Mycophenolate Side Effects

Please note - some side effects for Mycophenolate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Mycophenolate - for the Consumer

Mycophenolate Mofetil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mycophenolate Mofetil:

Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Mycophenolate Mofetil:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, blood in the urine; difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Mycophenolate Mofetil Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mycophenolate Mofetil Capsules:

Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Mycophenolate Mofetil Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, blood in the urine; difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Mycophenolate Mofetil Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mycophenolate Mofetil Solution:

Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; pain, redness, or swelling at the injection site; tremor; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Mycophenolate Mofetil Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual skin lumps or growths; unusual tiredness or weakness; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Mycophenolate Mofetil Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mycophenolate Mofetil Suspension:

Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Mycophenolate Mofetil Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual skin lumps or growths; unusual tiredness or weakness; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Mycophenolate Side Effects - for the Professional

Mycophenolate

The principal adverse reactions associated with the administration of Mycophenolate mofetil include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection.The adverse event profile associated with the administration of Mycophenolate mofetil intravenous has been shown to be similar to that observed after administration of oral dosage forms of Mycophenolate mofetil.

Mycophenolate Mofetil Oral

The incidence of adverse events for Mycophenolate mofetil was determined in randomized, comparative, double-blind trials in prevention of rejection in renal (2 active, 1 placebo-controlled trials), cardiac (1 active-controlled trial), and hepatic (1 active-controlled trial) transplant patients.

Geriatrics

Elderly patients (≥ 65 years), particularly those who are receiving Mycophenolate mofetil as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus [CMV] tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared to younger individuals.

Safety data are summarized below for all active-controlled trials in renal (2 trials), cardiac (1 trial), and hepatic (1 trial) transplant patients. Approximately 53% of the renal patients, 65% of the cardiac patients, and 48% of the hepatic patients have been treated for more than 1 year. Adverse events reported in ≥ 20% of patients in the Mycophenolate mofetil treatment groups are presented below.

 

Table 8 Adverse Events in Controlled Studies in Prevention of Renal, Cardiac or Hepatic Allograft Rejection (Reported in ≥ 20% of Patients in the Mycophenolate Mofetil Group)

	Renal Studies			Cardiac Study		Hepatic Study
	Mycophenolate mofetil 2 g/day	Mycophenolate mofetil 3 g/day	Azathioprine 1 to 2 mg/kg/day or 100 to 150 mg/day	Mycophenolate mofetil 3 g/day	Azathioprine 1.5 to 3 mg/kg/day	Mycophenolate mofetil 3 g/day	Azathioprine 1 to 2 mg/kg/day
	(n=336)	(n=330)	(n=326)	(n=289)	(n=289)	(n=277)	(n=287)
	%	%	%	%	%	%	%
Body as a Whole
Pain	33	31.2	32.2	75.8	74.7	74	77.7
Abdominal pain	24.7	27.6	23	33.9	33.2	62.5	51.2
Fever	21.4	23.3	23.3	47.4	46.4	52.3	56.1
Headache	21.1	16.1	21.2	54.3	51.9	53.8	49.1
Infection	18.2	20.9	19.9	25.6	19.4	27.1	25.1
Sepsis	–	–	–	–	–	27.4	26.5
Asthenia	–	–	–	43.3	36.3	35.4	33.8
Chest pain	–	–	–	26.3	26	–	–
Back pain	–	–	–	34.6	28.4	46.6	47.4
Ascites	–	–	–	–	–	24.2	22.6
Hematologic and Lymphatic
Anemia	25.6	25.8	23.6	42.9	43.9	43	53
Leukopenia	23.2	34.5	24.8	30.4	39.1	45.8	39
Thrombocytopenia	–	–	–	23.5	27	38.3	42.2
Hypochromic anemia	–	–	–	24.6	23.5	–	–
Leukocytosis	–	–	–	40.5	35.6	22.4	21.3
Urogenital
Urinary tract infection	37.2	37	33.7	–	–	–	–
Kidney function abnormal	–	–	–	21.8	26.3	25.6	28.9
Cardiovascular
Hypertension	32.4	28.2	32.2	77.5	72.3	62.1	59.6
Hypotension	–	–	–	32.5	36	–	–
Cardiovascular disorder	–	–	–	25.6	24.2	–	–
Tachycardia	–	–	–	20.1	18	22	15.7
Metabolic and Nutritional
Peripheral edema	28.6	27	28.2	64	53.3	48.4	47.7
Hyper-cholesteremia	–	–	–	41.2	38.4	–	–
Edema	–	–	–	26.6	25.6	28.2	28.2
Hypokalemia	–	–	–	31.8	25.6	37.2	41.1
Hyperkalemia	–	–	–	–	–	22	23.7
Hyperglycemia	–	–	–	46.7	52.6	43.7	48.8
Creatinine increased	–	–	–	39.4	36	–	–
BUN increased	–	–	–	34.6	32.5	–	–
Lactic dehydrogenase increased	–	–	–	23.2	17	–	–
Hypomagnesemia	–	–	–	–	–	39	37.6
Hypocalcemia	–	–	–	–	–	30	30
Digestive
Diarrhea	31	36.1	20.9	45.3	34.3	51.3	49.8
Constipation	22.9	18.5	22.4	41.2	37.7	37.9	38.3
Nausea	19.9	23.6	24.5	54	54.3	54.5	51.2
Dyspepsia	–	–	–	–	–	22.4	20.9
Vomiting	–	–	–	33.9	28.4	32.9	33.4
Anorexia	–	–	–	–	–	25.3	17.1
Liver function tests abnormal	–	–	–	–	–	24.9	19.2
Respiratory
Infection	22	23.9	19.6	37	35.3	–	–
Dyspnea	–	–	–	36.7	36.3	31	30.3
Cough increased	–	–	–	31.1	25.6	–	–
Lung disorder	–	–	–	30.1	29.1	22	18.8
Sinusitis	–	–	–	26	19	–	–
Pleural effusion	–	–	–	–	–	34.3	35.9
Skin and Appendages
Rash	–	–	–	22.1	18	–	–
Nervous System
Tremor	–	–	–	24.2	23.9	33.9	35.5
Insomnia	–	–	–	40.8	37.7	52.3	47
Dizziness	–	–	–	28.7	27.7	–	–
Anxiety	–	–	–	28.4	23.9	–	–
Paresthesia	–	–	–	20.8	18	–	–

