85/100 · Critical
Manufactured by Astellas Pharma US, Inc.
TACROLIMUS Adverse Events: High Seriousness and Diverse Reactions
222,557 FDA adverse event reports analyzed
Last updated: 2026-05-12
TACROLIMUS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. Based on analysis of 222,557 FDA adverse event reports, TACROLIMUS has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TACROLIMUS include OFF LABEL USE, DRUG INEFFECTIVE, DRUG INTERACTION, PRODUCT USE IN UNAPPROVED INDICATION, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TACROLIMUS.
Tacrolimus has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 222,557 adverse event reports for this medication, which is primarily manufactured by Astellas Pharma Us, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Drug Interaction. Of classified reports, 90.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (90.1%)
Diverse range of reactions including kidney injury, infections, and transplant rejection Significant report volume with over 220,000 total reports
Patients taking Tacrolimus should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. TACROLIMUS can cause drug interactions, and its use should be monitored for potential interactions with other immunosuppressants and agents affecting renal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tacrolimus received a safety concern score of 85/100 (high concern). This is based on a 90.1% serious event ratio across 148,832 classified reports. The score accounts for 222,557 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 72,676, Female: 57,099, Unknown: 845. The most frequently reported age groups are age 59 (2,622 reports), age 58 (2,606 reports), age 57 (2,602 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 148,832 classified reports for TACROLIMUS:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
TACROLIMUS can cause drug interactions, and its use should be monitored for potential interactions with other immunosuppressants and agents affecting renal function.
If you are taking Tacrolimus, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, drug interaction, product use in unapproved indication, acute kidney injury. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of infection and kidney function regularly, especially in transplant patients. Be aware of the risk of graft-versus-host disease and adjust dosing as necessary. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings for serious adverse events.
The FDA has received approximately 222,557 adverse event reports associated with Tacrolimus. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Tacrolimus include Off Label Use, Drug Ineffective, Drug Interaction, Product Use In Unapproved Indication, Acute Kidney Injury. By volume, the top reported reactions are: Off Label Use (14,225 reports), Drug Ineffective (9,831 reports), Drug Interaction (6,223 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tacrolimus.
Out of 148,832 classified reports, 134,093 (90.1%) were classified as serious and 14,739 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Tacrolimus break down by patient sex as follows: Male: 72,676, Female: 57,099, Unknown: 845. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Tacrolimus adverse events are: age 59: 2,622 reports, age 58: 2,606 reports, age 57: 2,602 reports, age 60: 2,588 reports, age 63: 2,551 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Tacrolimus adverse event reports is Astellas Pharma Us, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Tacrolimus include: Diarrhoea, Transplant Rejection, Death, Pyrexia, Cytomegalovirus Infection. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Tacrolimus to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Tacrolimus has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (90.1%)
Key safety signals identified in Tacrolimus's adverse event data include: Acute kidney injury and renal impairment are common. Multiple severe infections, including pneumonia and cytomegalovirus infection. High incidence of transplant rejection and graft-versus-host disease. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
TACROLIMUS can cause drug interactions, and its use should be monitored for potential interactions with other immunosuppressants and agents affecting renal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tacrolimus.
Monitor for signs of infection and kidney function regularly, especially in transplant patients. Be aware of the risk of graft-versus-host disease and adjust dosing as necessary.
Tacrolimus has 222,557 adverse event reports on file with the FDA. Diverse range of reactions including kidney injury, infections, and transplant rejection The volume of reports for Tacrolimus reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings for serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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