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Sandimmune

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Sandimmune

Sandimmune Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sandimmune (cyclosporine) is used to prevent organ rejection after a kidney, liver, or heart transplant. It is also used to treat severe psoriasis or severe rheumatoid arthritis. It is a cyclic polypeptide immunosuppressant agent. This medication is available in generic form. Common side effects include headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure.

The initial oral dose of Sandimmune is given 4-12 hours prior to transplantation as a single dose of 15 mg/kg. The single daily dose is continued postoperatively for 1-2 weeks and tapered 5% per week to a maintenance dose of 5-10 mg/kg/day. Sandimmune may interact with etoposide, lithium, methotrexate, nefazodone, repaglinide, St. John's wort, ACE inhibitors, heart or blood pressure medication, medicines used to treat ulcerative colitis, other medicines used to prevent organ transplant rejection, pain or arthritis medicines, IV antibiotics, antiviral medicines, or cancer medicine. Tell your doctor all medications and supplements you are taking. Sandimmune should be used only when prescribed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other serious problems have been reported, including death. This medication passes into breast milk. Breast-feeding is not recommended while using this drug.

Our Sandimmune (cyclosporine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sandimmune in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, sweating, chills, body aches, flu symptoms, sores in your mouth and throat, weight loss;
  • change in your mental state, problems with speech or walking, decreased vision (may start gradually and get worse quickly);
  • easy bruising or bleeding, pale skin, confusion or weakness;
  • feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • pain in the lower back or side, blood in your urine, pain or burning when you urinate;
  • urinating less than usual or not at all, rapid weight gain;
  • swelling, warmth, redness, or oozing of the skin;
  • vomiting and bloody diarrhea;
  • seizure (convulsions);
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats).

Less serious side effects may include:

  • swollen or painful gums;
  • mild headache;
  • stomach pain, constipation, mild diarrhea; or
  • tremors or shaking, muscle spasm, numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sandimmune (Cyclosporine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sandimmune Overview - Patient Information: Side Effects

SIDE EFFECTS: See also the Warning section.

Headache, nausea, vomiting, diarrhea, stomach upset, acne, cramps, increased hair growth on the face/body, shaking fingers/hands (tremor), swollen/red/painful gums, dizziness, flushing, and high blood pressure may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Your risk of infection may be higher while you are taking this medication. Tell your doctor immediately if any of these symptoms of infection occur: fever, sore throat, flu-like symptoms, painful urination.

Tell your doctor right away if you have any serious side effects, including: muscle spasms/weakness, fast/irregular heartbeat, change in the amount/color of urine, unusual weight gain/loss, tingling of the hands/feet, hearing problems, easy bruising/bleeding, unusual tiredness, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing of the skin/eyes, vomit that looks like coffee grounds, change in the appearance or size of skin moles/lesions, changes in skin color, loss of consciousness, mental/mood changes (such as confusion, difficulty concentrating), vision changes, swollen glands, unusual lumps, night sweats, problems with speech, clumsiness, loss of coordination, weakness on one side of the body.

Get medical help right away if you have any very serious side effects, including: chest pain, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sandimmune (Cyclosporine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sandimmune FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The principal adverse reactions of Sandimmune® (cyclosporine) therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia.

Hypertension

Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients.

Glomerular Capillary Thrombosis

Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resemble those seen in the hemolytic-uremic syndrome and include 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 immunosuppressives have been employed posttransplantation.

Hypomagnesemia

Hypomagnesemia has been reported in some, but not all, patients exhibiting convulsions while on cyclosporine therapy. 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 cyclosporine appear to be related to the neurological manifestations of cyclosporine toxicity.

