Myfortic Side Effects Center

Last updated on RxList: 3/29/2022
Myfortic Side Effects Center

What Is Myfortic?

Myfortic (mycophenolic acid) is an immunosuppressive agent used to prevent the body from rejecting a kidney transplant. Myfortic is usually given with cyclosporine and a steroid medication.

What Are Side Effects of Myfortic?

Common side effects of Myfortic include:

  • constipation,
  • nausea,
  • headache,
  • diarrhea,
  • vomiting,
  • stomach upset,
  • gas,
  • trouble sleeping (insomnia),
  • weight gain,
  • joint or muscle pain,
  • back pain,
  • dizziness,
  • anxiety, or
  • swelling in your hands or feet.

Tell your doctor if you develop any signs of infection after taking Myfortic, including persistent sore throat or fever, night sweats, flu-like symptoms, painful urination, vision changes, or a sore or wound on the skin that feels warm/tender/painful and appears reddened.

Dosage for Myfortic

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.

What Drugs, Substances, or Supplements Interact with Myfortic?

Myfortic 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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Myfortic Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mycophenolic acid may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Mycophenolic acid affects your immune system and may increase your risk of cancer or serious infection. Call your doctor right away if you have:

  • fever of 100.5 degrees F or higher, swollen glands, painful mouth sores, cold or flu symptoms, headache, ear pain;
  • stomach pain, vomiting, diarrhea, weight loss;
  • weakness on one side of your body, loss of muscle control;
  • confusion, thinking problems, loss of interest in things that normally interest you;
  • pain or burning when you urinate;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • pain or tenderness around the transplanted kidney;
  • tingly or painful blistering rash on one side of your body;
  • swelling, warmth, redness, or oozing around a skin wound; or
  • a new skin lesion, or a mole that has changed in size or color.

Also call your doctor at once if you have:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects may include:

  • upset stomach, nausea, vomiting;
  • diarrhea, constipation;
  • low blood cell counts, infections;
  • sleep problems (insomnia);
  • painful urination; or
  • pain after surgery.

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)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Myfortic Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label.

  • Embryo-Fetal Toxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Lymphomas and Other Malignancies [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • Serious Infections [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
  • New or Reactivated Viral Infections [see WARNINGS AND PRECAUTIONS]
  • Blood Dyscrasias, Including Pure Red Cell Aplasia [see WARNINGS AND PRECAUTIONS]
  • Serious GI Tract Complications [see WARNINGS AND PRECAUTIONS]
  • Acute Inflammatory Syndrome Associated with Mycophenolate Products [see WARNINGS AND PRECAUTIONS]
  • Rare Hereditary Deficiencies [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below derive from two randomized, comparative, active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and converted stable kidney transplant patients.

In the de novo trial, patients were administered either Myfortic 1.44 grams per day (N = 213) or MMF 2 grams per day (N = 210) within 48 hours post-transplant for 12 months in combination with cyclosporine, USP MODIFIED and corticosteroids. Forty-one percent of patients also received antibody therapy as induction treatment. In the conversion trial, renal transplant patients who were at least 6 months post-transplant and receiving 2 grams per day MMF in combination with cyclosporine USP MODIFIED, with or without corticosteroids for at least two weeks prior to entry in the trial were randomized to Myfortic 1.44 grams per day (N = 159) or MMF 2 grams per day (N = 163) for 12 months.

The average age of patients in both studies was 47 years and 48 years (de novo study and conversion study, respectively), ranging from 22 to 75 years. Approximately 66% of patients were male; 82% were white, 12% were black, and 6% other races. About 40% of patients were from the United States and 60% from other countries.

In the de novo trial, the overall incidence of discontinuation due to adverse reactions was 18% (39/213) and 17% (35/210) in the Myfortic and MMF arms, respectively. The most common adverse reactions leading to discontinuation in the Myfortic arm were graft loss (2%), diarrhea (2%), vomiting (1%), renal impairment (1%), CMV infection (1%), and leukopenia (1%). The overall incidence of patients reporting dose reduction at least once during the 0- to 12-month study period was 59% and 60% in the Myfortic and MMF arms, respectively. The most frequent reasons for dose reduction in the Myfortic arm were adverse reactions (44%), dose reductions according to protocol guidelines (17%), dosing errors (11%) and missing data (2%).

The most common adverse reactions (≥ 20%) associated with the administration of Myfortic were anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.

The adverse reactions reported in ≥ 10% of patients in the de novo trial are presented in Table 2 below.

