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Myfortic Side Effects

Generic Name: mycophenolic acid

Note: This document contains side effect information about mycophenolic acid. Some of the dosage forms listed on this page may not apply to the brand name Myfortic.

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mycophenolic acid: oral tablet enteric coated

Along with its needed effects, mycophenolic acid (the active ingredient contained in Myfortic) 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 mycophenolic acid:

More Common

  • Abdominal or stomach pain or cramps
  • 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
  • blurred vision
  • body aches or pain
  • bone pain
  • burning or stinging of the skin
  • chest pain
  • cloudy urine
  • confusion
  • constipation
  • convulsions
  • cough
  • decrease in the amount of urine
  • decreased frequency or amount of urine
  • depression
  • difficult, burning, or painful urination
  • dizziness or lightheadedness
  • drowsiness
  • dry mouth
  • ear congestion
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever or chills
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • incoherent speech
  • increase in heart rate
  • increased blood pressure
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain, stiffness, or swelling
  • loss of appetite
  • loss of consciousness
  • loss of voice
  • lower back, side, or stomach pain
  • metallic taste
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle spasms or twitching
  • muscle weakness
  • nausea or vomiting
  • nervousness
  • noisy, rattling breathing
  • numbness and tingling around the mouth, fingertips, hands, or feet
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pale skin
  • pinpoint red spots on the skin
  • rapid breathing
  • red, tender, or oozing skin at incision
  • runny nose
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sunken eyes
  • sweating
  • swelling
  • swollen glands
  • thirst
  • tightness in the chest
  • tremor
  • trouble breathing at rest or with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • weakness or heaviness of the legs

Some side effects of mycophenolic acid 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
  • anxiety
  • back pain
  • belching
  • bleeding gums
  • blemishes on the skin
  • bruising
  • diarrhea
  • difficulty moving
  • excess air or gas in the stomach or intestines
  • facial hair growth in females
  • full feeling
  • full or round face, neck, or trunk
  • heartburn
  • increased hair growth, especially on the face
  • increased thirst or urination
  • indigestion
  • irritability
  • irritation in the mouth
  • itching skin
  • loose stools
  • loss of sexual desire or ability
  • menstrual irregularities
  • muscle pains or stiffness
  • pain
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • pimples
  • redness and swelling of the gums
  • shakiness in the legs, arms, hands, or feet
  • sleeplessness
  • sore mouth or tongue
  • stomach discomfort or upset
  • trouble sleeping
  • upper abdominal or stomach pain
  • white patches in the mouth or on the tongue

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, KaposiĀ“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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Mycophenolic Acid (mycophenolic acid)." Apotex Corporation, Weston, FL.

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.

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