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Gengraf Capsules Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Gengraf (cyclosporine capsules, modified) is an immunosuppressant agent used to prevent organ rejection after a kidney, liver, or heart transplant. Gengraf is also used to treat severe psoriasis or severe rheumatoid arthritis. Gengraf is available in generic form. Common side effects of Gengraf include tremors or shaking, increased hair growth on the face or body, headache, body pain, stomach pain or upset, diarrhea, constipation, nausea, vomiting, numbness or tingly feeling, swollen or painful gums, muscle spasm, acne, cramps, dizziness, flushing, and high blood pressure.
The initial oral dose of Gengraf can be given 4-12 hours prior to transplantation or be given postoperatively. Initial dosing varies depending on the transplanted organ and other immunosuppressive agents given. To treat rheumatoid arthritis, the dose is based on the patient's weight. Gengraf may interact with etoposide, lithium, methotrexate, nefazodone, repaglinide, St. John's wort, ACE inhibitors, heart or blood pressure medications, medicines used to treat ulcerative colitis, other medicines used to prevent organ transplant rejection, pain or arthritis medicines, IV antibiotics, antiviral medicines, or cancer medicines. Tell your doctor all medications and supplements you use. During pregnancy, Gengraf should be used only if prescribed. This drug passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.
Our Gengraf (cyclosporine capsules, modified) 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.
Gengraf Capsules 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 Gengraf Capsules (Cyclosporine Capsules)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Gengraf Capsules Overview - Patient Information: Side Effects
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 Gengraf Capsules (Cyclosporine Capsules)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Gengraf Capsules FDA Prescribing Information: Side Effects
Kidney, Liver, And Heart Transplantation
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 resembled those seen in the hemolytic-uremic syndrome and included 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 post-transplantation.
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.
In controlled studies, the nature, severity, and incidence of the adverse events that were observed in 493 transplanted patients treated with cyclosporine (MODIFIED) were comparable with those observed in 208 transplanted patients who received Sandimmune® in these same studies when the dosage of the two drugs was adjusted to achieve the same cyclosporine blood trough concentrations.
Based on the historical experience with Sandimmune®, 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||Cyclosporine Patients (Sandimmune®)|
(N = 227) %
(N = 228) %
(N = 705) %
(N = 112) %
(N = 75) %
|Cramps||4||< 1||2||< 1||0|
|Central Nervous System|
|Hepatotoxicity||< 1||< 1||4||7||4|
|Abdominal Discomfort||< 1||0||< 1||7||0|
|Autonomic Nervous System|
|Gynecomastia||< 1||0||< 1||4||3|
Among 705 kidney transplant patients treated with cyclosporine oral solution (Sandimmune®) in clinical trials, the reason for treatment discontinuation was renal toxicity in 5.4%, infection in 0.9%, lack of efficacy in 1.4%, acute tubular necrosis in 1.0%, lymphoproliferative disorders in 0.3%, hypertension in 0.3%, and other reasons in 0.7% of the patients.
The following reactions occurred in 2% or less of cyclosporine-treated patients: allergic reactions, anemia, anorexia, confusion, conjunctivitis, edema, fever, brittle fingernails, gastritis, hearing loss, hiccups, hyperglycemia, migraine (Gengraf®), 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.
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 Historical Randomized
Studies in Renal Transplant Patients Using Sandimmune®
(N=227) % of Complications
|Azathioprine with Steroids*
(N=228) % of Complications
|Systemic Fungal Infection||2.2||3.9|
|Local Fungal Infection||7.5||9.6|
|Other Viral Infections||15.9||18.4|
|Urinary Tract Infections||21.1||20.2|
|Wound and Skin Infections||7.0||10.1|
|*Some patients also received ALG.|
Postmarketing Experience, Kidney, Liver And Heart Transplantation
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.
Pain of lower extremities
Isolated cases of pain of lower extremities have been reported in association with cyclosporine. Pain of lower extremities has also been noted as part of Calcineurin-Inhibitor Induced Pain Syndrome (CIPS) as described in the literature.
The principal adverse reactions associated with the use of cyclosporine in rheumatoid arthritis are renal dysfunction (See WARNINGS), hypertension (See PRECAUTIONS), headache, gastrointestinal disturbances, and hirsutism/hypertrichosis.
In rheumatoid arthritis patients treated in clinical trials within the recommended dose range, cyclosporine therapy was discontinued in 5.3% of the patients because of hypertension and in 7% of the patients because of increased creatinine. These changes are usually reversible with timely dose decrease or drug discontinuation. The frequency and severity of serum creatinine elevations increase with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced without dose reduction or discontinuation.
