Gengraf Side Effects

Generic name: cyclosporine

Medically reviewed by Drugs.com. Last updated on Jan 27, 2024.

Note: This document contains side effect information about cyclosporine. Some dosage forms listed on this page may not apply to the brand name Gengraf.

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 Gengraf

Along with its needed effects, cyclosporine (the active ingredient contained in Gengraf) 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

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
skin rash
slow or fast heartbeat
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stomach pain or tenderness
swelling of the feet or lower legs
swollen glands
trembling or shaking of the hands or feet
trouble breathing
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
chest tightness
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
seizures
severe or continuing stomach pain

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 Gengraf

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

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
stomach discomfort
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
trouble concentrating
trouble sleeping
tunnel vision
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
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]