Summary
Commonly reported side effects of cyclosporine include: hirsutism, hypertension, increased blood urea nitrogen, increased serum creatinine, nephrotoxicity, and tremor. Continue reading for a comprehensive list of adverse effects.
Applies to cyclosporine: oral capsule, oral capsule liquid filled, oral solution. Other dosage forms:
- intravenous solution
Warning
Oral route (Capsule; Capsule, Liquid Filled; Solution)
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe cyclosporine. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development lymphoma may result from immunosuppression.Cyclosporine capsules and cyclosporine solution have decreased bioavailability in comparison to cyclosporine MODIFIED capsules and cyclosporine MODIFIED solution.Cyclosporine and cyclosporine MODIFIED are not bioequivalent and cannot be used interchangeably without physician supervision.The absorption of cyclosporine during chronic administration of cyclosporine capsules and oral solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood concentrations of cyclosporine. Comparisons of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed.
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.
Serious side effects of Cyclosporine
Along with its needed effects, cyclosporine 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:
More common
- Abdominal or stomach pain or tenderness
- back pain
- black, tarry stools
- blurred vision
- chest pain
- chills
- clay colored stools
- cloudy urine
- cough
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- decreased appetite
- dizziness
- drowsiness
- fever
- headache
- headache, severe and throbbing
- itching
- loss of appetite
- muscle spasms (tetany) or twitching
- nausea and vomiting
- nervousness
- painful or difficult urination
- pounding in the ears
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- skin rash
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the feet or lower legs
- swollen glands
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Less common
- Bleeding gums
- blood in the urine
- blood in the vomit
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- convulsions
- difficulty swallowing
- hives
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe or continuing stomach pain
- tightness in the chest
- troubled breathing with exertion
Rare
- Bloating
- chest discomfort
- constipation
- darkened urine
- hoarseness
- indigestion
- lower back or side pain
- night sweats
- pain or discomfort in the arms, jaw, back, or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- sweating
- vomiting of blood or material that looks like coffee grounds
Other side effects of 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:
More common
- Abdominal or stomach discomfort
- bleeding, tender, or enlarged gums
- blemishes on the skin
- increased hair growth, especially on the face
- pain or tenderness around the eyes and cheekbones
- pimples
- stuffy or runny nose
Less common
- Brittle fingernails
- burning feeling in the chest or stomach
- burning, dry, or itching eyes
- continuing ringing or buzzing or other unexplained noise in the ears
- cramps
- discharge or excessive tearing
- feeling of warmth
- hearing loss
- redness of the face, neck, arms, and occasionally, upper chest
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- swelling of the breasts or breast soreness in both females and males
- weight loss
Rare
- Blurred or loss of vision
- discouragement
- disturbed color perception
- double vision
- fear
- feeling sad or empty
- halos around lights
- irritability
- joint pain
- loss of interest or pleasure
- night blindness
- overbright appearance of lights
- tiredness
- trouble concentrating
- trouble sleeping
- tunnel vision
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- weakness
- weight loss
For Healthcare Professionals
Applies to cyclosporine: compounding powder, injectable solution, oral capsule, oral liquid, oral solution.
Cardiovascular
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[Ref]
Hypertension, usually mild to moderate, occurs in approximately 50% of patients following renal transplantation and in most cardiac transplant patients.[Ref]
Hematologic
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[Ref]
Hypersensitivity
Common (1% to 10%): Allergic reactions[Ref]
Immunologic
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[Ref]
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.[Ref]
Musculoskeletal
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[Ref]
Ocular
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)[Ref]
Metabolic
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[Ref]
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.[Ref]
Psychiatric
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[Ref]
Genitourinary
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[Ref]
Hepatic
Common (1% to 10%): Hepatic function abnormal, bilirubinemia
Frequency not reported: Hepatotoxicity (e.g., cholestasis, jaundice, hepatitis, liver failure [sometimes fatal])
Postmarketing reports: Cholestasis[Ref]
Oncologic
Frequency not reported: Lymphomas or lymphoproliferative disorders and other malignancies (particularly of the skin), breast fibroadenosis[Ref]
The frequency of malignancies increases with the intensity and duration of therapy and may be fatal.[Ref]
Respiratory
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[Ref]
Other
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[Ref]
Nervous system
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[Ref]
Renal
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[Ref]
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.[Ref]
Dermatologic
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[Ref]
Endocrine
Common (1% to 10%): Dysmenorrhea, amenorrhea, goiter
Uncommon (0.1% to 1%): Gynecomastia, leucorrhea
Rare (less than 0.1%): Menstrual disorder[Ref]
Gastrointestinal
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[Ref]