The following adverse events occurred in controlled clinical trials:
Cyclosporine (MODIFIED)/Sandimmune® Rheumatoid
Arthritis Percentage of Patients with Adverse Events ≥ 3% in any
Cyclosporine Treated Group
|Body System||Preferred Term||Studies 651+652 +2008||Study 302||Study 654||Study 654||Study 302||Studies 651+652 +2008|
|Sand- ® immune
|Methotrexate & Sandimmune®
|Metho- trexate & Placebo
|Autonomic Nervous System Disorders|
|Body As A Whole-General Disorders|
|Edema NOS*||5%||14%||12%||4%||10%||< 1%|
|Influenza-like symptoms||< 1%||6%||1%||0%||3%||2%|
|Central and Peripheral Nervous System Disorders|
|Gastrointestinal System Disorders|
|Gastrointestinal Disorder NOS*||0%||2%||1%||4%||4%||0%|
|Hearing and Vestibular Disorders|
|Ear Disorder NOS*||0%||5%||0%||0%||1%||0%|
|Metabolic and Nutritional Disorders|
|Musculoskeletal System Disorders|
|Leg Cramps / Involuntary Muscle Contractions||2%||11%||11%||3%||12%||1%|
|Creatinine elevations > 30%||43%||39%||55%||19%||48%||13%|
|Creatinine elevations > 50%||24%||18%||26%||8%||18%||3%|
|Reproductive Disorders, Female|
|Respiratory System Disorders|
|Upper Respiratory Tract||0%||14%||23%||15%||13%||0%|
|Skin and Appendages Disorders|
|Urinary System Disorders|
|Urinary Tract Infection||0%||3%||5%||4%||3%||0%|
|Vascular (Extracardiac) Disorders|
|† Includes patients in 2.5 mg/kg/day dose group only.
*NOS=Not Otherwise Specified.
In addition, the following adverse events have been reported in 1% to < 3% of the rheumatoid arthritis patients in the cyclosporine treatment group in controlled clinical trials.
Gastrointestinal: constipation, dysphagia, enanthema, eructation, esophagitis, gastric ulcer, gastritis, gastroenteritis, gingival bleeding, glossitis, peptic ulcer, salivary gland enlargement, tongue disorder, tooth disorder
Liver and Biliary System: bilirubinemia
Neoplasms: breast fibroadenosis, carcinoma
Respiratory System: abnormal chest sounds, bronchospasm
*NOS=Not Otherwise Specified
The principal adverse reactions associated with the use of cyclosporine in patients with psoriasis are renal dysfunction, headache, hypertension, hypertriglyceridemia, hirsutism/hypertrichosis, paresthesia or hyperesthesia, influenza-like symptoms, nausea/vomiting, diarrhea, abdominal discomfort, lethargy, and musculoskeletal or joint pain.
In psoriasis patients treated in US controlled clinical studies within the recommended dose range, cyclosporine therapy was discontinued in 1.0% of the patients because of hypertension and in 5.4% of the patients because of increased creatinine. In the majority of cases, these changes were reversible after dose reduction or discontinuation of cyclosporine.
There has been one reported death associated with the use of cyclosporine in psoriasis. A 27-year-old male developed renal deterioration and was continued on cyclosporine. He had progressive renal failure leading to death.
Frequency and severity of serum creatinine increases with dose and duration of cyclosporine therapy. These elevations are likely to become more pronounced and may result in irreversible renal damage without dose reduction or discontinuation.
Adverse Events Occurring in 3% or More of Psoriasis
Patients in Controlled Clinical Trials
|Body System*||Preferred Term||Cyclosporine (MODIFIED)
|Infection or Potential Infection||24.7%||24.3%|
|Upper Respiratory Tract Infections||7.7%||11.3%|
|Central and Peripheral Nervous System||26.4%||20.5%|
|Body As a Whole-General||29.1%||22.2%|
|Metabolic and Nutritional||9.3%||9.7%|
|Reproductive, Female||8.5% (4 of 47 females)||11.5% (6 of 52 females)|
|Skin and Appendages||17.6%||15.1%|
|Bronchospasm, Coughing, Dyspnea, Rhinitis||5.0%||4.9%|
|White cell and RES||4.4%||2.7%|
|*Total percentage of events within the system
**Newly occurring hypertension=SBP ≥ 160 mm Hg and/or DBP ≥ 90 mm Hg
The following events occurred in 1% to less than 3% of psoriasis patients treated with cyclosporine:
Body as a Whole: fever, flushes, hot flushes
Cardiovascular: chest pain
Central and Peripheral Nervous System: appetite increased, insomnia, dizziness, nervousness, vertigo
Gastrointestinal: abdominal distention, constipation, gingival bleeding
Liver and Biliary System: hyperbilirubinemia
Neoplasms: skin malignancies [squamous cell (0.9%) and basal cell (0.4%) carcinomas]
Reticuloendothelial: platelet, bleeding, and clotting disorders, red blood cell disorder
Respiratory: infection, viral and other infection
Skin and Appendages: acne, folliculitis, keratosis, pruritus, rash, dry skin
Urinary System: micturition frequency
Vision: abnormal vision
Mild hypomagnesemia and hyperkalemia may occur but are asymptomatic. Increases in uric acid may occur and attacks of gout have been rarely reported. A minor and dose related hyperbilirubinemia has been observed in the absence of hepatocellular damage. Cyclosporine therapy may be associated with a modest increase of serum triglycerides or cholesterol. Elevations of triglycerides ( > 750 mg/dL) occur in about 15% of psoriasis patients; elevations of cholesterol ( > 300 mg/dL) are observed in less than 3% of psoriasis patients. Generally these laboratory abnormalities are reversible upon dose reduction or discontinuation of cyclosporine.
Postmarketing Experience, Psoriasis
Read the entire FDA prescribing information for Gengraf Capsules (Cyclosporine Capsules)
Additional Gengraf Capsules Information
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