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Myfortic

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Myfortic

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

SIDE EFFECTS: See also Warnings section.

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

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
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 < 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 mycophenolic acid (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 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 postapproval use of Myfortic: agranulocytosis, asthenia, osteomyelitis, lymphadenopathy, lymphopenia, wheezing, dry mouth, gastritis, peritonitis, anorexia, alopecia, pulmonary edema, Kaposi's sarcoma.

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

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Myfortic - User Reviews

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