SALAGEN

Generic: PILOCARPINE HYDROCHLORIDE

Advanz Pharma (US) Corp.Manufacturer
ORALRoute
PILOCARPINE HYDROCHLORIDEActive Substance
1994-03-22Original Approval

SALAGEN is FDA application NDA020237, sponsored by ADVANZ PHARMA. 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 III2017-03-22
Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratorie

Failed Impurities/Degradation Specifications.

Top Reported Reactions

1
DRUG INEFFECTIVE
127 reports
2
FATIGUE
92 reports
3
PAIN
91 reports
4
HEADACHE
90 reports
5
EYE PAIN
87 reports
6
DYSPNOEA
83 reports
7
DIARRHOEA
71 reports
8
DIZZINESS
71 reports
9
NAUSEA
71 reports
10
COUGH
67 reports