FLUOCINOLONE ACETONIDE and OFF LABEL USE

Overview

OFF LABEL USE is the #1 most commonly reported adverse reaction for FLUOCINOLONE ACETONIDE, manufactured by ANI Pharmaceuticals, Inc.. There are 584 FDA adverse event reports linking FLUOCINOLONE ACETONIDE to OFF LABEL USE. This represents approximately 9.0% of all 6,482 adverse event reports for this drug.

Patients taking FLUOCINOLONE ACETONIDE 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 USE584 of 6,482 reports

OFF LABEL USE is moderately reported among FLUOCINOLONE ACETONIDE users, representing a notable but not dominant share of adverse events.

Other Side Effects of FLUOCINOLONE ACETONIDE

In addition to off label use, the following adverse reactions have been reported for FLUOCINOLONE ACETONIDE:

DRUG INEFFECTIVE — 242 reports
PRURITUS — 202 reports
INTRAOCULAR PRESSURE INCREASED — 200 reports
PRODUCT DOSE OMISSION ISSUE — 200 reports
RASH — 157 reports
DEVICE DISLOCATION — 152 reports
DEVICE FAILURE — 150 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR — 141 reports
NO ADVERSE EVENT — 132 reports
DIARRHOEA — 129 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 FLUOCINOLONE ACETONIDE cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 584 FDA reports for FLUOCINOLONE ACETONIDE. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with FLUOCINOLONE ACETONIDE?

OFF LABEL USE accounts for approximately 9.0% of all adverse event reports for FLUOCINOLONE ACETONIDE, making it one of the most commonly reported side effect.

What should I do if I experience OFF LABEL USE while taking FLUOCINOLONE ACETONIDE?

If you experience off label use while taking FLUOCINOLONE ACETONIDE, 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.