Simulect Side Effects

Generic name: basiliximab

Medically reviewed by Drugs.com. Last updated on Mar 5, 2024.

Note: This document provides detailed information about Simulect Side Effects associated with basiliximab. Some dosage forms listed on this page may not apply specifically to the brand name Simulect.

Applies to basiliximab: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe basiliximab.

The physician responsible for basiliximab administration should have complete information requisite for the follow-up of the patient.

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

Serious side effects of Simulect

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 side effects

• 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 side effects

• 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

Other side effects of Simulect

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 side effects

• acne
• constipation
• diarrhea
• headache
• heartburn
• nausea
• trouble in sleeping
• weight gain

Less common side effects

• excessive hair growth
• joint pain
• muscle pain

For healthcare professionals

Applies to basiliximab: intravenous powder for injection.

Cardiovascular adverse events

• 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]

Hematologic

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

Hypersensitivity

• Postmarketing reports: Severe acute hypersensitivity reactions (including anaphylaxis)

Immunologic

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

Musculoskeletal

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

Ocular

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

Metabolic

• 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

Psychiatric

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

Genitourinary

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

Respiratory

• 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

Other

• 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

Renal

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

Dermatologic

• 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

Endocrine

• Common (1% to 10%): Increased glucocorticoids

Gastrointestinal

• 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

Further information

Simulect 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer