85/100 · Critical
Manufactured by Encube Ethicals, Inc.
Tacrolimus Ointment 0.1% Reports High Incidence of Serious Adverse Events
181,625 FDA adverse event reports analyzed
Last updated: 2026-05-12
TACROLIMUS OINTMENT 0.1% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Encube Ethicals, Inc.. Based on analysis of 181,625 FDA adverse event reports, TACROLIMUS OINTMENT 0.1% 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 OINTMENT 0.1% 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 OINTMENT 0.1%.
Tacrolimus Ointment 0.1% 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 181,625 adverse event reports for this medication, which is primarily manufactured by Encube Ethicals, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Product Use In Unapproved Indication. Of classified reports, 90.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (90.8%) indicates significant safety concerns.
Multiple reports of kidney and respiratory issues suggest potential organ toxicity. Drug ineffectiveness and product use issues are common, indicating potential misuse.
Patients taking Tacrolimus Ointment 0.1% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tacrolimus ointment can cause drug interactions, particularly with other immunosuppressants, leading to increased drug levels and potential toxicity. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tacrolimus Ointment 0.1% received a safety concern score of 85/100 (high concern). This is based on a 90.8% serious event ratio across 117,525 classified reports. The score accounts for 181,625 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: 57,238, Female: 43,605, Unknown: 602. The most frequently reported age groups are age 57 (2,136 reports), age 58 (2,094 reports), age 59 (2,046 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 117,525 classified reports for TACROLIMUS OINTMENT 0.1%:
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 ointment can cause drug interactions, particularly with other immunosuppressants, leading to increased drug levels and potential toxicity.
If you are taking Tacrolimus Ointment 0.1%, 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. Patients should strictly follow prescribed usage and dosage instructions. Healthcare providers should regularly monitor patients for signs of adverse reactions and adjust treatment 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 necessary due to the high number of serious adverse events, and healthcare providers should monitor patients closely for signs of organ toxicity and infection.
The FDA has received approximately 181,625 adverse event reports associated with Tacrolimus Ointment 0.1%. 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 Ointment 0.1% 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 (11,721 reports), Drug Ineffective (8,325 reports), Product Use In Unapproved Indication (5,811 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 Ointment 0.1%.
Out of 117,525 classified reports, 106,695 (90.8%) were classified as serious and 10,830 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 Ointment 0.1% break down by patient sex as follows: Male: 57,238, Female: 43,605, Unknown: 602. 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 Ointment 0.1% adverse events are: age 57: 2,136 reports, age 58: 2,094 reports, age 59: 2,046 reports, age 55: 2,043 reports, age 65: 2,032 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 Ointment 0.1% adverse event reports is Encube Ethicals, 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 Ointment 0.1% 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 Ointment 0.1% 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 Ointment 0.1% 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 (90.8%) indicates significant safety concerns.
Key safety signals identified in Tacrolimus Ointment 0.1%'s adverse event data include: Acute kidney injury and renal impairment are frequently reported.. Respiratory failure and pneumonia are significant concerns.. Drug ineffectiveness and product use in unapproved indications are common.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tacrolimus ointment can cause drug interactions, particularly with other immunosuppressants, leading to increased drug levels and potential toxicity. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tacrolimus Ointment 0.1%.
Patients should strictly follow prescribed usage and dosage instructions. Healthcare providers should regularly monitor patients for signs of adverse reactions and adjust treatment as necessary.
Tacrolimus Ointment 0.1% has 181,625 adverse event reports on file with the FDA. Multiple reports of kidney and respiratory issues suggest potential organ toxicity. The volume of reports for Tacrolimus Ointment 0.1% reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is necessary due to the high number of serious adverse events, and healthcare providers should monitor patients closely for signs of organ toxicity and infection. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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