Myfortic Side Effects

Generic name: mycophenolic acid

Note: This document contains side effect information about mycophenolic acid. Some of the dosage forms listed on this page may not apply to the brand name Myfortic.

Some side effects of Myfortic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to mycophenolic acid: oral delayed release tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking mycophenolic acid (the active ingredient contained in Myfortic) 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 of mycophenolic acid 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.

For Healthcare Professionals

Applies to mycophenolic acid: oral delayed release tablet

Hematologic

Pure red cell aplasia (PRCA) is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of mycophenolic acid (the active ingredient contained in Myfortic) therapy.

Hematologic side effects including anemia (21.6% de novo), leukopenia (19.2% de novo), neutropenia, and pure red cell aplasia (PRCA) have been reported. Lymphocele, thrombocytopenia, increased blood creatinine and decreased hemoglobin have been reported in de novo patients. Leukopenia, anemia, and increased blood creatinine have been reported in maintenance patients.

Gastrointestinal

Gastrointestinal side effects including constipation (38.0% de novo), nausea (29.1% de novo and 24.5% maintenance), diarrhea (23.5% de novo and 21.4% maintenance), vomiting (23.0% de novo), and dyspepsia (22.5%de novo) have been reported. Upper, lower, and general abdominal pain, flatulence, abdominal distension, sore throat, gingival hyperplasia, and loose stool have been reported in de novo patients. Vomiting, dyspepsia, general and upper abdominal pain, constipation, gastroesophageal reflux disease, and loose stool have been reported in maintenance patients.

Immunologic

Immunologic side effects manifesting as infection have been reported. Infections have included urinary tract infection (29.1% de novo) and CMV infection (20.2% de novo). Viral and fungal infections reported have included any cytomegalovirus (21.6% de novo and 1.9% maintenance), cytomegalovirus disease (4.7% de novo), herpes simplex (8.0% de novo and 1.3% maintenance), herpes zoster (4.7% de novo and 1.9% maintenance), polyomavirus infections, any fungal infection (10.8% de novo and 2.5% maintenance), Candida NOS (5.6% de novo), and Candida albicans (2.3% de novo and 0.6% maintenance). Aspergillus and Cryptococcus have been reported rarely. Nasopharyngitis, upper respiratory tract infection, oral candidiasis, sinusitis, wound infection, implant infection, and pneumonia have been reported in de novo patients. Nasopharyngitis, upper respiratory tract infection, urinary tract infection, influenza, and sinusitis have been reported in maintenance patients.

Nervous system

Nervous system side effects including insomnia (23.5%), tremor, headache, and dizziness (excluding vertigo) have been reported in de novo patients. Headache, dizziness, insomnia, and progressive multifocal leukoencephalopathy have also been reported in maintenance patients.

General

General side effects including postoperative pain (23.9%), edema, lower limb edema, peripheral edema, pyrexia, pain, fatigue, and chest pain have been reported in de novo patients, Fatigue, pyrexia, edema, increased weight, peripheral edema, and chest pain have been reported in maintenance patients

Oncologic

Oncologic side effects including lymphoma (0.9% de novo and 1.3% maintenance). Non-melanoma skin carcinoma (0.9% de novo and 1.8% maintenance) has also been reported. Other (0.5% de novo and 0.6% maintenance) malignancies have also been reported.

Endocrine

Endocrine side effects including cushingoid and hirsutism have been reported in de novo patients.

Other

Other side effects including drug toxicity, complications of transplant surgery, postoperative complications, and postoperative wound complications have been reported in de novo patients. Post procedural pain has been reported in maintenance patients. Postmarketing reports of congenital malformations and an increased incidence of first trimester pregnancy loss have been reported following exposure to mycophenolate mofetil.

Metabolic

Metabolic side effects including hypocalcemia, hyperuricemia, hyperlipidemia, hypokalemia, hypophosphatemia, hypercholesterolemia, hyperkalemia, hypomagnesemia, diabetes mellitus, hyperphosphatemia, dehydration, fluid overload, hyperglycemia, and hypercalcemia have been reported in de novo patients. Dehydration, hypokalemia, and hypercholesterolemia have been reported in maintenance patients.

Musculoskeletal

Musculoskeletal side effects including back pain, arthralgia, limb pain, muscle cramps, and myalgia have been reported in de novo patients. Arthralgia, limb pain, back pain, muscle cramps, peripheral swelling, and myalgia have been reported in maintenance patients.

Psychiatric

Psychiatric side effects including anxiety have been reported in de novo patients. Depression has been reported in maintenance patients.

Genitourinary

Genitourinary side effects including renal tubular necrosis, renal impairment, dysuria, hematuria, hydronephrosis, bladder spasm, and urinary retention have been reported in de novo patients.

Cardiovascular

Cardiovascular side effects including tachycardia, hypertension, aggravated hypertension, and hypotension have been reported in de novo patients. Hypertension has also been reported in maintenance patients.

Respiratory

Respiratory side effects including cough, dyspnea, and exertional dyspnea have been reported in de novo patients. Cough dyspnea, pharyngolaryngeal pain, and sinus congestion have been reported in maintenance patients.

Ocular

Ocular side effects including blurred vision have been reported in de novo patients.

Hepatic

Hepatic side effects including abnormal liver function tests have been reported. A case of mycophenolate sodium-induced hepatotoxicity has been reported.

Dermatologic

Dermatologic side effects including acne and pruritus have been reported in de novo patients. Rash and contusion have been reported in maintenance patients.

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