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

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]