LOXAPINE
Generic: LOXAPINE
Elite LaboratoriesManufacturer
ORALRoute
LOXAPINE SUCCINATEActive Substance
2005-08-04Original Approval
LOXAPINE is FDA application ANDA076868, sponsored by ELITE LABS INC. 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 III2012-04-17
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC #Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used wh
Class III2012-04-17
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx oLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used wh
Class III2012-04-17
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDCLabeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used wh
Top Reported Reactions
1
DRUG INEFFECTIVE
318 reports
2
COMA
262 reports
3
SOMNOLENCE
255 reports
4
TOXICITY TO VARIOUS AGENTS
231 reports
5
DRUG INTERACTION
213 reports
6
WEIGHT INCREASED
209 reports
7
POISONING DELIBERATE
206 reports
8
OFF LABEL USE
191 reports
9
SUICIDE ATTEMPT
177 reports
10
AKATHISIA
157 reports