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Simulect Side Effects

Generic Name: basiliximab

Note: This document contains side effect information about basiliximab. Some of the dosage forms listed on this page may not apply to the brand name Simulect.

For the Consumer

Applies to basiliximab: intravenous powder for solution

Along with its needed effects, basiliximab (the active ingredient contained in Simulect) 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 as soon as possible if any of the following side effects occur while taking basiliximab:

More common
  • Abdominal pain
  • back pain
  • coughing
  • dizziness
  • fever or chills
  • loss of energy or weakness
  • painful urination
  • shortness of breath
  • sore throat
  • swelling of the ankles, body, face, feet or lower legs
  • trembling or shaking of the hands or feet
  • vomiting
  • white patches in the mouth or throat or on the tongue
Less common
  • Abnormal vision
  • agitation
  • anxiety
  • bleeding, tender, or enlarged gums
  • blood in the stool
  • bruising
  • chest pain
  • depression
  • difficulty in urinating
  • fatigue
  • itching
  • numbness or pain in the legs
  • skin rash
  • sores in the mouth
  • “stocking and gloves” sensation of the hands or feet
  • tingling

Some side effects of basiliximab 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 Less common

For Healthcare Professionals

Applies to basiliximab: intravenous powder for injection


Very common (10% or more): Peripheral edema (29%), hypertension (27%), general edema (21%)
Common (1% to 10%): Chest pain, face edema, leg edema, abnormal heart sounds, angina pectoris, cardiac failure, hypotension, arrhythmia, atrial fibrillation, tachycardia
Postmarketing reports: Capillary leak syndrome[Ref]


Very common (10% or more): Anemia (26%)
Common (1% to 10%): Hematoma, hemorrhage, purpura, thrombocytopenia, thrombosis, polycythemia, leukopenia


Postmarketing reports: Severe acute hypersensitivity reactions (including anaphylaxis)


Very common (10% or more): Infection, sepsis
Postmarketing reports: Cytokine release syndrome


Common (1% to 10%): Arthralgia, arthropathy, back pain, bone fracture, cramps, hernia, myalgia, leg pain


Common (1% to 10%): Cataract, conjunctivitis, abnormal vision


Very common (10% or more): Hyperkalemia (22%), hypercholesterolemia (11%), hypokalemia, hyperglycemia, hypophosphatemia, hyperuricemia
Common (1% to 10%): Acidosis, dehydration, diabetes mellitus, fluid overload, hyperlipidemia, hypertriglyceridemia, hypocalcemia, hypoglycemia, hypomagnesemia, hypoproteinemia, weight increase


Very common (10% or more): Insomnia (24%)
Common (1% to 10%): Agitation, anxiety, depression


Very common (10% or more): Urinary tract infection (46%)
Common (1% to 10%): Unspecified bladder disorders, genital edema, impotence, ureteral disorder, urinary retention, oliguria


Very common (10% or more): Upper respiratory tract infection (20%), rhinitis, dyspnea
Common (1% to 10%): Bronchitis, bronchospasm, abnormal chest sounds, coughing, pharyngitis, pneumonia, pulmonary disorder, pulmonary edema, rhinitis, sinusitis
Postmarketing reports: Respiratory failure


Very common (10% or more): Pain (42%), fever (20%)
Common (1% to 10%): Asthenia, malaise

Nervous system

Very common (10% or more): Headache (24%), tremor (19%)
Common (1% to 10%): Rigors, dizziness, neuropathy, paresthesia, hypoesthesia


Common (1% to 10%): Albuminuria, bladder disorder, dysuria, frequent micturition, hematuria, increased non-protein nitrogen, abnormal renal function, renal tubular necrosis


Very common (10% or more): Hypertrichosis, surgical wound complication, acne
Common (1% to 10%): Cyst, herpes simplex, herpes zoster, hypertrichosis, pruritus, rash, skin disorder, skin ulceration


Common (1% to 10%): Increased glucocorticoids


Very common (10% or more): Constipation (48%), nausea (34%), abdominal pain (21%), diarrhea (21%), vomiting (20%), dyspepsia
Common (1% to 10%): Enlarged abdomen, esophagitis, flatulence, GI disorder, gastroenteritis, GI hemorrhage, gum hyperplasia, melena, moniliasis, ulcerative stomatitis


1. "Product Information. Simulect (basiliximab)." Novartis Pharmaceuticals, East Hanover, NJ.

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

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

Some side effects of Simulect 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. 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.