ALENDRONATE SODIUM

Generic: ALENDRONATE SODIUM

ANI PharmaceuticalsManufacturer
ORALRoute
ALENDRONATE SODIUMActive Substance
2023-05-11Original Approval

ALENDRONATE SODIUM is FDA application ANDA214512, sponsored by NOVITIUM 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 II2026-04-07
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu

This recall is being conducted due to out of specification assay results in a limited number of bott

Top Reported Reactions

1
PAIN
5,875 reports
2
FATIGUE
5,760 reports
3
DRUG INEFFECTIVE
5,561 reports
4
ARTHRALGIA
5,232 reports
5
RHEUMATOID ARTHRITIS
5,015 reports
6
RASH
4,654 reports
7
FEMUR FRACTURE
4,624 reports
8
ABDOMINAL DISCOMFORT
4,572 reports
9
ALOPECIA
4,545 reports
10
ARTHROPATHY
4,310 reports