Basiliximab Side Effects

Brand Names: Simulect

Please note - some side effects for Basiliximab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Basiliximab - for the Consumer

Basiliximab

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Basiliximab:

Acne; constipation; diarrhea; headache; indigestion; nausea; runny nose; sleeplessness; stomach pain; tremor; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark, bloody stools; dizziness; fast heartbeat; fever, chills, or sore throat; increased thirst or urination; painful urination; pain, swelling, or redness at injection site; pain, swelling, or redness at surgical site; shortness of breath; swelling of the hands or feet; unusual sneezing; unusual weakness or tiredness; wheezing.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have been reported in 75% of treated patients (vs 73% in placebo treated patients), making them the most frequently reported side effect with the use of basiliximab. Other gastrointestinal effects including constipation, nausea, diarrhea, abdominal pain, vomiting, dyspepsia, and moniliasis have been reported in at least 10% of patients. Enlarged abdomen, flatulence, gastrointestinal disorder, gastroenteritis, GI hemorrhage, gum hyperplasia, melena, esophagitis, and ulcerative stomatitis have been reported in between 3% and 10% of patients.

Hypersensitivity

Hypersensitivity side effects including seventeen cases of severe acute hypersensitivity reactions (including anaphylaxis) have been reported. Reactions may include hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing.

If a severe hypersensitivity reaction occurs, it is recommended that therapy with basiliximab be permanently discontinued.

Metabolic

Metabolic side effects including hyperkalemia, hypokalemia, hyperglycemia, hyperuricemia, hypophosphatemia, hypocalcemia, weight increase, hypercholesterolemia, and acidosis have been reported in at least 10% of patients. Dehydration, diabetes mellitus, fluid overload, hypercalcemia, hyperlipidemia, hypoglycemia, hypoproteinemia, and hypomagnesemia have been reported in between 3% and 10% of patients.

Nervous system

Nervous system side effects including headache, tremor, and dizziness have been reported in at least 10% of patients. Hypoesthesia, neuropathy, and paraesthesia have been reported in between 3% and 10% of patients.

Genitourinary

Genitourinary side effects including dysuria, increased nonprotein nitrogen, and urinary tract infection have been reported in at least 10% of patients. Male genital edema, impotence, albuminuria, bladder disorder, hematuria, frequent micturition, oliguria, abnormal renal function, renal tubular necrosis, surgery, urethral disorder, and urinary retention have been reported in between 3% and 10% of patients.

General

General side effects including pain, peripheral edema, edema, fever, viral infection, leg edema, and asthenia have been reported in at least 10% of patients. Accidental trauma, chest pain, increased drug level, face edema, fatigue, infection, malaise, generalized edema, rigors, and sepsis have been reported in between 3% and 10% of patients.

Cardiovascular

Cardiovascular side effects including hypertension have been reported in at least 10% of patients. Angina pectoris, cardiac failure, chest pain, abnormal heart sounds, aggravated hypertension, arrhythmia, atrial fibrillation, tachycardia, vascular disorder, and hypotension have been reported in between 3% and 10% of patients.

Respiratory

Respiratory side effects including dyspnea, upper respiratory tract infection, coughing, rhinitis, and pharyngitis have been reported in at least 10% of patients. Bronchitis, bronchospasm, abnormal chest sounds, pneumonia, pulmonary disorder, pulmonary edema, and sinusitis have been reported in between 3% and 10% of patients.

Dermatologic

Dermatologic side effects including surgical wound complications and acne have been reported in at least 10% of patients. Cyst, herpes simplex, herpes zoster, hypertrichosis, pruritus, rash, skin disorder, and skin ulceration have been reported in between 3% and 10% of patients.

Psychiatric

Psychiatric side effects including insomnia have been reported in at least 10% of patients. Agitation, anxiety, and depression have been reported in between 3% and 10% of patients.

Musculoskeletal

Musculoskeletal side effects including leg pain and back pain have been reported in at least 10% of patients. Arthralgia, arthropathy, bone fractures, cramps, hernia, and myalgia have been reported in between 3% and 10% of patients.

Hematologic

Hematologic side effects including anemia have been reported in at least 10% of patients. Hematoma, hemorrhage, purpura, thrombocytopenia, polycythemia, and thrombosis have been reported in between 3% and 10% of patients.

Endocrine

Endocrine side effects including increased glucocorticoids have been reported in between 3% and 10% of patients.

Ocular

Ocular side effects including cataract, conjunctivitis, and abnormal vision have been reported in between 3% and 10% of patients.

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