Myfortic
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Myfortic
Myfortic Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Myfortic (mycophenolic acid) is used to prevent the body from rejecting a kidney transplant. This medication is usually given with cyclosporine and a steroid medication. It is an immunosuppressive agent. Common side effects include constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, or trouble sleeping.
The recommended dose of Myfortic is 720 mg administered twice daily (1440 mg total daily dose) on an empty stomach, one hour before or two hours after food intake may interact with cholestyramine, colesevelam, colestipol, acyclovir, ganciclovir, or other medicines that weaken the immune system. Tell your doctor all medications and supplements you use. Myfortic is not recommended for use during pregnancy because of possible harm to the fetus. Women should have a negative pregnancy test within 1 week of starting this medication. Use two forms of birth control starting 4 weeks before beginning therapy, and continue for at least 6 weeks after stopping. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug and for 6 weeks after stopping.
Our Myfortic (mycophenolic acid) 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.
Myfortic in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with mycophenolic acid. Call your doctor right away if you have signs of infection such as:
- fever, flu symptoms, runny or stuffy nose, cough, sore throat, swollen glands;
- stomach pain, vomiting, diarrhea, weight loss;
- ear pain, headache;
- white patches or sores in your mouth or throat;
- pale skin, easy bruising or unusual bleeding;
- confusion, change in your mental state, problems with vision, speech, memory, balance, or walking;
- weakness in your legs, lack of coordination;
- blood in your urine, pain or burning when you urinate;
- swelling, warmth, redness, or oozing around a skin wound; or
- a new bump or lesion on your skin, or a mole that has changed in size or color.
Call your doctor at once if you have a serious side effect such as:
- rapid heart rate, rapid and shallow breathing, fainting;
- coughing up blood or vomit that looks like coffee grounds;
- bloody, black, or tarry stools;
- thirst, increased urination, hot and dry skin;
- chest pain, dry cough, wheezing, feeling short of breath;
- feeling like you might pass out;
- slow or uneven heart rate, weak pulse, tingly feeling, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
- pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate).
Less serious side effects may include:
- constipation, weight gain;
- joint or muscle pain, back pain;
- dizziness, anxiety, sleep problems (insomnia); or
- swelling in your hands or feet.
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 Myfortic (Mycophenolic Acid) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Myfortic Overview - Patient Information: Side Effects
Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, or trouble sleeping 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.
Because this medication weakens your immune system, you are more likely to develop infections which may be serious. Tell your doctor immediately if you develop any of the following signs of infection: persistent sore throat/fever, night sweats, flu-like symptoms, painful urination, vision changes, a sore or wound on the skin that feels warm/tender/painful and appears reddened.
This drug increases the risk of a rare and possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, fast/irregular heartbeat, muscle weakness, easy bleeding/bruising, swelling of the feet or ankles, mental/mood changes, weakness on one side of the body, unusual change in the amount of urine.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, shortness of breath/rapid breathing.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may 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 Myfortic (Mycophenolic Acid)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Myfortic FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The incidence of adverse events for Myfortic® (mycophenolic acid) was determined in randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and maintenance kidney transplant patients.
The principal adverse reactions associated with the administration of Myfortic include constipation, nausea, and urinary tract infection in de novo patients and nausea, diarrhea and nasopharyngitis in maintenance patients.
Adverse events reported in ≥ 20% of patients receiving Myfortic or mycophenolate mofetil in the 12-month de novo renal study and maintenance renal study, when used in combination with cyclosporine, USP (MODIFIED) and corticosteroids, are listed in Table 5. Adverse event rates were similar between Myfortic and mycophenolate mofetil in both de novo and maintenance patients.
Table 5 : Adverse Events (%) in Controlled de novo and
Maintenance Renal Studies Reported in ≥ 20% of Patients
| de novo Renal Study | Maintenance Renal Study | |||
| Myfortic® 1.44 g/day (n=213) |
mycophenolate mofetil 2 g/day (n=210) |
Myfortic® 1.44 g/day (n=159) |
mycophenolate mofetil 2 g/day (n=163) |
|
| Blood and Lymphatic System Disorders | ||||
| Anemia | 21.6 | 21.9 | - | - |
| Leukopenia | 19.2 | 20.5 | - | - |
| Constipation | 38.0 | 39.5 | - | - |
| Nausea | 29.1 | 27.1 | 24.5 | 19.0 |
| Diarrhea | 23.5 | 24.8 | 21.4 | 24.5 |
| Vomiting | 23.0 | 20.0 | - | - |
| Dyspepsia | 22.5 | 19.0 | - | - |
| Urinary Tract Infection | 29.1 | 33.3 | - | - |
| CMV Infection | 20.2 | 18.1 | - | - |
| Insomnia | 23.5 | 23.8 | - | - |
| Postoperative Pain | 23.9 | 18.6 | ||
Table 6 summarizes the incidence of opportunistic infections in de novo and maintenance transplant patients, which were similar in both treatment groups.
Table 6 : Viral and Fungal Infections (%) Reported Over 0-12 Months
| de novo Renal Study | Maintenance Renal Study | |||
| Myfortic® 1.44 g/day (n = 213) (%) |
mycophenolate mofetil 2 g/day (n = 210) (%) |
Myfortic® 1.44 g/day (n = 159) (%) |
mycophenolate mofetil 2 g/day (n = 163) (%) |
|
| Any Cytomegalovirus | 21.6 | 20.5 | 1.9 | 1.8 |
| - Cytomegalovirus Disease | 4.7 | 4.3 | 0 | 0.6 |
| Herpes Simplex | 8.0 | 6.2 | 1.3 | 2.5 |
| Herpes Zoster | 4.7 | 3.8 | 1.9 | 3.1 |
| Any Fungal Infection | 10.8 | 11.9 | 2.5 | 1.8 |
| - Candida NOS | 5.6 | 6.2 | 0 | 1.8 |
| - Candida Albicans | 2.3 | 3.8 | 0.6 | 0 |
The following opportunistic infections occurred rarely in the above controlled trials: aspergillus and cryptococcus.
