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Tacrolimus lowers the body's ability to fight an infection/disease (immunosuppression). This effect may increase your risk of developing an infection or certain types of cancer (such as skin cancer, lymphoma). To reduce the risk of these serious side effects, take this medication at the lowest effective dose as directed by your doctor. Keep all medical and lab appointments. Tell your doctor right away if you develop any of the following: unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen glands, night sweats, unexplained weight loss, signs of infection (such as sore throat that doesn't go away, fever). This medication may increase the risk of death when it is used by women to prevent organ rejection after a liver transplant. Discuss the risks and benefits of this medication with the doctor.

Shaking, headache, diarrhea, nausea/vomiting, upset stomach, and trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), mental/mood changes, hearing problems (such as hearing loss, ringing in the ears), numbness/tingling of the hands/feet, dizziness, pain/redness/swelling of arms or legs, easy bruising/bleeding, signs of liver problems (such as nausea/vomiting that doesn't stop, yellowing eyes/skin, dark urine, stomach/abdominal pain), muscle weakness, severe leg pain, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). This medication may also increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes. Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, severe dizziness, chest/jaw/left arm pain, black stools, vomit that looks like coffee grounds. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication. Tacrolimus may cause diabetes. Tell your doctor or pharmacist if you experience symptoms of high blood sugar such as increased thirst/hunger, frequent urination. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Some products that may interact with this drug include: aluminum/magnesium antacid, cyclosporine, sirolimus, temsirolimus, ziprasidone, other drugs that may increase the level of potassium in the blood (such as "water pills" including amiloride, spironolactone), other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab). Avoid alcohol when using this medication because it may cause the medication to be released too quickly and increase the risk of side effects. Other medications can affect the removal of tacrolimus from your body, which may affect how tacrolimus works. Examples include azole antifungals (such as itraconazole, voriconazole), cimetidine, danazol, ethinyl estradiol, methylprednisolone, nefazodone, HIV protease inhibitors (such as nelfinavir), rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, certain anti-seizure drugs (such as phenobarbital, phenytoin), among others.