PREDNISONE
Generic: PREDNISONE
Strides Pharma Science LimitedManufacturer
ORALRoute
PREDNISONEActive Substance
2020-09-02Original Approval
PREDNISONE is FDA application ANDA210785, sponsored by STRIDES 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 III2020-03-04
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Predni
Class III2013-06-14
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per cLabeling: Missing Label; missing label on blister card
Class II2016-10-03
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 077Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Class II2022-07-19
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 5621Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Top Reported Reactions
1
DRUG INEFFECTIVE
66,431 reports
2
OFF LABEL USE
55,472 reports
3
FATIGUE
40,819 reports
4
PAIN
37,879 reports
5
DYSPNOEA
34,949 reports
6
ARTHRALGIA
33,218 reports
7
CONDITION AGGRAVATED
28,620 reports
8
NAUSEA
28,565 reports
9
DIARRHOEA
28,441 reports
10
HEADACHE
26,617 reports