The placebo-controlled renal transplant study generally showed fewer adverse events occurring in ≥20% of patients. In addition, those that occurred were not only qualitatively similar to the azathioprine-controlled renal transplant studies, but also occurred at lower rates, particularly for infection, leukopenia, hypertension, diarrhea and respiratory infection.

The above data demonstrate that in three controlled trials for prevention of renal rejection, patients receiving 2 g/day of Mycophenolate mofetil had an overall better safety profile than did patients receiving 3 g/day of Mycophenolate mofetil.

The above data demonstrate that the types of adverse events observed in multicenter controlled trials in renal, cardiac, and hepatic transplant patients are qualitatively similar except for those that are unique to the specific organ involved.

Sepsis, which was generally CMV viremia, was slightly more common in renal transplant patients treated with Mycophenolate mofetil compared to patients treated with azathioprine. The incidence of sepsis was comparable in Mycophenolate mofetil and in azathioprine-treated patients in cardiac and hepatic studies.

In the digestive system, diarrhea was increased in renal and cardiac transplant patients receiving Mycophenolate mofetil compared to patients receiving azathioprine, but was comparable in hepatic transplant patients treated with Mycophenolate mofetil or azathioprine.

Patients receiving Mycophenolate mofetil alone or as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin. The incidence of malignancies among the 1483 patients treated in controlled trials for the prevention of renal allograft rejection who were followed for ≥1 year was similar to the incidence reported in the literature for renal allograft recipients.

Lymphoproliferative disease or lymphoma developed in 0.4% to 1% of patients receiving Mycophenolate mofetil (2 g or 3 g daily) with other immunosuppressive agents in controlled clinical trials of renal, cardiac, and hepatic transplant patients followed for at least 1 year. Non-melanoma skin carcinomas occurred in 1.6% to 4.2% of patients, other types of malignancy in 0.7% to 2.1% of patients. Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.

In pediatric patients, no other malignancies besides lymphoproliferative disorder (2/148 patients) have been observed.

Severe neutropenia (ANC <0.5 × 103/µL) developed in up to 2% of renal transplant patients, up to 2.8% of cardiac transplant patients and up to 3.6% of hepatic transplant patients receiving Mycophenolate mofetil 3 g daily.

