BOTULINUM TOXIN TYPE A and OFF LABEL USE

Overview

OFF LABEL USE is the #1 most commonly reported adverse reaction for BOTULINUM TOXIN TYPE A, manufactured by Galderma Laboratories, L.P.. There are 4,497 FDA adverse event reports linking BOTULINUM TOXIN TYPE A to OFF LABEL USE. This represents approximately 6.0% of all 74,480 adverse event reports for this drug.

Patients taking BOTULINUM TOXIN TYPE A 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 USE4,497 of 74,480 reports

OFF LABEL USE is moderately reported among BOTULINUM TOXIN TYPE A users, representing a notable but not dominant share of adverse events.

Other Side Effects of BOTULINUM TOXIN TYPE A

In addition to off label use, the following adverse reactions have been reported for BOTULINUM TOXIN TYPE A:

DRUG INEFFECTIVE — 3,495 reports
HEADACHE — 1,481 reports
DRUG INTOLERANCE — 1,228 reports
PRODUCT USE IN UNAPPROVED INDICATION — 1,168 reports
NAUSEA — 1,151 reports
MIGRAINE — 1,081 reports
PAIN — 1,060 reports
HYPOAESTHESIA — 999 reports
DIZZINESS — 990 reports
FATIGUE — 958 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 BOTULINUM TOXIN TYPE A cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 4,497 FDA reports for BOTULINUM TOXIN TYPE A. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is OFF LABEL USE with BOTULINUM TOXIN TYPE A?

OFF LABEL USE accounts for approximately 6.0% of all adverse event reports for BOTULINUM TOXIN TYPE A, making it one of the most commonly reported side effect.

What should I do if I experience OFF LABEL USE while taking BOTULINUM TOXIN TYPE A?

If you experience off label use while taking BOTULINUM TOXIN TYPE A, 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.