PROPARACAINE HYDROCHLORIDE and OFF LABEL USE

Overview

OFF LABEL USE is the #1 most commonly reported adverse reaction for PROPARACAINE HYDROCHLORIDE, manufactured by Alcon Laboratories, Inc.. There are 89 FDA adverse event reports linking PROPARACAINE HYDROCHLORIDE to OFF LABEL USE. This represents approximately 5.8% of all 1,545 adverse event reports for this drug.

Patients taking PROPARACAINE HYDROCHLORIDE 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 USE89 of 1,545 reports

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

Other Side Effects of PROPARACAINE HYDROCHLORIDE

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

CONJUNCTIVAL HYPERAEMIA — 65 reports
EYE PAIN — 61 reports
DRUG ABUSE — 59 reports
CORNEAL OEDEMA — 54 reports
HYPOPYON — 52 reports
CORNEAL EPITHELIUM DEFECT — 42 reports
VISION BLURRED — 42 reports
ULCERATIVE KERATITIS — 36 reports
PHOTOPHOBIA — 33 reports
VISUAL ACUITY REDUCED — 33 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 PROPARACAINE HYDROCHLORIDE cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 89 FDA reports for PROPARACAINE HYDROCHLORIDE. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with PROPARACAINE HYDROCHLORIDE?

OFF LABEL USE accounts for approximately 5.8% of all adverse event reports for PROPARACAINE HYDROCHLORIDE, making it one of the most commonly reported side effect.

What should I do if I experience OFF LABEL USE while taking PROPARACAINE HYDROCHLORIDE?

If you experience off label use while taking PROPARACAINE HYDROCHLORIDE, 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.