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Simulect Side Effects

Generic Name: basiliximab

Note: This page contains side effects data for the generic drug basiliximab. It is possible that some of the dosage forms included below may not apply to the brand name Simulect.

For the Consumer

Applies to basiliximab: intravenous powder for solution

As well as its needed effects, basiliximab (the active ingredient contained in Simulect) may cause unwanted side effects that require medical attention.

Severity: Moderate

If any of the following side effects occur while taking basiliximab, check with your doctor or nurse as soon as possible:

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

Minor Side Effects

Some basiliximab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Acne
  • constipation
  • diarrhea
  • headache
  • heartburn
  • nausea
  • trouble in sleeping
  • weight gain
Less common:
  • Excessive hair growth
  • joint pain
  • muscle pain

For Healthcare Professionals

Applies to basiliximab: intravenous powder for injection

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 (the active ingredient contained in Simulect) 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.[Ref]

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.[Ref]

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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Endocrine

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

Ocular

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

References

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

It is possible that some side effects of Simulect may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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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