RISEDRONATE SODIUM

Generic: RISEDRONATE SODIUM

Teva Pharmaceuticals USAManufacturer
ORALRoute
RISEDRONATE SODIUM MONOHYDRATEActive Substance
2007-10-05Original Approval

RISEDRONATE SODIUM is FDA application ANDA077132, sponsored by TEVA PHARMS USA. 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 III2022-03-10
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 0

FAILED CONTENT UNIFORMITY SPECIFICATIONS

Top Reported Reactions

1
PAIN
2,483 reports
2
DRUG INEFFECTIVE
2,482 reports
3
OFF LABEL USE
2,472 reports
4
DRUG HYPERSENSITIVITY
2,219 reports
5
VOMITING
2,189 reports
6
DYSPNOEA
2,171 reports
7
ARTHRALGIA
2,161 reports
8
PNEUMONIA
1,992 reports
9
FATIGUE
1,915 reports
10
RHEUMATOID ARTHRITIS
1,867 reports