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 tablet enteric coated
Along with its needed effects, mycophenolic acid (the active ingredient contained in Myfortic) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking mycophenolic acid:More common
- Abdominal or stomach pain or cramps
- black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision
- body aches or pain
- bone pain
- burning or stinging of the skin
- chest pain
- cloudy urine
- decrease in the amount of urine
- decreased frequency or amount of urine
- difficult, burning, or painful urination
- dizziness or lightheadedness
- dry mouth
- ear congestion
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- incoherent speech
- increase in heart rate
- increased blood pressure
- increased hunger
- increased thirst
- increased urination
- joint pain, stiffness, or swelling
- loss of appetite
- loss of consciousness
- loss of voice
- lower back, side, or stomach pain
- metallic taste
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms or twitching
- muscle weakness
- nausea or vomiting
- noisy, rattling breathing
- numbness and tingling around the mouth, fingertips, hands, or feet
- painful blisters on the trunk of the body
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pale skin
- pinpoint red spots on the skin
- rapid breathing
- red, tender, or oozing skin at incision
- runny nose
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sunken eyes
- swollen glands
- tightness in the chest
- troubled breathing at rest
- trouble breathing at rest or with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- weakness or heaviness of the legs
Some side effects of mycophenolic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- back pain
- bleeding gums
- blemishes on the skin
- difficulty moving
- excess air or gas in the stomach or intestines
- facial hair growth in females
- full feeling
- full or round face, neck, or trunk
- increased hair growth, especially on the face
- increased thirst or urination
- irritation in the mouth
- itching skin
- loose stools
- loss of sexual desire or ability
- menstrual irregularities
- muscle pains or stiffness
- pain or tenderness around the eyes and cheekbones
- passing gas
- redness and swelling of the gums
- shakiness in the legs, arms, hands, or feet
- sore mouth or tongue
- stomach discomfort or upset
- trouble sleeping
- upper abdominal or stomach pain
- white patches in the mouth or on the tongue
For Healthcare Professionals
Applies to mycophenolic acid: oral delayed release tablet
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 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 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 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 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 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 side effects including cushingoid and hirsutism have been reported in de novo patients.
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 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 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 side effects including anxiety have been reported in de novo patients. Depression has been reported in maintenance patients.
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 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 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 side effects including blurred vision have been reported in de novo patients.
Hepatic side effects including abnormal liver function tests have been reported. A case of mycophenolate sodium-induced hepatotoxicity has been reported.
Dermatologic side effects including acne and pruritus have been reported in de novo patients. Rash and contusion have been reported in maintenance patients.
More about Myfortic (mycophenolic acid)
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