyrexia, peripheral edema
• Common (1% to 10%): Vertigo, ear pain, tinnitus, fatigue, malaise, impaired healing, C-reactive protein increased, blood parathyroid hormone increased
• Uncommon (0.1% to 1%): Hypoacusis, fibrosis, inflammation, feeling hot^[Ref]

Further information

Belatacept side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer