TACROLIMUS EXTENDED RELEASE CAPSULES and OFF LABEL USE

Overview

OFF LABEL USE is the #1 most commonly reported adverse reaction for TACROLIMUS EXTENDED RELEASE CAPSULES, manufactured by Astellas Pharma US, Inc.. There are 11,734 FDA adverse event reports linking TACROLIMUS EXTENDED RELEASE CAPSULES to OFF LABEL USE. This represents approximately 6.5% of all 181,869 adverse event reports for this drug.

TACROLIMUS EXTENDED RELEASE CAPSULES has an overall safety score of 92 out of 100. Patients taking TACROLIMUS EXTENDED RELEASE CAPSULES who experience off label use should discuss this symptom with their healthcare provider to determine whether it may be related to their medication and what alternatives may be available.

Reporting Frequency

OFF LABEL USE11,734 of 181,869 reports

OFF LABEL USE is moderately reported among TACROLIMUS EXTENDED RELEASE CAPSULES users, representing a notable but not dominant share of adverse events.

Other Side Effects of TACROLIMUS EXTENDED RELEASE CAPSULES

In addition to off label use, the following adverse reactions have been reported for TACROLIMUS EXTENDED RELEASE CAPSULES:

DRUG INEFFECTIVE — 8,329 reports
PRODUCT USE IN UNAPPROVED INDICATION — 5,813 reports
DRUG INTERACTION — 5,363 reports
ACUTE KIDNEY INJURY — 5,057 reports
DIARRHOEA — 4,324 reports
TRANSPLANT REJECTION — 3,983 reports
CYTOMEGALOVIRUS INFECTION — 3,844 reports
PYREXIA — 3,690 reports
COVID 19 — 3,632 reports
TOXICITY TO VARIOUS AGENTS — 3,493 reports

Other Drugs Associated with OFF LABEL USE

The following drugs have also been linked to off label use in FDA adverse event reports:

0XYGEN ABACAVIR SULFATE ABATACEPT ABIRATERONE ACETATE ACALABRUTINIB ACETAMINOPHEN ACETAMINOPHEN 500MG ACETAMINOPHEN AND CODEINE ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, ASPIRIN, AND CAFFEINE ACETAMINOPHEN, ASPIRIN, CAFFEINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE ACETAMINOPHEN, CAFFEINE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE ACETAMINOPHEN, IBUPROFEN

Does TACROLIMUS EXTENDED RELEASE CAPSULES cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 11,734 FDA reports for TACROLIMUS EXTENDED RELEASE CAPSULES. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with TACROLIMUS EXTENDED RELEASE CAPSULES?

OFF LABEL USE accounts for approximately 6.5% of all adverse event reports for TACROLIMUS EXTENDED RELEASE CAPSULES, making it one of the most commonly reported side effect.

What should I do if I experience OFF LABEL USE while taking TACROLIMUS EXTENDED RELEASE CAPSULES?

If you experience off label use while taking TACROLIMUS EXTENDED RELEASE CAPSULES, contact your healthcare provider. They can evaluate whether the symptom is related to your medication and discuss potential adjustments to your treatment plan. Do not stop taking prescribed medication without consulting your doctor.