ASENAPINE
Generic: ASENAPINE
Alembic Pharmaceuticals LimitedManufacturer
SUBLINGUALRoute
ASENAPINEActive Substance
2020-12-10Original Approval
ASENAPINE is FDA application ANDA206098, sponsored by ALEMBIC. 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 III2021-04-19
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavori
Class III2021-04-19
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavori
Top Reported Reactions
1
DRUG INEFFECTIVE
222 reports
2
TOXICITY TO VARIOUS AGENTS
160 reports
3
OFF LABEL USE
132 reports
4
SUICIDE ATTEMPT
115 reports
5
WEIGHT INCREASED
112 reports
6
AKATHISIA
101 reports
7
DRUG INTERACTION
98 reports
8
PRODUCT USE IN UNAPPROVED INDICATION
89 reports
9
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
85 reports
10
COMPLETED SUICIDE
80 reports