Gengraf Side Effects
Generic name: cyclosporine
Medically reviewed by Drugs.com. Last updated on Sep 12, 2024.
Note: This document provides detailed information about Gengraf Side Effects associated with cyclosporine. Some dosage forms listed on this page may not apply specifically to the brand name Gengraf.
Applies to cyclosporine: oral capsule, oral capsule liquid filled, oral solution.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
Do not take cyclosporine (the active ingredient contained in Gengraf) if you are receiving treatment for psoriasis, including PUVA or UVB therapy, methotrexate (Rheumatrex®), coal tar, or radiation therapy.
Check with your doctor right away if you have blood in the urine, change in the frequency of urination or amount of urine, difficulty breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, or swelling of the feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.
Do not use supplements or salt substitutes containing potassium without first checking with your doctor.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase your risk of getting skin cancer or lymphoma. Talk to your doctor if you have concerns about this risk.
This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
This medicine may cause thrombotic microangiopathy (damage in the smallest blood vessels) and hemolytic anemia. Tell your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body welling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, sudden, severe chest pain, sudden weakness in arms or legs, or yellowing of the eyes or skin.
Tell your doctor if you are taking a corticosteroid or another medicine that may weaken your immune system. This may increase your risk for developing a serious infection.
If you are taking this medicine after a kidney transplant, it may increase your risk for developing rare and serious virus infections, including polyoma virus-associated nephropathy (PVAN), progressive multiple leukoencephalopathy (PML), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.
Tell your doctor right away if you have seizures, headaches, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).
While you are being treated with cyclosporine, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Cyclosporine may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
In some patients (usually younger patients), tenderness, swelling, or bleeding of the gums may appear soon after treatment with cyclosporine is started. Brushing and flossing your teeth, carefully and regularly, and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.
This medicine may make your skin more sensitive to sunlight and can increase your risk of having skin cancer. If you are being treated for psoriasis, check with your doctor first before having an ultraviolet (UV) light treatment. Use a sunscreen when you are outdoors and avoid sunlamps and tanning beds.
This medicine may cause a serious nervous system problem. Tell your doctor right away if you have confusion, loss of consciousness, mental changes, muscle weakness, seizures, or vision changes.
This medicine may cause dizziness, confusion, or sleepiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of Gengraf
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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 adverse events
- 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]
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References
1. (2022) "Product Information. SandIMMUNE (cycloSPORINE)." Apothecon Inc
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. "Product Information. CycloSPORINE (cycloSPORINE)." Teva Pharmaceuticals (formerly IVAX)
5. (2022) "Product Information. CycloSPORINE Modified (cycloSPORINE)." Sandoz Laboratories, Eon Division
6. (2022) "Product Information. Gengraf (cycloSPORINE)." AbbVie US LLC
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Further information
Gengraf side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.