All transplant patients are at increased risk of opportunistic infections. The risk increases with total immunosuppressive load. Table 9 shows the incidence of opportunistic infections that occurred in the renal, cardiac, and hepatic transplant populations in the azathioprine-controlled prevention trials:

Table 9 Viral and Fungal Infections in Controlled Studies in Prevention of Renal, Cardiac or Hepatic Transplant Rejection

	Renal Studies			Cardiac Study		Hepatic Study
	Mycophenolate mofetil 2 g/day	Mycophenolate mofetil 3 g/day	Azathioprine 1 to 2 mg/kg/day or 100 to 150 mg/day	Mycophenolate mofetil 3 g/day	Azathioprine 1.5 to 3 mg/kg/day	Mycophenolate mofetil 3 g/day	Azathioprine 1 to 2 mg/kg/day
	(n=336)	(n=330)	(n=326)	(n=289)	(n=289)	(n=277)	(n=287)
	%	%	%	%	%	%	%
Herpes simplex	16.7	20	19	20.8	14.5	10.1	5.9
CMV
– Viremia/    syndrome	13.4	12.4	13.8	12.1	10	14.1	12.2
– Tissue invasive    disease	8.3	11.5	6.1	11.4	8.7	5.8	8
Herpes zoster	6	7.6	5.8	10.7	5.9	4.3	4.9
– Cutaneous    disease	6	7.3	5.5	10	5.5	4.3	4.9
Candida	17	17.3	18.1	18.7	17.6	22.4	24.4
– Mucocutaneous	15.5	16.4	15.3	18	17.3	18.4	17.4

The following other opportunistic infections occurred with an incidence of less than 4% in Mycophenolate mofetil patients in the above azathioprine-controlled studies: Herpes zoster, visceral disease; Candida, urinary tract infection, fungemia/disseminated disease, tissue invasive disease; Cryptococcosis; Aspergillus/Mucor; Pneumocystis carinii.

In the placebo-controlled renal transplant study, the same pattern of opportunistic infection was observed compared to the azathioprine-controlled renal studies, with a notably lower incidence of the following: Herpes simplex and CMV tissue-invasive disease.

In patients receiving Mycophenolate mofetil (2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic rejection, fatal infection/sepsis occurred in approximately 2% of renal and cardiac patients and in 5% of hepatic patients.

In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with Mycophenolate mofetil than in those receiving azathioprine, but this difference was not associated with excess mortality due to infection/sepsis among patients treated with Mycophenolate mofetil.

The following adverse events were reported with 3% to <20% incidence in renal, cardiac, and hepatic transplant patients treated with Mycophenolate mofetil, in combination with cyclosporine and corticosteroids.

Table 10 Adverse Events Reported in 3% to < 20% of Patients Treated With Mycophenolate Mofetil in Combination With Cyclosporine and Corticosteroids

Body System
Body as a Whole	abdomen enlarged, abscess, accidental injury, cellulitis, chills occurring with fever, cyst, face edema, flu syndrome, hemorrhage, hernia, lab test abnormal, malaise, neck pain, pelvic pain, peritonitis
Hematologic and Lymphatic	coagulation disorder, ecchymosis, pancytopenia, petechia, polycythemia, prothrombin time increased, thromboplastin time increased
Urogenital	acute kidney failure, albuminuria, dysuria, hydronephrosis, hematuria, impotence, kidney failure, kidney tubular necrosis, nocturia, oliguria, pain, prostatic disorder, pyelonephritis, scrotal edema, urine abnormality, urinary frequency, urinary incontinence, urinary retention, urinary tract disorder
Cardiovascular	angina pectoris, arrhythmia, arterial thrombosis, atrial fibrillation, atrial flutter, bradycardia, cardiovascular disorder, congestive heart failure, extrasystole, heart arrest, heart failure, hypotension, pallor, palpitation, pericardial effusion, peripheral vascular disorder, postural hypotension, pulmonary hypertension, supraventricular tachycardia, supraventricular extrasystoles, syncope, tachycardia, thrombosis, vasodilatation, vasospasm, ventricular extrasystole, ventricular tachycardia, venous pressure increased
Metabolic and Nutritional	abnormal healing, acidosis, alkaline phosphatase increased, alkalosis, bilirubinemia, creatinine increased, dehydration, gamma glutamyl transpeptidase increased, generalized edema, gout, hypercalcemia, hypercholesteremia, hyperlipemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypochloremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, hypovolemia, hypoxia, lactic dehydrogenase increased, respiratory acidosis, SGOT increased, SGPT increased, thirst, weight gain, weight loss
Digestive	anorexia, cholangitis, cholestatic jaundice, dysphagia, esophagitis, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, gum hyperplasia, hepatitis, ileus, infection, jaundice, liver damage, liver function tests abnormal, melena, mouth ulceration, nausea and vomiting, oral moniliasis, rectal disorder, stomach ulcer, stomatitis
Respiratory	apnea, asthma, atelectasis, bronchitis, epistaxis, hemoptysis, hiccup, hyperventilation, lung edema, lung disorder, neoplasm, pain, pharyngitis, pleural effusion, pneumonia, pneumothorax, respiratory disorder, respiratory moniliasis, rhinitis, sinusitis, sputum increased, voice alteration
Skin and Appendages	acne, alopecia, fungal dermatitis, hemorrhage, hirsutism, pruritus, rash, skin benign neoplasm, skin carcinoma, skin disorder, skin hypertrophy, skin ulcer, sweating, vesiculobullous rash
Nervous	agitation, anxiety, confusion, convulsion, delirium, depression, dry mouth, emotional lability, hallucinations, hypertonia, hypesthesia, nervousness, neuropathy, paresthesia, psychosis, somnolence, thinking abnormal, vertigo
Endocrine	Cushing's syndrome, diabetes mellitus, hypothyroidism, parathyroid disorder
Musculoskeletal	arthralgia, joint disorder, leg cramps, myalgia, myasthenia, osteoporosis
Special Senses	abnormal vision, amblyopia, cataract (not specified), conjunctivitis, deafness, ear disorder, ear pain, eye hemorrhage, tinnitus, lacrimation disorder

