ANAGRELIDE
Generic: ANAGRELIDE
Torrent Pharmaceuticals LimitedManufacturer
ORALRoute
ANAGRELIDE HYDROCHLORIDE ANHYDROUSActive Substance
2017-06-30Original Approval
ANAGRELIDE is FDA application ANDA209151, sponsored by TORRENT. 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 I2020-11-25
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ Failed Dissolution Specifications
Class II2019-09-06
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking RiFailed Impurities/Degradation Specifications: High Out Of Specification results for impurities detec
Top Reported Reactions
1
OFF LABEL USE
139 reports
2
FATIGUE
106 reports
3
PLATELET COUNT INCREASED
102 reports
4
HEADACHE
89 reports
5
HAEMOGLOBIN DECREASED
73 reports
6
ANAEMIA
68 reports
7
DIARRHOEA
68 reports
8
DRUG INEFFECTIVE
67 reports
9
DYSPNOEA
66 reports
10
DIZZINESS
61 reports