85/100 · Critical
Manufactured by Astellas Pharma US, Inc.
High Safety Concerns with Tacrolimus Extended-Release Capsules
181,869 FDA adverse event reports analyzed
Last updated: 2026-05-12
TACROLIMUS EXTENDED RELEASE CAPSULES is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. Based on analysis of 181,869 FDA adverse event reports, TACROLIMUS EXTENDED RELEASE CAPSULES 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 EXTENDED RELEASE CAPSULES include OFF LABEL USE, DRUG INEFFECTIVE, PRODUCT USE IN UNAPPROVED INDICATION, DRUG INTERACTION, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TACROLIMUS EXTENDED RELEASE CAPSULES.
Tacrolimus Extended-Release Capsules 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 181,869 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, Product Use In Unapproved Indication. Of classified reports, 90.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Acute kidney injury and renal impairment are among the most serious adverse events reported.
Drug interactions and ineffective drug performance are common issues. Infections, particularly cytomegalovirus and pneumonia, are frequent and serious.
Patients taking Tacrolimus Extended-Release Capsules should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tacrolimus can interact with various drugs, potentially leading to increased toxicity or reduced efficacy. Warnings are issued for specific drug combinations. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tacrolimus Extended-Release Capsules received a safety concern score of 85/100 (high concern). This is based on a 90.7% serious event ratio across 117,850 classified reports. The score accounts for 181,869 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: 57,391, Female: 43,746, Unknown: 605. The most frequently reported age groups are age 57 (2,140 reports), age 58 (2,101 reports), age 55 (2,052 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 117,850 classified reports for TACROLIMUS EXTENDED RELEASE CAPSULES:
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 interact with various drugs, potentially leading to increased toxicity or reduced efficacy. Warnings are issued for specific drug combinations.
If you are taking Tacrolimus Extended-Release Capsules, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, product use in unapproved indication, drug interaction, 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 kidney function regularly, especially in patients with pre-existing kidney conditions. Be cautious with drug interactions and inform healthcare providers of all medications being taken. 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.
The FDA closely monitors Tacrolimus Extended-Release Capsules due to high safety concerns, particularly for kidney function and infections.
The FDA has received approximately 181,869 adverse event reports associated with Tacrolimus Extended-Release Capsules. 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 Extended-Release Capsules include Off Label Use, Drug Ineffective, Product Use In Unapproved Indication, Drug Interaction, Acute Kidney Injury. By volume, the top reported reactions are: Off Label Use (11,734 reports), Drug Ineffective (8,329 reports), Product Use In Unapproved Indication (5,813 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 Extended-Release Capsules.
Out of 117,850 classified reports, 106,867 (90.7%) were classified as serious and 10,983 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 Extended-Release Capsules break down by patient sex as follows: Male: 57,391, Female: 43,746, Unknown: 605. 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 Extended-Release Capsules adverse events are: age 57: 2,140 reports, age 58: 2,101 reports, age 55: 2,052 reports, age 59: 2,050 reports, age 65: 2,035 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 Extended-Release Capsules 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 Extended-Release Capsules include: Diarrhoea, Transplant Rejection, Cytomegalovirus Infection, Pyrexia, Covid-19. 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 Extended-Release Capsules 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 Extended-Release Capsules 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. Acute kidney injury and renal impairment are among the most serious adverse events reported.
Key safety signals identified in Tacrolimus Extended-Release Capsules's adverse event data include: Acute kidney injury and renal impairment. Drug interactions and ineffectiveness. Frequent and serious infections. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tacrolimus can interact with various drugs, potentially leading to increased toxicity or reduced efficacy. Warnings are issued for specific drug combinations. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tacrolimus Extended-Release Capsules.
Monitor kidney function regularly, especially in patients with pre-existing kidney conditions. Be cautious with drug interactions and inform healthcare providers of all medications being taken.
Tacrolimus Extended-Release Capsules has 181,869 adverse event reports on file with the FDA. Drug interactions and ineffective drug performance are common issues. The volume of reports for Tacrolimus Extended-Release Capsules reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Tacrolimus Extended-Release Capsules due to high safety concerns, particularly for kidney function and infections. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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