 

Pediatrics

The type and frequency of adverse events in a clinical study in 100 pediatric patients 3 months to 18 years of age dosed with Mycophenolate mofetil oral suspension 600 mg/m2 bid (up to 1 g bid) were generally similar to those observed in adult patients dosed with Mycophenolate mofetil capsules at a dose of 1 g bid with the exception of abdominal pain, fever, infection, pain, sepsis, diarrhea, vomiting, pharyngitis, respiratory tract infection, hypertension, leukopenia, and anemia, which were observed in a higher proportion in pediatric patients.

Mycophenolate Mofetil Intravenous

The adverse event profile of Mycophenolate mofetil intravenous was determined from a single, double-blind, controlled comparative study of the safety of 2 g/day of intravenous and oral Mycophenolate mofetil in renal transplant patients in the immediate posttransplant period (administered for the first 5 days). The potential venous irritation of Mycophenolate mofetil intravenous was evaluated by comparing the adverse events attributable to peripheral venous infusion of Mycophenolate mofetil intravenous with those observed in the intravenous placebo group; patients in this group received active medication by the oral route.

Adverse events attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with Mycophenolate mofetil intravenous.

In the active controlled study in hepatic transplant patients, 2 g/day of Mycophenolate mofetil intravenous were administered in the immediate posttransplant period (up to 14 days). The safety profile of intravenous Mycophenolate mofetil was similar to that of intravenous azathioprine.

Postmarketing Experience

Congenital Disorders

Congenital malformations including ear malformations have been reported in offspring of patients exposed to Mycophenolate mofetil during pregnancy.

Digestive

Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy.

Hematologic and Lymphatic

Cases of pure red cell aplasia (PRCA) have been reported in patients treated with Mycophenolate mofetil in combination with other immunosuppressive agents.

Infections

Serious life-threatening infections such as meningitis and infectious endocarditis have been reported occasionally and there is evidence of a higher frequency of certain types of serious infections such as tuberculosis and atypical mycobacterial infection. Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with Mycophenolate mofetil. The reported cases generally had risk factors for PML, including treatment with immunosuppressant therapies and impairment of immune function. BK virus-associated nephropathy has been observed in patients receiving immunosuppressants, including Mycophenolate mofetil. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.

Respiratory

Interstitial lung disorders, including fatal pulmonary fibrosis, have been reported rarely and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in posttransplant patients receiving Mycophenolate mofetil.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects appear to have been dose related.

A well designed, placebo-controlled study of mycophenolate (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for prevention of acute renal allograft rejection reported a similar frequency of adverse events. There was a trend towards more diarrhea (16% vs. 12%), nausea (6% vs. 3%), gastroenteritis (4% vs. 1%), and vomiting (4% vs. 1%) in the mycophenolate group, especially with the higher dose. Gastrointestinal, rectal, and duodenal hemorrhage, hemorrhagic pancreatitis and large intestine perforation occurred rarely and only in the mycophenolate mofetil group. In general, adverse effects occurred with a higher frequency as the dose was increased above 2 grams per day. Mycophenolate mofetil should be used cautiously in patients with active gastrointestinal disease.

