SCOPOLAMINE

Generic: SCOPOLAMINE

Mylan Pharmaceuticals Inc.Manufacturer
TRANSDERMALRoute
SCOPOLAMINEActive Substance
2019-06-19Original Approval

SCOPOLAMINE is FDA application ANDA203753, sponsored by MYLAN TECHNOLOGIES. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2018-05-11
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46);

Defective delivery system

Top Reported Reactions

1
NAUSEA
412 reports
2
OFF LABEL USE
411 reports
3
VOMITING
290 reports
4
DRUG INEFFECTIVE
251 reports
5
PRODUCT ADHESION ISSUE
241 reports
6
HEADACHE
225 reports
7
DIZZINESS
219 reports
8
DEATH
203 reports
9
DIARRHOEA
194 reports
10
FATIGUE
189 reports