Note: This document contains side effect information about mycophenolic acid. Some dosage forms listed on this page may not apply to the brand name Myfortic.
Summary
Common side effects of Myfortic include: cytomegalovirus disease, urinary tract infection, anemia, constipation, diarrhea, dyspepsia, insomnia, leukopenia, nausea, vomiting, and postoperative pain. Other side effects include: herpes simplex infection, and herpes zoster infection. Continue reading for a comprehensive list of adverse effects.
Applies to mycophenolic acid: oral tablet delayed release.
Warning
- Use of this drug during pregnancy may cause birth defects or death of the unborn baby. If you are able to become pregnant, you must use birth control that you can trust to prevent pregnancy while taking this drug. Your doctor must talk with you about how to avoid getting pregnant while taking this drug. A pregnancy test will be done right before starting this drug and repeated 8 to 10 days later to show that you are NOT pregnant. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away.
- This drug may raise the chance of getting cancer like lymphoma or skin cancer. Call your doctor right away if you have a change in color or size of a mole, a skin lump or growth, a big weight loss, night sweats, or swollen glands.
- You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
- Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
Serious side effects of Myfortic
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of skin infection like oozing, heat, swelling, redness, or pain.
- Chest pain or pressure.
- Fast or slow heartbeat.
- A heartbeat that does not feel normal.
- Feeling very tired or weak.
- Any unexplained bruising or bleeding.
- Throwing up blood or throw up that looks like coffee grounds.
- Black, tarry, or bloody stools.
- A burning, numbness, or tingling feeling that is not normal.
- Muscle cramps.
- Very bad belly pain.
- Swelling.
- Pale skin.
- White patches in mouth.
- Vaginal itching or discharge.
- Yellow skin or eyes.
- Some people have had lung problems with this drug. Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.
Other side effects of Myfortic
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Back pain.
- Constipation.
- Headache.
- Dizziness.
- Not hungry.
- Stomach pain or diarrhea.
- Gas.
- Feeling tired or weak.
- Shakiness.
- Upset stomach or throwing up.
- Trouble sleeping.
- Joint pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to mycophenolic acid: oral delayed release tablet.
Dermatologic
Common (1% to 10%): Acne, pruritus
Uncommon (0.1% to 1%): Alopecia[Ref]
Cardiovascular
Very common (10% or more): Hypertension
Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Tachycardia, ventricular extrasystoles, lymphocele[Ref]
Hematologic
Very common (10% or more): Leukopenia
Common (1% to 10%): Anemia, thrombocytopenia
Uncommon (0.1% to 1%): Lymphopenia, neutropenia, lymphadenopathy
Frequency not reported: Pancytopenia, pure red cell aplasia (PRCA), abnormal neutrophil morphology (including the acquired Pelger-Huet anomaly)[Ref]
Immunologic
Very common (10% or more): Infections (viral, bacterial, fungal)
Uncommon (0.1% to 1%): Wound infection, sepsis, osteomyelitis, influenza like illness
Frequency not reported: Hypogammaglobulinemia[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia
Common (1% to 10%): Myalgia
Uncommon (0.1% to 1%): Arthritis, back pain, muscle cramps[Ref]
Ocular
Uncommon (0.1% to 1%): Conjunctivitis, vision blurred[Ref]
Metabolic
Very common (10% or more): Hypocalcemia, hypokalemia, hyperuricemia
Common (1% to 10%): Hyperkalemia, hypomagnesemia
Uncommon (0.1% to 1%): Anorexia, hyperlipidemia, diabetes mellitus, hypercholesterolemia, hypophosphatemia, thirst[Ref]
Psychiatric
Very common (10% or more): Anxiety
Uncommon (0.1% to 1%): Abnormal dreams, delusional perception, insomnia[Ref]
Genitourinary
Uncommon (0.1% to 1%): Impotence[Ref]
Hepatic
Common (1% to 10%): Abnormal liver function tests[Ref]
Oncologic
Uncommon (0.1% to 1%): Skin papilloma, basal cell carcinoma, Kaposi´s sarcoma, lymphoproliferative disorder, squamous cell carcinoma[Ref]
Respiratory
Very common (10% or more): Cough, dyspnea, exertional dyspnea
Common (1% to 10%): Upper respiratory tract infection, pneumonia, cough, dyspnea
Uncommon (0.1% to 1%): Interstitial lung disease (including fatal pulmonary fibrosis), pulmonary congestion, wheezing, pulmonary edema[Ref]
Other
Common (1% to 10%): Asthenia, fatigue, peripheral edema, pyrexia
Uncommon (0.1% to 1%): Lower limb edema, pain, rigors, weakness, contusion
Frequency not reported: Congenital malformations, spontaneous abortion[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Tremor[Ref]
Renal
Common (1% to 10%): Blood creatinine increased
Uncommon (0.1% to 1%): Hematuria, renal tubular necrosis, urethral stricture[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea
Common (1% to 10%): Abdominal distension, abdominal pain, constipation, dyspepsia, flatulence, gastritis, nausea, vomiting
Uncommon (0.1% to 1%): Abdominal tenderness, GI hemorrhage, eructation, halitosis, ileus, lip ulceration, esophagitis, subileus, tongue discoloration, dry mouth, gastroesophageal reflux disease, gingival hyperplasia, pancreatitis, parotid duct obstruction, peptic ulcer, peritonitis
Frequency not reported: Colitis, CMV gastritis, intestinal perforation, gastric ulcers, duodenal ulcers[Ref]
