DAPSONE
Generic: DAPSONE
Chartwell RXManufacturer
ORALRoute
DAPSONEActive Substance
2016-05-10Original Approval
DAPSONE is FDA application ANDA204074, sponsored by CHARTWELL RX. 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 II2024-10-29
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: VioCrystallization
Class II2024-12-10
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona PharmCrystallization
Class II2024-09-24
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: VioCrystallization
Class II2024-12-10
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona PharCrystallization
Top Reported Reactions
1
OFF LABEL USE
1,197 reports
2
DRUG INEFFECTIVE
1,010 reports
3
METHAEMOGLOBINAEMIA
477 reports
4
FATIGUE
457 reports
5
PYREXIA
457 reports
6
NAUSEA
453 reports
7
DIARRHOEA
400 reports
8
PNEUMONIA
383 reports
9
DYSPNOEA
368 reports
10
ANAEMIA
359 reports