Mycophenolate mofetil Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 17, 2023.
Applies to mycophenolate mofetil: intravenous powder for solution. Other dosage forms:
Warning
Intravenous route (Powder for Solution)
Embryofetal Toxicity, Malignancies and Serious InfectionsUse during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning.Increased risk of development of lymphoma and other malignancies, particularly of the skin.Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes.
Serious side effects
Along with its needed effects, mycophenolate mofetil 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 or nurse immediately if any of the following side effects occur while taking mycophenolate mofetil:
More common
- Blood in the urine
- chest pain or discomfort
- cough or hoarseness
- difficulty in moving
- fever or chills
- increased cough
- loss of strength or energy
- lower back or side pain
- muscle pain, cramps, stiffness, or weakness
- pain in the joints
- painful or difficult urination
- swelling of the feet or lower legs
- trouble breathing
Less common
- Black, tarry stools
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at injection site
- bloody vomit
- enlarged gums
- irregular heartbeat
- joint pain
- pinpoint red spots on the skin
- red, inflamed, or bleeding gums
- sores inside the mouth
- stomach pain
- trembling or shaking of the hands or feet
- unusual bleeding or bruising
- white patches on the mouth, tongue, or throat
Incidence not known
- Back pain
- bloody, black, tarry stools
- blue lips, fingernails, or skin
- blurred vision
- chronic or occasional diarrhea
- clumsiness
- confusion
- coughing or spitting up blood
- difficulty speaking or understanding what others say
- dizziness
- drowsiness
- general feeling of illness or nausea
- headache
- heart murmur
- irregular, fast or slow, or shallow breathing
- loss of coordination
- memory loss
- night sweats
- seizures
- severe headache
- sore throat
- stiff neck or back
- stomach distention
- stools that float, are foul smelling, or "fatty"
- sudden high fever or low-grade fever for months
- unusual tiredness or weakness
- vision changes
- weakness in the legs
Other side effects
Some side effects of mycophenolate mofetil 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
- Constipation
- diarrhea
- heartburn
- nausea
- vomiting
- weakness
Less common
- Acne
- skin rash
- trouble sleeping
For Healthcare Professionals
Applies to mycophenolate mofetil: intravenous powder for injection, oral capsule, oral powder for reconstitution, oral tablet.
Gastrointestinal
Very common (10% or more): Diarrhea (36%), nausea (20%), vomiting (13%), abdominal pain
Common (1% to 10%): GI infection, gastroenteritis
Rare (less than 0.1%): Gingival hyperplasia, colitis including cytomegalovirus colitis, pancreatitis intestinal villous atrophy
Frequency not reported: Ischaemic colitis[Ref]
Hematologic
Very common (10% or more): Leukopenia (11% to 35%), anemia (35%)
Common (1% to 10%): Blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, thrombocytopenia, neutropenia
Very rare (less than 0.01%): Deep venous thrombosis
Postmarketing reports: Pure red cell aplasia (PRCA), abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, bone marrow failure, lymphocele[Ref]
Immunologic
Very common (10% or more): Sepsis (primarily cytomegalovirus viremia) (20%), gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster
Common (1% to 10%): Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis
Postmarketing reports: Hypogammaglobulinemia, hypersensitivity, and serious life-threatening infections including meningitis, endocarditis, tuberculosis, atypical mycobacterial infection[Ref]
Oncologic
Common (1% to 10%): Lymphoma, lymphoproliferative disease, non-melanoma skin carcinoma
Uncommon (0.1% to 1%): Post-transplant lymphoproliferative disease (pseudolymphoma)[Ref]
Renal
Very common (10% or more): Hematuria (13%), kidney tubular necrosis (up to 10%)
Common (1% to 10%): Renal impairment
Frequency not reported: BK virus-associated nephropathy[Ref]
Metabolic
Very common (10% or more): Edema (12% to 28%), hyperphosphatemia (13%), hypokalemia (10%), hyperglycaemia (10%)
Common (1% to 10%): Weight loss, hyperkalemia[Ref]
Respiratory
Very common (10% or more): Respiratory tract infection (23%), dyspnea (16%), increased cough (16%)
Common (1% to 10%): Pneumonia, respiratory moniliasis, bronchitis, pharyngitis, sinusitis, rhinitis, pleural effusion
Postmarketing reports: Bronchiectasis, interstitial lung disease, fatal pulmonary fibrosis[Ref]
Dermatologic
Common (1% to 10%): Fungal skin infection, skin hypertrophy, rash, acne, alopecia
Very rare (less than 0.01%): Dyshidrotic eczema, papulosquamous psoriatic-like skin eruption[Ref]
Other
Common (1% to 10%): Edema, pyrexia, chills, pain, malaise, asthenia
Frequency not reported: Congenital malformations, increased incidence of first trimester pregnancy loss[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia
Very rare (less than 0.01%): Myopathy[Ref]
Hepatic
Common (1% to 10%): Hepatitis, jaundice, hyperbilirubinemia, hepatic enzyme increased
Very rare (less than 0.01%): Sodium-induced hepatotoxicity[Ref]
Cardiovascular
Common (1% to 10%): Tachycardia, hypotension, hypertension, vasodilatation
Postmarketing reports: Endocarditis, venous thrombosis[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection (up to 45%), vaginal candidiasis[Ref]
Hypersensitivity
Postmarketing reports: Angioneurotic edema, anaphylactic reaction[Ref]
More about mycophenolate mofetil
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Patient resources
- Mycophenolate mofetil oral/injection drug information
- Mycophenolate (Intravenous) (Advanced Reading)
- Mycophenolate mofetil (Advanced Reading)
- Mycophenolate Mofetil Tablets
- Mycophenolate Mofetil Capsules
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Professional resources
- Mycophenolate monograph
- Mycophenolate (FDA)
- Mycophenolate Mofetil (FDA)
- Mycophenolate Mofetil Injection (FDA)
- Mycophenolate Suspension (FDA)
- Mycophenolate Tablets (FDA)
Other brands
Related treatment guides
References
1. Product Information. CellCept (mycophenolate mofetil). Roche Laboratories. 2001;PROD.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.