From the Guidelines
Mycophenolate is associated with several notable side effects, including gastrointestinal issues, blood disorders, and increased susceptibility to infections, as reported in the most recent study 1. The most common side effects of mycophenolate include:
- Gastrointestinal issues such as diarrhea, nausea, vomiting, and abdominal pain
- Blood disorders, including leukopenia, anemia, and thrombocytopenia, which necessitate regular blood count monitoring
- Increased susceptibility to infections, particularly viral infections like cytomegalovirus and BK virus, due to the medication's immunosuppressive effects Other side effects of mycophenolate include:
- Headache
- Hypertension
- Peripheral edema
- Rarely, progressive multifocal leukoencephalopathy It is essential to note that mycophenolate carries a black box warning regarding pregnancy, and effective contraception is crucial for women of childbearing age, as stated in the 2023 guideline 1. The side effects of mycophenolate occur because it inhibits inosine monophosphate dehydrogenase, an enzyme crucial for purine synthesis in rapidly dividing cells like lymphocytes and gastrointestinal epithelial cells. Patients should report unusual bleeding, signs of infection, or severe gastrointestinal symptoms to their healthcare provider immediately, as recommended in the guideline 1. The monitoring guidance for mycophenolate includes:
- CBC with differential and CMP at baseline, 2–3 weeks after starting and 2–3 weeks after any dose increase, and every 3 months once on a stable dose
- Full body skin examination, preferably by a dermatologist, annually This monitoring is essential to minimize the risk of adverse effects and ensure the safe use of mycophenolate, as emphasized in the study 1.
From the FDA Drug Label
Mycophenolate mofetil for injection may cause serious side effects, including: Low blood cell counts. Stomach problems. Inflammatory reactions. diarrhea changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) blood problems including low white and red blood cell counts stomach problems including diarrhea, constipation, nausea and vomiting infections rash blood pressure problems nervous system problems such as headache, dizziness and tremor fast heartbeat swelling of the lower legs, ankles and feet
The possible side effects of mycophenolate mofetil for injection include:
- Low blood cell counts: white blood cells, red blood cells, and platelets
- Stomach problems: intestinal bleeding, perforation, stomach ulcers, diarrhea, constipation, nausea, and vomiting
- Inflammatory reactions: fever, joint stiffness, joint pain, and muscle pain
- Infections
- Nervous system problems: headache, dizziness, tremor
- Blood pressure problems
- Rash
- Fast heartbeat
- Swelling of the lower legs, ankles, and feet 2
From the Research
Mycophenolate Side Effects
- Gastrointestinal adverse effects are a major concern with mycophenolate mofetil (MMF) use, including diarrhea, nausea, and vomiting 3
- The aetiology of the rarest gastrointestinal adverse effects is still not completely clear, but may be partially explained by the increased immune suppression, mode of action, and interactions with other immunosuppressants 3
- Severe gastrointestinal complications with MMF are rare, but when they do occur, they may require extensive diagnosis and treatment, including endoscopy and biopsy, and the search for opportunistic infections 3
Management of Side Effects
- Therapy depends upon the clinical gravity of the adverse effects and may involve adjusting the dosage of immunosuppressants, spreading the total dosage over more than 2 daily doses, or switching to enteric-coated mycophenolate sodium (EC-MPS) 3, 4
- Conversion to EC-MPS may be an effective option for patients experiencing gastrointestinal side effects, with two open-label studies showing a significant and clinically relevant benefit in GI-related symptom burden after conversion from MMF to EC-MPS 4
- Monitoring of gastrointestinal complications is essential following renal transplantation, and maintaining adequate mycophenolic acid exposure should be a priority when considering treatment options 4
Efficacy and Safety of EC-MPS
- EC-MPS was developed to reduce the upper-gastrointestinal effects of MMF, but has been shown to be similar to MMF in efficacy and safety, and did not significantly improve the GI side effects 5
- EC-MPS is a safe and effective immunosuppressive agent approved for use in the prevention of acute rejection after renal transplantation, but the anticipated improvement of GI side effects has not been forthcoming 5