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Note: This document contains side effect information about cyclosporine. Some of the dosage forms listed on this page may not apply to the brand name Sandimmune.
Common side effects of Sandimmune include: hirsutism, hypertension, increased blood urea nitrogen, increased serum creatinine, nephrotoxicity, and tremor. See below for a comprehensive list of adverse effects.
Applies to cyclosporine: oral capsule, oral capsule liquid filled, oral solution
Other dosage forms:
Oral route (Capsule; Capsule, Liquid Filled; Solution)
Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Sandimmune® (cycloSPORINE) and Neoral® (cycloSPORINE, modified). CycloSPORINE should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. CycloSPORINE and cycloSPORINE, modified are not bioequivalent and cannot be used interchangeably without physician supervision. CycloSPORINE absorption is erratic during chronic administration of Sandimmune® capsules and oral solution. Monitor cycloSPORINE blood levels to avoid toxicity due to high concentrations and possible organ rejection due to low levels .
Oral route (Capsule, Liquid Filled; Solution)
Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cycloSPORINE, modified. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Hypertension and nephrotoxicity can occur at recommended dosages, and the risk increases with increasing dose and duration of cycloSPORINE therapy. Monitor blood levels and renal function to avoid toxicity. CycloSPORINE, modified (Neoral® or Gengraf®) and cycloSPORINE (Sandimmune®) are not bioequivalent and cannot be used interchangeably without physician supervision. Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UV-B, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking cycloSPORINE.
Along with its needed effects, cyclosporine (the active ingredient contained in Sandimmune) 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 immediately if any of the following side effects occur while taking cyclosporine:
Some side effects of cyclosporine 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:
Applies to cyclosporine: compounding powder, injectable solution, oral capsule, oral liquid, oral solution
Hypertension, usually mild to moderate, occurs in approximately 50% of patients following renal transplantation and in most cardiac transplant patients.
Very common (10% or more): Hypertension (26%)
Common (1% to 10%): Flushing, arrhythmia, purpura, abnormal heart sounds, cardiac failure, peripheral ischemia
Rare (less than 0.1%): Hypertension with fluid retention and convulsions (mainly in children), chest pain, myocardial infarction
Common (1% to 10%): Leukopenia
Uncommon (0.1% to 1%): Thrombocytopenia, anemia
Rare (less than 0.1%): Hemolytic uremic syndrome, microangiopathic hemolytic anemia
Frequency not reported: Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, platelet/bleeding/clotting disorders, red blood cell disorder
Common (1% to 10%): Allergic reactions
Common (1% to 10%): Increased susceptibility to infections, septicemia, abscess, systemic fungal infection, localized or generalized infections (viral, bacterial, fungal, parasitic), cytomegalovirus, wound and skin infections, cellulitis, folliculitis, herpes simplex, herpes zoster
Frequency not reported: JC virus-associated progressive multifocal leukoencephalopathy (PML) (sometimes fatal), polyoma virus-associated nephropathy (PVAN), BK virus resulting in graft loss
Preexisting infections may be aggravated and reactivation of Polyomavirus infections may lead to Polyomavirus associated nephropathy (PVAN) or to JC virus associated progressive multifocal leukoencephalopathy (PML); serious and/or fatal outcomes have been reported.
Common (1% to 10%): Myalgia, muscle cramps, muscle pain
Rare (less than 0.1%): Muscle weakness, myopathy, joint pain, tingling
Frequency not reported: Pain of lower extremities, arthralgia, bone fracture, bursitis, joint dislocation, stiffness, synovial cyst, tendon disorder
Common (1% to 10%): Conjunctivitis, visual disturbance, abnormal vision, cataract, eye pain
Very rare (less than 0.01%): Optic disc edema (including papilledema with possible visual impairment secondary to benign intracranial hypertension)
Hypomagnesemia has been reported in some patients exhibiting convulsions while taking this drug. Although magnesium-depletion studies in normal subjects suggest that hypomagnesemia is associated with neurologic disorders, multiple factors, including hypertension, high dose methylprednisolone, hypocholesterolemia, and nephrotoxicity associated with high plasma concentrations of this drug appear to be related to the neurological toxicity.