Table 2: Adverse Reactions (%) Reported in ≥ 10% of de novo Kidney Transplant Patients in Either Treatment Group

System Organ Class
Adverse drug reactions
de novo Renal Trial**
Myfortic 1.44 grams per day
(n = 213) (%)
mycophenolate mofetil (MMF) 2 grams per day
(n = 210) (%)
Blood and Lymphatic System Disorders
Anemia 22 22
Leukopenia 19 21
Gastrointestinal System Disorders
Constipation 38 40
Nausea 29 27
Diarrhea 24 25
Vomiting 23 20
Dyspepsia 23 19
Abdominal pain upper 14 14
Flatulence 10 13
General and Administrative Site Disorders
Edema 17 18
Edema lower limb 16 17
Pyrexia 13 19
Investigations
Increased blood creatinine 15 10
Infections and Infestations
Urinary tract infection 29 33
CMV infection 20 18
Metabolism and Nutrition Disorders
Hypocalcemia 11 15
Hyperuricemia 13 13
Hyperlipidemia 12 10
Hypokalemia 13 9
Hypophosphatemia 11 9
Musculoskeletal, Connective Tissue and Bone Disorders
Back pain 12 6
Arthralgia 7 11
Nervous System Disorder
Insomnia 24 24
Tremor 12 14
Headache 13 11
Vascular Disorders
Hypertension 18 18
**The trial was not designed to support comparative claims for Myfortic for the adverse reactions reported in this table.

Table 3 summarizes the incidence of opportunistic infections in de novo transplant patients.

Table 3: Viral and Fungal Infections (%) Reported Over 0 to 12 Months

de novo Renal Trial
Myfortic 1.44 grams per day
(n = 213) (%)
mycophenolate mofetil (MMF) 2 grams per day
(n = 210) (%)
Any Cytomegalovirus 22 21
- Cytomegalovirus Disease 5 4
Herpes Simplex 8 6
Herpes Zoster 5 4
Any Fungal Infection 11 12
- Candida NOS 6 6
- Candida albicans 2 4

Lymphoma developed in 2 de novo patients (1%), (1 diagnosed 9 days after treatment initiation) and in 2 conversion patients (1%) receiving Myfortic with other immunosuppressive agents in the 12-month controlled clinical trials.

Nonmelanoma skin carcinoma occurred in 1% de novo and 12% conversion patients. Other types of malignancy occurred in 1% de novo and 1% conversion patients [see WARNINGS AND PRECAUTIONS].

The adverse reactions reported in less than 10% of de novo or conversion patients treated with Myfortic in combination with cyclosporine and corticosteroids are listed in Table 4.

Table 4: Adverse Reactions Reported in < 10% of Patients Treated with Myfortic in Combination With Cyclosporine* and Corticosteroids

Blood and Lymphatic Disorders Lymphocele, thrombocytopenia
Cardiac Disorder Tachycardia
Eye Disorder Vision blurred
Gastrointestinal Disorders Abdominal pain, abdominal distension, gastroesophageal reflux disease, gingival hyperplasia
General Disorders and Administration-Site Conditions Fatigue, peripheral edema
Infections and Infestations Nasopharyngitis, herpes simplex, upper respiratory infection, oral candidiasis, herpes zoster, sinusitis, influenza, wound infection, implant infection, pneumonia, sepsis
Investigations Hemoglobin decrease, liver function tests abnormal
Metabolism and Nutrition Disorders Hypercholesterolemia, hyperkalemia, hypomagnesemia, diabetes mellitus, hyperglycemia
Musculoskeletal and Connective Tissue Disorders Arthralgia, pain in limb, peripheral swelling, muscle cramps, myalgia
Nervous System Disorders Dizziness (excluding vertigo)
Psychiatric Disorders Anxiety
Renal and Urinary Disorders Renal tubular necrosis, renal impairment, hematuria, urinary retention
Respiratory, Thoracic and Mediastinal Disorders Cough, dyspnea, dyspnea exertional
Skin and Subcutaneous Tissue Disorders Acne, pruritus, rash
Vascular Disorders Hypertension aggravated, hypotension
*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: Intestinal perforation, gastrointestinal hemorrhage, gastric ulcers, duodenal ulcers [see WARNINGS AND PRECAUTIONS], colitis (including CMV colitis), pancreatitis, esophagitis, and ileus.

Infections: Serious life-threatening infections, such as meningitis and infectious endocarditis, tuberculosis, and atypical mycobacterial infection [see WARNINGS AND PRECAUTIONS].

Respiratory: Interstitial lung disorders, including fatal pulmonary fibrosis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Myfortic or other MPA derivatives. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

  • Congenital malformations, including ear, facial, cardiac and nervous system malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to MMF during pregnancy [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
  • Infections [see WARNINGS AND PRECAUTIONS]
    • Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal.
    • Polyomavirus associated nephropathy (PVAN), especially due to BK virus infection, associated with serious outcomes, including deteriorating renal function and renal graft loss.
    • Viral reactivation in patients infected with HBV or HCV.
  • Cases of pure red cell aplasia (PRCA) have been reported in patients treated with MPA derivatives in combination with other immunosuppressive agents [see WARNINGS AND PRECAUTIONS].

