ERENUMAB AOOE and OFF LABEL USE

Overview

OFF LABEL USE is the #11 most commonly reported adverse reaction for ERENUMAB AOOE, manufactured by Amgen Inc. There are 2,624 FDA adverse event reports linking ERENUMAB AOOE to OFF LABEL USE. This represents approximately 1.7% of all 151,566 adverse event reports for this drug.

Patients taking ERENUMAB AOOE 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 USE2,624 of 151,566 reports

OFF LABEL USE is a less commonly reported adverse event for ERENUMAB AOOE, but still significant enough to appear in the safety profile.

Other Side Effects of ERENUMAB AOOE

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

ACCIDENTAL EXPOSURE TO PRODUCT — 10,036 reports
DEVICE DIFFICULT TO USE — 9,770 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS — 9,454 reports
DRUG DOSE OMISSION BY DEVICE — 6,524 reports
MIGRAINE — 4,766 reports
DRUG INEFFECTIVE — 4,236 reports
HEADACHE — 3,200 reports
CONSTIPATION — 3,173 reports
PRODUCT STORAGE ERROR — 2,972 reports
INJECTION SITE PAIN — 2,821 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 ERENUMAB AOOE cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 2,624 FDA reports for ERENUMAB AOOE. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with ERENUMAB AOOE?

OFF LABEL USE accounts for approximately 1.7% of all adverse event reports for ERENUMAB AOOE, making it a notable side effect.

What should I do if I experience OFF LABEL USE while taking ERENUMAB AOOE?

If you experience off label use while taking ERENUMAB AOOE, 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.