Very common (10% or more): Hyperlipidemia
Common (1% to 10%): Hyperglycemia, hypoglycemia, anorexia, hyperuricemia, hyperkalemia, hypomagnesemia, diabetes mellitus
Rare (less than 0.1%): Weight loss, weight gain
Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Confusion, lethargy, depression, disorientation, decreased responsiveness, agitation, visual hallucinations
Rare (less than 0.1%): Anxiety
Frequency not reported: Libido decreased
Very common (10% or more): Urinary tract infection (21%)
Common (1% to 10%): Dysuria, micturition frequency, hot flushes
Rare (less than 0.1%): Hematuria, gynecomastia
Frequency not reported: Increased BUN, abnormal urine, nocturia, polyuria
Common (1% to 10%): Hepatic function abnormal, bilirubinemia
Frequency not reported: Hepatotoxicity (e.g., cholestasis, jaundice, hepatitis, liver failure [sometimes fatal])
Postmarketing reports: Cholestasis
Frequency not reported: Lymphomas or lymphoproliferative disorders and other malignancies (particularly of the skin), breast fibroadenosis
The frequency of malignancies increases with the intensity and duration of therapy and may be fatal.
Common (1% to 10%): Pneumonia, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection
Rare (0.01% to 0.1%): Respiratory distress syndrome
Frequency not reported: Bronchospasm
Very common (10% or more): Fatigue, pyrexia
Common (1% to 10%): Lethargy, pain, rigors, malaise
Uncommon (0.1% to 1%): Hearing loss, tinnitus
Rare (less than 0.1%): Weakness
Frequency not reported: Deafness, taste perversion
Very common (10% or more): Tremor (12%), headache, burning sensation in hands and feet (usually during the first week of therapy)
Common (1% to 10%): Convulsions, paresthesia, dizziness, paresthesia, hypoesthesia, neuropathy, vertigo
Uncommon (0.1% to 1%): Encephalopathy (including Posterior Reversible Encephalopathy Syndrome [PRES] manifested by convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis, and cerebellar ataxia)
Rare (less than 0.1%): Motor polyneuropathy
Frequency not reported: Migraine
The pathologic changes of glomerular capillary thrombosis resemble those seen in hemolytic-uremic syndrome including thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. Similar findings have been observed when other immunosuppressants have been used post-transplantation.
Very common (10% or more): Renal dysfunction (32%), elevated creatinine
Uncommon (0.1% to 1%): Renal failure (which may result in graft failure)
Frequency not reported: Glomerular capillary thrombosis
Very common (10% or more): Hirsutism (21%)
Common (1% to 10%): Acne, hypertrichosis, brittle fingernails, hair breaking, alopecia, bullous eruption, skin ulceration, increased sweating, dry skin
Uncommon (0.1% to 1%): Allergic rashes, pruritus
Rare (less than 0.1%): Burning sensation, pigmentation, night sweats
Common (1% to 10%): Dysmenorrhea, amenorrhea, goiter
Uncommon (0.1% to 1%): Gynecomastia, leucorrhea
Rare (less than 0.1%): Menstrual disorder
Very common (10% or more): Gingival hyperplasia, GI disturbances (e.g., nausea, vomiting, diarrhea, abdominal pain/discomfort)
Common (1% to 10%): Peptic ulcer, acute pancreatitis, gastritis, hiccups, flatulence, gingivitis, stomatitis, dry mouth, dysphagia, enanthema, eructation, esophagitis, glossitis, gingival bleeding, salivary gland enlargement, tongue disorder, tooth disorder, abdominal distention, keratosis
Rare (less than 0.1%): Pancreatitis, gastroenteritis, asymptomatic hyperamylasemia, biliary calculous disease (associated with moderate or severe hepatotoxicity), constipation, mouth sores, upper GI bleeding, rectal hemorrhage
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Sandimmune (www.drugs.com/cdi/sandimmune-cyclosporine-injection.html).
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