The following additional adverse reactions have been identified during post-approval use of Myfortic: agranulocytosis, asthenia, osteomyelitis, lymphadenopathy, lymphopenia, wheezing, dry mouth, gastritis, peritonitis, anorexia, alopecia, pulmonary edema, Kaposi's sarcoma, de novo purine synthesis inhibitors-associated acute inflammatory syndrome.

DRUG INTERACTIONS

Antacids With Magnesium And Aluminum Hydroxides

Concomitant use of Myfortic and antacids decreased plasma concentrations of mycophenolic acid (MPA). It is recommended that Myfortic and antacids not be administered simultaneously [see CLINICAL PHARMACOLOGY].

Azathioprine

Given that azathioprine and MMF inhibit purine metabolism, it is recommended that Myfortic not be administered concomitantly with azathioprine or MMF.

Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal And Other Drugs That Interfere With Enterohepatic Recirculation

Drugs that interrupt enterohepatic recirculation may decrease MPA plasma concentrations when coadministered with MMF. Therefore, do not administer Myfortic with cholestyramine or other agents that may interfere with enterohepatic recirculation or drugs that may bind bile acids, e.g., bile acid sequestrates or oral activated charcoal, because of the potential to reduce the efficacy of Myfortic [see CLINICAL PHARMACOLOGY].

Sevelamer

Concomitant administration of sevelamer and MMF may decrease MPA plasma concentrations. Sevelamer and other calcium-free phosphate binders should not be administered simultaneously with Myfortic [see CLINICAL PHARMACOLOGY].

Cyclosporine

Cyclosporine inhibits the enterohepatic recirculation of MPA, and therefore, MPA plasma concentrations may be decreased when Myfortic is coadministered with cyclosporine. Clinicians should be aware that there is also a potential change of MPA plasma concentrations after switching from cyclosporine to other immunosuppressive drugs or from other immunosuppressive drugs to cyclosporine in patients concomitantly receiving Myfortic [see CLINICAL PHARMACOLOGY].

Norfloxacin And Metronidazole

MPA plasma concentrations may be decreased when MMF is administrated with norfloxacin and metronidazole. Therefore, Myfortic is not recommended to be given with the combination of norfloxacin and metronidazole. Although there will be no effect on MPA plasma concentrations when Myfortic is concomitantly administered with norfloxacin or metronidazole when given separately [see CLINICAL PHARMACOLOGY].

Rifampin

The concomitant administration of MMF and rifampin may decrease MPA plasma concentrations. Therefore, Myfortic is not recommended to be given with rifampin concomitantly unless the benefit outweighs the risk [see CLINICAL PHARMACOLOGY].

Hormonal Contraceptives

In a drug interaction study, mean levonorgestrel AUC was decreased by 15% when coadministered with MMF. Although Myfortic may not have any influence on the ovulation-suppressing action of oral contraceptives, additional barrier contraceptive methods must be used when Myfortic is coadministered with hormonal contraceptives (e.g., birth control pill, transdermal patch, vaginal ring, injection, and implant) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, CLINICAL PHARMACOLOGY].

Acyclovir (Valacyclovir), Ganciclovir (Valganciclovir), And Other Drugs That Undergo Renal Tubular Secretion

The coadministration of MMF and acyclovir or ganciclovir may increase plasma concentrations of mycophenolic acid glucuronide (MPAG) and acyclovir/valacyclovir/ganciclovir/valganciclovir as their coexistence competes for tubular secretion. Both acyclovir/valacyclovir/ganciclovir/valganciclovir and MPAG concentrations will be also increased in the presence of renal impairment.

Acyclovir/valacyclovir/ganciclovir/valganciclovir may be taken with Myfortic; however, during the period of treatment, physicians should monitor blood cell counts [see CLINICAL PHARMACOLOGY].

Ciprofloxacin, Amoxicillin Plus Clavulanic Acid And Other Drugs That Alter The Gastrointestinal Flora

Drugs that alter the gastrointestinal flora, such as ciprofloxacin or amoxicillin plus clavulanic acid may interact with MMF by disrupting enterohepatic recirculation. Interference of MPAG hydrolysis may lead to less MPA available for absorption when Myfortic is concomitantly administered with ciprofloxacin or amoxicillin plus clavulanic acid. The clinical relevance of this interaction is unclear; however, no dose adjustment of Myfortic is needed when coadministered with these drugs [see CLINICAL PHARMACOLOGY].

Pantoprazole

Administration of pantoprazole at a dose of 40 mg twice daily for 4 days to healthy volunteers did not alter the pharmacokinetics of a single dose of Myfortic [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Myfortic (Mycophenolic Acid)

© Myfortic Patient Information is supplied by Cerner Multum, Inc. and Myfortic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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