Summary

Commonly reported side effects of mycophenolate mofetil include: asthma, herpes simplex infection, infection, metabolic acidosis, oral candidiasis, pleural effusion, respiratory tract infection, systemic cytomegalovirus disease, urinary tract infection, viremia, abdominal pain, acne vulgaris, anemia, anxiety, asthenia, back pain, cardiovascular disorder, chest pain, constipation, cough, depression, diarrhea, disorder of integument, drowsiness, dyspepsia, dyspnea, edema, fever, headache, hypercholesterolemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypervolemia, hypokalemia, hypotension, increased lactate dehydrogenase, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum creatinine, leukopenia, lower limb cramp, myalgia, myasthenia, nausea, pain, paresthesia, peripheral edema, pulmonary disease, rhinitis, sinusitis, tachycardia, thrombocytopenia, tremor, vomiting, weight gain, chills, and flatulence. Other side effects include: malignant neoplasm of skin, dizziness, and insomnia. Continue reading for a comprehensive list of adverse effects.

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

• intravenous powder for solution

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

• 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
• bloody or cloudy urine
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or tightness
• confusion
• cough or hoarseness
• decreased urine
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty in moving
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• fever or chills
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• headache
• heartburn
• increased hunger
• increased thirst
• increased urination
• irregular heartbeats
• irregular pulse
• irritability
• lightheadedness
• loss of appetite
• loss of strength or energy
• lower back or side pain
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain, stiffness, cramps, or weakness
• muscle spasms (tetany) or twitching
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain in the joints
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid weight gain
• rapid, shallow breathing
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps, pain, and bloating
• sweating
• swollen glands
• tingling of the hands or feet
• trembling
• tremor
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs

Incidence not known

• Back pain
• bloody, black, tarry stools
• constipation
• coughing or spitting up blood
• darkened urine
• general feeling of illness
• indigestion
• night sweats
• pain
• pains in the stomach, side, or abdomen, possibly radiating to the back
• severe headache
• sudden high fever or low-grade fever for months
• tenderness
• watery or bloody diarrhea
• yellow eyes or skin

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

• Acid or sour stomach
• belching
• fear
• heartburn
• lack or loss of strength
• rash
• trouble sleeping
• weight loss

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]