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Mycophenolate mofetil Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 24, 2023.

Applies to mycophenolate mofetil: oral capsule, oral powder for suspension, oral tablet. Other dosage forms:

Warning

Oral route (Capsule; Tablet; Powder for Suspension)

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 immediately if any of the following side effects occur while taking mycophenolate mofetil:

More common

Incidence not known

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

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]

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.