Gastrointestinal side effects including diarrhea (36%), nausea (20%), and vomiting (13%) have been the most common side effects. A case of mycophenolate mofetil-induced ischemic colitis also has been reported.

Hematologic

A well designed, placebo-controlled study noted that hematologic adverse events resolved within one week. Hematologic side effects tend to occur early in the course of treatment and be dose-related. Careful monitoring of hematologic parameters may be warranted early in the course of therapy.

A well designed, placebo-controlled study of mycophenolate mofetil (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for prevention of acute renal allograft rejection reported a similar frequency of adverse events. A trend towards higher frequencies of leukopenia (11% to 14%) and anemia (4% to 7%) were reported in the active groups. Pancytopenia and agranulocytosis occurred rarely. The proportion of patients with leukopenia between 31 and 180 days after transplantation was 3 times higher in the mycophenolate mofetil group. All observed hematologic effects resolved within one week. Adverse effects occur with a higher frequency as the dose exceeds 2 grams/day.

Hematologic side effects have included dose-related leukopenia (11% to 35%), anemia (25%), and thrombocytopenia (9%). Severe neutropenia has occurred in up to 2% of patients. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressive agents. A case in of mycophenolate mofetil causing deep venous thrombosis has also been reported.

Immunologic

Immunologic side effects have included immunosuppression. Immunosuppression associated with therapy has resulted in sepsis (primarily cytomegalovirus viremia) in approximately 20% of patients. Other opportunistic infections have included herpes simplex virus (18%), herpes zoster (7%), and invasive candidal infections (1%).

On a positive note, mycophenolate has been found to delay the recurrence of hepatitis C in liver transplant recipients.

Immunosuppression appeared to be dose-related.

In three controlled studies for the prevention of rejection, similar rates of fatal infections/sepsis (less than 2%) occurred in patients receiving mycophenolate mofetil or the control drug (usually azathioprine) in addition to other immunosuppressives. A well designed, placebo-controlled study of mycophenolate mofetil (2 or 3 grams daily) combined with cyclosporine and corticosteroids versus cyclosporine and corticosteroids alone for the prevention of acute renal allograft rejection reported a similar frequency of adverse events. Cytomegalovirus tissue-invasive disease (7%), herpes zoster (7%), and herpes simplex (15%) showed a trend towards a higher frequency in the mycophenolate mofetil group. In general, adverse effects occur with a higher frequency as the dose is increased above 2 grams per day.

Oncologic

Oncologic side effects including lymphoma and lymphoproliferative disease (1%) and non-melanoma skin carcinoma (2% to 4%) have been associated with therapy.

The incidence of new malignancies in patients receiving mycophenolate mofetil followed for greater than 1 year was similar to that reported in the literature for renal allograft recipients.

Renal

Epinette, et al reported a long-term follow up (to 13 years) of patients treated with mycophenolate mofetil on a compassionate-use basis for psoriasis. Dosages averaged between 3 and 4 grams daily (range 2 to 7 grams), higher than the currently recommended dose for renal transplant patients. Dysuria, urgency, and frequency occurred in 28% of patients during the first year and decreased to less than 5% thereafter. Subsequent dose reductions after the first year lessened renal adverse effects considerably.

Renal side effects have included urinary tract infections (37% to 45%), hematuria (13%), and kidney tubular necrosis (6% to 10%).

BK virus-associated nephropathy has been reported. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.

Metabolic

Metabolic side effects have included edema (12% to 28%), hyperphosphatemia (13%), hypokalemia (10%), hyperglycemia (10%), and hyperkalemia (9%).

Respiratory

Respiratory system side effects have included respiratory infection (23%), dyspnea (16%), and increased cough (16%). A case of primary tuberculosis one year after conversion from azathioprine to mycophenolate mofetil has also been reported.

Dermatologic

Dermatologic side effects including acne (10%) and rash (8%) have been reported in clinical trials. A case of dyshidrotic eczema has been reported. A case of papulosquamous psoriatic-like skin eruption has also been reported.

Musculoskeletal

Musculoskeletal side effects including a case of mycophenolate mofetil induced myopathy have been reported.

Other

Abdominal pain has been reported to be a critical complication of mycophenolate mofetil in renal transplant recipients.

Other side effects have included abdominal pain.

Hepatic

Hepatic side effects including a case of mycophenolate sodium-induced hepatotoxicity have been reported.

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