Contraindications and precautions
Contraindications and precautions include:
Hepatic disease
Immunosuppression
Infants
Infection
Neoplastic disease, such as:
Skin cancer
Lung cancer
Oliguria
Pregnancy
QT interval prolongation
Sunlight (UV) exposure
Grapefruit juice

Topical use
Occlusive dressing
Known or suspected malignant lesions
Nethertons syndrome or similar skin diseases
Certain skin infections

Side effects
By mouth or intravenous use
Side effects can be severe and include infection, cardiac damage, hypertension, blurred vision, liver and kidney problems (tacrolimus nephrotoxicity), hyperkalemia, hypomagnesemia, hyperglycemia, diabetes mellitus, itching, lung damage (sirolimus also causes lung damage), and various neuropsychiatric problems such as loss of appetite, insomnia, posterior reversible encephalopathy syndrome, confusion, weakness, depression, vivid nightmares, cramps, neuropathy, seizures, tremors, and catatonia.In addition, it may potentially increase the severity of existing fungal or infectious conditions such as herpes zoster or polyoma viral infections. Carcinogenesis and mutagenesis
In people receiving immunosuppressants to reduce transplant graft rejection, an increased risk of malignancy (cancer) is a recognised complication. The most common cancers are non-Hodgkins lymphoma and skin cancers. The risk appears to be related to the intensity and duration of treatment. Topical use
The most common adverse events associated with the use of topical tacrolimus ointments, especially if used over a wide area, include a burning or itching sensation on the initial applications, with increased sensitivity to sunlight and heat on the affected areas. Less common are flu-like symptoms, headache, cough, and burning eyes. Cancer risks
Tacrolimus and a related drug for eczema (pimecrolimus) were suspected of carrying a cancer risk, though the matter is still a subject of controversy. The FDA issued a health warning in March 2005 for the drug, based on animal models and a small number of patients.
"Comparative efficacy of 20 graft-versus-host disease prophylaxis therapies for patients after hematopoietic stem-cell transplantation: A multiple-treatments network meta-analysis". Crit. Rev. Oncol. Hematol. 150: 102944. doi:10.1016/j.critrevonc.2020.102944. PMID 32247246. S2CID 214794350. External links
"Tacrolimus". Drug Information Portal. U.S. National Library of Medicine. "Tacrolimus Injection". MedlinePlus. "Tacrolimus Topical". MedlinePlus. Tacrolimus at the US National Library of Medicine Medical Subject Headings (MeSH)
"FDA Approves New Use of Transplant Drug Based on Real-World Evidence". U.S. Food and Drug Administration (FDA). 30 September 2021.