The incidence of malignancies and lymphoma is consistent with that reported in the literature for this patient population. Lymphoma developed in 2 de novo patients (0.9%), (one diagnosed 9 days after treatment initiation) and in 2 maintenance patients (1.3%) (one was AIDS-related), receiving Myfortic with other immunosuppressive agents in the 12-month controlled clinical trials. Nonmelanoma skin carcinoma occurred in 0.9% de novo and 1.8% maintenance patients. Other types of malignancy occurred in 0.5% de novo and 0.6% maintenance patients.
The following adverse events were reported between 3% to < 20% incidence in de novo and maintenance patients treated with Myfortic in combination with cyclosporine and corticosteroids are listed in Table 7.
Table 7 : Adverse Events
Reported in 3% to < 20% of Patients Treated with Myfortic® in
Combination with Cyclosporine* and Corticosteroids
| de novo Renal Study | Maintenance Renal Study | |
| Blood and Lymphatic Disorders | Lymphocele, thrombocytopenia | Leukopenia, anemia |
| Cardiac Disorder | Tachycardia | - |
| Eye Disorder | Vision blurred | - |
| Endocrine Disorders | Cushingoid, hirsutism | - |
| Gastrointestinal Disorders | Abdominal pain upper, flatulence, abdominal distension, sore throat, abdominal pain lower, abdominal pain, gingival hyperplasia, loose stool | Vomiting, dyspepsia, abdominal pain, constipation, gastroesophageal reflux disease, loose stool, flatulence, abdominal pain upper |
| General Disorders and Administration Site Conditions | Edema, edema lower limb, pyrexia, pain, fatigue, edema peripheral, chest pain | Fatigue, pyrexia, edema, chest pain, peripheral edema |
| Infections and Infestations | Nasopharyngitis, herpes simplex, upper respiratory tract infection, oral candidiasis, herpes zoster, sinusitis, wound infection, implant infection, pneumonia | Nasopharyngitis, upper respiratory tract infection, urinary tract infection, influenza, sinusitis |
| Injury, Poisoning, and Procedural Complications | Drug toxicity | Postprocedural pain |
| Investigations | Blood creatinine increased hemoglobin decrease, blood pressure increased, liver function tests abnormal | Blood creatinine increase, weight increase |
| Metabolism and Nutrition Disorders | Hypocalcemia, hyperuricemia, hyperlipidemia, hypokalemia, hypophosphatemia hypercholesterolemia, hyperkalemia, hypomagnesemia, diabetes mellitus, hyperphosphatemia, dehydration, fluid overload, hyperglycemia, hypercalcemia | Dehydration, hypokalemia, hypercholesterolemia |
| Musculoskeletal and Connective Tissue Disorders | Back pain, arthralgia, pain in limb, muscle cramps, myalgia | Arthralgia, pain in limb, back pain, muscle cramps, peripheral swelling, myalgia |
| Nervous System Disorders | Tremor, headache, dizziness (excluding vertigo) | Headache, dizziness |
| Psychiatric Disorders | Anxiety | Insomnia, depression |
| Renal and Urinary Disorders | Renal tubular necrosis, renal impairment, dysuria, hematuria, hydronephrosis, bladder spasm, urinary retention | - |
| Respiratory, Thoracic and Mediastinal Disorders | Cough, dyspnea, dyspnea exertional | Cough, dyspnea, pharyngolaryngeal pain, sinus congestion |
| Skin and Subcutaneous Tissue Disorders | Acne, pruritus | Rash, contusion |
| Surgical and Medical Procedures | Complications of transplant surgery, postoperative complications, postoperative wound complication | - |
| Vascular Disorders | Hypertension, hypertension aggravated, hypotension | Hypertension |
| *USP (MODIFIED) | ||
The following additional adverse reactions have been associated with the exposure to MPA when administered as a sodium salt or as mofetil ester:
Gastrointestinal: Colitis (sometimes caused by CMV), pancreatitis, esophagitis, intestinal perforation, gastrointestinal hemorrhage, gastric ulcers, duodenal ulcers, and ileus (see PRECAUTIONS).
Resistance Mechanism Disorders: 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.
Respiratory: Interstitial lung disorders, including fatal pulmonary fibrosis, have been reported rarely with MPA administration and should be considered in the differential diagnosis of pulmonary symptoms ranging from dyspnea to respiratory failure in posttransplant patients receiving MPA derivatives.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Myfortic. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
Congenital disorder: Embryofetal toxicity: Congenital malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to mycophenolate mofetil (MMF) during pregnancy (see PRECAUTIONS: Pregnancy).
Infections: Polyomavirus associated nephropathy (PVAN), especially due to BK virus infection, has been observed in patients receiving immunosuppressants, including Myfortic. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss (see WARNINGS, Polyomavirus Infections). Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with MPA derivatives (see WARNINGS, Polyomavirus Infections).
Hematologic: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives in combination with other immunosuppressive agents (see WARNINGS).
Dermatologic: Cases of rash have been reported in patients treated with MPA derivatives.
Read the entire FDA prescribing information for Myfortic (Mycophenolic Acid) »
Additional Myfortic Information
Myfortic - User Reviews
Myfortic User Reviews
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