Clinical Studies

The following reactions occurred in 3% or greater of 892 patients involved in clinical trials of kidney, heart, and liver transplants:

Body System/Adverse Reactions Randomized Kidney Patients All Sandimmune® (cyclosporine) Patients
Sandimmune®
(N=227) %
Azathioprine
(N=228) %
Kidney
(N=705) %
Heart
(N=112) %
Liver
(N=75) %
Genitourinary
  Renal Dysfunction 32 6 25 38 37
Cardiovascular
  Hypertension 26 18 13 53 27
  Cramps 4 < 1 2 < 1 0
Skin
  Hirsutism 21 < 1 21 28 45
  Acne 6 8 2 2 1
Central Nervous System
  Tremor 12 0 21 31 55
  Convulsions 3 1 1 4 5
  Headache 2 < 1 2 15 4
Gastrointestinal
  Gum Hyperplasia 4 0 9 5 16
  Diarrhea 3 < 1 3 4 8
  Nausea/Vomiting 2 < 1 4 10 4
  Hepatotoxicity < 1 < 1 4 7 4
  Abdominal Discomfort < 1 0 < 1 7 0
Autonomic Nervous System
  Paresthesia 3 0 1 2 1
  Flushing < 1 0 4 0 4
Hematopoietic
  Leukopenia 2 19 < 1 6 0
  Lymphoma < 1 0 1 6 1
Respiratory
  Sinusitis < 1 0 4 3 7
Miscellaneous
  Gynecomastia < 1 0 < 1 4 3

The following reactions occurred in 2% or less of patients: allergic reactions, anemia, anorexia, confusion, conjunctivitis, edema, fever, brittle fingernails, gastritis, hearing loss, hiccups, hyperglycemia, muscle pain, peptic ulcer, thrombocytopenia, tinnitus.

The following reactions occurred rarely: anxiety, chest pain, constipation, depression, hair breaking, hematuria, joint pain, lethargy, mouth sores, myocardial infarction, night sweats, pancreatitis, pruritus, swallowing difficulty, tingling, upper GI bleeding, visual disturbance, weakness, weight loss.

Renal Transplant Patients in Whom Therapy Was Discontinued

Reason for Discontinuation Randomized Patients All Sandimmune® Patients
(N=705) %
Sandimmune®
(N=227) %
Azathioprine
(N=228) %
Renal Toxicity 5.7 0 5.4
Infection 0 0.4 0.9
Lack of Efficacy 2.6 0.9 1.4
Acute Tubular Necrosis 2.6 0 1.0
Lymphoma/Lymphoproliferative Disease 0.4 0 0.3
Hypertension 0 0 0.3
Hematological Abnormalities 0 0.4 0
Other 0 0 0.7
Sandimmune® (cyclosporine) was discontinued on a temporary basis and then restarted in 18 additional patients.

Patients receiving immunosuppressive therapies, including cyclosporine and cyclosporine -containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic). Both generalized and localized infections can occur. Pre-existing infections may also be aggravated. Fatal outcomes have been reported. (See WARNINGS)

Infectious Complications in the Randomized Renal Transplant Patients

Complication Sandimmune® Treatment
(N=227)
% of Complications
Standard Treatment*
(N=228)
% of Complications
Septicemia 5.3 4.8
Abscesses 4.4 5.3
Systemic Fungal Infection 2.2 3.9
Local Fungal Infection 7.5 9.6
Cytomegalovirus 4.8 12.3
Other Viral Infections 15.9 18.4
Urinary Tract Infections 21.1 20.2
Wound and Skin Infections 7.0 10.1
Pneumonia 6.2 9.2
*Some patients also received ALG.

Cremophor® EL (polyoxyethylated castor oil) is known to cause hyperlipemia and electrophoretic abnormalities of lipoproteins. These effects are reversible upon discontinuation of treatment but are usually not a reason to stop treatment.

Postmarketing Experience

Hepatotoxicity

Cases of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure; serious and/or fatal outcomes have been reported. [See WARNINGS, Hepatotoxicity]

Increased Risk of Infections

Cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), sometimes fatal; and polyoma virus-associated nephropathy (PVAN), especially BK virus resulting in graft loss have been reported. [See WARNINGS, Polyoma Virus Infection]

Headache, including Migraine

Cases of migraine have been reported. In some cases, patients have been unable to continue cyclosporine, however, the final decision on treatment discontinuation should be made by the treating physician following the careful assessment of benefits versus risks.

Read the entire FDA prescribing information for Sandimmune (Cyclosporine) »

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Sandimmune - User Reviews

Sandimmune User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Sandimmune sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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