ROFLUMILAST
Generic: ROFLUMILAST
Ascend LaboratoriesManufacturer
ORALRoute
ROFLUMILASTActive Substance
2023-04-18Original Approval
ROFLUMILAST is FDA application ANDA212490, sponsored by ALKEM LABS LTD. 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.
Top Reported Reactions
1
DYSPNOEA
441 reports
2
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
240 reports
3
ASTHMA
205 reports
4
PNEUMONIA
205 reports
5
COUGH
184 reports
6
WHEEZING
167 reports
7
DIARRHOEA
163 reports
8
DRUG INEFFECTIVE
142 reports
9
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
140 reports
10
NAUSEA
138 reports